Šalis: Malta
kalba: anglų
Šaltinis: Malta Medicines Authority
MOXONIDINE
Mylan Products Limited
C02AC05
MOXONIDINE
TABLET
MOXONIDINE 200 µg
POM
ANTIHYPERTENSIVES
Authorised
Page 1 of 9 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. Page 2 of 9 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 fail Perskaitykite visą dokumentą