Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
POLYMETHYLSILOXANE,ACTIVATED/SIMETHICONE; DICYCLOMINE HYDROCHLORIDE
KOTRA PHARMA (M) SDN. BHD.
POLYMETHYLSILOXANE,ACTIVATED/SIMETHICONE; DICYCLOMINE HYDROCHLORIDE
100 ml; 60 ml; 120 ml
KOTRA PHARMA (M) SDN. BHD.
AXCEL DICYCLOMINE-S SYRUP Dicyclomine Hydrochloride/Simethicone (5mg/50mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Axcel Dicyclomine-S Syrup is used for. 2. How Axcel Dicyclomine-S Syrup works. 3. Before you use Axcel Dicyclomine-S Syrup. 4. How to take Axcel Dicyclomine- S Syrup. 5. While you are using it. 6. Side effects. 7. Storage and disposal of Axcel Dicyclomine-S Syrup. 8. Product description. 9. Manufacturer and Product Registration Holder. 10. Date of revision. WHAT AXCEL DICYCLOMINE-S SYRUP IS USED FOR Axcel Dicyclomine-S Syrup is used for the relief of gastrointestinal colic, flatulence and abdominal discomfort due to entrapped gas. HOW AXCEL DICYCLOMINE-S SYRUP WORKS Dicyclomine is a medicine for reducing cramps and pain in the digestive tract. Simethicone lowers surface tension cause bubbles of gas in the digestive tract to coalesce, thus aiding their elimination. BEFORE YOU USE AXCEL DICYCLOMINE-S SYRUP _-When you must not use it _ Do not take Axcel Dicyclomine-S Syrup if: • The infants younger than 6 months. • You have closed angle glaucoma (a buildup of pressure in the eye). • You have urinary tract or stomach and intestinal obstruction. • You have unstable cardiovascular (heart or blood vessel) status in acute bleeding or backflow of gastric content leading to esophagus (food pipe) irritation. • You suffer from reduced intestinal movement or paralysis. • You are allergic or hypersensitive to Dicyclomine and other ingredients. • The ambient temperature is high especially in children. _-Before you start to use it _ Tell your doctor if you: • Have fever, asthma or hiatal hernia (part of the stomach pushes upward into the chest). • Have serious liver or kidney disease, acute heart attack or high blood pressure. • Are elderly and in conditions characterized by a faster than normal heart rate & debilitate individuals with long term obstructive lung disease. • Are pregnant. • Are allergic to any medicines. _ _ _-Taking other medicines _ Lees het volledige document
COMPOSITION: Each 5ml contains Dicyclomine hydrochloride 5mg Simethicone 50mg 0.1% w/v Methylparaben as preservative PRESENTATION: Orange coloured and orange flavoured syrup. INDICATIONS: Relief of gastro-intestinal colic, flatulence & abdominal discomfort due to entrapped gas. PHARMACOLOGY: _Mechanism of Action:_ Dicyclomine Hydrochloride is a tertiary amine with antimuscarinic effects similar to but weaker than those atropine; it also has a direct anti-spasmodic action. Simethicone lowers surface tension and when administered by mouth causes bubbles of gas in the gastro-intestinal tract to coalesce, thus aiding their dispersion. _Pharmacokinetics: _ Dicyclomine is used in gastrointestinal spasm, particularly that associated with the irritable bowel syndrome, and is also given in association with antacids as an adjunct in the treatment of peptic ulcer. Simethicone is used to relieve flatulence and abdominal discomfort due to excess gastrointestinal gas and also used as defoaming agent in radiography or endoscopy of the gastrointestinal tract. DOSAGE AND ADMINISTRATION: To be taken orally, 15 minutes before meal. Adults : 10 - 20ml, 3 - 4 times a day; Children (2 - 12 years) : 10ml, 3 - 4 times daily, (6 months - 2 years) : 5 - 10ml, 3 - 4 times daily, total daily dose should not exceeding 40ml. CONTRAINDICATION: Contraindicated in patients with closed-angle glaucoma, urinary or GI obstruction, intestinal atony, paralytic ileus, hypersensitivity to Dicyclomine, unstable cardiovascular status in acute hemorrhage and reflux oesophagitis. PRECAUTION: Due to the risk of provoking hyperpyrexia, it should not be given to patients, especially children when the ambient temperature is high. It should also be used cautiously in patient with fever, asthma, hiatal hernia, serious hepatic or renal disease. Precaution in acute myocardial infarction, hypertension. Elderly and in conditions characterized by tachycardia & in debilitate patients with COPD. _Use in Pregnancy and Lactation:_ The safety use of Axcel Dicyclomine-S Syr Lees het volledige document