Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Famotidine 20 mg film-coated tablet
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Famotidine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Famotidine belongs to a group of medicines called histamine H2 antagonists, which reduce the amount of acid in the stomach. Famotidine 20 mg Tablets are used:
- to treat ulcers of the stomach and small intestine (duodenum)
- to prevent ulcers of the small intestine (duodenum) recurring
- to treat Zollinger-Ellison Syndrome, a condition where the stomach produces too much acid
- to treat the symptoms (e.g. heartburn) of mild reflux oesophagitis (mild inflammation of the gullet). Famotidine 40 mg Tablets are used:
- to treat ulcers of the stomach and small intestine (duodenum)
- to treat Zollinger-Ellison Syndrome, a condition where the stomach produces too much acid
- to treat mild to moderate reflux oesophagitis (mild to moderate inflammation of the gullet), a condition which causes heartburn.
What you need to know before you take it
e Famotidine Tablets
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy Experience with the use of famotidine during pregnancy is limited. If you are pregnant, you may only take Famotidine Tablets if your doctor considers the benefits of taking the tablets to be greater than the possible risks to your unborn child. Breast-feeding Famotidine, the active substance contained in Famotidine Tablets, passes into human milk. As there is no known information about the effects of famotidine on the infant when absorbed and impaired stomach acid secretion cannot be ruled out, you should not breast-feed during treatment. In consultation with your doctor, you may have to stop taking Famotidine Tablets.
Driving and using machines Some patients have experienced side effects such as dizziness and headache while taking Famotidine Tablets. You should therefore avoid driving vehicles or operating machinery or doing activities which require prompt vigilance if you experience these symptoms (see section 4. 'Possible side effects').
Do not take Famotidine Tablets –
if you are allergic to famotidine or any of the other ingredients of this medicine (listed in section 6). if you have had an allergic reaction to another histamine H2 receptor antagonist in the past, as cross sensitivity has been observed in this substance class.
Warnings and precautions Talk to your doctor before taking Famotidine Tablets:
- if you have kidney problems (see section 3, 'How to take Famotidine Tablets', below)
- if you are taking atazanavir for HIV infection (see 'Other medicines and Famotidine Tablets' below). Famotidine is not suitable for the treatment of minor, transient symptoms. Your doctor may also carry out further investigations to exclude cancer if you suffer from a gastric ulcer. Please especially report to your doctor symptoms such as:
- unintentional weight loss
- repeated vomiting
- difficulty swallowing
- vomiting blood
- looking pale and feeling weak (anaemia)
- blood in your stools. Some ulcers may be due to a bacterium called Helicobacter pylori. Your doctor will carry out some tests to determine if you need additional treatment for this infection to help your ulcer to heal.
Children No sufficient experience has been gained on the safety and efficacy of famotidine in children. Therefore children should not be treated with famotidine. Continued in the next column.
How to take it
Famotidine Tablets Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. If you see another doctor or go into hospital, let the doctor or staff know what medicines you are taking. The recommended dose is:
Adults (including the elderly) Famotidine 20 mg Tablets •
•
•
•
Treatment of ulcers of the stomach or small intestine: Two 20 mg tablets taken in the evening before going to bed. Treatment may last 4 to 8 weeks. To prevent ulcers of the small intestine recurring: One 20 mg tablet taken in the evening. Your doctor will decide how long your treatment will last. Zollinger-Ellison Syndrome: Usually one 20 mg tablet taken every 6 hours, but your doctor may adjust this dose, based on your response to the medicine. Your doctor will decide how long your treatment will last. Symptoms (e.g. heartburn) of mild reflux oesophagitis: One 20 mg tablet should be taken two times a day. Treatment usually lasts for 6 weeks, but your doctor may continue your treatment for up to 12 weeks.
Famotidine 40 mg Tablets •
Treatment of ulcers of the stomach or small intestine: One 40 mg tablet taken in the evening before going to bed. Treatment may last 4 to 8 weeks. Continued in the next page.
•
•
Zollinger-Ellison Syndrome: Usually 20 mg taken every 6 hours. For this dose Famotidine 20 mg is available. Your doctor may adjust this dose and prescribe Famotidine 40 mg for this condition, based on your response to the 20 mg tablets. Your doctor will decide how long your treatment will last. Mild to moderate reflux oesophagitis: Usually one 40 mg tablet should be taken two times a day. Your doctor may adjust this dose based on your response to treatment. Treatment usually lasts for 6 weeks, but your doctor may continue your treatment for up to 12 weeks.
