Consumer medicine information

FAMOTIDINE AN TABLETS

Famotidine

BRAND INFORMATION

Brand name

Famotidine AN Tablets

Active ingredient

Famotidine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using FAMOTIDINE AN TABLETS.

What is in this leaflet

This leaflet answers some common questions about Famotidine AN.

It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Famotidine AN against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

Keep this leaflet with your medicine.

You may need to read it again.

What Famotidine AN is used for

Famotidine AN tablets belong to a group of medicines called H2-antagonists. They are used for:

  • Treat stomach and duodenal ulcer disease (also known as peptic ulcer) and stop ulcers coming back.
  • Treat Zollinger-Ellison Syndrome (rare condition caused by too much acid production in the stomach).

Famotidine AN works by reducing the amount of acid in the stomach thereby reducing the pain and allowing the ulcer to heal.

Your doctor may have prescribed Famotidine AN for another reason. Ask your doctor if you have any questions as to why this medicine has been prescribed for you.

Do not take Famotidine AN to treat any other complaints unless your doctor has instructed you to do so.

Famotidine AN is only available with a doctor’s prescription.

Famotidine AN should not be given to children under 18 years of age as there is limited experience with the use of famotidine in children.

There is no evidence that Famotidine AN tablets are addictive.

Before you take Famotidine AN

Do not take Famotidine AN if:

  • You have an allergy to famotidine or to any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include, shortness of breath, swelling of the tongue or face, skin rash and itchiness.
  • You are breast-feeding or plan to breast-feed. Famotidine AN passes into breast milk. There is a possibility that this may affect your breast-fed baby.
  • The expiry date (EXP) on the pack has passed.
    If you take this medicine after the date has passed it may have no effect at all, or worse, an entirely unexpected effect.
  • The packaging is torn or shows signs of tampering.

If you are not sure whether you should take Famotidine AN, talk to your doctor or pharmacist.

Tell your doctor if:

  • You are pregnant, plan to become pregnant or to breast-feed. Like most medicines, Famotidine AN is not recommended for use during pregnancy.
  • You have kidney disease
  • You are allergic to any medicine
  • You are allergic to any other substances such as foods, dyes or preservatives
  • You have or have ever had any other health problems.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Famotidine AN.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may affect the way other medicines work. Famotidine AN has not been shown to interfere with other medicines.

How to take Famotidine AN

Carefully follow all directions given to you by your doctor and pharmacist.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

The dosage depends on the disease that you are suffering from. Your doctor or pharmacist will tell you how many Famotidine AN tablets to take and how often to take them.

When to take it

It is preferable for you to take the tablets at the same time each day. It will help you to remember when to take your tablets.

Famotidine AN tablets should be swallowed whole with a glass of water and may be taken before or after food.

How long to take it

For peptic ulcers (ulcers in the stomach or duodenum), you will need to take Famotidine AN tablets for 4 to 8 weeks. Do not stop taking the tablets too early as your ulcer may reoccur. In some cases, you may need more than 8 weeks treatment.

For the treatment of reflux disease and Zollinger-Ellison Syndrome, you will need to take Famotidine AN tablets for a longer period.

Your doctor will advise you how long to take your tablets.

If you forget to take it

If it is almost time to take your next dose, skip the dose that you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember, then go back to taking your tablets as usual.

If you are not too sure whether to skip the dose, talk to your doctor or pharmacist.

Do not take a double dose to make up for the dose you missed.

If you have trouble remembering to take your tablets, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Famotidine AN. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Keep telephone numbers of these places/services handy.

While you are taking Famotidine AN

Things you must do

If you are pregnant or likely to become pregnant while you are taking Famotidine AN tablets, tell your doctor.

If you are about to start taking a new medicine tell your doctor and pharmacist that you are taking Famotidine AN tablets.

If your stomach discomfort continues, tell your doctor. If your symptoms continue for more than 5 days, or your symptoms come back within two weeks of completing a course of Famotidine AN, tell your doctor or pharmacist.

