Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Famotidine belongs to a group of medicines called H 2 −receptor antagonists. These work by reducing the amount of acid you produce in your stomach.
Famotidine is used to treat the following:
• Stomach ulcers (gastric/duodenal ulcers)
• Mild to moderate irritation and inflammation caused by stomach acid leaking up into the gullet (reflux oesophagitis)
• Zollinger−Ellison Syndrome (a rare disorder that involves recurrent ulcers and tumours in the stomach and intestines)
Do not take Famotidine if: • you are allergic to famotidine , other H 2 −receptor antagonists or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions Talk to your doctor or pharmacist before taking Famotidine if:
• there is a possibility of a malignant growth (tumour) being present in your stomach.
• you suffer from kidney problems .
• you have been taking a high dose of famotidine for a long time . Your doctor may monitor your blood count and liver function.
Other medicines and Famotidine Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without prescription. This includes herbal medicines.
Medicines which may interact with famotidine:
• Famotidine may decrease the effect of posaconazole oral suspension (a drinkable medicine used to prevent and treat some fungal infections).
• Famotidine may decrease the effect of dasatinib, erlotinib, gefitinib, pazopanib (medicines used to treat cancer).
• ketoconazole (should be administered 2 hours before famotidine) or itraconazole , used to treat fungal infections
• probenicid , used to treat gout
• antacids , for indigestion (famotidine should be administered 1-2 hours before taking an antacid)
• sucralfate , used to treat and prevent the recurrence of ulcers (sucralfate should not be administered within 2 hours of taking famotidine)
• calcium carbonate , when used as a medicine for high blood phosphate levels in patients on dialysis
• atazanavir , used for treatment of HIV infection
Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnant
If you are pregnant or suspect you are pregnant, you should not take famotidine unless your doctor thinks the benefits outweigh the risks.
Breast-feeding
If you are breast−feeding, you should either stop taking famotidine or stop breast-feeding as it is excreted in breast milk.
Driving and using machines Whilst taking famotidine you may feel dizzy or have a headache. If you develop these symptoms, you should not drive or operate machinery or do activities which require you to be alert and have quick reactions.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• These tablets are to be taken orally.
• The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
• Famotidine can be taken with or without food.
Adults and Elderly Stomach Ulcers
• The recommended dose is 40mg once a day at night.
• The duration of treatment will normally be between 4−8 weeks. In most cases the ulcer will heal with this treatment within 4 weeks. If your ulcer has not healed completely, treatment may be continued for another 4 weeks.
• For treatment of a recurrent ulcer, the recommended dose is 20mg at night.
Zollinger−Ellison Syndrome
The recommended dose is 20mg every six hours. The dosage should then be adjusted.
Reflux Oesophagitis
• The recommended dose for treating mild symptoms is 20mg twice a day.
• The recommended dose for treating mild to moderate symptoms is 40mg twice a day.
• Treatment should be continued for 6−12 weeks.
Patients with Kidney disorders/on dialysis • If you suffer from kidney disorders, your doctor is likely to reduce your dose.
• Famotidine should be administered at the end of dialysis or after since some of the active ingredient is removed by dialysis.
Use in children Famotidine is not recommended for children.
If you take more Famotidine than you should If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.
If you forget to take Famotidine Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.
If you stop taking Famotidine It is important that you keep taking Famotidine for as long as your doctor has told you to.
