Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DOMPERIDONE
SPG PHARMA (MALAYSIA) SDN BHD
DOMPERIDONE
10 blister packs x 10 Tablets
SIAM BHEASACH CO LTD
_ _ _ _ _ _ _ Consumer Medication Information Leaflet (RiMUP)_ MOLAX-M FILM-COATED TABLET Domperidone Maleate (10mg) 1 WHAT IS IN THIS LEAFLET 1. What Molax-M is used for 2. How Molax-M works 3. Before you use Molax-M 4. How to use Molax-M 5. While you are using Molax-M 6. Side effects 7. Storage and Disposal of Molax-M 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT MOLAX-M IS USED FOR Molax-M is used for the relief of the symptoms of nausea and vomiting from various causes (including chemotherapy, radiotherapy or other medicines). HOW MOLAX-M WORKS Molax-M works by blocking the action of a chemical messenger in the brain which causes the feeling of nausea and vomiting, as well as increasing the movement or contractions of the stomach and intestines, allowing food to move more easily through the stomach. BEFORE YOU USE MOLAX-M _When you must not use it _ Do not use Molax-M if you: ▪ are allergic to domperidone maleate, or any other ingredients listed at the end of this leaflet ▪ suffer from a tumor of the pituitary gland called prolactinoma ▪ have bleeding, obstruction and hole in the stomach and bowel (e.g. severe stomach cramps or persistent black stools) ▪ have moderate to severe liver disease ▪ have abnormal potassium level, low magnesium level in the blood ▪ have or had heart problems including heart failure, heart rhythm disorders such as a slow or irregular heartbeat Stop taking Molax-M and contact your doctor immediately if you experience abnormal heartbeat. _ _ _Pregnancy _ If you are, or think you may be pregnant, tell your doctor, who will decide if you can take Molax-M. _Breast-feeding _ Small amounts of Molax-M can end up in the mother's milk. Breast- feeding is not recommended for mothers who are taking Molax-M. Talk to your doctor if you have any questions. _Before you start to use it _ Talk to your doctor before using Molax-M if you: ▪ have allergies to any medicines, foods, preservatives or dyes ▪ have severe kidn Lees het volledige document
PRODUCT NAME MOLAX-M FILM COATED TABLET NAME AND STRENGTH OF ACTIVE SUBSTANCE Each film-coated tablet contains 10 mg Domperidone Maleate PRODUCT DESCRIPTION White, round and biconvex film coated tablet with “M” on one side and SIAM logo on the other PHARMACODYNAMICS Domperidone is a dopamine antagonist with anti-emetic properties. It does not readily cross the blood-brain barrier. In domperidone users, especially in adults, extrapyramidal side effects are very rare, but domperidone promotes the release of prolactin from the pituitary. Its anti-emetic effect may be due to a combination of peripheral (gastrokinetic) effects and antagonism of dopamine receptors in the chemoreceptor trigger zone, which lies outside the blood-brain barrier in the area postrema. Animal studies, together with the low concentrations found in the brain, indicate a predominantly peripheral effect of domperidone on dopamine receptors. Studies in human have shown oral domperidone to increase lower oesophageal pressure, improve antroduodenal motility and accelerate gastric emptying. There is no effect on gastric secretion. PHARMACOKINETICS Absorption Domperidone is rapidly absorbed after oral administration with peak plasma concentrations at approximately 1 hr after dosing. The C max and AUC values of domperidone increased proportionally with dose in the 10 mg to 20 mg dose range. A 2- to 3-fold accumulation of domperidone AUC was observed with repeated four times daily (every 5 hr) dosing of domperidone for 4 days. The low absolute bioavailability of oral domperidone (approximately 15%) is due to an extensive first-pass metabolism in the gut wall and liver. Although domperidone’s bioavailability is enhanced in normal subjects when taken after a meal, patients with gastrointestinal complaints should take domperidone 15-30 minutes before a meal. Reduced gastric acidity impairs the absorption of domperidone. Oral bioavailability is decreased by prior concomitant administration of cimetidine and sodium bicarbonate. The time of peak absorpt Lees het volledige document