Zofran Tablets 4mg

1. Name Of The Medicinal Product

Zofran Tablets 4mg

2. Qualitative And Quantitative Composition

Each Zofran Tablet 4mg is a yellow, oval, film coated tablet engraved "GLAXO" on one face and "4" on the other. Each tablet contains ondansetron 4mg (as hydrochloride dihydrate).

3. Pharmaceutical Form

Film coated tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

Adults:

Zofran is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Zofran is indicated for the prevention and treatment of post-operative nausea and vomiting (PONV).Paediatric Population:

Zofran is indicated for the management of chemotherapy-induced nausea and vomiting (CINV) in children aged

4.2 Posology And Method Of Administration

Chemotherapy and radiotherapy induced nausea and vomiting.

Adults:

The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The route of administration and dose of Zofran should be flexible in the range of 8-32mg a day and selected as shown below.

Emetogenic Chemotherapy and Radiotherapy: Zofran can be given either by rectal, oral (tablets or syrup), intravenous or intramuscular administration.

For oral administration: 8mg 1-2 hours before treatment, followed by 8mg 12 hours later.

To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with Zofran should be continued for up to 5 days after a course of treatment.

The recommended dose for oral administration is 8mg twice daily.

Highly Emetogenic Chemotherapy: For patients receiving highly emetogenic chemotherapy, eg. high-dose cisplatin, Zofran can be given either by oral, rectal, intravenous or intramuscular administration.

The recommended oral dose is 24 mg taken together with oral dexamethasone sodium phosphate 12 mg, 1 to 2 hours before treatment.

To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with Zofran should be continued for up to 5 days after a course of treatment.

The recommended dose for oral administration is 8mg twice daily.

Paediatric Population:

CINV in children aged

The dose for CINV can be calculated based on body surface area (BSA) or weight – see below. Weight-based dosing results in higher total daily doses compared to BSA-based dosing (sections 4.4.and 5.1).

Zofran injection should be diluted in 5% dextrose or 0.9% sodium chloride or other compatible infusion fluid (see section 6.6) and infused intravenously over not less than 15 minutes.

There are no data from controlled clinical trials on the use of Zofran in the prevention of delayed or prolonged CINV. There are no data from controlled clinical trials on the use of Zofran for radiotherapy-induced nausea and vomiting in children.

Dosing by BSA:

Zofran should be administered immediately before chemotherapy as a single intravenous dose of 5 mg/m². The intravenous dose must not exceed 8 mg.

Oral dosing can commence twelve hours later and may be continued for up to 5 days (Table 1).

The total daily dose must not exceed adult dose of 32 mg.

Table 1: BSA-based dosing for Chemotherapy - Children aged

BSA	Day 1 (a,b)	Days 2-6(b)
< 0.6 m2	5 mg/m2 i.v. plus 2 mg syrup after 12 hrs	2 mg syrup every 12 hrs
0.6 m2	5 mg/m2 i.v. plus 4 mg syrup or tablet after 12 hrs	4 mg syrup or tablet every 12 hrs

a The intravenous dose must not exceed 8mg.

b The total daily dose must not exceed adult dose of 32 mg

Dosing by bodyweight:

Weight-based dosing results in higher total daily doses compared to BSA-based dosing (sections 4.4. and 5.1).

Zofran should be administered immediately before chemotherapy as a single intravenous dose of 0.15 mg/kg. The intravenous dose must not exceed 8 mg.

Two further intravenous doses may be given in 4-hourly intervals. The total daily dose must not exceed adult dose of 32 mg.

Oral dosing can commence twelve hours later and may be continued for up to 5 days (Table 2).

Table 2: Weight-based dosing for Chemotherapy - Children aged

Weight	Day 1 (a,b)	Days 2-6(b)
	Up to 3 doses of 0.15 mg/kg every 4 hrs	2 mg syrup every 12 hrs
> 10 kg	Up to 3 doses of 0.15 mg/kg every 4 hrs	4 mg syrup or tablet every 12 hrs

a The intravenous dose must not exceed 8mg.

b The total daily dose must not exceed adult dose of 32 mg.

Elderly:

Zofran is well tolerated by patients over 65 years and no alteration of dosage, dosing frequency or route of administration are required.

Patients with Renal Impairment:

No alteration of daily dosage or frequency of dosing, or route of administration are required.

Patients with Hepatic Impairment:

Clearance of Zofran is significantly reduced and serum half-life significantly prolonged in subjects with moderate or severe impairment of hepatic function. In such patients a total daily dose of 8mg should not be exceeded and therefore parenteral or oral administration is recommended.

Post operative nausea and vomiting:

Adults:

For the prevention of PONV: Zofran can be administered orally or by intravenous or intramuscular injection.

For oral administration: 16mg one hour prior to anaesthesia. Alternatively, 8mg one hour prior to anaesthesia followed by two further doses of 8mg at eight hourly intervals.

For the treatment of established PONV: Intravenous or intramuscular administration is recommended.

Paediatric population

PONV in children aged

Oral formulation:

No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment of post-operative nausea and vomiting; slow i.v. injection is recommended for this purpose.

Injection:

For prevention of PONV in paediatric patients having surgery performed under general anaesthesia, a single dose of ondansetron may be administered by slow intravenous injection (not less than 30 seconds) at a dose of 0.1mg/kg up to a maximum of 4mg either prior to, at or after induction of anaesthesia.

For the treatment of PONV after surgery in paediatric patients having surgery performed under general anaesthesia, a single dose of Zofran may be administered by slow intravenous injection (not less than 30 seconds) at a dose of 0.1mg/kg up to a maximum of 4mg.

There are no data on the use of Zofran in the treatment of PONV in children below 2 years of age.

Elderly:

There is limited experience in the use of Zofran in the prevention and treatment of post-operative nausea and vomiting in the elderly, however Zofran is well tolerated in patients over 65 years receiving chemotherapy.

Patients with Renal impairment:

No alteration of daily dosage or frequency of dosing, or route of administration are required.

Patients with Hepatic impairment:

Clearance of Zofran is significantly reduced and serum half life significantly prolonged in subjects with moderate or severe impairment of hepatic function. In such patients a total daily dose of 8mg should not be exceeded and therefore parenteral or oral administration is recommended.

Patients with poor Sparteine/Debrisoquine Metabolism:

The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers of sparteine and debrisoquine. Consequently in such patients repeat dosing will give drug exposure levels no different from those of the general population. No alteration of daily dosage or frequency of dosing are required.

4.3 Contraindications

Hypersensitivity to any component of the preparation.