In case of long-standing ulcer disease, abrupt withdrawal after symptom relief should be avoided.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek medical advice immediately if you develop the following symptoms: • allergic reactions : swelling of the face throat or tongue, difficulty in breathing or dizziness (anaphylaxis)
• difficulty in breathing or wheezing (bronchospasm)
• severe blistering of the skin, mouth, eyes and genitals (Stevens Johnson syndrome, toxic epidermal necrolysis)
• shortness of breath or dry cough due to inflammation of the lungs (interstitial pneumonia)
• swelling of the deeper layers of the skin caused by a build-up of fluid (angioneurotic oedema)
Common side effects (may affect up to 1 in 10 people)
• headache
• dizziness
• constipation
• diarrhoea
Uncommon side effects (may affect up to 1 in 100 people)
• feeling and/or being sick (nausea/vomiting)
• abdominal pain
• excessive wind/feeling bloated (flatulence)
• tiredness (fatigue)
• dry mouth
• loss of appetite (anorexia)
• taste disorder
• severe itching (pruritus)
• rash
• skin rashes with the formation of wheals (urticaria)
Rare side effects (may affect up to 1 in 1,000 people)
• an increase in liver enzymes in the blood (detected through blood tests)
Very rare side effects (may affect less than 1 in 10,000 people)
• reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
• reduction in white blood cells (leukopenia, neutropenia),
• reduction in white blood cells which may make infections more likely (agranulocytosis)
• reduction in blood cells which can cause weakness, bruising or make infections more likely (pancytopenia)
• reversible psychic disturbances including: • hallucinations (seeing or hearing things that are not real)
• disorientation
• confusion
• anxiety disorders
• restlessness (agitation)
• depression
• disorders of sexual function (reduced libido)
• difficulty in sleeping (insomnia)
• inability to maintain an erection (impotence)
• tingling or numbness in the hands or feet (paraesthesia)
• sleepiness or drowsiness (somnolence)
• fits (convulsions), epileptic seizures including grand mal seizures (particularly in patients with kidney problems)
• hair loss (alopecia)
• chest tightness
• muscle cramps
• joint pain (arthralgia)
• inflammation of liver (hepatitis)
• yellowing of the skin and whites of the eyes (jaundice)
• abnormal liver function tests
• worsening of existing liver disease
• abnormal heart rhythm where the heart beats too slowly (AV block)
• disrupted heart rhythm/irregular heartbeat (arrhythmias)
• heart rhythm condition that may cause a fast heartbeat (QT prolongation) (especially in patients with impaired kidney function)
Other side effects
• enlargement of breasts in men (gynaecomastia) (not known if caused by Famotidine)
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton/blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Famotidine Tablet contains • Each 20mg film-coated tablet contains 20mg of famotidine.
• Each 40mg film-coated tablet contains 40mg of famotidine.
The other ingredients are: microcrystalline cellulose, pregelatinised starch, hydroxypropylcellulose, magnesium stearate, purified water.
20 mg Film coating ingredients: macrogol poly(vinyl alcohol) grafted copolymer, talc, glycerol monocaprylocaprate type I, poly(vinyl alcohol), titanium dioxide (E171), iron oxide red (E 172), iron oxide black (E 172), iron oxide yellow (E 172) and purified water.
40 mg Film coating ingredients: macrogol poly(vinyl alcohol) grafted copolymer, talc, glycerol monocaprylocaprate type I, poly(vinyl alcohol), titanium dioxide (E171), quinoline yellow aluminium lake (E 104), and purified water.
What Famotidine Tablet looks like and contents of the pack: Famotidine 20 mg are brown, round film-coated tablets, scored on one side.
Famotidine 40 mg are yellow, round film-coated tablets, scored on one side.
Famotidine is available in: Famotidine Tablets are available in packs of 5, 7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 90, 98 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation holder :
Dr. Reddy's Laboratories (UK) Ltd.
410 Cambridge Science Park
Milton Road
Cambridge
CB4 0PE
United Kingdom
Manufacturer:
Remedica Ltd.
Aharnon Street
Limassol Industrial Estate
3056 Limassol
Cyprus
This leaflet was last revised in June 2024 .