Things you must not do

Do not stop taking your tablets because you are feeling better, unless advised to do so by your doctor.

If you do not complete the full course prescribed by your doctor, your symptoms may return.

Do not give Famotidine AN to anyone else even if they have the same condition as you.

Do not use Famotidine AN to treat any other complaints unless your doctor tells you to.

Things to be careful of

Be careful driving or operating machinery until you know how Famotidine AN affects you.

Famotidine AN tablets do not normally cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, Famotidine AN may cause dizziness in some people.

Make sure you know how you react to Famotidine AN before you drive a car or operate machinery.

Things that may help your condition

Some self-help measures suggested below may help your condition. Talk to your doctor or pharmacist about these measures and for more information.

  • Alcohol - your pharmacist or doctor may advise you to limit your alcohol intake.
  • Asprin and many other medicines used to treat arthritis/period pain/headaches - these medicines may irritate the stomach and make your condition worse. Your pharmacist or doctor may suggest other medicines you can take.
  • Caffeine - your pharmacist or doctor may advise you to limit the number of drinks which contain caffeine, such as coffee, tea, cocoa, and cola drinks because these contain ingredients that may irritate your stomach.
  • Eating habits - eat smaller, more frequent meals. Eat slowly and chew your food carefully. Try not to rush at meal times.
  • Food - avoid foods that cause you pain or discomfort.
  • Smoking - your pharmacist or doctor may advise you to stop smoking or at least cut down on smoking.
  • Weight - your pharmacist or doctor may suggest losing some weight to help your condition.

Side Effects

Check with your doctor or pharmacist as soon as possible if you have any problems while you are taking Famotidine AN, even if you do not think that the problems are connected with the medicine or are not listed in this leaflet.

Like all medicines, Famotidine AN can cause side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • Headache
  • Dizziness
  • Diarrhoea, constipation, nausea, vomiting, abdominal discomfort, anorexia, dry mouth
  • Fever, fatigue
  • Irregular or rapid heart beat, palpitations
  • Muscle pain, cramps, painful joints
  • Hallucinations, confusion, agitation, depression, anxiety, inability to sleep, sleeplessness, tingling in the fingers or toes, decreased sex drive, fits
  • Breathing difficulties caused by narrowing of the airways
  • Ringing in the ears
  • Taste disorders
  • Acne, dry skin, flushing, loss of hair

These are generally mild side effects.

Rarely, more serious side effects may occur. If you experience any of the following, stop taking Famotidine AN, tell your doctor immediately or go to casualty at your nearest hospital:

  • Swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
  • Swelling of the hands, feet or ankles
  • Any severe skin reaction (skin rash, itchiness)
  • Hives or nettle rash (pinkish, itchy swellings on the skin)
  • Yellowing of the skin and/or eyes, also called jaundice

These may be some of the serious side effects. If you have them, you may have an allergic reaction to Famotidine AN. You may need urgent medical attention or hospitalisation. These side effects are rare.

Other side effects not listed above may also occur in some patients. Tell your doctor or pharmacist if you notice any of these effects.

Do not be alarmed by this list of possible side effects you may not experience any of them.

After taking Famotidine AN

Storage

Keep your tablets in the blister pack until it is time to take them.

If you take the tablets out of the blisters they may not keep as well.

Keep Famotidine AN in a cool dry place away from direct sunlight where the temperature stays below 30°C.

Do not store Famotidine AN or any other medicine in the bathroom or near a sink.

Do not leave Famotidine AN in the car or on windowsills.

Heat and dampness can destroy some medicines.

Keep Famotidine AN where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Famotidine AN, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product Description

What it looks like

Famotidine AN 20 mg & 40 mg tablets are presented in pack sizes of 30 & 100 tablets in a PVC/PVDC/Al blister.

  • Famotidine AN 20 mg (AUST R 186280)
    Beige, round, biconvex tablets with ‘20’ on one face and plain on the other side.
  • Famotidine AN 40 mg (AUST R 186281)
    Brown, round, biconvex tablets with ‘40’ on one face and plain on the other side.