Patients with impaired kidney function Your doctor may prescribe a lower dose. If you suffer from a severely impaired kidney function, the dose is usually halved.
Use in children Famotidine must not be taken by children.
How you should take Famotidine Tablets The tablets should be swallowed preferably with a drink of water.
Taking in combination with other medicines: The following medicines may affect the absorption of Famotidine Tablets if they are taken at the same time.
- Antacids: Take Famotidine Tablets at least 1 to 2 hours before taking an antacid.
- Ketoconazole or Itraconazole: Take Famotidine Tablets at least 2 hours after taking Ketoconazole or Itraconazole.
- Sucralfate: Take Famotidine Tablets at least 2 hours before or 2 hours after taking Sucralfate.
If you take more Famotidine Tablets than you should If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Famotidine Tablets If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time. Regular intake of famotidine – in accordance with the dosage recommendations and instructions of the doctor – contributes significantly to the success of treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital: Very rare: may affect up to 1 in 10,000 people
- an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives)
- a severe blistering rash in which the surface layers of the skin peel (Stevens Johnson syndrome/toxic epidermal necrolysis) You may need urgent medical attention or hospitalisation. The following side effects have been reported at the approximate frequencies shown: Common: may affect up to 1 in 10 people
- headache
- dizziness
- constipation
- diarrhoea Uncommon: may affect up to 1 in 100 people
- loss of appetite
- taste disorder
- dry mouth
- stomach problems, nausea, vomiting, excessive intestinal gas
- skin rash
- itching
- nettle rash
- tiredness Rare: may affect up to 1 in 1,000 people
- joint pain
- abnormal blood test results
Company Name
Very rare: may affect up to 1 in 10,000 people
- blood disorders which may be characterised by fever or chills, sore throat, unusual bleeding or unexplained bruising, ulcers in your mouth or throat
- depression
- anxiety
- agitation
- disorientation
- confusion
- hallucinations
- difficulty falling or staying asleep
- decrease in sexual desire
- epileptic fits
- pins and needles or numbness
- drowsiness
- a lung disease characterized by progressive scarring of the lungs (interstitial pneumonia)
- liver enzyme abnormalities
- yellowing of the skin and whites of the eyes (hepatitis)
- hair loss
- muscle cramps
- impotence (inability to achieve or maintain an erection)
- feeling of tightness in the chest
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.
How to store it
Famotidine Tablets 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 and blister after EXP. The expiry date refers to the last day of that month. This medicine 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.
Contents of the pack and other information
What Famotidine Tablets contain –
The active substance is famotidine. Each 20 mg film-coated tablet contains 20 mg of famotidine. Each 40 mg film-coated tablet contains 40 mg of famotidine. The other ingredients are microcrystalline cellulose, pregelatinised starch, hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, titanium dioxide, yellow iron oxide, red iron oxide
–
What Famotidine Tablets look like and contents of the pack Famotidine 20 mg Tablets are yellow, square, biconvex, film-coated tablets with slightly rounded edges, approximately 5.2 mm in size, debossed with "F1" on one side and plain on the other side. Famotidine 40 mg Tablets are brown, square, biconvex, film-coated tablets with slightly rounded edges, approximately 7.3 mm in size, debossed with "F2" on one side and plain on the other side. Famotidine Tablets are available in packs of 28 tablets. Marketing Authorisation Holder Celix Pharma Ltd. 12 Constance Street London, E16 2DQ United Kingdom Manufacturer Celix Pharma Ltd. 1st Floor, Building 2, Croxley Business Park, Watford, WD18 8YA United Kingdom or GMP Manufacturing Ltd, Marfleet House, Valletta Street, Hull HU9 5NP, United Kingdom
If you are blind or partially sighted and require this leaflet in a different format, call 0800 669 6825 or contact [email protected]. This leaflet was last revised in October 2024.
CEL20240006P
Product Description
Celix / OLS
Famotidine 20 and 40 mg
Celix
Version No.