Dr. Reddy's Laboratories (UK) Ltd
Address
Dr. Reddy's Laboratories (UK) Limited, 410 Cambridge Science Park, Milton Road, Cambridge, CB4 0PE, UK
Telephone
+44 (0)1223 728 010
Medical Information Direct Line
+44 (0)1748 828 873
Medical Information e-mail
[email protected]
Customer Care direct line
+44 (0)1223 651 475
WWW
http://www.drreddys.com/united-kingdom
E-mail
[email protected]
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Famotidine 40 mg Film-coated Tablets comes as tablet containing 40mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Famotidine 40 mg Film-coated Tablets is famotidine.
Medicines with the same active substance, strength and form include: Famotidine 40 mg Film-coated Tablets, Famotidine 40 mg film coated tablet, Famotidine 40 mg film-coated tablets. In total there are 8 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Famotidine 40 mg Film-coated Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Duodenal ulcers and prevention of relapses of duodenal ulceration.
Benign gastric ulcers.
Zollinger-Ellison syndrome.
Symptomatic treatment of mild to moderate reflux oesophagitis.
Posology
Adults
Duodenal ulcers - The initial recommended dose is 40 mg of famotidine to be taken at night. Healing generally occurs in most patients within 4 weeks. This period, however, may be shortened if an endoscopic examination reveals that the ulcer has healed. However, in those patients whose ulcers have not healed within this 4 week period, treatment should continue for a further 4 weeks.
Prevention of relapses of duodenal ulceration - To prevent ulcers from reoccurring the recommended dose is 20 mg of famotidine to be taken at night.
Benign gastric ulcers - The recommended dose of 40 mg of famotidine to be taken at night. Treatment should continue for between 4-8 weeks unless earlier healing is revealed by endoscopy.
Zollinger-Ellison syndrome - Patients who are not receiving any antisecretory therapy should be started on a dose of 20mg of famotidine every 6 hours. The dosage should then be adjusted to individual response. Doses up to 800 mg daily have been used up to one year without the development of significant adverse effects or tachyphylaxis.
If the desired inhibition of acid secretion cannot be attained with a daily dosage of 800 mg, alternative treatment should be considered to regulate acid secretion, since no long-term experience with dosages of more than 800 mg of famotidine/day have been recorded.
Treatment should be continued for as long as necessary. Patients who have been receiving other H2-receptor antagonist treatment may be switched directly to famotidine treatment at a higher dosage than the initial dosage that is usually recommended. The starting dosage will depend on the severity of the condition and the size of the last dose of H2-antagonist previously used.
Symptomatic treatment of mild to moderate oesophagitis - The recommended dose in case of mild oesophagitis is 20 mg of famotidine twice daily. In case of mild to moderate oesophagitis, the recommended dose is 40 mg twice daily. Generally, treatment should be conducted for 6 weeks. If the condition has not improved, treatment should be continued for a further 6 weeks.
Renal impairment:
Famotidine is primarily eliminated via the kidneys. For patients with impaired renal function in whom creatinine clearance is less than 30 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 dosages that are reduced by 50%. Famotidine 20 mg tablets should be administered at the end of dialysis or thereafter since some of the active ingredient is removed by dialysis.
Elderly:
The dosage regimen recommended for elderly patients is the same as for adults.
Paediatric population:
The efficacy and safety of famotidine in children have not been established.
Method of administration
For oral use.
Famotidine tablets can be taken with or without food (see section 5.2).
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.
Gastric neoplasm
The presence of gastric malignancy should be excluded prior to the use of famotidine for the treatment of gastric ulcers. Symptomatic responses of gastric ulcers following treatment with famotidine do not preclude the presence of gastric malignancy.
Renal insufficiency
As famotidine is excreted primarily via the kidneys, caution should be exercised when treating patients who are suffering from impaired renal function. A reduction in the daily dose to 20 mg at night should be considered if creatinine clearance falls below 10 ml/min (see section 4.2).
Paediatric population
The safety and efficacy for the use of Famotidine in children has not been established.
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.
No clinically important drug interactions have been identified.
Famotidine does not interact with the cytochrome P450 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.
