Famotidine Tablets USP 20mg Taj Pharma

Name of the medicinal product

Famotidine Tablets USP 20mg Taj Pharma
Famotidine Tablets USP 40mg Taj Pharma

Qualitative and quantitative composition

Each tablet contains
Famotidine                     20 mg.
Excipient                          qs

Each tablet contains
Famotidine                     40 mg.
Excipient                          qs

For the full list of excipients, see section 6.1

Pharmaceutical form

Tablet

Clinical particulars

Therapeutic indications

Duodenal and benign gastric ulcers which have been confirmed by radiological or endoscopic examination.

Zollinger-Ellison syndrome

Reflux oesophagitis confirmed by endoscopy, including curative treatment of erosion or ulcer associated with reflux oesophagitis.

Posology and method of administration

 

Posology

Duodenal ulcer.

Initiation of treatment: The recommended dose is 40 mg of famotidine per day at bedtime. The treatment should be continued for 4-8 weeks, but it may be discontinued even earlier if it is found by endoscopic examination that the ulcer has healed. In most cases the ulcer will heal with this treatment within four weeks. Treatment should be continued for another four weeks in patients whose ulcer has not healed completely within four weeks.

Maintenance treatment: In prophylactic treatment of recurrent ulcer it is recommended that famotidine therapy be continued with a dose of 20 mg per day at bedtime.

Non-malignant gastric ulcer.

The recommended dose is 40 mg per day at bedtime. The treatment is continued for 4- 8 weeks, but a shorter course of treatment is adequate if an endoscopic examination shows that the ulcer is healed.

Zollinger-Ellison syndrome.

If the patient has not previously received drugs to reduce the secretion of acid, the treatment is introduced by giving 20 mg of famotidine every 6 hours. The dosage should be adjusted according to the patient’s needs and it should be continued as long as it is clinically indicated. Daily doses up to 800 mg have been administered without any significant undesirable effects or tachyphylaxis. If the patient has received another H2 blocking agent, famotidine therapy can be introduced in a larger dose than otherwise recommended. The size of the initial dose is dependent on the severity of the condition and on the size of doses of H2 blocking agents received until that time.

 

Reflux oesophagitis.

The recommended dose for the relief of symptoms of reflux oesophagitis is 20 mg of famotidine twice daily. Doses should be continued for as long as indicated.

The recommended dose for the treatment of erosion or ulcer associated with reflux oesophagitis is 40 mg of famotidine twice daily. The recommended treatment length is 6-8 weeks.

Maintenance treatment:

If long-term management of reflux oesophagitis by famotidine is considered relevant, the recommended dose is 20 mg twice daily.

At present, this prophylactic treatment is not recommended to be extended beyond six months.

 

Renal impairment:

Famotidine is primarily eliminated via the kidneys. For patients with impaired renal function in whom creatinine clearance is less than 10 ml/min, the daily dose of famotidine should be reduced by 50%. Caution is advised in patients with renal impairment. Dialysis patients should also take doses that are reduced by 50%.Famotidine tablets should be administered at the end of dialysis or later since some of the active ingredient is removed by dialysis.

 

Hepatic impairment

In patients with cirrhosis of the liver, the plasma concentration and elimination of famotidine in the urine were the same as that of healthy volunteers. Reduction of the dose is therefore not necessary in these patients.

 

Elderly:

When famotidine was administered to elderly patients in clinical studies the undesirable effects associated with the drug were not found to increase nor were they found to be different from those exhibited in younger patients. Adjustment of dose based on age is therefore not necessary.

Paediatric population: Not recommended.

 

Method of administration

The tablets should be taken with some liquid. They can be divided, but they must not be crushed or chewed.

 

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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.

 

For administration to breast-feeding women: see section 4.6

Special warnings and precautions for use

 

Since cross sensitivity has been observed among H2-receptor antagonists, famotidine should not be administered to patients with a history of hypersensitivity to other drugs in this class.

 

Gastric neoplasm

Before starting treatment of gastric ulcer with famotidine, the possibility of malignant gastric tumour should be excluded. The symptomatic response of a gastric ulcer to famotidine therapy does not exclude the possible existence of a malignant tumour.

 

Do not administer famotidine tablets in cases of minor gastro-intestinal complaints. In patients with duodenal ulcers and benign gastric ulcers the H. Pylori status should be determined. Wherever possible, patients with H. Pylori should undergo eradication therapy to eliminate the bacteria.

