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Famotidine 20 mg Film-coated Tablets

Active Ingredient:
famotidine
Company:  
Dr. Reddy's Laboratories (UK) Ltd See contact details
ATC code: 
A02BA03
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About Medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 26 Sep 2024

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 08553/0764.

Famotidine 20 mg, 40 mg Film-coated Tablets

Package leaflet: Information for the patient

Famotidine 20 mg Film-coated Tablets

Famotidine 40 mg Film-coated Tablets

famotidine

Famotidine 20 mg/40 mg Film-coated Tablets will also be referred to in this leaflet as Famotidine.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Famotidine is and what it is used for
2. What you need to know before you take Famotidine
3. How to take Famotidine
4. Possible side effects
5. How to store Famotidine
6. Contents of the pack and other information

1. What Famotidine is and what it is used for

Famotidine belongs to a group of medicines called H2−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)

2. What you need to know before you take Famotidine
Do not take Famotidine if:
  • you are allergic to famotidine, other H2−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.

3. How to take Famotidine

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.

4. Possible side effects

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.

5. How to store Famotidine

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.

6. Contents of the pack and other information
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
Company image
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