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Nizatidine Capsules 150mg & 300mg
The name of your medicine is Nizatidine Capsules 150mg & 300mg, which will be referred to as Nizatidine 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 Nizatidine capsules are and what they are used for
2. Before you take Nizatidine capsules
3. How to take Nizatidine capsules
4. Possible side effects
5. How to store Nizatidine capsules
6. Further information
1 What Nizatidine capsules are and what they are used for
Nizatidine capsules contain the active ingredient nizatidine, which is one of a group of medicines known as H2 receptor antagonists. Nizatidine 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 Nizatidine capsules
Do not take Nizatidine capsules if
■ you are allergic (hypersensitive) to nizatidine, H2 receptor antagonists (other similar drugs) or any of the other ingredients of Nizatidine capsules (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat ortongue.
Take special care with Nizatidine 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 Nizatidine capsules:
■ aspirin (this can be bought without prescription).
It may still be all right for you to be given Nizatidine 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 Nizatidine capsules if you are. Ask your doctor for advice before taking any medicine.
Driving and using machines
Nizatidine capsules should have no effect on your ability to drive or use machines.
3 Howto take Nizatidine capsules
Always take Nizatidine 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 300mg taken orally in the eveningfor 4 weeks. The same dose is used forthe 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
Nizatidine capsules are not recommended for children.
Patients with kidney disorders will need a reduced dose depending on their condition.
If you take more Nizatidine capsules than you should
Tell your doctor straight away.
If you forget to take Nizatidine 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 anyfurther questions on the use of this product, ask your doctor or pharmacist.
■ 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.
What Nizatidine 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.
Marketing Authorisation Holder
Flynn Pharma Limited Alton House 4 Herbert Street Dublin Ireland.
This leaflet was last revised in
December 2010
4 Possible side effects
Like all medicines, Nizatidine 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 Bullet textyour 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
5 Howto store Nizatidine 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 Nizatidine capsules contain
The active substance is nizatidine.
The other ingredients are: starch flowable powder, starch, silicone fluid 350 cs, magnesium stearate (Nizatidine 150mg), povidone (Nizatidine 300mg), carboxymethyl cellulose sodium cross-linked (Nizatidine 300mg), talc (Nizatidine 300mg), yellow iron oxide, red iron oxide(Nizatidine 300mg), titanium dioxide, gelatin and colorcon black ink S-1-8100.
FLYNN
PHARMA
LTD