Ingredients

Active Ingredient:
Famotidine

Each tablet may contain either 10 mg or 20 mg of Famotidine.

Other Ingredients:

  • Pregelatinised maize starch
  • Microcrystalline cellulose
  • Magnesium stearate
  • Purified talc
  • Opadry Buff OY-3690 (20 mg)
  • Opadry Buff OY-3682 (40 mg)

Please read this leaflet carefully before you start taking Famotidine AN. You may wish to keep it to read again.

Name and Address of the Sponsor

Amneal Pharma Australia Pty Ltd
12 River St
South Yarra
Vic - 3141
Australia

Date of Preparation
September 2014

BRAND INFORMATION

Brand name

Famotidine AN Tablets

Active ingredient

Famotidine

Schedule

S4

 

Name of the medicine

Famotidine.

Excipients.

Pregelatinised maize starch, microcrystalline cellulose, magnesium stearate, purified talc, Opadry Buff OY-3690 (20 mg only) and Opadry Buff OY-3682 (40 mg only).

Description

Chemical name: 3- [[[2-[(aminoiminomethyl)amino]-4-thiazolyl]methyl]thio]-N- (aminosulfonyl)propanimidamide. Molecular formula: C8H15N7O2S3. MW: 337.45. CAS: 76824-35-6. It is a guanylthiazole derivative. Famotidine is a white to pale yellow nonhygroscopic crystalline substance. Very slightly soluble in water, freely soluble in glacial acetic acid, very slightly soluble in anhydrous ethanol, practically insoluble in ethyl acetate. It dissolves in dilute mineral acids. It shows polymorphism.

Pharmacology

Gastrointestinal effects.

Famotidine is a competitive inhibitor of histamine H2-receptors. The primary clinically important pharmacological activity of famotidine is inhibition of gastric secretion. Both the acid concentration and volume of basal, nocturnal and stimulated gastric secretion are suppressed by famotidine, while changes in pepsin secretion are proportional to volume output. In normal volunteers and hypersecretors, famotidine inhibited basal and nocturnal gastric secretion, as well as secretion stimulated by food and pentagastrin. After oral administration, the onset of the antisecretory effect occurred within one hour; the maximum effect was dose dependent, occurring within one to three hours. Duration of inhibition of secretion by doses of 20 and 40 mg was ten to twelve hours.
Single evening oral doses of 20 and 40 mg inhibited basal and nocturnal acid secretion in all subjects; mean nocturnal gastric acid secretion was inhibited 86% and 94% respectively, for a period of at least ten hours. The same doses given in the morning suppressed food stimulated acid secretion in all subjects. The mean suppression was 76% and 84% respectively, three to five hours after administration, and 25% and 30% respectively, eight to ten hours after administration. In some subjects who received the 20 mg dose, however, the antisecretory effect was dissipated within six to eight hours. Clinical efficacy studies have not been carried out with a 20 mg dose in acute ulceration. There is no cumulative effect with repeated doses. The nocturnal intragastric pH was raised by evening doses of famotidine 20 and 40 mg to mean values of 5.0 and 6.4 respectively. When famotidine was given after breakfast, the basal daytime interdigestive pH at three and eight hours after famotidine 20 or 40 mg was raised to about 5.
The presence of gastro-oesophageal reflux disease appears to correlate best with the percentage of time over 24 hours during which the oesophagus is exposed to acid. In patients with gastro-oesophageal reflux disease, famotidine 20 and 40 mg twice daily reduced intraoesophageal acid exposure into the normal range as measured by 24 hour intraoesophageal pH monitoring. In a clinical study of patients with gastro-oesophageal reflux disease with endoscopically verified erosive or ulcerative oesophagitis, famotidine 20 and 40 mg twice daily were superior to placebo, and 40 mg twice daily was statistically significantly more effective than 20 mg twice daily in healing oesophageal lesions. In another study however, the results for the 40 mg twice daily group were similar to the results for the 20 mg twice daily group.
In patients treated for six months with famotidine 20 mg twice daily, relapse of oesophageal erosions or ulceration was significantly less than in patients treated with placebo. Famotidine was also shown to be superior to placebo in preventing symptomatic deterioration.
Famotidine had little effect on fasting or postprandial serum gastrin levels. Gastric emptying and exocrine pancreatic function were not affected by famotidine.