4.4 Special Warnings And Precautions For Use

Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5HT₃ receptor antagonists. Respiratory events should be treated symptomatically and clinicians should pay particular attention to them as precursors of hypersensitivity reactions.

Very rarely and predominantly with intravenous Zofran, transient ECG changes including QT interval prolongation have been reported. Therefore caution should be exercised in patients with cardiac rhythm or conduction disturbances, in patients treated with anti-arrhythmic agents or beta-adrenergic blocking agents and in patients with significant electrolyte disturbances.

As ondansetron is known to increase large bowel transit time, patients with signs of subacute intestinal obstruction should be monitored following administration.

In patients with adenotonsillar surgery prevention of nausea and vomiting with ondansetron may mask occult bleeding. Therefore, such patients should be followed carefully after ondansetron.

Paediatric Population:

Paediatric patients receiving ondansetron with hepatotoxic chemotherapeutic agents should be monitored closely for impaired hepatic function.

CINV: When calculating the dose on an mg/kg basis and administering three doses at 4-hourly intervals, the total daily dose will be higher than if one single dose of 5mg/m² followed by an oral dose is given. The comparative efficacy of these two different dosing regimens has not been investigated in clinical trials. Cross-trial comparison indicates similar efficacy for both regimens (section 5.1).

Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There is no evidence that ondansetron either induces or inhibits the metabolism of other drugs commonly coadministered with it. Specific studies have shown that there are no interactions when ondansetron is administered with alcohol, temazepam, furosemide, alfentanil, tramadol, morphine, lignocaine, thiopental, or propofol.

Ondansetron is metabolised by multiple hepatic cytochrome P-450 enzymes: CYP3A4, CYP2D6 and CYP1A2. Due to the multiplicity of metabolic enzymes capable of metabolising ondansetron, enzyme inhibition or reduced activity of one enzyme (e.g. CYP2D6 genetic deficiency) is normally compensated by other enzymes and should result in little or no significant change in overall ondansetron clearance or dose requirement.

Phenytoin, Carbamazepine and Rifampicin: In patients treated with potent inducers of CYP3A4 (i.e. phenytoin, carbamazepine, and rifampicin), the oral clearance of ondansetron was increased and ondansetron blood concentrations were decreased.

Tramadol: Data from small studies indicate that ondansetron may reduce the analgesic effect of tramadol.

Use of Zofran with QT prolonging drugs may result in additional QT prolongation. Concomitant use of Zofran with cardiotoxic drugs (e.g. anthracyclines) may increase the risk of arrhythmias (section 4.4).

4.6 Pregnancy And Lactation

The safety of ondansetron for use in human pregnancy has not been established. Evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to the development of the embryo, or foetus, the course of gestation and peri- and post-natal development. However as animal studies are not always predictive of human response the use of ondansetron in pregnancy is not recommended.

Tests have shown that ondansetron passes into the milk of lactating animals. It is therefore recommended that mothers receiving Zofran should not breast-feed their babies.

4.7 Effects On Ability To Drive And Use Machines

Ondansetron has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable Effects

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (

The following frequencies are estimated at the standard recommended doses of ondansetron according to indication and formulation.

Immune system disorders
Rare:	Immediate hypersensitivity reactions sometimes severe, including anaphylaxis.
Nervous system disorders
Very common:	Headache.
Uncommon:	Seizures, movement disorders including extrapyramidal reactions such as dystonic reactions, oculogyric crisis and dyskinesia.(1) Rare: Dizziness during i.v. administration, which in most cases is prevented or resolved by lengthening the infusion period.
Eye disorders
Rare:	Transient visual disturbances (eg. blurred vision) during i.v. administration.
Very rare:	Transient blindness predominantly during intravenous administration. (2)
Cardiac disorders
Uncommon:	Arrhythmias, chest pain with or without ST segment depression, bradycardia.
Vascular disorders
Common:	Sensation of warmth or flushing.
Uncommon:	Hypotension.
Respiratory, thoracic and mediastinal disorders
Uncommon:	Hiccups.
Gastrointestinal disorders
Common:	Constipation.
Hepatobiliary disorders
Uncommon:	Asymptomatic increases in liver function tests.(3)

1. Observed without definitive evidence of persistent clinical sequelae.

2. The majority of the blindness cases reported resolved within 20 minutes.

Most patients had received chemotherapeutic agents, which included cisplatin. Some cases of transient blindness were reported as cortical in origin.

3. These events were observed commonly in patients receiving chemotherapy with cisplatin.

Paediatric population

The adverse event profile in children and adolescents was comparable to that seen in adults.

4.9 Overdose

Little is known at present about overdosage with ondansetron, however, a limited number of patients received overdoses. Manifestations that have been reported include visual disturbances, severe constipation, hypotension and a vasovagal episode with transient second degree AV block. In all instances, the events resolved completely. There is no specific antidote for ondansetron, therefore in all cases of suspected overdose, symptomatic and supportive therapy should be given as appropriate. The use of ipecacuanha to treat overdose with ondansetron is not recommended, as patients are unlikely to respond due to the anti-emetic action of ondansetron itself.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Ondansetron is a potent, highly selective 5HT3 receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known. Chemotherapeutic agents and radiotherapy may cause release of 5HT in the small intestine initiating a vomiting reflex by activating vagal afferents via 5HT3 receptors. Ondansetron blocks the initiation of this reflex. Activation of vagal afferents may also cause a release of 5HT in the area postrema, located on the floor of the fourth ventricle, and this may also promote emesis through a central mechanism. Thus, the effect of ondansetron in the management of the nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy is probably due to antagonism of 5HT3 receptors on neurons located both in the peripheral and central nervous system. The mechanisms of action in post-operative nausea and vomiting are not known but there may be common pathways with cytotoxic induced nausea and vomiting.

Ondansetron does not alter plasma prolactin concentrations.

The role of ondansetron in opiate-induced emesis is not yet established.

Paediatric population

CINV

The efficacy of ondansetron in the control of emesis and nausea induced by cancer chemotherapy was assessed in a double-blind randomised trial in 415 patients aged 1 to 18 years (S3AB3006). On the days of chemotherapy, patients received either ondansetron 5 mg/m² intravenous + ondansetron 4 mg orally after 8-12 hrs or ondansetron 0.45 mg/kg intravenous + placebo orally after 8-12 hrs. Post-chemotherapy both groups received 4 mg ondansetron syrup twice daily for 3 days. Complete control of emesis on worst day of chemotherapy was 49% (5 mg/m² intravenous + ondansetron 4 mg orally) and 41% (0.45 mg/kg intravenous + placebo orally). Post-chemotherapy both groups received 4 mg ondansetron syrup twice daily for 3 days. There was no difference in the overall incidence or nature of adverse events between the two treatment groups.

