TEVA UK Ref: 231-30-85105-W LEA FAMOTIDINE A/S TAB TUK Version: 2 7 May 2015

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FAMOTIDINE 20 mg AND 40 mg FILM-COATED TABLETS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you

start taking this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms 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.

IN THIS LEAFLET:

1.    What Famotidine is and what it is used for

2.    Before you take Famotidine

3.    How to take Famotidine

4.    Possible side effects

5.    How to store Famotidine

6.    Further information

OWHAT FAMOTIDINE IS AND WHAT IT IS USED FOR

Famotidine belongs to a group of medicines called histamine H2 antagonists, which reduce the amount of acid in the stomach.

Famotidine 20 mg is 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 is 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.

BEFORE YOU TAKE FAMOTIDINE

Do NOT take Famotidine if you:

• are allergic (hypersensitive) to famotidine or any of the other ingredients of famotidine • are a child.

Take special care with Famotidine

Tell your doctor before you start to take this medicine if you:

• have kidney problems (see section 3, 'How to take Famotidine', below)

• are taking atazanavir for HIV infection (see 'Taking other medicines' 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 additonal treatment for this infection to help your ulcer to heal.

Taking other medicines

Do NOT take Famotidine in combination with:

• probenecid (used to treat gout)

•    atazanavir in combination with ritonavir and tenofovir (for HIV infection).

Talk to your doctor if you are taking any of the following (also see 'Taking in combination with other medicines' in section 3, How to take Famotidine):

•    antacids used to treat indigestion, e.g. milk of magnesia

•    ketoconazole, itraconazole (used to treat severe fungal infections)

•    sucralfate (used to treat ulcers of the gut).

•    atazanavir with ritonavir (for HIV infection). Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Famotidine is not recommended during pregnancy, unless your doctor considers that the benefit outweighs the possible risk.

If you are breast-feeding, you should avoid taking Famotidine as it passes into breast milk. Ask your doctor for advice before taking any medicine.

Driving and using machines

Famotidine is not expected to affect your ability to drive or operate machines.

Important information about some of the ingredients of Famotidine

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.

^ 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. If you see another doctor or go into hospital, let the doctor or staff know what medicines you are taking. The tablets should be swallowed preferably with a drink of water.

The usual dose is:

Adults (including the elderly):

Famotidine 20 mg

•    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

•    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.

•    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.

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Treatment usually lasts for 6 weeks, but your doctor may continue your treatment for up to 12 weeks.

Patients with kidney problems

Your doctor may prescribe a lower dose. If you have severe kidney problems, the dose is usually halved.

Children:

Famotidine must not be taken by children.

How you should take Famotidine

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 if they are taken at the same time

•    Antacids:

Take Famotidine at least 1 to 2 hours before taking an antacid.

•    Ketoconazole or Itraconazole:

Take Famotidine at least 2 hours after taking Ketoconazole or Itraconazole.

•    Sucralfate:

Take Famotidine at least 2 hours before or 2 hours after taking Sucralfate.

If you take more Famotidine 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

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.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

^ POSSIBLE SIDE EFFECTS

Like all medicines, Famotidine 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:

•    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.

These are very serious but rare side effects (i.e. affects 1 to 10 users in 10,000). You may need urgent medical attention or hospitalisation.

The following side effects have been reported at the approximate frequencies shown: Common (affects less than 1 in 10 patients receiving the medicine):

•    headache

•    dizziness

•    constipation

•    diarrhoea.

Uncommon (affects less than 1 in 100 patients receiving the medicine):

•    dry mouth

•    stomach problems, nausea, vomiting, wind

•    loss of appetite

•    skin rash

•    itching

•    tiredness.

Rare (affects less than 1 in 1,000 patients receiving the medicine):

•    yellowing of the skin and whites of the eyes

•    nettle rash

•    joint pain

•    abnormal blood test results.

Very rare (affects less than 1 in 10,000 patients receiving the medicine):

•    blood disorders which may be characterised by fever or chills, sore throat, unusual bleeding or unexplained bruising, ulcers in your mouth or throat.

•    hallucinations

•    disorientation

•    confusion, anxiety, agitation

•    depression

•    pins and needles or numbness

•    sleepiness or difficulty sleeping

•    epileptic fits

•    feeling of tightness in the chest

•    hair loss

•    muscle cramps

•    impotence (inability to achieve or maintain an erection)

•    enlargement of one or both breasts in males (reversible when treatment is stopped)

•    decrease in sexual desire.

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.

HOW TO STORE FAMOTIDINE

Keep out of the reach and sight of children.

Do not use Famotidine after the expiry date which is stated on the blister and outer packaging.The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

^ FURTHER INFORMATION

What Famotidine Tablets contain:

•    The active ingredient is famotidine.

•    Each Famotidine 20 mg film-coated tablet contains 20 mg of famotidine.

•    Each Famotidine 40 mg film-coated tablet contains 40 mg of famotidine.

•    The other ingredients are pregelatinised starch, maize starch, microcrystalline cellulose, hyprolose, colloidal anhydrous silica, magnesium stearate, lactose monohydrate, hypromellose, macrogol 4000 and the colourings red and yellow iron oxide (E172) and titanium dioxide (E171).

What Famotidine Tablets look like and contents of the pack:

•    The Famotidine 20 mgTablets are beige, round, biconvex, film-coated tablets.They are marked '93' on one side and '896' on the other.

•    The Famotidine 40 mgTablets are tan, round, biconvex, film-coated tablets. They are marked '93' on one side and '897' on the other.

•    The product is available in pack sizes of 7, 14, 20, 21,28, 30, 50, 56, 60, 100 and 200 tablets. The 40 mg strength is also available in a pack size of 15 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder and company responsible for manufacture isTEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: May 2015 PL 00289/0344-0345

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