Other effects.

Systemic effects of famotidine on the central nervous, cardiovascular, respiratory or endocrine systems have not been found to date. No antiandrogenic effects have been detected.

Pharmacokinetics.

Famotidine is incompletely absorbed. The bioavailability of oral doses is 40 to 45%. Bioavailability may be slightly increased by food, or slightly decreased by antacids; however, these effects are of no clinical consequence. Famotidine undergoes minimal first pass metabolism. After oral doses, peak plasma levels occur in 1 to 3 hours. Plasma levels after multiple doses are similar to those after single doses. 15 to 20% of famotidine in plasma is protein bound. Famotidine has an elimination half-life of 2.5 to 3.5 hours. Famotidine is eliminated by renal (65 to 70%) and metabolic (30 to 35%) routes. Renal clearance is 250 to 450 mL/minute, indicating some tubular excretion. 25 to 30% of an oral dose and 65 to 70% of an intravenous dose are recovered in the urine as unchanged compound. The only metabolite identified in humans is the S-oxide.

Intravenous administration.

After single doses of famotidine, the mean plasma half-life was approximately three hours and the mean urinary recovery in the urine over 24 hours was 80% of the dose of which 65 to 70% was recovered as the unchanged compound. There was no evidence for drug accumulation following multiple dose treatment (for three days). The only metabolite identified in humans is the S-oxide.
There is a close relationship between creatinine clearance values and the elimination half-life of famotidine. In patients with severe renal insufficiency, i.e. creatinine clearance less than 10 mL/minute, famotidine elimination half-life may exceed 20 hours and adjustment of dose or dosing intervals in moderate and severe renal insufficiency may be necessary (see Precautions, Dosage and Administration).
Renal excretion increases in a dose dependent linear fashion, but the area under the curve (AUC) and Cmax are not dose proportional. Further studies may be required to define the kinetics of famotidine.
In elderly patients, there are no clinically significant age related changes in the pharmacokinetics of famotidine. However, in elderly patients with decreased renal function, the clearance of the drug may be decreased (see Precautions, Dosage and Administration).

Hepatic dysfunction.

Does not appear to alter famotidine pharmacokinetics. In a study comparing eleven patients with alcohol related cirrhosis to five healthy control subjects, there were no significant between group differences in famotidine pharmacokinetics following single oral 20 mg doses, single intravenous 20 mg doses or multiple (once daily for seven days) oral 40 mg doses.

Indications

Symptomatic relief of heartburn, dyspepsia and indigestion due to gastro-oesophageal reflux in adults over 18 years of age.
Famotidine is indicated for the treatment of duodenal ulcer; benign gastric ulcer; Zollinger-Ellison syndrome; prevention of relapses of duodenal ulceration. Short-term (no more than 12 weeks) symptomatic relief of gastro-oesophageal reflux not responsive to conservative measures. Healing of oesophageal erosion or ulceration associated with gastro-oesophageal reflux disease. Prevention of relapses of symptoms and erosions or ulcerations associated with gastro-oesophageal reflux disease.

Contraindications

Hypersensitivity to any component of these products. Cross sensitivity in this class of compounds has been observed. Therefore, famotidine should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.

Precautions

Gastric neoplasm.

Gastric malignancy should be excluded prior to initiation of therapy of gastric ulcer with famotidine. Symptomatic response of gastric ulcer to therapy with famotidine does not preclude the presence of gastric malignancy.

Intensive care units.

Agents that elevate gastric pH may increase the already present risk of nosocomial pneumonia in intubated intensive care unit patients receiving mechanical ventilation.

Impaired renal function.

CNS adverse effects have been reported in patients with moderate (creatinine clearance < 50 mL/min) and severe (creatinine clearance < 10 mL/min) renal insufficiency. Consequently, the famotidine dosage should be reduced in patients with moderate or severe renal insufficiency (see Pharmacology, Dosage and Administration).