A double-blind randomised placebo-controlled trial (S3AB4003) in 438 patients aged 1 to 17 years demonstrated complete control of emesis on worst day of chemotherapy in:

• 73% of patients when ondansetron was administered intravenously at a dose of 5 mg/m² intravenous together with 2-4 mg dexamethasone orally

• 71% of patients when ondansetron was administered as syrup at a dose of 8 mg + 2-4 mg dexamethasone orally on the days of chemotherapy.

Post-chemotherapy both groups received 4 mg ondansetron syrup twice daily for 2 days. There was no difference in the overall incidence or nature of adverse events between the two treatment groups.

The efficacy of ondansetron in 75 children aged 6 to 48 months was investigated in an open-label, non-comparative, single-arm study (S3A40320). All children received three 0.15 mg/kg doses of intravenous ondansetron, administered 30 minutes before the start of chemotherapy and then at four and eight hours after the first dose. Complete control of emesis was achieved in 56% of patients.

Another open-label, non-comparative, single-arm study (S3A239) investigated the efficacy of one intravenous dose of 0.15 mg/kg ondansetron followed by two oral ondansetron doses of 4 mg for children aged < 12 yrs and 8 mg for children aged

PONV

The efficacy of a single dose of ondansetron in the prevention of post-operative nausea and vomiting was investigated in a randomised, double-blind, placebo-controlled study in 670 children aged 1 to 24 months (post-conceptual age

Four double-blind, placebo-controlled studies have been performed in 1469 male and female patients (2 to 12 years of age) undergoing general anaesthesia. Patients were randomised to either single intravenous doses of ondansetron (0.1 mg/kg for paediatric patients weighing 40 kg or less, 4 mg for paediatric patients weighing more than 40 kg; number of patients = 735)) or placebo (number of patients = 734). Study drug was administered over at least 30 seconds, immediately prior to or following anaesthesia induction. Ondansetron was significantly more effective than placebo in preventing nausea and vomiting. The results of these studies are summarised in Table 3.

Table 3 Prevention and treatment of PONV in Paediatric Patients – Treatment response over 24 hours

Study	Endpoint	Ondansetron %	Placebo %	p value
S3A380	CR	68	39
S3GT09	CR	61	35
S3A381	CR	53	17
S3GT11	no nausea	64	51	0.004
S3GT11	no emesis	60	47	0.004

CR = no emetic episodes, rescue or withdrawal

5.2 Pharmacokinetic Properties

Following oral administration, ondansetron is passively and completely absorbed from the gastrointestinal tract and undergoes first pass metabolism. Peak plasma concentrations of about 30ng/ml are attained approximately 1.5 hours after an 8mg dose. For doses above 8mg the increase in ondansetron systemic exposure with dose is greater than proportional; this may reflect some reduction in first pass metabolism at higher oral doses. Mean bioavailability in healthy male subjects, following the oral administration of a single 8 mg tablet, is approximately 55 to 60%. Bioavailability, following oral administration, is slightly enhanced by the presence of food but unaffected by antacids. Studies in healthy elderly volunteers have shown slight, but clinically insignificant, age-related increases in both oral bioavailability (65%) and half-life (5 hours) of ondansetron. Gender differences were shown in the disposition of ondansetron, with females having a greater rate and extent of absorption following an oral dose and reduced systemic clearance and volume of distribution (adjusted for weight).

The disposition of ondansetron following oral, intramuscular(IM) and intravenous(IV) dosing is similar with a terminal half life of about 3 hours and steady state volume of distribution of about 140L. Equivalent systemic exposure is achieved after IM and IV administration of ondansetron.

A 4mg intravenous infusion of ondansetron given over 5 minutes results in peak plasma concentrations of about 65ng/ml. Following intramuscular administration of ondansetron, peak plasma concentrations of about 25ng/ml are attained within 10 minutes of injection.

Following administration of ondansetron suppository, plasma ondansetron concentrations become detectable between 15 and 60 minutes after dosing. Concentrations rise in an essentially linear fashion, until peak concentrations of 20-30 ng/ml are attained, typically 6 hours after dosing. Plasma concentrations then fall, but at a slower rate than observed following oral dosing due to continued absorption of ondansetron. The absolute bioavailability of ondansetron from the suppository is approximately 60% and is not affected by gender. The half life of the elimination phase following suppository administration is determined by the rate of ondansetron absorption, not systemic clearance and is approximately 6 hours. Females show a small, clinically insignificant, increase in half-life in comparison with males.

Ondansetron is not highly protein bound (70-76%). Ondansetron is cleared from the systemic circulation predominantly by hepatic metabolism through multiple enzymatic pathways. Less than 5% of the absorbed dose is excreted unchanged in the urine. The absence of the enzyme CYP2D6 (the debrisoquine polymorphism) has no effect on ondansetron's pharmacokinetics. The pharmacokinetic properties of ondansetron are unchanged on repeat dosing.

Special Patient Populations

Children and Adolescents (aged 1 month to 17 years)

In paediatric patients aged 1 to 4 months (n=19) undergoing surgery, weight normalised clearance was approximately 30% slower than in patients aged 5 to 24 months (n=22) but comparable to the patients aged 3 to 12 years. The half-life in the patient population aged 1 to 4 month was reported to average 6.7 hours compared to 2.9 hours for patients in the 5 to 24 month and 3 to 12 year age range. The differences in pharmacokinetic parameters in the 1 to 4 month patient population can be explained in part by the higher percentage of total body water in neonates and infants and a higher volume of distribution for water soluble drugs like ondansetron.

In paediatric patients aged 3 to 12 years undergoing elective surgery with general anaesthesia, the absolute values for both the clearance and volume of distribution of ondansetron were reduced in comparison to values with adult patients. Both parameters increased in a linear fashion with weight and by 12 years of age, the values were approaching those of young adults. When clearance and volume of distribution values were normalised by body weight, the values for these parameters were similar between the different age group populations. Use of weight-based dosing compensates for age-related changes and is effective in normalising systemic exposure in paediatric patients.

Population pharmacokinetic analysis was performed on 428 subjects (cancer patients, surgery patients and healthy volunteers) aged 1 month to 44 years following intravenous administration of ondansetron. Based on this analysis, systemic exposure (AUC) of ondansetron following oral or IV dosing in children and adolescents was comparable to adults, with the exception of infants aged 1 to 4 months. Volume was related to age and was lower in adults than in infants and children. Clearance was related to weight but not to age with the exception of infants aged 1 to 4 months. It is difficult to conclude whether there was an additional reduction in clearance related to age in infants 1 to 4 months or simply inherent variability due to the low number of subjects studied in this age group. Since patients less than 6 months of age will only receive a single dose in PONV a decreased clearance is not likely to be clinically relevant.

