Maa: Malta
Kieli: englanti
Lähde: Medicines Authority
DOMPERIDONE MALEATE
Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta
A03FA03
DOMPERIDONE MALEATE 10 mg
TABLET
DOMPERIDONE MALEATE 10 mg
POM
DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2020-12-16
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DOMPERIDONE CRESCENT 10MG TABLETS Domperidone 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 The full name of your medicine is Domperidone Crescent 10mg Tablets but within the leaflet it will be referred to as Domperidone Tablets. 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 to domperidone or to any of the other ingredients of this medicine (listed in section 6). • have a moderate or severe liver disease. • have an ECG (echocardiogram) that shows a heart problem called “prolonged QT corrected interval”. • have or had a problem where your heart cannot pump the blood around your body as well as it should (condition called heart failure). • have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in your blood. • are taking certain medicines (see “Other medicines and Domperidone Tablets”). • have a tumour of the pituitary gland (prolactin Lue koko asiakirja
Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Domperidone Crescent 10mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of domperidone (as maleate). Excipient with known effect: Each tablet contains 54.2 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, round, biconvex tablet embossed DM10 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 Domperidone 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 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. 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 daily dose of 30 mg. 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). Page 2 of 10 Renal Impairment Since the elimination half-life of domperidone is prolonged in severe renal impairment, on repeated administration, the dosing frequency of Domperidone should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced. Paediatric population The efficacy of domperidone in children less than 12 years of age has not been established (see section 5.1). The efficacy of domperidone in adolescents 12 years of age and older and weighing less than 35 kg has not been esta Lue koko asiakirja