Artwork Code
1
CEL20240006P
Component
Dimension
PIL
120 W x 460 H mm
Market
Font Size (Minimum)
CCR No. Artwork Creation Date
Reviewed / Approved by
UK
9 pt Font Type
Sign / Date
Dummy
Myriad Pro
04 October 2024 Colors Printing Colors (Pantone/CMYK)
Black
Technical Colors
(Non-printable colors)
Frequently asked questions about Famotidine 20 mg film-coated tablet
How do I take Famotidine 20 mg film-coated tablet?
Famotidine 20 mg film-coated tablet comes as tablet containing 20mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Famotidine 20 mg film-coated tablet?
The active substance in Famotidine 20 mg film-coated tablet is famotidine.
Are there equivalent medicines to Famotidine 20 mg film-coated tablet?
Medicines with the same active substance, strength and form include: Famotidine 20 mg Film-coated Tablets, Famotidine 20 mg Film-coated Tablets, Famotidine 20 mg film-coated tablets. In total there are 8 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Famotidine 20 mg film-coated tablet, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Famotidine 20 mg film-coated tablet without a prescription?
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.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: famotidine
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
- Prevention of recurrent duodenal ulcers
- Duodenal ulcer
- Benign gastric ulcer
- Zollinger-Ellison syndrome
- Symptomatic treatment of mild reflux oesophagitis
4.2. Posology and method of administration
Posology
Adults and the elderly
Duodenal ulcers and benign gastric ulcers
40 mg of famotidine once before going to bed.
Prophylactic treatment of recurrent duodenal ulcers
20 mg of famotidine in the evening.
Zollinger-Ellison syndrome
If no preceding treatment with medicines which inhibit secretion has been conducted, the therapy of the Zollinger-Ellison syndrome should be initiated with 20 mg famotidine every 6 hours. For further treatment doses have to be adjusted according to the extent of acid secretion and the patient's clinical response until acid secretion has been reduced to an acceptable level (e.g. <10 mEq/h the hour before the next famotidine dose).
If a dosage of 800 mg/d does not result in sufficient inhibition of acid secretion, an alternative therapy for the regulation of acid secretion should be considered, because there are no experiences with the long-term application of doses higher than 800 mg famotidine/d.
The therapy should be continued as long as it is clinically necessary.
Patients who have been previously treated with other H2-receptor-antagonists can change immediately to a higher initial dose than that recommended for new patients. The initial dose is dependent on the severity of the clinical picture and on the dose of medication taken prior to the change of medicine.
Symptomatic treatment of mild reflux oesophagitis
A twice daily dose of one 20 mg famotidine is recommended.
Renal impairment
Famotidine is mainly excreted via the kidneys. In patients with impaired kidney function whose creatinine clearance amounts to less than 30 ml/min (serum creatinine above 3.0 mg/100 ml) a reduction of the daily dose to 50% is recommended.
For patients under dialysis a reduction of the daily dose to 50% is recommended as well. Famotidine 20 mg film-coated tablets should be given at the end or after dialysis, because part of the active ingredient will be removed in the course of dialysis.
Method and duration of administration
Famotidine 20 mg Film-coated Tablets should be swallowed whole with some liquid. The film-coated tablets may be taken independently of meals.
Prophylactic treatment of recurrent duodenal ulcers
With regards to the maintenance therapy for preventing the recurrence of duodenal ulceration, the recommended maintenance dose of 20 mg has been continued effectively in clinical studies of 12 months duration.
Duodenal ulcers and benign gastric ulcers
The treatment of duodenal ulcers and benign gastric ulcers should be conducted for 4 to 8 weeks. The period of time can be shorter if a healing of the ulcer can be endoscopically proved. In case the ulcers do not endoscopically heal after 4 weeks the treatment should be continued for another 4 weeks.
Zollinger-Ellison syndrome
The treatment should be continued as long as it is clinically necessary.
Symptomatic treatment of mild reflux oesophagitis
Generally, treatment should be conducted for 6 weeks, if necessary 12 weeks.
Paediatric population
The safety and efficacy of Famotidine 20 mg Film-coated Tablets in children has not been established. Therefore, children should not be treated with Famotidine 20 mg Film-coated Tablets.
4.3. Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Patients with a history of hypersensitivity to other H2-receptor antagonists.