Renal impairment

In patients with renal impairment (creatinine clearance 15-60 ml/min), both systemic clearance and volume of distribution are reduced following IV administration of ondansetron, resulting in a slight, but clinically insignificant, increase in elimination half-life (5.4h). A study in patients with severe renal impairment who required regular haemodialysis (studied between dialyses) showed ondansetron's pharmacokinetics to be essentially unchanged following IV administration.

Elderly or renal impairment

Specific studies in the elderly or patients with renal impairment have been limited to IV and oral administration. However, it is anticipated that the half-life of ondansetron after rectal administration in these populations will be similar to that seen in healthy volunteers, since the rate of elimination of ondansetron following rectal administration is not determined by systemic clearance.

Hepatic impairment

Following oral, intravenous or intramuscular dosing in patients with severe hepatic impairment, ondansetron's systemic clearance is markedly reduced with prolonged elimination half-lives (15-32 h) and an oral bioavailability approaching 100% due to reduced pre-systemic metabolism. The pharmacokinetics of ondansetron following administration as a suppository have not been evaluated in patients with hepatic impairment.

5.3 Preclinical Safety Data

No additional data of relevance.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose, microcrystalline cellulose, pregelatinised maize starch, magnesium stearate, methylhydroxypropylcellulose, titanium dioxide (E171), iron oxide (E172).

6.2 Incompatibilities

None reported.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store below 30°C.

6.5 Nature And Contents Of Container

Blister packs of 10 or 30 tablets comprising aluminium/PVC blister film and aluminium foil lidding.

Securitainer packs of 30 or 100 tablets.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

None stated.

Administrative Data

7. Marketing Authorisation Holder

Glaxo Wellcome UK Limited

Trading as GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex UB11 1BT

8. Marketing Authorisation Number(S)

PL 10949/0110

9. Date Of First Authorisation/Renewal Of The Authorisation

9 January 2002

10. Date Of Revision Of The Text

10 October 2011

11. LEGAL STATUS

POM

Strepsils Cool

1. Name Of The Medicinal Product

Strepsils Cool

2. Qualitative And Quantitative Composition

Amylmetacresol BP 0.6mg

2,4-Dichlorobenzyl alcohol HSE 1.2mg

For excipients, see 6.1

3. Pharmaceutical Form

White to pale yellow coloured lozenge with a characteristic taste of cool mint and the Strepsils brand icon intagliated on both sides

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of mouth and throat infections.

4.2 Posology And Method Of Administration

Adults: One lozenge to be dissolved slowly in the mouth every 2-3 hours up to a maximum of 12 lozenges in 24 hours.

Children over 12 years: One lozenge to be dissolved slowly in the mouth every 2-3 hours up to a maximum of 8 lozenges in 24 hours.

Elderly: There is no need for dosage reduction in the elderly.

Not suitable for children under 12 years.

For oral administration.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Keep all medicines out of the reach of children.

If symptoms persist consult your doctor.

Patients with rare hereditary problems of fructose intolerance, glucose-glalctose malabsorption or sucrose-isomaltose insufficiency should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant interactions are known.

4.6 Pregnancy And Lactation

The safety of Strepsils Cool has not been established, therefore not recommended.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects are known.

4.8 Undesirable Effects

Occasional hypersensitivity reactions.

4.9 Overdose

Overdose should not present a problem other than gastrointestinal discomfort. Treatment should be symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

2,4-Dichlorobenzyl alcohol and amylmetacresol have antiseptic properties.

5.2 Pharmacokinetic Properties

Pharmacokinetically the active ingredients, when present in a dosage form such as a lozenge, will exert their desired effect locally on the oropharynx.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber, which are additional to that included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Xylitol,

Cool Mint Sensation Flavour (contains propylene glycol),

Levomenthol,

Spearmint,

Eucalyptus oil,

Liquid Sucrose,

Liquid Glucose,

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months for lozenges packed in blister strips within a carton.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

A blister push-through pack consisting of 15 or 20µm hard temper aluminium foil heat-sealed to a 250µm PVC/40gms PVDC blister.

The tray contains an appropriate number of lozenges to give pack sizes of 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 36, 40, 44, 48 and 720 lozenges in a cardboard carton or a flow wrap composed of PET/aluminium foil/polyethylene

A blister push-through pack consisting of 15 or 20µm hard temper aluminium foil heat-sealed to a 250µm PVC/40gms PVDC blister. The tray contains an appropriate number of lozenges to give a pack size of 8 lozenges in a wrap around cardboard carton with tamper-evident seal.

An injection moulded white pigmented polypropylene tube with an injection moulded white polyethylene cap (containing white silica gel that is sealed with a white cardboard disc).

The tube contains 10 lozenges.

20 lozenges consisting of a bundled pack of 2 tubes of 10 lozenges each.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Ltd

Slough

SL1 3UH

8. Marketing Authorisation Number(S)

PL 00063/0469

9. Date Of First Authorisation/Renewal Of The Authorisation

11/02/2010

10. Date Of Revision Of The Text

11/02/2010

11 DOSIMETRY

(IF APPLICABLE)

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

(IF APPLICABLE)

QDALL 24-Hour Sustained-Release Capsules

Pronunciation: klor-fen-IHR-ah-meen/sue-do-eh-FED-rin
Generic Name: Chlorpheniramine/Pseudoephedrine
Brand Name: QDALL

QDALL 24-Hour Sustained-Release Capsules are used for:

Relieving symptoms of sinus congestion, sinus pressure, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

QDALL 24-Hour Sustained-Release Capsules are an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, relieving congestion and pressure.

Do NOT use QDALL 24-Hour Sustained-Release Capsules if:

• you are allergic to any ingredient in QDALL 24-Hour Sustained-Release Capsules


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you take sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using QDALL 24-Hour Sustained-Release Capsules:

Some medical conditions may interact with QDALL 24-Hour Sustained-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a fast, slow, or irregular heartbeat


• if you have a history of asthma, lung problems (eg, emphysema), adrenal gland problems (eg, adrenal gland tumor), heart problems, high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, a blockage of your stomach or intestines, ulcers, a blockage of your bladder, trouble urinating, an enlarged prostate, seizures, or an overactive thyroid

Some MEDICINES MAY INTERACT with QDALL 24-Hour Sustained-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of QDALL 24-Hour Sustained-Release Capsules's side effects


• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by QDALL 24-Hour Sustained-Release Capsules


• Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by QDALL 24-Hour Sustained-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if QDALL 24-Hour Sustained-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use QDALL 24-Hour Sustained-Release Capsules:

Use QDALL 24-Hour Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take QDALL 24-Hour Sustained-Release Capsules by mouth with or without food.


