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Document: leaflet MAH GENERIC_PL 21880-0100 change

• leaflet MAH GENERIC_PL 08553-0187
• leaflet MAH GENERIC_PL 21880-0100

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zatidine 150 mg & 300 mg Capsules

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 further questions, please ask your doctor or pharmacist.

•    This medicine has been prescribed for you personally and you should not pass it on to others.

It may harm them, even if their symptoms are the same as yours.

In this leaflet:

1.    Nizatidine; What it is and what it's used for

2.    Before you take Nizatidine

3.    How to take Nizatidine

4.    Possible side effects

5.    Storing Nizatidine

The name of your medicine is Nizatidine 150 mg or 300 mg Capsules.

•    The active ingredient is nizatidine.

•    Other ingredients are pregelatinised starch, dimeticone, povidone, magnesium stearate, gelatin, titanium dioxide (E171), red, black and yellow iron oxide (E172) and shellac.

NIZATIDINE; WHAT IT IS AND WHAT IT'S USED FOR

Each capsule contains either 150 or 300 mg of nizatidine. Nizatidine belongs to a group of medicines called H₂ antagonists, which reduce the amount of acid in the stomach

The 150 mg capsules are available in pack sizes of 30 capsules.

The 300 mg capsules are available in pack sizes of 30 capsules Your medicine is used to treat ulcers of the stomach and small intestine (duodenum), including those caused by non-steroidal anti-inflammatory drugs (NSAIDS) e.g. ibuprofen, diclofenac.

It is also used to prevent these ulcers from recurring and in the treatment of reflux disease (heartburn).

2. BEFORE YOU TAKE NIZATIDINE Do not take nizatidine if you:

•    Are allergic to any of the ingredients in your medicine or have a known sensitivity to H₂-receptor antagonists e.g. cimetidine.

Take special care with nizatidine if you have:

•    kidney problems

•    Liver problems.

Pregnancy and Breast-feeding:

•    Nizatidine is not recommended if you are pregnant, breast-feeding, or planning on becoming pregnant.

Be careful if you are taking:

•    Very high doses of salicylates e.g. aspirin, as nizatidine may increase their absorption leading to higher than expected blood levels.

3. HOW TO TAKE NIZATIDINE

Your doctor has decided the dose which is suited to you. Always follow your doctor's instructions and those which are on the pharmacy label.

If you do not understand these instructions, or you are in any doubt, ask your doctor or pharmacist.

The capsules should be swallowed with a drink of water.

The usual doses are:

ADULTS:

For the treatment of ulcers of the stomach or small intestine:

One 300 mg capsule of nizatidine taken as a single dose every evening or one 150 mg capsule taken in the morning and evening.

Treatment will last for four to eight weeks depending on how fast healing occurs.

For the treatment of ulcers caused by NSAIDs use:

One 300 mg capsule of nizatidine taken as a single dose every evening or one 150 mg capsule taken in the morning and evening.

Treatment will last for up to eight weeks. NSAIDS can still be used during ulcer treatment.

For the prevention of ulcer recurrence:

One 150 mg capsule every evening.

For the treatment of reflux disease:

Either one 150 mg capsule twice a day or one 300 mg capsule of nizatidine twice a day. Treatment may last for up to 12 weeks.

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CHILDREN:

Not recommended.

PATIENTS WITH KIDNEY PROBLEMS:

If you have moderate or severe kidney problems your doctor may advise a lower dose.

If you take more Nizatidine than you should

If you (or someone else) swallow a lot of the capsules all together, or if you think a child has swallowed any of the capsules, contact your nearest hospital casualty department or your doctor immediately. Overdose may cause excess production of tears, increased saliva production, vomiting, constriction of the pupils of the eyes and diarrhoea.

If you forget to take Nizatidine

If you forget to take a capsule take one as soon as you remember, unless it is nearly time to take the next one. Never take two doses together.

Take the remaining doses at the correct time.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, nizatidine can have side effects.

The most common side effects are:

•    Increased sweating

•    Skin rash (nettle rash or hives).

The following have also been reported:

Liver problems including

•    Jaundice (yellowing of the skin and whites of the eyes)

•    Hepatitis (Inflammation of the liver).

Rarely allergic reactions have occurred. Tell your doctor immediately if you experience any of the following symptoms:

•    Difficulty in breathing

•    Swelling of the face, tongue or throat

•    Rash, itching

•    Blood problems (a bruise-like rash, unusual bleeding or unexplained bruising).

The following rare side effects have also been reported but may not be directly due to nizatidine:

•    Blood disorders, gout and blood vessel inflammation

•    Joint pain, muscle pain

•    Dermatitis (causing itchy, flaking skin)

•    Breast enlargement in men

•    Impotence

•    Fever

•    Feeling sick

•    Confusion.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5.    STORING NIZATIDINE

Keep out of the reach and sight of children.

Store in the package supplied. Do not transfer the capsules to another container. Do not use nizatidine after the expiry date shown on the outer packaging. Return all unused medicines to your pharmacist for safe disposal.

Revised: October 2010.

PL No.: 21880/0100 and PL No.: 21880/0101

POM