Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Domperidone maleate
Zentiva Pharma UK Ltd
A03FA03
Domperidone maleate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04060000; GTIN: 5000283602576 5000283602569
PATIENT INFORMATION LEAFLET DOMPERIDONE 10MG TABLETS PLEASE ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. o KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. o IF YOU HAVE FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR OR YOUR PHARMACIST. o 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. o IF ANY OF THE SIDE EFFECTS GET SERIOUS, OR IF YOU NOTICE ANY SIDE EFFECTS NOT LISTED IN THE LEAFLET, PLEASE TELL YOUR DOCTOR OR PHARMACIST. IN THIS LEAFLET 1. What Domperidone 10mg Tablets are and what they are used for 2. What you need to know before you take Domperidone 10mg Tablets 3. How to take Domperidone 10mg Tablets 4. Possible side effects 5. How to store Domperidone 10mg Tablets 6. Contents of the pack and other information _ _ 1. WHAT DOMPERIDONE 10MG TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Domperidone 10mg Tablets. Domperidone is an anti-emetic which can stop you feeling sick. The active ingredient is domperidone maleate. Each tablet contains 10mg domperidone as domperidone maleate. Domperidone is used to treat nausea (feeling sick) and vomiting (being sick). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOMPERIDONE 10MG TABLETS DO NOT TAKE DOMPERIDONE 10MG TABLETS: o if you have ever had an allergic reaction to domperidone or any of the other ingredients (listed in section 6) o if you have moderate or severe liver disease o if your ECG (electrocardiogram) shows a heart problem called “prolonged QT corrected interval” o if you have or had a problem where your heart cannot pump the blood round your body as well as it should (condition called heart failure) o if you have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in your blood. o if you have or think you may have a serious intestinal problem such as internal bleeding (symptom being persistent black bowel motions), or an obstruction or perforation of the stomach or intestine (usually this Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Domperidone 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). 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 established. 4.3 CONTRAINDICATIONS Domp Lugege kogu dokumenti