Quốc gia: Nam Phi
Ngôn ngữ: Tiếng Anh
Nguồn: South African Health Products Regulatory Authority (SAHPRA)
Adcock Ingram Limited
See ingredients
CAPSULES
EACH CAPSULE CONTAINS LANSOPRAZOLE 15,0 mg
Registered
2006-07-07
Page 1 of 6 N.N 2021/01/28 PATIENT INFORMATION LEAFLET SCHEDULING STATUS: PROPREITARY NAME AND DOSAGE FORM: BURNLOC (CAPSULES) Lansoprazole 15 mg READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU BURNLOC is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless you still need to use BURNLOC carefully to get the best results from it. Keep this leaflet. You may need to read it again. Do not share BURNLOC with any other person. Ask your pharmacist if you need more information or advice. You must see a doctor if your symptoms worsen or do not improve after (14 days) days READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU BURNLOC is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless you still need to use BURNLOC carefully to get the best results from it. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must see a doctor if your symptoms worsen or do not improve after 14 days. S2 Page 2 of 6 N.N 2021/01/28 1. WHAT BURNLOC CONTAINS: The active substance is lansoprazole 15 mg Contains sugar: Sucrose [101 mg] 0.1 g The other ingredients are gelatine, hypromellose, macrogol 6 000, mannitol, maize starch, N-methylglucamine, polysorbate 80, purified water, quinolone yellow, sodium laurilsulfate, talc, titanium dioxide. 2. WHAT BURNLOC IS USED FOR: BURNLOC contains the active substance lansoprazole. Lansoprazole belongs to a group of medicines called proton pump inhibitors. BURNLOC is used to treat conditions in which there is too much acid in the stomach. BURNLOC is used for the short-term symptomatic relief of heartburn and acid indigestion at a maximum daily dose of 15 mg for a maximum period of 14 days. 3. BEFORE YOU USE BURNLOC: DO NOT TAKE BURNLOC: If you are hypersensitive (allergic) to lansoprazole or any of the other ingredients in BURNLOC. If you are breastfeeding or pregnant. Đọc toàn bộ tài liệu
Page 1 of 6 N.N 2021/01/28 PROFESSIONAL INFORMATION SCHEDULING STATUS: S2 PROPRIETARY NAME AND DOSAGE FORM: BURNLOC (CAPSULE) COMPOSITION: Each capsule contains 15 mg Lansoprazole Contains sugar: Sucrose 0.1 g Each BURNLOC capsule contains the following excipients: gelatine, hypromellose, macrogol 6 000, mannitol, maize starch, N-methylglucamine, polysorbate 80, purified water, quinolone yellow, sodium laurilsulfate, talc, titanium dioxide. CATEGORY AND CLASS: A 11.4.3 Medicines acting on the gastrointestinal tract PHARMACOLOGICAL ACTION: Lansoprazole is an inhibitor of the gastric H + K + - ATPase (proton pump). Lansoprazole inhibits gastric acid secretion in a dose related manner irrespective of the source of stimulation. Gastric secretory functions recover gradually following discontinuation of the medicine. Lansoprazole has no effect on histamine, gastrin or cholinergic receptors. PHARMACOKINETICS: Following oral administration, lansoprazole is well absorbed with a resultant bioavailability of approximately 78 %. The bioavailability is decreased if lansoprazole is taken with food. Peak serum concentrations are achieved approximately 1 to 2 hours following ingestion. Lansoprazole is highly protein bound (97 %). Page 2 of 6 N.N 2021/01/28 Lansoprazole is extensively metabolised via the hepatic cytochrome P450 system to the inactive, sulphated metabolites – sulphone, sulphide and 5-hydroxyllansoprazole. The half life for lansoprazole is 1,4 to 1,5 hours. The main route of elimination is via the bile with 15 to 30 % of lansoprazole being excreted via the kidneys as the hydroxylated metabolite. INDICATIONS: BURNLOC is indicated in the short-term symptomatic relief of heartburn and hyperacidity at a maximum daily dose of 15 mg for a maximum period of 14 days. CONTRAINDICATIONS: Hypersensitivity to lansoprazole or to any of the ingredients. Pregnancy and lactation. Liver impairment. WARNINGS AND SPECIAL PRECAUTIONS: Safety and efficacy in children has not been established. Treatment with BURNLOC ma Đọc toàn bộ tài liệu