Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LOPERAMIDE HYDROCHLORIDE
PRIME PHARMACEUTICAL SDN. BHD.
LOPERAMIDE HYDROCHLORIDE
1000 Capsules; 1000 Capsules
PRIME PHARMACEUTICAL SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET(RIMUP) _ _ _ PRIMODIUM CAPSULES 2MG Loperamide hydrochloride (2mg) 1 WHAT IS IN THIS LEAFLET 1. What Primodium is used for 2. How Primodium works 3. Before you use Primodium 4. How to use Primodium 5. While you are using it 6. Side effects 7. Storage and Disposal of Primodium 8. Product description 9. Manufacturer and Product Registration Holder 10.Date of revision WHAT PRIMODIUM_ _IS USED FOR For control and symptomatic relief of short and long term diarrhoea associated with inflammatory bowel disease. HOW PRIMODIUM WORKS Loperamide inhibits movement of the intestines by direct effect on the muscles of the intestinal wall. BEFORE YOU USE PRIMODIUM _- When you must not use it _ - you are allergic to loperamide or any of the other ingredients of Primodium. - you are constipating. _ _ _- Before you start to use it _ Please inform your doctor/pharmacist if: - you have lost body fluids and salts through diarrhoea especially in young children with severe diarrhoea. - you have very smelly stools, blood or pus in your stools, stomach pain, or a fever. - you have liver disease. - you have inflammation of the intestines (ulcerative colitis). - you are pregnant and breastfeeding. _ _ _- Taking other medicines _ Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. HOW TO USE PRIMODIUM _- How much to use_ _ _ Adults: 4mg, initially, followed by 2mg after each loose stool, not exceeding 16mg daily. Long term diarrhoea: initial: 4mg followed by 2mg after each loose stool until diarrhoea is controlled. Maintenance: 4 – 8 mg a day in single or divided daily doses as needed. Children: as directed by physician. Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet. If you do not understand the instructions on the label, ask your doctor or pharmacist for help. _ _ _- When to use it _ Use as directed by yo Прочетете целия документ
® PRIMODIUM CAPSULES 2MG _Description:_ _Sz 4: Green opaque/grey opaque capsules. _ CONTENT: Loperamide hydrochloride 2mg/capsule INDICATION: For control and symptomatic relief of acute non-specific diarrhoea and of chronic diarrhoea associated with inflammatory bowel disease. PHARMACOLOGY: Loperamide inhibits intestinal peristalsis by direct effect on the muscles of the intestinal wall. Oral absorption is incomplete and elimination half-life ranges from 9.1 to 14.4 hours. It is mainly excreted in the feces. ADVERSE EFFECTS Abdominal pain, constipation, dizziness, dry mouth, tiredness, nausea and vomiting and hypersensitivity reactions may occur occasionally. Post- marketing Experience - Cardiac Disorders: QT/QTc interval prolongation, Torsades de Pointes, other ventricular arrhythmias, cardiac arrest, syncope, and death (see Warning and Precautions) WARNINGS AND PRECAUTIONS Caution in patients with dehydration, diarrhoea caused by infectious organisms, and hepatic function impairment. It should be discontinued if abdominal distention occurs or if other untoward symptoms develop in patients with ulcerative colitis. In acute diarrhoea, treatment should be discontinued after 48 hours if improvement does not occur. In chronic diarrhoea, if no improvement has occurred after 10 days of treatment with the maximum dose, loperamide is unlikely to be effective. Appropriate fluid and electrolyte therapy should be given to protect against dehydration in all cases of diarrhoea. Oral rehydration therapy which is the use of appropriate fluids including oral rehydration salts remains the most effective treatment for dehydration due to diarrhoea. The intake of as much of these fluids as possible is therefore imperative. Drug-induced inhibition of peristalsis may result in fluid retention in the intestine, which may aggravate and mask dehydration and depletion of electrolytes. If severe dehydration or electrolyte imbalance is present. Loperamide should be withheld until appropriate corrective therapy has been initiated. The use Прочетете целия документ