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Package leaflet: Information for the user

Axid Capsules 150mg & 300mg

Nizatidine

The name of your medicine is Axid Capsules 150mg & 300mg, which will be referred to as Axid capsules throughout this document.

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 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.

In this leaflet:

1.    What Axid capsules are and what they are used for

2.    Before you take Axid capsules

3.    How to take Axid capsules

4.    Possible side effects

5.    How to store Axid capsules

6.    Further information

What Axid capsules are and what they are used for

Axid capsules contain the active ingredient nizatidine, which is one of a group of medicines known as H2 receptor antagonists. Axid capsules are used to reduce gastric acid (a digestive acid produced by the stomach). This helps to treat the following conditions: Duodenal ulcer (the duodenum is the part of the intestine leaving the stomach)

Non-cancerous (benign) stomach (gastric) ulcer

To prevent the return of a duodenal or benign gastric ulcer

Heartburn caused by acid from the stomach leaking up into the oesophagus [gullet] (gastric oesophageal reflux disease)

Gastric and/or duodenal ulcer caused by a type of painkiller such as ibuprofen (a nonsteroidal anti-inflammatory drug).

2 Before you take Axid capsules

Do not take Axid capsules if

you are allergic (hypersensitive) to nizatidine, H2 receptor antagonists (other similar drugs) or any of the other ingredients of Axid capsules (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

Take special care with Axid capsules if you

have a liver or kidney disorder respond to treatment but have other symptoms such as loss of appetite, weight loss, feeling tired all the time or notice blood in your stool.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. This is especially important of the following, as they may interact with your Axid capsules: aspirin (this can be bought without prescription).

It may still be all right for you to be given Axid capsules and your doctor will be able to decide what is suitable for you.

Pregnancy and breast-feeding

You should tell your doctor if you are pregnant, planning to become pregnant, or are breast-feeding because you should not normally take Axid if you are. Ask your doctor for advice before taking any medicine.

Driving and using machines

Axid capsules should have no effect on your ability to drive or use machines.

3 How to take Axid capsules

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

Dosage

Adults and the elderly

For treatment of duodenal ulcer, the usual daily dose is 300 mg taken orally in the eveningfor 4 weeks. The same dose is used for the treatment of benign gastric ulcer, but may continue for 8 weeks. If preferred, the 300mg daily dose may be given as 150mg in the morning and evening.

To prevent a duodenal or benign gastric ulcer recurring, the usual daily dose is 150mg in the evening.

For the treatment of heartburn, the dose is 150mg to 300mg twice daily, for up to 12 weeks.

For the treatment of gastric and/or duodenal ulcer caused by non-steroidal antiinflammatory drugs, the usual daily dose is 300mg (either 300mg at bedtime or 150mg in the morning and in the evening) for up to 8 weeks.

Children

Axid capsules are not recommended for children.

Patients with kidney disorders will need a reduced dose depending on their condition.

If you take more Axid capsules than you should

Tell your doctor straight away.

If you forget to take Axld capsules

If you miss a dose, take one as soon as you can. If you have missed several doses, tell your doctor.

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

Possible side effects

Like all medicines, Axid capsules can cause side effects, although not everybody gets them. All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor immediately if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

The most common side effects reported are:

sweating

nettle rash (urticaria) sleepiness Other side effects:

raised liver enzymes* inflammation of the liver (hepatitis)* jaundice (yellow skin and eyes) bruising easily (caused by low platelets)* severe peeling skin

damage to small blood vessels (vaculitis) which may cause rashes, blistering of the skin, nodules in the skin and, in severe cases, gangrene of hands or feet joint pain muscle pain

development of breasts in men

impotence

gout

fever

nausea

confusion

rash with wide spread joint pain and/or stiffness, swollen lymph glands, fever and, possibly, cloudy urine.

* a blood test will be needed to show this.

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.

How to store Axid capsules

Keep out of the sight and reach of children. Do not use the drug after the date indicated on the carton.

Do not store above 25°C.

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

6 Further information

What Axid capsules contain

The active substance is nizatidine.

The other ingredients are: starch flowable powder, starch, silicone fluid 350 cs, magnesium stearate (Axid 150mg), povidone (Axid 300mg), carboxymethyl cellulose sodium cross-linked (Axid 300mg), talc (Axid 300mg), yellow iron oxide, red iron oxide(Axid 300mg), titanium dioxide, gelatin and colorcon black ink S-l-8100.

What Axid capsules look like and contents of the pack

Opaque ortransparent PVC/aluminium foil blisters.

Packs contain 28 or 30 capsules.

Not all pack sizes may be marketed.

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