4.4. Special warnings and precautions for use
Gastric neoplasm
Gastric malignancy should be excluded prior to initiation of therapy of gastric ulcer with famotidine. Symptomatic response of gastric ulcer to famotidine therapy does not preclude the presence of gastric malignancy.
Renal impairment
Since famotidine is excreted primarily by the kidney, caution should be observed in patients with impaired renal function. A reduction in daily dosage should be considered if creatinine clearance falls below 30 ml/min (see section 4.2).
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.
In patients with duodenal and benign gastric ulcers the H. pylori-status should be determined. For H. pylori-positive patients, removal of the bacterium H. pylori by means of eradication therapy should be striven for whenever possible.
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.
4.5. Interaction with other medicinal products and other forms of interaction
No drug interactions of clinical importance have been identified.
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 an altered absorption.
The absorption of ketoconazole and itraconazole could be reduced. Ketoconazole should be given 2 hours before famotidine administration.
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.
Antacids may decrease the absorption of famotidine and lead to lower plasma concentrations of famotidine. Famotidine should therefore be taken 1-2 hours before the application of an antacid.
The administration of probenecid can delay the elimination of famotidine. Concomitant use of probenecid and famotidine should be avoided.
The concomitant use of sucralfate should be avoided within two hours of the famotidine dose.
Risk of loss of efficacy of calcium carbonate when co-administered as phosphate binder with famotidine in haemodialysis patients.
If famotidine, atazanavir and ritonavir are co-administered, a dose of 20 mg famotidine should not be exceeded. If a higher dose of famotidine is required (e.g. famotidine 40 mg) dose adjustment of atazanavir and ritonavir may be considered. Co-administration of famotidine, atazanavir, ritonavir and tenofovir should be avoided. If the combination of famotidine, atazanavir, ritonavir and tenefovir is judged unavoidable, close clinical monitoring is recommended.
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.
4.6. 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.
Breast-feeding
Famotidine is detectable in human milk. Nursing mothers should either stop this drug or stop nursing.
4.7. 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).
4.8. Undesirable effects
Tabulated list of adverse reactions
Frequencies are defined as common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
System Organ Class
Common
Uncommon
Rare
Very rare
Blood and lymphatic system disorders
Leukopenia, thrombocytopenia, neutropenia, agranulocytosis, pancytopenia
Immune system disorders
Hypersensitivity reactions (anaphylaxis, angioneurotic oedema, bronchospasm)
Metabolism and nutrition disorders
Anorexia
Psychiatric disorders
Reversible psychic disturbances including depression, anxiety disorders, agitation, disorientation, confusion, hallucinations, insomnia
Nervous system disorders
Headache, dizziness
Convulsions, grand mal seizures (particularly in patients with impaired renal function), paresthesia, drowsiness, somnolence
Respiratory, thoracic and mediastinal disorders
Interstitial pneumonia sometimes fatal
Gastrointestinal disorders
Constipation, diarrhoea
Dry mouth, nausea and/or vomiting, abdominal discomfort or distension, flatulence,
Hepatobiliary disorders
Liver enzyme abnormalities, hepatitis, cholestatic jaundice
Skin and subcutaneous tissue disorders
Rash, pruritus, urticaria
Alopecia, Stevens Johnson syndrome/toxic epidermal necrolysis sometimes fatal
Musculoskeletal and connective tissue disorders
Arthralgia
Muscle cramps
Reproductive system and breast disorders
Impotence, reduced libido
General disorders and administration site conditions
Fatigue
Chest tightness
Investigations
Increase in laboratory values (transaminases, gamma-GT, alkaline phosphatase, bilirubin)
Adverse effects - causal relationship unknown
Rare cases of gynaecomastia, 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
The adverse reactions in overdose cases are similar to the adverse reactions encountered in normal clinical experience (see section 4.8).
Patients with Zollinger-Ellison syndrome have tolerated doses up to 800 mg/day for more than a year without development of significant side effects.
The usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed.
💬 Ask about this leaflet
Ask anything about Famotidine 20 mg film-coated tablet. 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.
Medicines containing Famotidine
- Famotidine 20 mg film-coated tablets
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- Famotidine 20mg film-coated tablets
- Famotidine 20mg Tablets
- Famotidine 40 mg film coated tablet
- Famotidine 40 mg film-coated tablets
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