Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Domperidone maleate
Waymade Healthcare Plc
A03FA03
Domperidone maleate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000
PACKAGE LEAFLET: INFORMATION FOR THE USER Domperidone 10mg Tablets (domperidone maleate) This medicine is subject to additional monitoring. This will allow quick identifi- cation of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Domperidone Tablets are and what they are used for 2. What you need to know before you take Domperidone Tablets 3. How to take Domperidone Tablets 4. Possible side effects 5. How to store Domperidone Tablets 6. Contents of the pack and other information 1. WHAT DOMPERIDONE TABLETS ARE AND WHAT THEY ARE USED FOR Domperidone Tablets contain domperidone as the active ingredient, which belongs to a group of medicines called 'dopamine antagonists'. Domperidone works by helping to move food faster through your food pipe (oesopha- gus), stomach and gut. This is so that it does not stay in the same place for too long. It also helps stop food flowing the wrong way back up your food pipe. This medicine is used to treat nausea (feeling sick) and vomiting (being sick) in adults and adolescents (12 years of age and older and weighing 35 kg or more). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOMPERIDONE TABLETS Do not take Domperidone Tablets if you: • are allergic (hypersensitive) to domperidone or any of the other ingredients in the tablets . Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Domperidone 10mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Domperidone maleate equivalent to 10mg domperidone base Excipients with known effect: Each tablet contains 54.2mg of lactose monohydrate For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM White to faintly cream coloured, circular, biconvex tabletswith Dm/10 inscription on one side. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Domperidone is indicated for the relief of the symptoms of nausea and vomiting. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Domperidone 10mg Tablets should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting. Patients should try to take each dose at the scheduled time. If a scheduled dose is missed, the missed dose should be omitted and the usual dosing schedule resumed. The dose should not be doubled to make up for a missed dose. Usually, the maximum treatment duration should not exceed one week. See section 4.4 for further information. Adults, and adolescents (12 years of age and older and weighing 35kg or more) One 10 mg tablet up to three times per day with a maximum dose of 30mg per day. Neonates, infants, children (less than 12 years of age) and adolescents weighing less than 35kg Due to the need for accurate dosing, Domperidone tablets are unsuitable for use in children and adolescents weighing less than 35kg. Hepatic Impairment Domperidone 10mg Tablets are contraindicated in moderate or severe hepatic impairment (see section 4.3). Dose modification in mild hepatic impairment is however not needed (see section 5.2). Renal Impairment Since the elimination half-life of domperidone is prolonged in severe renal impairment, on repeated administration, the dosing frequency of Domperidone 10mg Tablets should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced. Such patients on prolonged therapy should be reviewed Прочитать полный документ