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)

• 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 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.

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.

• 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 are 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 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 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:

o Hallucinations (seeing or hearing things that are not real)

o Disorientation

o Confusion

o Anxiety disorders

o Restlessness (agitation)

o Depression

o Disorders of sexual function (reduced libido)

o 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 at

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 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 in order to protect from light and moisture.

• 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 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

220 Butterfield

Great Marlings

Luton

LU2 8DL

Manufacturer:

Kleva Pharmaceuticals S.A

189 Parnithos Ave,

13675 Acharnai-Attiki

Greece

This leaflet was last revised in August 2023

Till−Ver.6