Renal insufficiency.

Since famotidine is secreted mainly via the kidneys, caution should be exercised when treating patients with renal insufficiency. A reduction in the daily dose should be considered if creatinine clearance falls below 10 ml/min (see section 4.2 Posology and Method of administration).

This medicine contains 1.99 mg of lactose monohydrate per tablet. Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Paediatric population

In the children are not established safety and efficacy

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 drug-related side effects was observed. No dosage adjustment is required based on age alone.

General

In case of long-term treatment with high dosage, monitoring of blood count and liver function is recommended.

In case of long-standing ulcer disease, abrupt withdrawal after symptom relief should be avoided.

Interaction with other medicinal products and other forms of interaction

No drug interactions of clinical importance have been identified.

During concomitant use of drugs where the absorption of the drug is affected by the amount of gastric juice, a possible effect on the absorption should be taken into consideration. The absorption of ketoconazole and itraconazole could be reduced. Ketoconazole should be given two hours before famotidine administration.

Probenecid inhibits renal tubular secretion of famotidine, and has been shown to cause a 50% increase in plasma levels of famotidine. Therefore, concomitant use of probenecid and famotidine should be avoided.

Concomitant use of famotidine and antacids could reduce the famotidine uptake and cause lower plasma levels of famotidine. Therefore, famotidine should be administered 1-2 hours before antacids.

Concomitant use of sucralfate inhibits absorption of famotidine. Therefore, sucralfate should not be administered within 2 hours after famotidine.

Famotidine does not interact with the cytochrome P450-linked drug metabolizing enzyme system. Compounds metabolized by this system which have been tested in man have included warfarin, theophylline, phenytoin, diazepam, propranolol, 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.

Studies in patients stabilized on phenprocoumon therapy have shown no pharmacokinetic interaction with famotidine and no effect on the pharmacokinetic or anticoagulant activity of phenprocoumon.

In addition, studies with famotidine have shown no augmentation of expected blood alcohol levels resulting from alcohol ingestion.

Alterations of gastric pH may affect the bioavailability of certain drugs resulting in a decrease in the absorption of atazanavir.

 

Risk of loss of efficacy of calcium carbonate when co-administered as phosphate binder with famotidine in hemodialysis patients.

Fertility, pregnancy and lactation

Pregnancy:

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 physician should weigh the potential benefits from the drug against the possible risks involved.

To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / foetal development, parturition or postnatal development (see section 5.3).

 

Breast-feeding:

Famotidine is excreted in breast milk. Breast-feeding mothers should either stop using this drug or stop breast-feeding, since there is a possibility of famotidine affecting the infant’s gastric acid secretion.

 

Effects on ability to drive and use machines

 

Some patients have experienced adverse reactions such as dizziness and headache while taking famotidine. Patients should be informed that they should avoid driving vehicles or operating machinery or doing activities which require prompt vigilance if they experience these symptoms. (see section 4.8).

 

Undesirable effects

Famotidine has been demonstrated to be generally well-tolerated.

[Very Common (>1/10) Common (>1/100, <1/10) Uncommon (>1/1000, <1/100) Rare (>1/10,000, <1/1,000) Very rare (<1/10,000) including isolated cases Not known (cannot be estimated from the available data)]

 

 

Blood and the lymphatic system disorders

Very rare

Thrombocytopenia Leukopenia Agranulocytosis Pancytopenia neutropenia

 

Psychiatric disorders

Very rare

Reversible psychic disturbances including Hallucinations Disorientation

Confusion Anxiety disorders Agitation Depression Reduced libido Insomnia.

 

Nervous system disorders

Common Headache Dizziness

Uncommon: taste disorder

 

Very rare Paraesthesia Somnolence

Epileptic seizures, convulsions; grand mal seizures (particularly in patients with impaired renal function);

 

Gastrointestinal disorders

Common Constipation Diarrhoea

 

Uncommon Nausea Vomiting

Abdominal discomfort or distension

Flatulence Dry mouth

Hepato-biliary disorders

Rare

Intrahepatic cholestasis (visible sign: jaundice),

Very rare

Hepatitis; cholestatic jaundice, Increase in liver enzyme abnormalities (transaminases, gamma GT, alkaline phosphatase, bilirubin)

Metabolism and nutrition disorders

Uncommon

Loss of appetite (anorexia)