• Swallow QDALL 24-Hour Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing.


• If you miss a dose of QDALL 24-Hour Sustained-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use QDALL 24-Hour Sustained-Release Capsules.

Important safety information:

• QDALL 24-Hour Sustained-Release Capsules may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use QDALL 24-Hour Sustained-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not take diet or appetite control medicines while you are taking QDALL 24-Hour Sustained-Release Capsules without checking with you doctor.


• QDALL 24-Hour Sustained-Release Capsules has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


• QDALL 24-Hour Sustained-Release Capsules may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to QDALL 24-Hour Sustained-Release Capsules. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• QDALL 24-Hour Sustained-Release Capsules may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking QDALL 24-Hour Sustained-Release Capsules for a few days before the tests.


• Tell your doctor or dentist that you take QDALL 24-Hour Sustained-Release Capsules before you receive any medical or dental care, emergency care, or surgery.


• Use QDALL 24-Hour Sustained-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using QDALL 24-Hour Sustained-Release Capsules in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using QDALL 24-Hour Sustained-Release Capsules while you are pregnant. It is not known if QDALL 24-Hour Sustained-Release Capsules are found in breast milk. Do not breast-feed while taking QDALL 24-Hour Sustained-Release Capsules.

Possible side effects of QDALL 24-Hour Sustained-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: QDALL side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of QDALL 24-Hour Sustained-Release Capsules:

Store QDALL 24-Hour Sustained-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep QDALL 24-Hour Sustained-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about QDALL 24-Hour Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.


• QDALL 24-Hour Sustained-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about QDALL 24-Hour Sustained-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More QDALL resources

• QDALL Side Effects (in more detail)
• QDALL Use in Pregnancy & Breastfeeding
• QDALL Drug Interactions
• QDALL Support Group
• 0 Reviews for QDALL - Add your own review/rating

Compare QDALL with other medications

• Hay Fever
• Sinusitis

Priadel tablets

Priadel 200mg and 400mg prolonged release tablets

lithium carbonate

Is this leaflet hard to see or read?

Phone 01483 505515 for help

Read all of this leaflet carefully before you start taking this medicine

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Priadel Tablets are and what they are used for


• 2. Before you take Priadel Tablets


• 3. How to take Priadel Tablets


• 4. Possible side effects


• 5. How to store Priadel Tablets


• 6. Further information

What Priadel Tablets are and what they are used for

The name of your medicine is Priadel 200mg or Priadel 400mg Prolonged Release Tablets (called Priadel Tablets in this leaflet). Priadel Tablets contain a medicine called lithium. This belongs to a group of medicines called mood stabilisers. It works by stabilising the levels of chemicals in your brain that affect your mood.

Priadel Tablets can be used to manage or control:

• Mania (feeling highly excited, being over-active and easily irritated or distracted)


• Hypo-mania (similar to mania, but less severe)


• Repeated periods of depression, where treatment with other medicines has not worked


• Aggressive or self-harming behaviour

It is also used to help prevent bipolar depression - where the mood changes between feeling very high (mania) and very low (depression).

Before you take Priadel Tablets

Do not take Priadel Tablets if:

• You are allergic (hypersensitive) to lithium carbonate or any of the other ingredients of Priadel Tablets (see Section 6: Further information) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue


• You are breast-feeding


• You have heart disease


• You have kidney problems


• You have an under-active thyroid gland that is not being treated


• You have low levels of sodium in your body. This can happen if you are dehydrated or on a low sodium diet


• You have an illness called ‘Addison’s disease’. This happens when your body does not produce enough hormones. This makes you feel tired, weak, light-headed and makes areas of your skin go darker.

Take special care with Priadel Tablets

Check with your doctor or pharmacist before taking your medicine if:

• You have a cold or flu


• You have gastroenteritis. This is when you have a problem with your stomach or gut. Signs include diarrhoea, stomach pain, being sick, headache, fever and chills


• You have a urinary infection


• You are elderly


• You are not eating or drinking properly

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Priadel Tablets.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Priadel Tablets can affect the way some other medicines work. Also, some medicines can affect the way Priadel Tablets work as this can affect the levels of lithium in your blood.

In particular, check with your doctor if you are taking any of the following:

• Any other medicines containing lithium


• Medicines used for infections (antibiotics) - such as metronidazole, doxycycline or oxytetracycline


• Steroids - used for inflammation and allergies (such as prednisolone, betamethasone or
  hydrocortisone)


• Theophylline - used for wheezing or difficulty in breathing


• Caffeine found in some medicines for pain relief that you buy without a prescription


• Water tablets (diuretics) - such as furosemide, chlortalidone, indapamide, spironolactone or acetazolamide


• Urea - used in some creams that soften and moisturise the skin


• Non-steroidal anti-inflammatory drugs (NSAIDs) - used to treat pain relief and swelling (such as aspirin, ibuprofen, indomethacin or diclofenac)


• Medicines used for heart problems or high blood pressure - such as enalapril, lisinopril or ramipril (ACE inhibitors)


• Some medicines for indigestion and heartburn (antacids) - such as sodium bicarbonate

The following medicines can increase the chance of side effects when taken with Priadel Tablets. Tell your doctor if you are taking any of the following before taking Priadel Tablets:

• Some medicines used for depression (SSRIs) - such as fluvoxamine, paroxetine or fluoxetine


• Medicines used to calm emotional and mental illnesses - such as haloperidol, flupentixol, diazepam, thioridazine, fluphenazine, chlorpromazine or clozapine


• Methyldopa used for high blood pressure


• Some medicines used for fits (epilepsy) - such as carbamazepine or phenytoin


• Medicines used for chest pain (angina) or high blood pressure - such as diltiazem or verapamil

Taking Priadel with food and drink

Your diet and the amount of fluid you drink while taking Priadel Tablets is very important (see section 3 below ‘Diet, food and drink while taking Priadel Tablets).

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Information for women who could become pregnant

• Talk to your doctor before taking this medicine if you plan to get pregnant, or think you may be pregnant. It is very important that you talk to your doctor about your treatment well before you become pregnant



• You should use an effective method of contraception while taking Priadel Tablets

Information for women who are pregnant

• If you find out you are pregnant while taking Priadel Tablets, tell your doctor straight away



• Do not take Priadel Tablets if you are pregnant, especially in the first 3 months of your pregnancy

If your doctor decides that you should have Priadel Tablets while you are pregnant, he or she will:

• Keep a close eye on the level of lithium in your blood. This is because your kidneys work differently while you are pregnant



• Arrange for appropriate tests before your baby is born

If it is decided you should have Priadel Tablets during late pregnancy or during labour, your baby may appear ‘floppy’. This returns to normal without any treatment.