Impaired hepatic function.

See Pharmacology, Pharmacokinetics.

Use in the elderly.

When famotidine was administered to elderly patients in clinical trials, no increase in the incidence or change in the type of adverse effects was observed. No dosage adjustment is required based on age alone.
As elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this patient group, and it may be useful to monitor renal function (see Precautions, Impaired renal function, Dosage and Administration).
In patients such as the elderly, persons with chronic lung disease, diabetes or the immunocompromised, there may be an increased risk of developing community acquired pneumonia. A large epidemiological study showed an increased risk of developing community acquired pneumonia in current users of H2-receptor antagonists versus those who had stopped treatment, with an observed adjusted relative risk of 1.63 (95% CI, 1.07-2.48).

Carcinogenesis, mutagenesis, impairment of fertility.

In a 106 week study in rats and a 92 week study in mice given oral doses of up to 2000 mg/kg/day (approximately 2500 times the recommended human dose for active duodenal ulcer), there was no evidence of carcinogenic potential for famotidine.
Famotidine was negative in the microbial mutagen test (Ames test) using Salmonella typhimurium and Escherichia coli with or without rat liver enzyme activation at concentrations up to 10,000 microgram/plate. In in vivo studies in mice, with a micronucleus test and a chromosomal aberration test, no evidence of a mutagenic effect was observed.
In studies with rats given oral doses of up to 2000 mg/kg/day or intravenous doses of up to 200 mg/kg/day, fertility and reproductive performance were not affected.

Use in pregnancy.

(Category B1)
Famotidine has been demonstrated to cross the placenta and enter the fetus when administered to pregnant rats.
Famotidine has not shown teratogenic effects when given to pregnant rats at doses up to 2,000 mg/kg orally or up to 200 mg/kg intravenously, or in rabbits at oral doses up to 500 mg/kg and 100 mg/kg intravenously.
Famotidine did not appear to affect fertility of rats at oral doses up to 2,000 mg/kg or intravenous doses up to 200 mg/kg.
Famotidine is not recommended for use in pregnancy and should be prescribed only if clearly needed. Before a decision is made to use famotidine during pregnancy, the doctor should weigh the potential benefits from the drug against the possible risks involved.

Use in lactation.

Famotidine is detectable in human milk. Breastfeeding mothers should either stop this drug or stop breastfeeding.

Use in children.

Safety and effectiveness of famotidine in children has not been established.

Interactions

No drug interactions of clinical importance have been identified. Famotidine does not interact with the cytochrome P450 linked drug metabolising enzyme system. Compounds metabolised by this system which have been tested in humans in short-term studies include warfarin, propranolol, theophylline, phenytoin, diazepam, aminopyrine and antipyrine. Indocyanine green as an index of hepatic blood flow and/or hepatic drug extraction has been tested, and no significant effects have been found.
A study of eleven patients stabilised on phenprocoumon therapy has shown no pharmacokinetic interaction with famotidine and no effect on the pharmacokinetic or anticoagulant activity of phenprocoumon.

Adverse Effects

Famotidine has been shown to be generally well tolerated. The following adverse reactions have been reported to occur in more than 1% of patients on therapy with famotidine in controlled clinical trials and may be causally related to the drug: headaches (4.7%), dizziness (1.3%), constipation (1.2%) and diarrhoea (1.7%).
A similar incidence of the same effects was seen in the placebo or active comparison arms of these studies.
The following other adverse reactions have been reported infrequently in clinical trials or since the drug was marketed. The relationship to therapy with famotidine has been unclear in many cases. Within each category the adverse reactions are listed in order of decreasing severity.

Body as a whole.

Fever, asthenia, fatigue.

Cardiovascular.

Arrhythmia, atrioventricular block, palpitations.

Gastrointestinal.

Cholestatic jaundice, liver enzyme abnormalities, nausea, vomiting, abdominal discomfort, anorexia, dry mouth.

