Страна: Новая Зеландия
Язык: английский
Источник: Medsafe (Medicines Safety Authority)
Hyoscine butylbromide 10mg
AdiraMedica Pty Ltd.
10 mg
Film coated tablet
Active: Hyoscine butylbromide 10mg Excipient: Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry white 85G18490 Povidone
Restricted
AdiraMedica Hyoscine butylbromide provides relief from stomach cramps and spasms.
Package - Contents - Shelf Life: Blister pack, PVC/Al - 10 tablets - 24 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/Al - 20 tablets - 24 months from date of manufacture stored at or below 25°C protect from light
2019-02-25
NEW ZEALAND DATA SHEET AdiraMedica Hyoscine Butylbromide New Zealand Data Sheet v 1.0 11 Oct 2021 Page 1 of 9 ADIRAMEDICA HYOSCINE BUTYLBROMIDE 1 PRODUCT NAME - ADIRAMEDICA HYOSCINE BUTYLBROMIDE 10 mg film-coated tablets - ADIRAMEDICA HYOSCINE BUTYLBROMIDE 20 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hyoscine-N-butylbromide 10 mg film-coated tablet, and 20 mg film coated tablet. Excipient with known effect: Lactose Monohydrate For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Oral, Film-Coated Tablet Presentation ADIRAMEDICA HYOSCINE BUTYLBROMIDE 10 mg and ADIRAMEDICA HYOSCINE BUTYLBROMIDE 20 mg tablets are both: White to off-white coloured, round, biconvex, film coated tablet plain on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Muscle spasm of the gastrointestinal tract. 4.2 DOSE AND METHOD OF ADMINISTRATION AdiraMedica Hyoscine Butylbromide 10 mg: Adults and children over 6 years: 2 tablets four times a day ADIRAMEDICA HYOSCINE BUTYLBROMIDE 10 mg tablets should be swallowed whole with a glass of water. NEW ZEALAND DATA SHEET AdiraMedica Hyoscine Butylbromide New Zealand Data Sheet v 1.0 11 Oct 2021 Page 2 of 9 ADIRAMEDICA HYOSCINE BUTYLBROMIDE 10 mg should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain. AdiraMedica Hyoscine Butylbromide 20 mg: Adults and children over 6 years: 1 tablet four times a day. ADIRAMEDICA HYOSCINE BUTYLBROMIDE 20 mg tablets and ADIRAMEDICA HYOSCINE BUTYLBROMIDE 20 mg tablet should be swallowed whole with a glass of water. ADIRAMEDICA HYOSCINE BUTYLBROMIDE 20 mg tablets should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain. 4.3 CONTRAINDICATIONS ADIRAMEDICA HYOSCINE BUTYLBROMIDE 10 mg and ADIRAMEDICA HYOSCINE BUTYLBROMIDE 20 mg are contraindicated in myasthenia gravis, mechanical stenosis in the gastrointestinal tract, paralytical or obstructive ileus, megacolon and in patients who have d Прочитать полный документ