Breast-feeding

• Do not breast-feed if you are taking Priadel Tablets. This is because small amounts may pass into the mother’s milk

Driving and using machines

Do not drive or use any tools or machines if you feel sleepy, tired or dizzy. Priadel Tablets may also cause other effects that can make it dangerous to drive or use tools and machines such as numbness, paralysis, weakness or fits (seizures).

Important information about some of the ingredients of Priadel Tablets

Your medicine contains mannitol. This may cause mild diarrohoea.

How to take Priadel Tablets

Always take Priadel Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Diet, food and drink while taking Priadel Tablets

The amount you eat and drink is very important as it can affect the levels of Priadel Tablets in your blood.

• Drink the same amount of fluids every day while taking Priadel Tablets. In hot environments or if you are dehydrated, you may need to drink extra fluids



• Have a normal balanced diet while taking Priadel Tablets. Do not change your diet without talking to your doctor first

How to take your medicine

• Take this medicine by mouth


• Swallow the tablets whole. Do not crush or chew them


• The tablets can be broken in half


• Take your medicine at the same times every day


• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but
  ask your doctor

• Adults weighing about 70kg
  
  
  • The usual starting dose is between 400mg to 1,200mg each day
  
  



• Elderly and adults weighing under 50kg
  
  
  • The usual starting dose is between 200mg to 400mg each day
  
  
  
  • Your doctor may decide to increase this dose by 200mg to 400mg every 3 to 5 days. Increasing the
    dose is usual, but do not do this unless your doctor tells you to
  
  
  
  • The maximum dose will depend on your blood levels and illness
  
  


• Children
  
  
  Priadel Tablets are not recommended for children and adolescents.

Blood Tests

• Within the first week of treatment your doctor will give you a blood test. This is to check the level of lithium in your blood



• Your daily dose will be changed depending on the results of your blood test



• Your doctor will carry out a blood test every week until the level of lithium in your blood is steady



• You will then have your blood tested every 3 months to check the level remains steady

If you are going to have other types of blood test, tell the doctor or nurse that you are taking lithium.

If you take more Priadel Tablets than you should

If you or someone else has taken more Priadel Tablets than you should, talk to a doctor or go to your nearest hospital casualty department straight away. Remember to take the medicine pack with you. This is so the doctor knows what you have taken.

The following effects may happen: feeling sick or being sick, blurred vision, increased need to pass water, lack of control over passing water or stools, feeling lightheaded or drowsy, confusion and blackouts. You may also experience shaking or muscle weakness, muscle twitches and jerks or spasms causing unusual movements of the face, tongue, eyes or neck. In severe cases you may lose consciousness, have fits, shortness of breath or chest pain.

If you forget to take Priadel Tablets

If you forget to take a dose at the right time, take it as soon as you remember, then go on as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking Priadel Tablets

Keep taking your medicine until your doctor tells you to stop. Do not stop taking Priadel Tablets just because you feel better. If you stop, your illness may return.

When your doctor says that you can stop taking Priadel Tablets, your dose will be lowered gradually. Your doctor will help you to do this.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Priadel tablets Side Effects

Like all medicines, Priadel Tablets can cause side effects, although not everybody gets them. Side- effects are more likely to happen at the start of treatment.

Allergic reactions

If you have an allergic reaction, stop taking Priadel and see a doctor or go to a hospital straight away. The signs
may include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

Stop taking Priadel and see your doctor or go to a hospital straight away if you notice a combination of any of the following serious side effects:

The following side effects may be signs of lithium toxicity (too much lithium in your blood):

• Loss of appetite, diarrhoea and vomiting (being sick)



• Muscle weakness, lack of co-ordination, muscle twitching or sudden jerks and shaking



• Feeling drowsy or very tired, balance problems and feeling dizzy with a spinning sensation
  (vertigo)



• Difficulty in walking or unusual involuntary movements, such as unusual eye
  movements



• Ringing in the ears (tinnitus) or blurred vision



• Difficulty in speaking or slurred speech

Other serious side effects which need urgent medical attention:

• Swelling around the feet and ankles, face and stomach and weight gain due to water retention



• Cloudy or foamy urine (water)



• Feeling confused, dazed or loss of conciousness



• Memory problems



• Fits (seizures)



• Irregular or slow heart beats, shortness of breath, chest pain and fainting

Tell a doctor or pharmacist straight away if you notice any of the following serious side effects:

• Increased thirst and passing water (urine) more often than normal. You may also feel tired and hungry. This could be due to high blood sugar levels or a condition called ‘diabetes insipidus’ It is important to tell your doctor if you are passing more water than usual as the amount of Priadel you are taking may need to be changed



• You have a swelling or a lump on your neck (which may be caused by an enlarged thyroid gland)



• You have a fast heartbeat, sweating, stress (anxiety), increased appetite, loss of weight, weakness and
  are unable to tolerate heat. This could be due to higher levels of thyroid hormone in the blood (hyperthyroidism)



• You feel tired, have cold skin and hair becomes dry, thinning of hair or fingernails, hoarse voice, joint
  or muscle pain and gain weight. This could be due to lower levels of thyroid hormone in the blood
  (hypothyroidism)



• You have increased thirst, pass more water than usual, feel tired or depressed, muscle aches or
  pains, bone or joint pain and stomach upsets. This could be due to a hormone problem called ‘hyperparathyroidism’



• You have indigestion or heartburn and are feeling sick, being sick or have abdominal pain. You may
  also have black tarry stools (faeces) or blood in your stools or you may notice blood or dark bits (like coffee grounds) when you are being sick. This could be due to a stomach problem called ‘gastritis’



• Headaches, a ‘rushing’ sound in your ears and feeling or being sick. This could be because of increased pressure in the brain

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:

• Hair loss or inflamed hair follicles



• Acne, skin spots or rashes, skin ulcers and/or itching



• Slight shaking of the hands



• You have skin irritation and swelling. Skin may appear red, itchy with silvery scales (psoriasis). If you already have this condition, you could notice that it is getting worse



• Feeling sick, a watery or dry mouth and/or changes in the way things taste



• Stomach pain



• Sexual problems including being unable to get an erection, having delayed ejaculation or being unable to have an orgasm



• Blurred vision or blind spots in your eyesight



• Uncontrolled movements of the eye



• Weight gain

Tests

Blood tests may show an increase in white blood cells (leucocytosis) or changes in the way the kidney is working. They may also show changes in the levels of calcium or magnesium in your blood.