Skin and subcutaneous tissue disorders

Uncommon Rash Pruritus Urticaria

Very rare

Alopecia, Stevens Johnson syndrome/toxic epidermal necrolysis sometimes fatal

Immune system disorders

Very rare

Hypersensitivity reactions (angioneurotic oedema, anaphylaxis, bronchospasm)

Respiratory, thoracic and mediastinal disorders

Very rare

Interstitial pneumonia sometimes fatal

Muscoskeletal, connective tissue and bone disorders

Very rare

Muscle cramps, Arthralgia

Cardiac disorders:

Very rare

AV block with H2 receptor antagonists administered intravenously

General disorders and administration site conditions:

Uncommon: fatigue

Very rare: chest tightness

Reproductive system and breast disorders:

Very rare: impotence

Adverse Effects – Causal Relationship Unknown

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

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Overdose

The adverse reactions in overdose cases are similar to the adverse reactions encountered in normal clinical experience (see Side Effects).

Patients suffering from Zollinger-Ellison syndrome have received daily doses of up to 800 mg over a period of one year without exhibiting any significant undesirable effects.

In the event of overdose the aim should be to remove any unabsorbed drug from the alimentary tract with the usual measures from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed.

Pharmacological properties

Pharmacotherapeutic group: Histamine H2 receptor antagonist.

Famotidine is an effective competitive H2 receptor antagonist, the effect of which is particularly clearly concentrated on H2 receptors. It reduces the concentration and amount of acid and pepsin of the gastric juices in the basal and stimulated secretion.

The effect of oral administration of famotidine is rapid. The effect of famotidine is long lasting when recommended doses are used, and it is effective with relatively low concentrations in the blood. The duration of effect, plasma concentration and secretion in the urine are dose dependent.

Oral administration of famotidine leads to the antacid effect starting within an hour of administration. The peak effect is dose dependent and it is achieved within 1-3 hours of administration.

In clinical studies famotidine was found to relieve the pain associated with ulceration, usually during the first week of treatment, and it reduced the gastric acid secretion with one single daily dose at bedtime.

Individual oral doses of 20mg and 40mg effectively inhibited the basal night-time secretion of gastric acid; mean gastric acid secretion was inhibited over a period of 10 hours by 86% and 94%, respectively. The same doses, administered in the morning, inhibited the gastric acid secretion stimulated by eating for 3-5 hours p.a. by a mean of 76% and 84%, respectively. 8-10 hours after administration, the levels were at 25% and 30%, respectively, although the effect of one 20mg dose persisted for only 6-8 hours in some of the volunteers.

The basal night-time intragastric pH value was increased to a mean of 5 and 6.4 by evening doses of 20mg and 40mg of famotidine, respectively. When famotidine was administered after breakfast, the pH value in both the 20mg and the 40mg groups was increased to approximately 5 after 3 and 8 hours.

Pharmacokinetic properties

Absorption.

Famotidine is rapidly absorbed. Peak plasma concentration is dose dependent and is achieved within 1-3 hours of administration. The kinetics of famotidine are linear. The bioavailability of oral famotidine is 40-45% on average. Food contained in the stomach will not affect the bioavailability. First pass metabolism of famotidine is minor. Repeat administration will not cause accumulation of the drug in the body.

Distribution.

The binding of famotidine in plasma proteins is relatively small (15-20%). The plasma half-life is about 3 hours both after oral single doses and during repeated administration (5 days).

Biotransformation

Up to 30-35 % of famotidine is metabolised in the liver to an inactive sulfoxide metabolite.

Elimination

When administered orally, an average of 65-70% of the absorbed famotidine is excreted in the urine. About 25-30% of the total oral dose is excreted unchanged in the urine. The renal clearance of famotidine is 250-450 ml/min, so consequently, excretion also takes place through tubular secretion. A small proportion may be secreted as sulfoxide.

Pharmacokinetics in different patient groups. The average elimination half-life of famotidine in plasma was prolonged to 11.7 hours in patients with creatinine clearance of 30ml/min or less. Patients with maximum creatinine clearance of 10 ml/min had an average plasma half-life of approximately 13 hours. The elimination half-life in these patients may exceed 20 hours. In patients with anuria the elimination half-life was prolonged to about 24 hours. In patients with creatinine clearance of 30 ml/min or less, only 21.2% of the intravenous injection was excreted in the urine.

In men with liver cirrhosis, famotidine plasma concentration and excretion of famotidine in the urine were of the same degree as in healthy trial subjects.

