Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Domperidone maleate
Milpharm Ltd
A03FA03
Domperidone maleate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 5060035111275 5060035111282
PACKAGE LEAFLET: INFORMATION FOR THE USER DOMPERIDONE 10MG TABLETS (domperidone maleate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE - 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. Do not pass it on to others. It may harm them, even if their symptoms 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 The name of your medicine is Domperidone 10mg Tablets (called Domperidone in this leaflet). Domperidone Tablets contain domperidone as the active ingredient, which belongs to a group of medicines called ‛dopamine antagonists’. 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 of Domperidone 10mg tablets (listed in section 6) • You have black, tarry bowel motions (stools) or notice blood in your bowel motions. This could be a sign of bleeding in the stomach or intestines • You have a blockage or tear in your intestines • You have a tumour of the pituitary gland (prolactinoma). • you have a moderate or severe liver disease • your ECG (electrocardiogram) shows a heart problem called “prolonged QT corrected interval” • you have or had a problem where your heart cannot pump the blood round your body as well as it Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Domperidone 10mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Domperidone maleate equivalent to 10mg domperidone base. Excipient(s) with known effect Domperidone 10mg tablets contains an excipient called Lactose. Each tablet contains 54.480 mg of Lactose. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablets Domperidone 10mg Tablet is presented as a white round biconvex tablet with “Dm 10” inscription on one side. 4 CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Domepridone is indicated for the relief of the symptoms of nausea and vomiting. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Domeperidone should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting. It is recommended to take oral domperidone tablets before meals. If taken after meals, absorption of the drug is somewhat delayed. Patients should try to take each dose at 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 35 kg or more) _ _ _ One 10mg tablet up to three times per day with maximum dose of 30 mg per day. Hepatic Impairment Domperidone is 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 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 regularly (see sections 4.4 and Izlasiet visu dokumentu