Kraj: Republika Południowej Afryki
Język: angielski
Źródło: South African Health Products Regulatory Authority (SAHPRA)
Biotech Laboratories (Pty) Ltd
See ingredients
TABLET
EACH TABLET CONTAINS DOMPERIDONE 10,0 mg
Registered
2012-02-11
BIOTECH LABORATORIES (PTY) LTD 1.3.2 - Patient Information Leaflet BIO-DOMPERIDONE 10, film-coated tablets Each tablet contains 10 mg domperidone _ _ Page 1 of 11 PATIENT INFORMATION LEAFLET SCHEDULING STATUS: BIO DOMPERIDONE 10, FILM-COATED TABLET . DOMPERIDONE CONTAINS SUGAR (LACTOSE MONOHYDRATE, 58 MG PER TABLET). READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING BIO DOMPERIDONE 10 • Keep the leaflet. You may need to read it again. • If you have further questions, please ask your doctor, pharmacist, nurse or other healthcare provider. • BIO DOMPERIDONE10 has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET 1. What BIO DOMPERIDONE10 is and what it is used for 2. What you need to know before you take BIO DOMPERIDONE10 3. How to take BIO DOMPERIDONE10 4. Possible side effects 5. How to store BIO DOMPERIDONE10 6. Contents of the pack and other information 1. WHAT BIO DOMPERIDONE 10 IS AND WHAT IT IS USED FOR Domperidone, the active ingredient in BIO DOMPERIDONE10 increases the movements or contractions of the stomach and bowel. BIO DOMPERIDONE10 is used in adults and adolescents over 12 years of age and weighing over 35 kg for: • Short term relief not exceeding 7 days for stomach discomfort due to food moving slowly through the stomach and intestines, where you may feel symptoms such as: S4 BIOTECH LABORATORIES (PTY) LTD 1.3.2 - Patient Information Leaflet BIO-DOMPERIDONE 10, film-coated tablets Each tablet contains 10 mg domperidone _ _ Page 2 of 11 o fullness during or shortly after a meal, o a “heavy stomach”, o bloated feeling, o excessive belching, o passing wind (flatulence), o nausea and vomiting, o a burning feeling and/or pain in the stomach area, • Short term use not exceeding 7 days for discomfort due to backflow of stomach acid, where you may experience belching and/or heartburn, • Short term use not exceeding 7 days except when used for nausea and Przeczytaj cały dokument
BIOTECH LABORATORIES (PTY) LTD 1.3.1.1 - Professional Information BIO-DOMPERIDONE 10, film-coated tablets Each tablet contains 10 mg domperidone Page 1 of 14 SCHEDULING STATUS S4 1 NAME OF THE MEDICINE BIO DOMPERIDONE 10 Film-coated tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg domperidone. Contains sugar (lactose monohydrate 58 mg per tablet.). For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. White, round, film-coated, biconvex tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BIO DOMPERIDONE 10 is indicated in adults and adolescents over 12 years of age and weighing over 35 kg for: - Short-term management (not exceeding 7 days) of delayed gastric emptying of functional origin with gastro-oesophageal reflux and/or dyspepsia. - Short term management (not exceeding 7 days) for control of nausea and vomiting of central or local origin. - As an anti-emetic in patients receiving cytostatic and radiation therapy for up to 4 weeks. - Facilitation of radiological examination of the upper gastrointestinal tract administered at the time before the examination as directed by the radiologist. BIOTECH LABORATORIES (PTY) LTD 1.3.1.1 - Professional Information BIO-DOMPERIDONE 10, film-coated tablets Each tablet contains 10 mg domperidone Page 2 of 14 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY ADULTS AND ADOLESCENTS > 12 YEARS OF AGE AND > 35 KG It is recommended to take oral BIO DOMPERIDONE 10, 15 – 30 minutes before meals. If taken after meals, absorption of the medicine is somewhat delayed. The dose of BIO DOMPERIDONE 10 film-coated tablets should be the lowest effective dose for the individual situation (typically 30 mg/day) with a maximum daily oral dose of 30 mg. If the conditions mentioned under indications are not resolved within the time frames indicated, patients should be re-evaluated and the need for continued treatment be assessed. FORMULATION (DOMPERIDONE PER UNIT) DOSAGE MAXIMUM DOSE PER DAY Film-coated tablets Przeczytaj cały dokument