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PATIENT INFORMATION LEAFLET

Famotidine 20mg and 40mg Film-coated Tablets

What this medicine is and what it is used for

Famotidine Tablets belong to a group of medicines called H2-receptor antagonists. These work by work by reducing the amount of acid you produce in your stomach.

Famotidine Tablets are 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)

Before you take

Do not take Famotidine Tablets:

■    If you are allergic (hypersensitive) to Famotidine, other H2-receptor antagonists or any of the other ingredients in the tablets (these are listed in Section 6, Further information)

■    If you are pregnant, planning to become pregnant or you suspect you are pregnant or if you are breast feeding

Take special care with Famotidine - Tell your doctor if any of the following apply to you:

■    If there is a possibility of a malignant growth (tumour) being present in your stomach

■    If there is an underlying infection e.g.

Helicobacter Pylori

■    If 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 Tablets for a long time.

Taking other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

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 suspect you are pregnant, you should not take Famotidine Tablets unless your doctor thinks the benefits outweigh the risks.

If you are breast-feeding, you should either stop taking Famotidine Tablets or stop breast-feeding as it is excreted in breast milk.

Ask your doctor for advice before taking any medicine.

Driving & using machinery

Whilst taking Famotidine Tablets you may feel dizzy or have a headache. If you have these symptoms, you should not drive, operate machinery or do activities which require you to be alert and have quick reactions.

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

Always take Famotidine as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

■ Famotidine tablets should be swallowed whole (not crushed or chewed) and with sufficient fluid (e.g. water).

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. 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 Reflux Oesophagitis, the recommended dose is 40mg twice a day to be taken for 6-8 weeks.

If long-term treatment of Reflux Oesophagitis 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 tablets should be administered at the end of dialysis or later since some of the active ingredient is removed by dialysis.

Do not change your dose unless your doctor tells you to do so.

Children

Famotidine Tablets are not recommended for children.

Continued....

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If you taken more Famotidine Tablets 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 FamotidineTablets

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 tablet.

If you stop taking/using Famotidine Tablets

It is important that you keep on taking Famotidine Tablets until the prescribed dose has finished. Do not stop taking the tablets even though you may feel better, especially if you have had ulcer disease for a long time. Do not stop or change your treatment before talking to your doctor.

■    Depression

■    Inability to maintain an erection (Impotence)

■    Disorders of sexual function

■    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). Symptoms include tiredness, pains in the abdomen, muscle and joint aches and yellowing of the skin and whites of the eyes (Jaundice)

■    Abnormal liver function tests

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

If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Possible side effects

Like all medicines, Famotidine Tablets can cause side effects, although not everybody gets them.

Stop taking Famotidine Tablets and seek medical advice immediately if you develop the following symptoms:

Allergic reactions

■    Swelling of the face or throat

■    Difficulty in breathing or dizziness (Anaphylaxis)

■    Difficulty in breathing or wheezing (Bronchospasm)

■    Itching

■    Rash

■    Skin rashes with the formation of wheals (Urticaria)

Other serious side effects (very rare)

■    Blistering of the skin, mouth, eyes and genitals (Stevens Johnson syndrome)

■    Blistering of the skin, which can sometimes be fatal (Toxic epidermal necrolysis)

■    Shortness of breath or dry cough due to inflammation of the lungs, which can sometimes be fatal (Interstitial pneumonia)

Common side effects (affects 1-10 users in 100)

■    Headache

■    Dizziness

■    Constipation

■    Diarrhoea

Uncommon side effects (affects 1-10 users in 1000)

■    Feeling or being sick (Nausea/Vomiting)

■    Abdominal pain

■    Excessive wind/feeling bloated (Flatulence)

■    Tiredness (Fatigue)

■    Dry mouth (Xerostomia)

■    Loss of appetite

■    Taste disorder

Rare side effects (affects 1-10 users in 10,000)

■    Enlargement of breasts in men (not known if caused by Famotidine)

Very rare side effects (affects less than 1 user in 10,000)

■    Blood disorders

-    reduction in blood platelets, which increases risk of bleeding or bruising

-    reduction in white blood cells, which may make infections more likely

-    reduction in blood cells which can cause weakness, bruising or make infections more likely

■    Reversible psychic disturbances    including

hallucinations (seeing or hearing    things that are

not real)

■    Disorientation

■    Confusion

■    Anxiety disorders

■    Restlessness (Agitation)

Keep out of the reach and sight of children.

Store in the original package. Do not store above 25°C.

Do not use Famotidine Tablets after the expiry date which is stated on the carton/blister after "EXP". The expiry date refers to the last day of that month. 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 contains:

The active ingredient in each tablet is:

Famotidine 20mg Tablets: 20mg of Famotidine Famotidine 40mg Tablets: 40mg of Famotidine

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: white, oblong, biconvex tablet, scored on one side.

Famotidine is available in:

Famotidine 20 and 40mg Tablets are available in packs of:

5, 7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 90, 98, 100

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Tillomed Laboratories Ltd.,

3 Howard Road, Eaton Socon,

St Neots, Cambs, PE19 8ET,

UK

Manufacturers:

Salutas Pharma GmbH Otto-Von-Guericke-Allee 1 39179 Barleben Germany

Product Licence Numbers:

Famotidine 20mg Tablets: PL 11311/0477 Famotidine 40mg Tablets: PL 11311/0478

This leaflet was revised in August 2010.