Disturbance of liver function apparently has no effect on the pharmacokinetics of famotidine.

Pharmacokinetic studies on elderly patients showed no signs of any clinically significant age-related changes; however, age-related impairment of renal function should be considered when determining the dose.

Preclinical safety data Non clinical data on famotidine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction.

Pharmaceutical particulars

List of excipients

Cellulose, microcrystalline Lactose monohydrate Macrogol 4000 Magnesium stearate Hypromellose

Sodium starch glycolate (type A) Silica, colloidal anhydrous Pregelatanized starch

Talc, Titanium dioxide.

Incompatibilities

Not applicable

Shelf life

3 years

Special precautions for storage

Do not store above 25°C Store in the original package.

Nature and contents of container

The tablets are packed in Al/PVC blisters which are inserted into a carton folder.

The following sizes of original packages are available:

5, 7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 90, 98, 100 film-coated tablets

Not all pack sizes may be marketed

Special precautions for disposal and other handling

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

 

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com

 

Famotidine Tablets USP 20mg and 40mg Taj Pharma

Package leaflet: Information for the user

Famotidine Tablets USP 20mg

Famotidine Tablets USP 40mg

Famotidine

What is in this leaflet

This leaflet answers some common questions about Famotidine.

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

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

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

Keep this leaflet with the medicine.

You may need to read it again.

What famotidine is used for

This medicine is used to treat peptic ulcers (gastric and duodenal ulcers), reflux oesophagitis (reflux disease) or a rare condition called Zollinger- Ellison syndrome. It is also used to help stop duodenal ulcers and reflux disease from coming back.

Peptic ulcers

This medicine is used to heal peptic ulcers. Depending on the position of the ulcer it is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum, which is the tube leading out of the stomach. These ulcers usually cause pain and discomfort (indigestion), which is felt between the navel and the breast bone. The pain may occur before or after meals, or in the middle of the night.

It is also used to help stop duodenal ulcers from coming back.

Reflux disease

This medicine is used to treat reflux oesophagitis (also called reflux disease), and to stop it from coming back. This condition is caused by the washing back, or reflux of food and acid from the stomach into the food pipe (also called the oesophagus).

This causes a painful burning sensation in the chest rising up to the throat (heartburn), and usually occurs after eating or at night.

Zollinger-Ellison syndrome

This medicine is used to treat a rare condition called Zollinger-Ellison syndrome, where the stomach produces very large amounts of acid, much more than in ulcers and reflux disease.

It contains the active ingredient famotidine.

Famotidine belongs to a group of medicines called histamine H2 antagonists or histamine H2 blockers.

It works by reducing the amount of acid made by the stomach. This helps to reduce the pain and also allows the ulcer and/or reflux disease to heal in most people.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

This medicine is not addictive.

This medicine is not recommended for use in children, as the safety and effectiveness have not been established.

Before you take famotidine

When you must not take it

Do not take this medicine if you have an allergy to:

  • famotidine, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description
  • any other similar medicines such as other ‘H2 antagonists or H2 blockers’.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the

Do not breastfeed if you are taking this medicine.

The active ingredient in Famotidine passes into breast milk and there is a possibility that your baby may be affected.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • kidney disease
  • lung disease
  • diabetes
  • any other medical conditions that may make you more susceptible to pneumonia.

Tell your doctor if you are pregnant or plan to become pregnant or plan to breastfeed.

This medicine is not recommended for use during pregnancy. If there is a need to consider Famotidine during pregnancy, your doctor will discuss with you the benefits and risks involved.

The active ingredient in Famotidine passes into breast milk.

If you have not told your doctor about any of the above, tell him/ her before you start taking Famotidine.

 

Taking other medicines

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

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

How to take famotidine

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

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

 

How much to take

Your doctor will tell you how many tablets you need to take each day. This depends on your condition.

To heal peptic ulcers, the usual dose is one 40mg tablet taken at night.

To help stop duodenal ulcers from coming back, the usual dose is one 20mg tablet taken at night.

For the treatment of reflux disease, the usual dose is one 20mg tablet taken twice a day.

For Zollinger-Ellison syndrome, the dose depends on how much acid your stomach makes. Your doctor will decide how much you need to take.

If you have impaired kidney function, your doctor may also lower your dose.

Ask your doctor or pharmacist if you are unsure of the correct dose for you.

They will tell you exactly how much to take.

