Famotidine 20mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Famotidine 20mg and 40mg Tablets
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 this medicine 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 this medicine 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)
• 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)
• You are breast feeding
Warnings and precautions
Talk to your doctor before taking Famotidine if:
• There is a possibility of a malignant growth (tumour) being present in your stomach
• There is an underlying infection e.g. Helicobacter Pylori
• You suffer from kidney problems
Your doctor may monitor your blood count and liver function if you have been taking a high dose of Famotidine for a long time.
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
• Ketoconazole or Itraconazole, used to treat fungal infections
• Probenicid, used to treat gout
• Antacids, for indigestion
• Sucralfate, used to treat and prevent the recurrence of ulcers
• 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.
Famotidine contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3 How to take Famotidine
Always take Famotidine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• These tablets are to be taken orally with some liquid.
• The score line is only there to help you break the tablet if you have difficulty swallowing it whole. The tablets can be divided, but must not be crushed or chewed.
Adults and Elderly
Stomach Ulcers
• The recommended dose is 40mg once a day at bedtime.
• 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, your doctor may decide it is necessary to take 20mg a day at bedtime.
Zollinger-Ellison Syndrome
The recommended dose is 20mg every six hours. Some patients may require higher doses. Your doctor will decide if this is necessary.
Reflux Oesophagitis
• The recommended dose for treating the symptoms of this condition is 20mg twice a day, to be taken for as long as is deemed necessary.
• For treatment of an ulcer associated with this condition, the recommended dose is 40mg twice a day to be taken for 6-8 weeks.
• If long-term treatment is required, the recommended dose is 20mg twice a day. This is not usually recommended beyond 6 months.
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 later since some of the active ingredient is removed by dialysis.
Use in children
Famotidine are not recommended for children.
If you taken 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 your 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, Famotidine 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 or being sick (nausea/vomiting)
• Abdominal pain
• Excessive wind/feeling bloated (flatulence)
• Tiredness (fatigue)
• Dry mouth (xerostomia)
• 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)
• Build up of bile acids in the bloodstream causing persistent itch (cholestasis)
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
• Inability to maintain an erection (impotence)
• Disorders of sexual function (reduced libido)
• Tingling or numbness in the hands or feet (paraesthesia)
• Sleepiness or drowsiness (somnolence)
• Difficulty in sleeping (insomnia)
• Fits (convulsions), epileptic seizures including gran mal seizures (particularly in patients with kidney problems)
• Hair loss (alopecia)
• Chest tightness
• Muscle cramps
• Joint pain (athralgia)
• Inflammation of liver (hepatitis)
• Yellowing of the skin and whites of the eyes (jaundice)
• Abnormal liver function tests
• Abnormal heart rhythm where the heart beats too slowly (AV block)
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 at www.mhra.gov.uk/yellowcard. 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 Famotidine after the expiry date which is stated on the carton/blister after EXP. The expiry date refers to the last day of that month.
• Do not store above 25°C. Store in the original package.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6 Contents of the pack and other information What Famotidine 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, lactose monohydrate, macrogol 4000, magnesium stearate, hypromellose, sodium starch glycolate (type A), colloidal anhydrous silica, pregelatinized starch, talc and titanium dioxide (E171).
What Famotidine looks like and contents of the pack:
Famotidine 20 and 40mg are white, oblong, biconvex, 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.
Product Licence Numbers:
Famotidine 20mg Tablets: PL 11311/0477 Famotidine 40mg Tablets: PL 11311/0478
Marketing Authorisation Holder:
Tillomed Laboratories Ltd 3 Howard Road Eaton Socon St Neots Cambridgeshire
PE198ET UK
Manufacturer:
Salutas Pharma GmbH Otto-Von-Guericke-Allee 1 39179 Barleben Germany
This leaflet was last revised in August 2016 Till-Ver. 1.1s