A test on your heart may show changes in the way your heart is working.

How to store Priadel Tablets

• Keep out of the reach and sight of children



• Do not use Priadel Tablets after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month



• Do not store above 25ºC. Store in the original package to protect from moisture.



• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment

Further information

What Priadel 200mg prolonged release tablets contain

• Each tablet contains 200mg of the the active substance, lithium carbonate



• The other ingredients are: Glycerol monostearate, glycerol distearate, mannitol, acacia spray dried, sodium laurilsulfate, magnesium stearate, maize starch and sodium starch glycolate (Type A).

What Priadel 400mg prolonged release tablets contain

• Each tablet contains 400mg of the the active substance, lithium carbonate



• The other ingredients are: Glycerol distearate, mannitol, acacia spray dried, sodium laurilsulfate, magnesium stearate, maize starch and sodium starch glycolate (Type A).

What Priadel Tablets look like and contents of the pack

Priadel 200mg prolonged release tablets are white, scored, capsule-shaped tablets engraved with P200 on one side. They are supplied in blister packs of 100 tablets.

Priadel 400mg prolonged release tablets are white, circular, bi-convex tablets engraved PRIADEL on one side, scored on the other side. They are supplied in blister packs of 100 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

Tel:01483 505515

Fax:01483 535432

email:uk-medicalinformation@sanofi-aventis.com

Manufacturer

Sanofi Winthrop Industrie

6 Boulevard de l’Europe

21800 Quetigny

France

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in 08/2007

© sanofi-aventis, 1997-2007

The MDF The Bipolar Organisation is a charity which can provide more information about Manic Depression/Bipolar Disorder. They can be contacted at:

MDF The Bipolar Organisation

Castle Works

21 St. Georges Road

London

SE1 6ES

Telephone:0207 793 2600

Fax:0207 7932639

E-mail:mdf@mdf.org.uk

CheeTah Chocolaty-Fudge oral and rectal

Generic Name: barium sulfate (oral and rectal) (BER ee um SUL fate)

Brand Names: Anatrast, Bar-Test, Baricon, Baro-Cat, Barosperse, Bear-E-Yum GI, CheeTah, CheeTah Butterscotch, CheeTah Chocolaty-Fudge, CheeTah Orange, CheeTah Raspberry, Digibar 190, E-Z AC, E-Z Disk, E-Z Dose Kit with Polibar Plus, E-Z Paste, E-Z-Cat, E-Z-Cat Dry, E-Z-HD, E-Z-Paque, Enecat, Eneset 2, Enhancer, Entero VU, Entero-H, Entrobar, Esopho-Cat, Intropaste, Liqui-Coat HD, Liquid Barosperse, Liquid E-Z Paque, Liquid Polibar, Liquid Polibar Plus, Maxibar, Medebar Plus, Medebar Super 250, Polibar ACB, Readi-Cat, Readi-Cat 2, Scan C, Sitzmarks, Smoothie Readi-Cat 2, Sol-O-Pake, Tagitol V, Tonojug, Tonopaque, Varibar Honey, Varibar Nectar, Varibar Pudding, Varibar Thin, Varibar Thin Honey, Volumen

What is barium sulfate?

Barium sulfate is in a group of drugs called contrast agents. Barium sulfate works by coating the inside of your esophagus, stomach, or intestines which allows them to be seen more clearly on a CT scan or other radiologic (x-ray) examination.

Barium sulfate is used to help diagnose certain disorders of the esophagus, stomach, or intestines.

Barium sulfate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about barium sulfate?

You should not use this medication if you are allergic to barium sulfate. Tell your doctor if you have ever had an allergic reaction to a contrast agent.

Before you use barium sulfate, tell your doctor if you have any allergies, or if you have asthma, cystic fibrosis, heart disease or high blood pressure, rectal cancer, a colostomy, a blockage in your stomach or intestines, a condition called pseudotumor cerebri, or if you have recently had a rectal biopsy or surgery on your esophagus, stomach, or intestines.

Tell your doctor if you are pregnant or breast-feeding before your medical test.

Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.

Serious side effects of barium sulfate may include severe stomach pain, sweating, ringing in your ears, pale skin, weakness, or severe cramping, diarrhea, or constipation

What should I discuss with my health care provider before using barium sulfate?

You should not use barium sulfate if you are allergic to it. Tell your doctor if you have ever had an allergic reaction to a contrast agent.

To make sure you can safely use barium sulfate, tell your doctor if you have any of these other conditions:

• 
  

  asthma, eczema, or allergies;

  
  


• 
  

  a blockage in your stomach or intestines;

  
  


• 
  

  cystic fibrosis;

  
  


• 
  

  a colostomy;

  
  


• 
  

  rectal cancer;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  Hirschsprung's disease (a disorder of the intestines);

  
  


• 
  

  a condition called pseudotumor cerebri (high pressure inside the skull that may cause headaches, vision loss, or other symptoms);

  
  


• 
  

  a recent history of surgery on your esophagus, stomach, or intestines;

  
  


• 
  

  a history of perforation (a hole or tear) in your esophagus, stomach, or intestines;

  
  


• 
  

  if you have recently had a rectal biopsy;

  
  


• 
  

  if you have ever choked on food by accidentally inhaling it into your lungs;

  
  


• 
  

  if you are allergic to simethicone (Gas-X, Phazyme, and others); or

  
  


• 
  

  if you are allergic to latex rubber.

  
  

It is not known whether barium sulfate will harm an unborn baby, but the radiation used in x-rays and CT scans may be harmful. Before your medical test, tell your doctor if you are pregnant. Barium sulfate may pass into breast milk and could harm a nursing baby. Before your medical test, tell your doctor if you are breast-feeding a baby.

How should I use barium sulfate?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Barium sulfate comes in tablets, paste, cream, or liquid forms.

In some cases, barium sulfate is taken by mouth. The liquid form may also be used as a rectal enema.

You may need to begin using this medication at home a day before your medical test. Follow your doctor's instructions about how much of the medication to use and how often.

If you are receiving barium sulfate as a rectal enema, a healthcare professional will give you the medication at the clinic or hospital where your testing will take place.

Do not crush, chew, or break a barium sulfate tablet. Swallow the pill whole.

Dissolve the barium sulfate powder in a small amount of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

If you receive the medication as a liquid to take by mouth, shake the liquid well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.

Store at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

If you are using barium sulfate at home, call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe stomach pain, ongoing diarrhea, confusion, or weakness.

