Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DOMPERIDONE
Y.S.P. INDUSTRIES (M) SDN BHD
DOMPERIDONE
100Tablet Tablets; 1,000Tablet Tablets; 500 Tablet Tablets
Y.S.P. INDUSTRIES (M) SDN BHD
_Consumer Medication Information Leaflet (RiMUP) _ 1 | P a g e DOMPER ® TABLET Domperidone 10mg WHAT IS IN THIS LEAFLET This leaflet contains information below: • What DOMPER® TABLET is used for • How DOMPER® TABLET works • Instructions before you use DOMPER® TABLET • How to take DOMPER® TABLET • Instructions while you are using DOMPER® TABLET • Side effects • Storage and disposal of DOMPER® TABLET • Product description • MAL No. • Address of Manufacturer • Address of Product Registration Holder WHAT DOMPER® TABLET IS USED FOR DOMPER® TABLET is indicated for the symptomatic relief of nausea and vomiting. HOW DOMPER® TABLET WORKS DOMPER® TABLET is an antiemetic and a prokinetic medicine. It 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 DOMPER® TABLET _When you must not take it _ Do not take DOMPER® TABLET if you: • are allergic to DOMPER® TABLET and other medicines containing domperidone • are allergic to any of the ingredients listed under the Ingredients section of this leaflet • have moderate to severe liver impairment • have a tumour of the pituitary gland known as prolactinoma • have a pre-existing heart condition. • have gastrointestinal hemorrhage or mechanical obstruction. _Before you start to take it _ Please inform your healthcare professional regarding the following: • You are pregnant or planning to become pregnant. • Your baby is under 1 year of age. • You are breast feeding or wish to breastfeed. (It is not advisable to take DOMPER® TABLET in pregnancy because domperidone is found in the breast milk but at very low levels) • You have or have ever had liver or kidney disease. • You are not able to digest lactose which is a sugar found in milk and milk products. Your doctor will advise you whether DOMPER® TABLET is suitable fo Prečítajte si celý dokument
INGREDIENT(S): Each tablet contains: Domperidone ................................................................................................................................. 10mg PHARMACOLOGY : PHARMACODYNAMICS: Domperidone is a dopamine antagonist (blocking both D1 & D2 receptors) which is structurally related to the benzimidazole. Domperidone is a potent gastrokinetic agent. Domperidone facilitates gastrointestinal smooth muscle activity by inhibiting dopamine at the D1 receptors and inhibiting the release of neural acetylcholine by blocking D2 receptors. Domperidone binds with high affinity to the dopamine receptor. It does not cross the blood brain barrier or the placental barrier but exerts its effects at peripheral sites: the chemoreceptor trigger zone (in the brainstem) and the gastrointestinal tract. Domperidone inhibits dopamine-induced gastric relaxaton and the inhibitory effects of secretin, whose actions may be mediated by dopamine release. Finally, it stimulates phasic activity in the gastro-duodenal area and improves gastro-duodenal coordination. PHARMACOKINETICS: Absorption Although absorption is rapid, the systemic bioavailability of domperidone is only about 13% to 17% in fasting subjects given an oral dose; this is increased when domperidone is given after food. The low bioavailability is thought to be due to first-pass hepatic and intestinal metabolism. Peak plasma concentrations are achieved 30 minutes after an oral dose. Distribution Domperidone is 91 - 93% bound to plasma proteins. Domperidone does not readily cross the blood-brain barrier .In humans, the apparent volume of distribution is 440 L .Small amounts of domperidone are distributed into breast milk; concentrations are 10 to 50% of those in maternal serum. Metabolism It undergoes rapid and extensive hepatic metabolism. The main metabolic pathways are N-dealkylation by cytochrome P450 isoenzyme CYP3A4, and aromatic hydroxylation by CYP3A4, CYP1A2, and CYP2E1. Excretion Urinary and faecal excretions amount to 31 and 66% of the ora Prečítajte si celý dokument