País: Israel
Língua: inglês
Origem: Ministry of Health
DOMPERIDONE
J-C HEALTH CARE LTD
A03FA03
TABLETS
DOMPERIDONE 10 MG
PER OS
Required
JANSSEN CILAG S.A., FRANCE
DOMPERIDONE
DOMPERIDONE
Motilium is indicated for the relief of the symptoms of nausea and vomiting.
2020-11-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only Name of the preparation, its form and strength MOTILIUM ® 10 MG TABLETS EACH TABLET CONTAINS DOMPERIDONE 10 MG Inactive ingredients and allergens in the preparation - see section 6 “Further Information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment/for you. Do not pass it on to others. It may harm them, even if it seems to you that their ailment/ medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Motilium is used to treat nausea and vomiting in adults and adolescents over 12 years of age and weighing over 35 kg. THERAPEUTIC GROUP: dopamine receptor antagonist. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • you are sensitive (allergic) to the active ingredient or to any of the other ingredients contained in the medicine (see section 6 - “Further Information”) • you suffer from abdominal bleeding or if you regularly suffer from severe abdominal pain or persistent black stools • you suffer from intestinal obstruction or perforation • you suffer from a tumor in the pituitary gland (prolactinoma) • you suffer from moderate to severe liver disease • you have an ECG that indicates a heart problem called “prolongation of the QT interval” • you have or had a problem where the heart cannot pump the blood around your body as well as it should (a condition called heart failure) • you have a problem that causes a low level of potassium or magnesium, or a high level of potassium in the blood • you are taking certain medicines (see below “DRUG INTERACTIONS”) SPECIAL WARNINGS REGARDING USE OF THE MEDICINE: BEFORE TREATMENT WITH MOTILIUM, TELL THE DOCTOR IF: • you suffer from liver problems (l Leia o documento completo
1/8 Motilium_SPC_02_2021_sub 1. NAME OF THE MEDICINAL PRODUCT MOTILIUM 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains domperidone 10 mg. Excipients with known effect Each film-coated tablet (domperidone) contains 54.2 lactose monohydrate and less than 1 mmol sodium (23 mg), that is to say essentially ‘sodium-free’. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White to faintly cream coloured, circular, biconvex tablet. 4. CLINICAL PARTICULARS 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. Adults, and adolescents (12 years of age and older and weighing 35 kg or more One 10 mg 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. Paediatric population Motilium is not indicated for children less than 12 years of age and adolescents weighing less than 35 kg. 2/8 Motilium_SPC_02_2021_sub 4.3 CONTRAINDICATIONS Motilium is contraindicated in the foll Leia o documento completo