País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Domperidone maleate
McNeil Products Ltd
A03FA03
Domperidone maleate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 5027097902876
MOTILIUM 10 mg fILM-cOaTed TabLeTs domperidone PaTIeNT INfORMaTION LeafLeT 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. • Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect In this leaflet: 1. What Motilium is and what it is used for 2. What you need to know before you take Motilium 3. How to take Motilium 4. Possible side effects 5. How to store Motilium 6. Contents of the pack and other information 1. WhaT MOTILIUM Is aNd WhaT IT Is Used fOR The name of your medicine is Motilium 10mg Film-Coated Tablets (called Motilium in this leaflet). Motilium contains a medicine called domperidone. This belongs to a group of medicines called ‘dopamine antagonists’. This medicine is used in adults and children to treat nausea (feeling sick) and vomiting (being sick). 2. WhaT YOU Need TO KNOW befORe YOU TaKe MOTILIUM do not take Motilium tablets if: • You are allergic (hypersensitive) to domperidone or any of the other ingredients of Motilium 10mg Film- Coated Tablets (listed in section 6: Contents of the pack and other information). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. • You have a tumour of the pituitary gland (prolactinoma) • You have a blockage or tear in your intestines • 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 moderate or severe liver disease. • Your ECG (el Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Motilium 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains domperidone maleate 12.72 mg equivalent to domperidone 10 mg. Excipients with known effect: Each film-coated tablet contains 53.88mg of lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets - white to faintly cream coloured, circular, biconvex tablets. 4.1 THERAPEUTIC INDICATIONS Motilium is indicated for the relief of the symptoms of nausea and vomiting. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Motilium should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting. It is recommended to take oral Motilium before meals. If taken after meals, absorption of the drug is somewhat delayed. 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 35 kg or _ _more) _ _ _ One 10mg tablet up to three times per day with a maximum dose of 30 mg per day. Hepatic Impairment Motilium 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 Motilium 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 5.2) 4.3 CONTRAINDICATIONS Motilium is contraindicated in the following situations: • Known hyper Llegiu el document complet