Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
HYOSCINE BUTYLBROMIDE
DCH AURIGA (MALAYSIA) SDN. BHD.
HYOSCINE BUTYLBROMIDE
100 ml
PT Actavis Indonesia
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ DHACOPAN TABLET/SYRUP Hyoscine butylbromide (10mg, 5mg/5ml) __________________________________________________________________________________________ __________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What Dhacopan is used for 2. How Dhacopan work 3. Before you use Dhacopan 4. How to take Dhacopan 5. While you are using Dhacopan 6. Side Effects 7. Storage and Disposal of Dhacopan 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT DHACOPAN IS USED FOR Dhacopan is used to relieve cramps in the smooth muscles of your: • Stomach • Gut (intestine) • Bladder and gallbladder • abdomen during menstruation HOW DHACOPAN WORK Dhacopan contain a medicine called “hyoscine butylbromide”. This belongs to a group of medicines called antispasmodics. BEFORE YOU USE DHACOPAN _-When you must not take it _ Do not take Dhacopan if: • You are allergic (hypersensitive) to hyoscine butylbromide or any of the other ingredients • You have glaucoma (an increase in pressure inside eye) • You have stomach or small intestine ulcer • You have enlarged prostate glands • You have paralytic ileus (paralysis of the intestine) • You have urinary retention • You have pyloric stenosis (narrowing of the opening from the stomach to the small intestine) • You are pregnant, likely to get pregnant, or are breast-feeding unless the potential advantage justifies the possible risk to the foetus. • you are consuming alcohol _-Before you start to take it _ You should check with your doctor or pharmacist before taking Dhacopan if: • You have a very fast heart rate or other heart problems Dhacopan may cause drowsiness, if affected do not drive or operate machinery. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Dhacopan. _-Taking other medicines_ Please tell your doctor or pharmacist if you are taking or have rece Lees het volledige document
DHACOPAN PRODUCT DESCRIPTION: Tablet : Orange film-coated tablets, round and deep convex, 8mm diameter without score-line and logo. Syrup : Clear yellow syrup, sweet taste with banana flavour. COMPOSITION: 1) Each tablet contains : Hyoscine Butylbromide BP 10mg 2) Each 5ml contains : Hyoscine Butylbromide BP 5mg/5ml Excipients: _Dhacopan Tablet 10mg :_ Corn Starch, Lactose mesh 200, Polyvidone 30, Magnesium stearate, Titanium Dioxide, Methocel E15, Sunset Yellow No.6 Alum lake, Propylene Glycol. _Dhacopan Syrup 5mg/5ml :_ Granulated Fine White Sugar, Sodium Saccharin, Propyl Hydroxybenzoate, Methyl Hydroxybenzoate, Propylene Glycol, Sodium Citrate Dihydrate, Citric Acid Monohydrate, FDC Yellow No. 6 Water Soluble (40-44%), Quinoline Yellow E104 Water Soluble 70-72%, Banana Flavour PCA 5639, Alcohol 96%, Purified Water. PHARMACOLOGY: Dhacopan contains Hyoscine Butylbromide which is a quaternary ammonium anticholinergic agent with both central and peripheral actions. The peripheral effects include decreased production of saliva, sweat, bronchial, lachrymal, nasal, gastric and intestinal secretions, decreased intestinal motility and inhibition of micturition. INDICATION: For relief of gastrointestinal and colonic spasm, acute spasm in renal or biliary colic; dysmenorrhoea. RECOMMENDED DOSAGE: Tablets : Adults and Children more than 12 years: 1 to 2 tablets, 3 or 4 times a day. Syrup : Children: 6 to 12 years: 2 teaspoonful 3 times a day. SIDE EFFECTS: Dry mouth with difficulty in swallowing and thirst, increased intraocular pressure, flushing, dry skin, difficulty in micturition, constipation, palpitations and arrhythmias. CONTRAINDICATIONS: Contraindicated in patients with glaucoma; with gastric or duodenal ulcer, with urinary retention; prostatic enlargement; paralytic ileus; pyloric stenosis. CAUTION: Tachycardia and cardiac insufficiency. May cause drowsiness, if affected do not drive or operate machinery. Avoid alcohol. USE IN PREGNANCY AND LACTATION: There are no adequate studies in pregnant and lactating wome Lees het volledige document