Follow the instructions they give you.

If you take the wrong dose, Famotidine may not work as well and your problem may not improve.

 

How to take it

It does not matter if you take the tablets with or without food.

The tablets should be swallowed whole with a full glass of water.

If you need to break Famotidine, hold the tablet with both hands and snap along the break line.

 

When to take Famotidine

If you are taking one dose a day, take the tablet at night. If you are taking two doses a day, take one tablet in the morning and one at night.

Take your medicine at about the same time each day.

Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

 

How long to take Famotidine

You will need to take this medicine for 4 to 8 weeks to treat your peptic ulcer. Your doctor will tell you how long to take the tablets.

Do not stop taking Famotidine just because you feel better.

Stopping your tablets too early may let the ulcer come back.

Sometimes you need more than 8 weeks treatment with Famotidine to stop the ulcer from coming back. Your doctor will decide if you need more treatment.

For the treatment of reflux disease and Zollinger-Ellison syndrome, you usually need to take this medicine for longer. Your doctor will let you know how long you need to take the tablets.

 

If you forget to take it

Take your dose as soon as you remember, and continue to take it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

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

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, 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 orgo to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Famotidine. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

While you are taking famotidine

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Famotidine.

If you become pregnant while taking this medicine, tell your doctor immediately.

Keep all of your doctor’s appointments so that your progress can be checked.

Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things you must not do

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

Do not give your medicine to anyone else, even if they have the same condition as you.

 

Things to be careful of

Be careful driving or operating

Suggestions that may help your condition

Below are some self help measures that may help your condition. Talk to your doctor or pharmacist for more information.

Alcohol –

your doctor or pharmacist may advise you to limit your alcohol intake.

Aspirin and many other medicines used to treat arthritis, period pain, headache –

these medicines may irritate the stomach and make your condition worse. Your doctor or pharmacist may suggest other medicines you can take.

Caffeine –

may irritate your stomach. Your doctor or pharmacist may advise you to limit the number of drinks that contain caffeine such as coffee, tea, cocoa or cola drinks.

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.

Weight –

losing some weight may help your condition.

Smoking –

your doctor or pharmacist may advise you to stop smoking or at least cut down.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

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

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

  • headache
  • dizziness
  • constipation

These are generally mild side effects of the medicine.

Tell your doctor as soon as possible if you notice any of the following:

  • nausea, vomiting
  • abdominal discomfort or swelling
  • loss of appetite
  • dry mouth
  • fatigue
  • muscle pain, cramps, painful joints
  • hallucinations, confusion, agitation, depression, anxiety, inability to sleep, sleepiness, tingling in the fingers or toes, decreased sexual drive
  • taste disorder
  • unusual hair loss or thinning.

The above list includes serious side effects that may require medical attention. Serious side effects are rare.

If any of the following happen, stop taking Famotidine and tell your doctor immediately or go to Accident and Emergency at your machinery until you know how nearest hospital:

 

 Famotidine affects you.

This medicine may cause certain side effects such as dizziness, confusion or hallucinations with some people and may affect your ability to drive or operate machinery. Individual responses may vary.

Make sure you know how you react to this medicine before you drive a car or operate machinery.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Famotidine.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

  • 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
  • hives or nettle rash (pinkish, itchy swellings on the skin)
  • yellowing of the skin and/or eyes, also called jaundice
  • convulsions (very rare) especially in people with kidney problems

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

Also, tell your doctor if you notice any skin rash or itchiness.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.

Other side effects not listed above may also occur in some people.

 

After taking famotidine
Storage

Keep your medicine in the original container.

If you take it out of its original container it may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 25°C.

Do not store Famotidine or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it 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 this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description 
What it looks like

Famotidine comes in two strengths:

Famotidine 20mg.- film-coated tablets with a break score on one side.

Available in blister packs of 60 tablets.

Famotidine 40mg.- film-coated tablets with a break score on one side.

Available in blister packs of 30 tablets.

 

Ingredients

Active ingredient:

  • Famotidine 20mg.- 20mg famotidine
  • Famotidine 40mg.- 40mg famotidine.

Inactive ingredients:

  • microcrystalline cellulose
  • pregelatinized maize starch
  • sodium starch glycollate type A
  • colloidal anhydrous silica
  • purified talc
  • magnesium stearate
  • lactose
  • hypromellose
  • titanium dioxide
  • macrogol 4000.

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

 

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com