What should I avoid before or after using barium sulfate?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Barium sulfate side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  severe stomach pain;

  
  


• 
  

  severe cramping, diarrhea, or constipation;

  
  


• 
  

  sweating;

  
  


• 
  

  ringing in your ears;

  
  


• 
  

  confusion, fast heart rate; or

  
  


• 
  

  pale skin, weakness.

  
  

Less serious side effects may include:

• 
  

  mild stomach cramps;

  
  


• 
  

  nausea, vomiting;

  
  


• 
  

  loose stools or mild constipation.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect barium sulfate?

There may be other drugs that can interact with barium sulfate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More CheeTah Chocolaty-Fudge resources

• CheeTah Chocolaty-Fudge Side Effects (in more detail)
• CheeTah Chocolaty-Fudge Use in Pregnancy & Breastfeeding
• CheeTah Chocolaty-Fudge Support Group
• 0 Reviews for CheeTah Chocolaty-Fudge - Add your own review/rating

Compare CheeTah Chocolaty-Fudge with other medications

• Computed Tomography

Where can I get more information?

• Your doctor or pharmacist can provide more information about barium sulfate.

See also: CheeTah Chocolaty-Fudge side effects (in more detail)

Fareston

Pronunciation: tore-EM-i-feen
Generic Name: Toremifene
Brand Name: Fareston

Fareston has been shown to cause a serious type of irregular heartbeat (QT prolongation). QT prolongation can also result in another serious and sometimes fatal type of irregular heartbeat called torsades de pointes, which may also cause fainting or seizures. Do not take Fareston if you have congenital or acquired QT prolongation (long QT syndrome), or if you have low blood potassium or magnesium levels. Certain medicines may increase the risk of irregular heartbeat and should be avoided. Check with your doctor to see if any of your medicines may increase the risk of irregular heartbeat.

Fareston is used for:

Treating breast cancer in women past menopause with estrogen-dependent tumors or unknown tumors. It may also be used for other conditions as determined by your doctor.

Fareston is an antiestrogen. It works by blocking the effects of estrogen on certain body tissues, including breast tissue. This helps block the growth of estrogen-activated tumors.

Do NOT use Fareston if:

• you are allergic to any ingredient in Fareston


• you have a certain type of irregular heartbeat (congenital or acquired QT prolongation, long QT syndrome), or low blood potassium or magnesium levels


• you are taking clozapine, ondansetron, or quetiapine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fareston:

Some medical conditions may interact with Fareston. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have bone cancer or an excess growth of the endometrium


• if you have a history of blood clots, cancer, or decreased blood platelets or white blood cells


• if you have a history of heart problems (eg, heart failure, irregular heartbeat), liver problems, or blood electrolyte problems


• if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with Fareston. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Antiarrhythmics (eg, amiodarone, dofetilide, sotalol), arsenic, astemizole, bepridil, chloroquine, cisapride, clozapine, crizotinib, dolasetron, domperidone, droperidol, granisetron, halofantrine, haloperidol, macrolide antibiotics (eg, clarithromycin, erythromycin), maprotiline, methadone, nilotinib, ondansetron, paliperidone, pentamidine, phenothiazines (eg, thioridazine), pimozide, quetiapine, quinolone antibiotics (eg, levofloxacin, ofloxacin), romidepsin, tacrolimus, terfenadine, tetrabenazine, tricyclic antidepressants (eg, amitriptyline), tyrosine kinase inhibitors (eg, dasatinib), vandetanib, vemurafenib, venlafaxine, or ziprasidone because the risk of severe and possibly fatal irregular heartbeat may be increased


• Fluorouracil because the risk of liver problems may be increased


• Thiazide diuretics (eg, hydrochlorothiazide) because the risk of high blood calcium levels may be increased


• Azole antifungals (eg, itraconazole, ketoconazole, voriconazole), mitomycin C, nefazodone, protease inhibitors (eg, boceprevir, ritonavir), or telithromycin because they may increase the risk of Fareston's side effects


• Carbamazepine, dexamethasone, hydantoins (eg, phenytoin), phenobarbital, rifamycins (eg, rifabutin, rifampin), or St. John's wort because the effectiveness of Fareston may be decreased


• Anticoagulants (eg, warfarin) or hydantoins (eg, phenytoin) because the actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fareston may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fareston:

Use Fareston as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Fareston may be taken with or without food.


• Do not eat grapefruit or drink grapefruit juice while you use Fareston.


• If you miss a dose of Fareston, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Fareston.

Important safety information:

• Fareston may cause dizziness or changes in vision. These effects may be worse if you take it with alcohol or certain medicines. Use Fareston with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• If Fareston causes nausea or vomiting, ask your doctor or pharmacist about ways to minimize this effect.


• Fareston is only indicated in women who have been through menopause. If you have not been through menopause and are able to become pregnant, use effective non-hormonal birth control (eg, condoms) while you take Fareston.


• Lab tests, including complete blood cell counts, blood electrolytes (eg, potassium, magnesium, calcium), electrocardiograms (ECGs), and liver function, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Fareston is not indicated for use in CHILDREN.


• PREGNANCY and BREAST-FEEDING: Fareston has been shown to cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fareston while you are pregnant. It is not known if Fareston is found in breast milk. If you are or will be breast-feeding while you are using Fareston, check with your doctor. Discuss any possible risks to your baby. Do not breast-feed while taking Fareston.

Possible side effects of Fareston:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; hot flashes; joint pain; loss of appetite; nausea; sweating; tiredness; vaginal discharge; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf or leg pain, swelling, redness, warmth, or tenderness; change in vision; chest pain; confusion; coughing up blood; decreased coordination; depression; fainting; fever, chills, or sore throat; flushing; hallucinations; irregular heartbeat; muscle or bone pain; numbness of an arm or leg; one-sided weakness; seizures; shortness of breath; sluggishness; slurred speech; sudden, severe headache or vomiting; swelling of the hands, ankles, or feet; tremor; unusual bleeding or bruising; vaginal bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Fareston side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness; hallucinations; headache; hot flashes; nausea; loss of coordination; vaginal bleeding; vomiting.

Proper storage of Fareston:

Store Fareston at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fareston out of the reach of children and away from pets.

General information:

• If you have any questions about Fareston, please talk with your doctor, pharmacist, or other health care provider.


• Fareston is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Fareston. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Fareston resources

• Fareston Side Effects (in more detail)
• Fareston Use in Pregnancy & Breastfeeding
• Drug Images
• Fareston Drug Interactions
• Fareston Support Group
• 0 Reviews for Fareston - Add your own review/rating

• Fareston Prescribing Information (FDA)


• Fareston Concise Consumer Information (Cerner Multum)


• Fareston Monograph (AHFS DI)


• Fareston Advanced Consumer (Micromedex) - Includes Dosage Information

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