Страна: Нова Зеландия
Език: английски
Източник: Medsafe (Medicines Safety Authority)
Hyoscine butylbromide 20mg; ; ;
AFT Pharmaceuticals Ltd
Hyoscine butylbromide 20 mg
20 mg
Film coated tablet
Active: Hyoscine butylbromide 20mg Excipient: Colloidal silicon dioxide Hypromellose Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Methylcellulose Microcrystalline cellulose Purified talc Purified water Sodium starch glycolate Titanium dioxide
Restricted
Alchem International Ltd
For the relief of stomach ache and pain due to cramps or spasm.
Package - Contents - Shelf Life: Blister pack, PVDC/PVC/Al foil - 10 tablets - 36 months from date of manufacture stored at or below 30°C
2014-02-11
CONSUMER MEDICINE INFORMATION GASTRO-SOOTHE & GASTRO-SOOTHE FORTE _HYOSCINE BUTYLBROMIDE _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Gastro-Soothe & Gastro-Soothe Forte tablets. It does not contain all available information. It does not take the place of talking to your doctor or pharmacist. Keep this information with your tablets. You may need to read it again later. TO FIND OUT MORE ABOUT GASTRO-SOOTHE & GASTRO-SOOTHE FORTE You should ask your doctor or pharmacist if you have any questions about your medicine or if you have any concerns about taking Gastro-Soothe or Gastro-Soothe Forte. WHAT GASTRO-SOOTHE & GASTRO-SOOTHE FORTE ARE USED FOR Gastro-Soothe & Gastro-Soothe Forte anticholinergic medicines. Anticholinergic medicines relieve pain caused by stomach and bowel cramps by helping your digestive system to relax. Always consult your doctor or pharmacist if the pain does not improve within 48 hours or if pain worsens after treatment. BEFORE TAKING GASTRO-SOOTHE OR GASTRO-SOOTHE FORTE _WHEN NOT TO TAKE GASTRO-SOOTHE OR GASTRO-SOOTHE FORTE _ Do not take Gastro-Soothe or Gastro-Soothe Forte if you are allergic to hyoscine butylbromide or any of the other ingredients in Gastro-Soothe or Gastro-Soothe Forte. These ingredients are listed in full at the end of this leaflet (See Ingredients). If you are uncertain as to whether you have such an allergy you should raise this concern with your doctor or pharmacist. Do not take Gastro-Soothe or Gastro-Soothe Forte if you have myasthenia gravis, glaucoma, porphyria or a condition of the bowel known as megacolon. Seek advice from your doctor or pharmacist if you have, or have had, a prostate or heart condition. This is because Gastro-Soothe & Gastro-Soothe Forte should not be used in some types of prostate disease and a certain type of heart complaint. Gastro-Soothe & Gastro-Soothe Forte should not be used when there is a blockage in the stomach or bowel, or in certain conditions when there is reduced bowel activity. These conditions are best Прочетете целия документ
Page 1 of 5 NEW ZEALAND DATA SHEET 1 GASTRO-SOOTHE ® (HYOSCINE-N-BUTYLBROMIDE 10MG FILM COATED TABLET) (Gastro-Soothe) 10 mg Hyoscine-N-butylbromide film coated tablet GASTRO-SOOTHE FORTE ® (HYOSCINE-N-BUTYLBROMIDE 20MG FILM COATED TABLET) (Gastro-Soothe Forte) 20 mg Hyoscine-N-butylbromide film coated tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Gastro-Soothe Each tablet contains 10 mg Hyoscine-N-butylbromide. Gastro-Soothe Forte Each tablet contains 20 mg Hyoscine-N-butylbromide. For the list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM White, circular 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 Gastro-Soothe and Gastro-Soothe Forte are for oral administration only. Gastro-Soothe and Gastro-Soothe Forte should be swallowed whole with adequate water. Gastro-Soothe 10 mg/tablet Adults and children over 6 years: 2 tablets (two 10 mg tablets = 20 mg) four times a day. Gastro-Soothe Forte 20 mg/tablet Adults and children over 6 years: 1 tablet (20 mg) four times a day. 4.3 CONTRAINDICATIONS Gastro-Soothe & Gastro-Soothe Forte are contraindicated in myasthenia gravis, megacolon, and narrow glaucoma. In addition, they should not be given to patients who have demonstrated prior sensitivity to the product. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Gastro-Soothe and Gastro-Soothe Forte should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure and in cardiac surgery where it may further accelerate the heart rate. Due to the risk of anticholinergic complications, caution should be used in patients susceptible to intestinal or urinary outlet obstructions. Page 2 of 5 Because of the possibility that anticholinergics may reduce sweating, Gastro-Soothe and Gastro- Soothe Forte should be administered with caution to patients with pyrexia Elevation of intraocular pressure may be produced by the administrat Прочетете целия документ