País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
NIZATIDINE
Flynn Pharma Ltd
A02BA04
NIZATIDINE
150 Milligram
Capsules Hard
Product subject to prescription which may be renewed (B)
H2-receptor antagonists
Authorised
2005-08-12
Package leaflet: Information for the user AXID 150MG CAPSULES Nizatidine The name of your medicine is Axid 150mg capsules, which will be referred to as Axid capsules throughout this document. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. n Keep this leaflet. You may need to read it again. n If you have any further questions, ask your doctor or pharmacist. n This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illnesss are the same as yours. n If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Axid capsules are and what they are used for 2. What you need to know before you take Axid capsules 3. How to take Axid capsules 4. Possible side effects 5. How to store Axid capsules 6. Contents of the pack and other information 1 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. This medicine is intended for use in adults. Axid capsules are used to reduce gastric acid (a digestive acid produced by the stomach). This helps to treat the following conditions: n Duodenal ulcer (the duodenum is the part of the intestine leaving the stomach) n Non-cancerous (benign) stomach (gastric) ulcer n To prevent the return of a duodenal or benign gastric ulcer n Gastric and/or duodenal ulcer caused by a type of painkiller such as ibuprofen (a non-steroidal anti-inflammatory drug). 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE AXID CAPSULES DO NOT TAKE AXID CAPSULES IF n you are allergic (hypersensitive) to nizatidine, H2 receptor antagonists (other similar drugs) or any of the other ingredients Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Axid 150 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 150 mg Nizatidine For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard (capsule) Hard gelatin capsule with dark yellow caps and pale yellow bodies coded FLYNN 3144, containing an off-white granular powder. 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 and/or duodenal ulcer associated with concomitant use of non-steroidal anti-inflammatory drugs Axid capsules are intended for use in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults: _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. 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. For the prevention of duodenal and/or benign gastric ulcer recurrence (prophylactic maintenance therapy) the recommended daily dose is 150mg in the evening. Patients should be kept under regular Leia o documento completo