البلد: مالطا
اللغة: الإنجليزية
المصدر: Medicines Authority
MOXONIDINE
Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
C02AC05
MOXONIDINE 200 µg
FILM-COATED TABLET
MOXONIDINE 200 µg
POM
ANTIHYPERTENSIVES
Authorised
2006-01-16
Helvetica Neue LT Pro 8.5 pt 8.5 pt Physiotens_0.3mg_400mcg_200mcg_28 Leaflet 2189856 NA 2189856 PL 46302/0045, PL 46302/0046, PL 46302/0047, MA 1187/01501, MA 1187/01502 Mylan Laboratories SAS (Chatillon sur Chalaronne - FR) 50074730 4143 400540804;400540792; 400540777 104060886/0120 3 United Kingdom; Malta Flat 158x315mm N/A 1 158 x 315 mm PROCESS BLACK Keyline 1 / 2 N/A v3/Jul 2017 Colours Non-Print Colours Date: Time: Equate CMYK with Dimensions Main Font Body Text Size Min Text Size used Page Count No. of colours Pharma Code SAP No. Vendor Job No. Trackwise Proof No. Client Market Keyline/Drawing No. Barcode Info Description Component Type Superceded Affiliate Item Code TrackWise PR No. MA No. Packing Site/Printer Supplier Code Sign-offs Affiliate Item Code 3D Render ID 10:17 10 Jul 20 Package Leaflet: Information for the user 200 micrograms, 300 micrograms and 400 micrograms Moxonidine 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 Physiotens is and what it is used for 2. What you need to know before you take Physiotens 3. How to take Physiotens 4. Possible side effects 5. How to store Physiotens 6. Contents of the pack and other information 1. What Physiotens is and what it is used for Physiotens contains a medicine called moxonidine. This medicine belongs to a group of medicines called “anti-hypertensives”. Physiotens is used to treat high blood pressure (hypertension). It works by making your blood vessels relax and widen. This helps to lower your blood pressure. 2. What yo اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Physiotens Tablets 200 micrograms 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 micrograms moxonidine. Excipients: 95.8 mg lactose per tablet For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablets Light pink, round, biconvex, film-coated tablets imprinted ‘0.2’ on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mild to moderate essential or primary hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ _Adults (including the elderly): _ Treatment should be started with 200 micrograms of Physiotens in the morning. The dose may be titrated after three weeks to 400 micrograms, given as one dose or as divided doses (morning and evening) until a satisfactory response has been achieved. If the response is still unsatisfactory after a further three weeks’ treatment, the dosage can be increased up to a maximum of 600 micrograms in divided doses (morning and evening). A single dose of 400 micrograms of Physiotens and a daily dose of 600 micrograms in divided doses (morning and evening) should not be exceeded. In patients with moderate renal dysfunction (GFR above 30 ml/min, but below 60 ml/min), the single dose should not exceed 200 micrograms and the daily dose should not exceed 400 micrograms of moxonidine. The tablets should be taken with sufficient liquid. As the intake of food has no influence on the pharmacokinetic properties of moxonidine, the tablets may be taken before, during or after the meal. Paediatric population Physiotens is not recommended for use in children and adolescents below 18 years due to lack of data on safety and efficacy. 4.3 CONTRAINDICATIONS Physiotens should not be used in cases of: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - sick sinus syndrome or sino-atrial block - 2nd or 3rd degree atrioventricular block - bradycardia (below 50 beats/minute at rest) - severe heart failure (see Section 4.4) - s اقرأ الوثيقة كاملة