Haematologic.

Rare cases of agranulocytosis, pancytopenia, leucopenia, thrombocytopenia.

Hypersensitivity.

Anaphylaxis, angioedema, orbital or facial oedema, urticaria, rash, conjunctival injection.

Musculoskeletal.

Musculoskeletal pain including muscle cramps, arthralgia.

Central nervous system.

Grand mal seizure, reversible psychic disturbances including hallucinations, confusion, agitation, depression, anxiety, decreased libido, paraesthesia, insomnia, somnolence.

Respiratory.

Bronchospasm.

Dermatological.

Toxic epidermal necrolysis (very rare), alopecia, acne, pruritus, dry skin, flushing.

Special senses.

Tinnitus, taste disorder.

Other.

Rare cases of impotence and gynaecomastia have been reported, however, in controlled clinical trials, the incidences were not greater than seen with placebo.

Dosage and Administration

Heartburn, dyspepsia and indigestion.

One tablet as needed when symptoms occur, or one tablet 30 to 60 minutes before eating for symptoms usually associated with food or beverage. Do not take more than two tablets in a 24 hour period. If symptoms persist beyond five days or is symptoms recur within two weeks of completing a course, clinical investigation is required.

Duodenal ulcer.

Initial therapy.

The recommended dose of famotidine is one 40 mg tablet daily, taken at night. Treatment should be given for four to eight weeks, but the duration of treatment may be shortened if endoscopy reveals that the ulcer has healed. In most cases, duodenal ulcer healing occurs within four weeks on this regimen. In those patients whose ulcers have not healed completely after four weeks, treatment should be continued for a further four week period.

Maintenance therapy.

For the prevention of recurrence of duodenal ulceration, it is recommended that therapy with famotidine be continued with a dose of one 20 mg tablet daily, taken at night. In ongoing clinical studies this regimen has been continued for twelve months.

Benign gastric ulcer.

The recommended dose of famotidine is one 40 mg tablet daily, taken at night. Treatment should be given for four to eight weeks, but the duration of treatment may be shortened if endoscopy reveals that the ulcer has healed.

Zollinger-Ellison syndrome.

Patients with prior antisecretory therapy should be started on a dose of 20 mg every six hours. Dosage should be adjusted to individual patient needs and should continue for as long as indicated clinically. Doses up to 800 mg daily have been used in a small number of patients for up to one year without the development of significant adverse effects or tachyphylaxis. Patients who have been receiving another H2-antagonist may be switched directly to famotidine at a starting dose higher than that recommended for new cases; this starting dose will depend on the severity of the condition and the last dose of the H2-antagonist previously used.

Gastro-oesophageal reflux disease.

The recommended dosage for the symptomatic relief of gastro-oesophageal reflux disease is famotidine 20 mg taken orally twice daily.
For the treatment of oesophageal erosion or ulceration associated with gastro-oesophageal reflux disease, the recommended dosage is famotidine 20 mg twice daily.

Maintenance therapy.

For the prevention of recurrence of symptoms and erosions or ulcerations associated with gastro-oesophageal reflux disease, the recommended dosage is famotidine 20 mg twice daily. Efficacy studies have not been conducted beyond six months.

Impaired renal function.

In patients with moderate (creatinine clearance < 50 mL/min) or severe (creatinine clearance < 10 mL/min) renal insufficiency, the elimination half life of famotidine is increased. For patients with severe renal insufficiency it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patients clinical response.

Overdosage

There is no experience to date with overdosage. Doses of up to 800 mg daily have been used in a small number of patients with Zollinger-Ellison syndrome for more than a year without development of significant adverse effects.
The usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring and supportive therapy should be employed

Presentation

Tablets (round, biconvex, film coated, plain on reverse), 20 mg (beige, marked 20 on one side): 30's, 60's (PVC/PVDC/Al blister pack); 40 mg (brown, marked 40 on one side): 30's (PVC/PVDC/Al blister pack).

Storage

Store below 30°C. Protect from light and moisture.

Poison Schedule

S4.