国家: 新西兰
语言: 英文
来源: Medsafe (Medicines Safety Authority)
Loperamide hydrochloride 2mg
Viatris Limited
Loperamide hydrochloride 2 mg
2 mg
Capsule
Active: Loperamide hydrochloride 2mg Excipient: HEG Gelatin capsule Size 4 Lactose
Blister pack, Clear PVC/Al foil blister; cardboard outer carton (not marketed), 20 capsules
Pharmacy only
Pharmacy only
Vasudha Pharma Chem Limited
Package - Contents - Shelf Life: Blister pack, Clear PVC/Al foil blister; cardboard outer carton - 10 capsules - 36 months from date of manufacture stored at or below 25°C - Blister pack, Clear PVC/Al foil blister; cardboard outer carton - 20 capsules - 36 months from date of manufacture stored at or below 25°C
2008-12-11
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION DIAMIDE RELIEF _LOPERAMIDE HYDROCHLORIDE CAPSULES 2 MG_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking DIAMIDE RELIEF. This leaflet answers some common questions about DIAMIDE RELIEF. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking DIAMIDE RELIEF against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DIAMIDE RELIEF IS TAKEN FOR DIAMIDE RELIEF is taken to treat patients with sudden (acute) or long-lasting (chronic) diarrhoea. It is also used to treat diarrhoea in people with an ileostomy or colostomy (part of the intestines removed by surgery). DIAMIDE RELIEF contains the active ingredient loperamide hydrochloride. It works by increasing gut transit time so that food takes longer to pass through the gastrointestinal tract. This allows the bowel time to absorb water and produce a more solid stool. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE DIAMIDE RELIEF _WHEN YOU MUST NOT TAKE _ _IT_ DO NOT TAKE DIAMIDE RELIEF IF: you are constipated you have severe diarrhoea with blood in the stools and fever you have ulcerative colitis (a type of inflammatory bowel disease) you have an infection of the bowel. DO NOT TAKE DIAMIDE RELIEF IF YOU HAVE AN ALLERGY TO: any medicine containing loperamide hydrochloride any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongue o 阅读完整的文件
Page 1 of 8 NEW ZEALAND DATA SHEET DIAMIDE RELIEF 1. PRODUCT NAME DIAMIDE RELIEF, 2 mg, capsules. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 2 mg of loperamide hydrochloride. Excipient with known effect: Contains sugars as lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard gelatin capsules of size 4 filled with almost white powder. Cap colour: grey. Body colour: green. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS_ DIAMIDE RELIEF is indicated for: The control and symptomatic treatment of acute nonspecific diarrhoea, and of chronic diarrhoea. Reducing the volume of discharge in patients with ileostomies, colostomies, and other intestinal resections. _4.2_ _DOSE AND METHOD OF ADMINISTRATION_ DOSE _ACUTE DIARRHOEA _ The recommended initial dose of DIAMIDE RELIEF in adults is two capsules (4 mg) followed by one capsule (2 mg) after each unformed stool. Daily dose should not exceed eight capsules (16 mg). Clinical improvement is usually observed within 48 hours. _CHRONIC DIARRHOEA AND REDUCTION IN VOLUME OF DISCHARGE OF INTESTINAL RESECTIONS _ The recommended initial dose of DIAMIDE RELIEF is two capsules (4 mg) followed by one capsule (2 mg) after each unformed stool until diarrhoea is controlled, after which dosage of DIAMIDE RELIEF should be reduced to meet individual requirements. When the optimal maintenance daily dosage has thus been established, this amount can then be administered as a single dose or in two or three divided doses. The average daily maintenance dosage in clinical trials was two to four capsules (4 to 8 mg). A dosage of five capsules (10 mg) was rarely exceeded. A temporary exacerbation of diarrhoea was controlled by increasing the Ioperamide dosage to achieve further control followed by titration back to the established maintenance dose. Page 2 of 8 _SPECIAL POPULATIONS_ USE IN CHILDREN DIAMIDE RELIEF capsules are contraindicated in children under the age of 12 years. METHOD OF ADMINISTRATION DIAMIDE RELIEF capsules sh 阅读完整的文件