Indocyanide 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 stabilised 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.
Iterations of gastric pH may affect the bioavailability of certain drugs, resulting in a decrease in the absorption of atazanavir. The absorption of ketoconazole and itraconazole could be reduced. Ketoconazole should be administered two hours before famotidine.
Probenecid inhibits the renal tubular secretion of famotidine and has been shown to cause a 50% increase in famotidine plasma concentrations. Therefore, concomitant use of probenecid and famotidine should be avoided.
Concomitant use of famotidine and antacids could reduce the famotidine absorption and lead to lower plasma levels of famotidine. Therefore, famotidine should be administered 1-2 hours before taking an antacid.
Concomitant use of sucralfate inhibits the absorption of famotidine. Therefore, sucralfate should not be administered within 2 hours of the famotidine dose.
Risk of loss of efficacy of calcium carbonate when co-administered as phosphate binder with famotidine in haemodialysis patients.
Co-administration of posaconazole oral-suspension with famotidine should be avoided if possible, since famotidine may reduce the absorption of posaconazole oral-suspension during concomitant use.
Co–administration of famotidine with the tyrosine kinase inhibitors (TKIs) dasatinib, erlotinib, gefitinib, pazopanib may decrease plasma concentrations of TKIs resulting in lower efficacy, therefore co-administration of famotidine with these TKIs is not recommended. For further specific recommendations please refer to the product information of individual TKI medicinal products.
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.
Breast-feeding
Famotidine is excreted in human breast milk. Therefore, breast-feeding mothers should either stop taking famotidine or stop breast-feeding.
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).
Famotidine has been demonstrated to be generally well-tolerated.
Adverse reactions are ranked under the heading of frequency, the most frequent first, using the following convention:
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).
System Organ Class
Frequency: Adverse drug reactions
Blood and lymphatic system disorders
Very rare: Thrombocytopenia, Leukopenia, Agranulocytosis, Pancytopenia, Neutropenia
Immune system disorders
Very rare: Hypersensitivity reactions (angioneurotic oedema, anaphylaxis, bronchospasm)
Metabolism and nutrition disorders
Uncommon: Loss of appetite (anorexia)
Psychiatric disorders
Very rare: Reversible psychological 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, Convulsions, Grand mal seizures (particularly in patients with impaired renal function)
Cardiac disorders
Very rare: AV block with H2-receptor antagonists administered intravenously, Arrhythmias, QT prolongation (especially in patients with impaired renal function)
Respiratory, thoracic and mediastinal disorders
Very rare: Interstitial pneumonia, sometimes fatal
Gastrointestinal disorders
Common: Constipation, Diarrhoea
Uncommon: Nausea and or vomiting, Abdominal discomfort or distension, Flatulence, Dry mouth
Hepatobiliary disorders
Very rare: Hepatitis, Cholestatic jaundice, Liver enzyme abnormalities, Isolated cases of worsening of existing hepatic disease
Skin and subcutaneous tissue disorders
Uncommon: Rash, Pruritus, Urticaria
Very rare: Alopecia, Stevens Johnson syndrome/toxic epidermal necrolysis sometimes fatal
Musculoskeletal and connective tissue disorders
Very rare: Muscle cramps, Arthralgia
Reproductive system and breast disorders
Very rare: Impotence
General disorders and administration site conditions
Uncommon: Fatigue
Very rare: Chest tightness
Investigations
Rare: Increase in laboratory values (transaminases, gamma GT, alkaline phosphatase, bilirubin)
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
The adverse reactions in overdose cases are similar to the adverse reactions encountered in normal clinical experience (see section 4.8).
In the event of overdose the usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring and supportive therapy should be employed.
Patients suffering from Zollinger-Ellison syndrome have tolerated doses of up to 800 mg/day. These patients have been treated for more than a year without the development of any significant adverse effects.
Ask anything about Famotidine 40 mg Film-coated Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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