Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nizatidine
A A H Pharmaceuticals Ltd
A02BA04
Nizatidine
150mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01030100
NIZATIDINE 150 MG & 300 MG CAPSULES (Nizatidine) PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Nizatidine Capsules are and what they are used for 2. What you need to know before you take Nizatidine Capsules 3. How to take Nizatidine Capsules 4. Possible side effects 5. How to store Nizatidine Capsules 6. Contents of the pack and other information 1. WHAT NIZATIDINE CAPSULES ARE AND WHAT THEY ARE USED FOR Nizatidine belongs to a group of medicines called histamine H2-receptor antagonists, which reduce acidity in your stomach. Nizatidine Capsules are used to • TREAT NON CANCEROUS STOMACH AND DUODENAL ULCERS (ulcers at the top of the small intestine) • PROTECT HEALED ULCERS in the intestines • TREAT A TYPE OF HEARTBURN called 'reflux oesophagitis' (irritation of the oesophagus, the tube that takes food and liquids into your stomach) • PREVENT ULCERS which may be caused by NSAID (NON-STEROIDAL ANTI-INFLAMMATORY DRUG) treatment i.e. ibuprofen, diclofenac - often used to treat arthritis. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NIZATIDINE CAPSULES DO NOT TAKE THIS MEDICINE and speak to your doctor if you have ever had an allergic reaction to: - Nizatidine, or any of the other ingredients of this medicine (listed under Section 6) - have taken a similar anti-ulcer medicine before and you suffered an unusual or allergic reaction. An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nizatidine 150mg capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Nizatidine 150mg Excipients with known effect: Propylene glycol and sunset yellow FCF (E 110). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, Hard 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of the following diseases where reduction of gastric acid is indicated: Duodenal ulcer Benign gastric ulcer Prevention of duodenal or benign gastric ulcer recurrence Gastric oesophageal reflux disease (including erosions, ulcerations and associated heartburn) Gastric and/or duodenal ulcer associated with concomitant use of non-steroidal anti- inflammatory drugs 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration For oral administration. Posology _Adults: _ _1._ _ _ For treatment of duodenal ulcer, the recommended daily dose is 300mg in the evening. Treatment should continue for four weeks, although this period may be reduced if healing is confirmed earlier by endoscopy. Most ulcers will heal within four weeks, but if complete ulcer healing has not occurred after four weeks therapy, patients should continue therapy for a further four weeks. _2._ _ _ For the treatment of benign gastric ulcer, the recommended daily dose is 300mg in the evening for four or, if necessary, eight weeks. Prior to treatment with nizatidine, care should be taken to exclude the possibility of gastric cancer. If preferred, the 300mg daily dose for the treatment of duodenal or benign gastric ulcer may be given as two divided doses of 150mg in the morning and evening. _3._ _ _ For the prevention of duodenal or benign gastric ulcer recurrence (prophylactic maintenance therapy), the recommended daily dose is 150mg in the evening. _4._ _ _ For the treatment of gastric oesophageal reflux disease, the recommended dosage is from 150mg twice daily, up to 300mg twice daily. Therapy for up to 12 weeks is indicated for erosions and ulcerations, and associated Perskaitykite visą dokumentą