País: Malta
Idioma: anglès
Font: Medicines Authority
INDAPAMIDE
Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia
C03BA11
INDAPAMIDE 1.5 mg
PROLONGED-RELEASE TABLET
INDAPAMIDE 1.5 mg
POM
DIURETICS
Withdrawn
2009-12-10
PROPOSED MOCK UP A healthy decision Sandoz Ltd, 37 Woolmer Way, Bordon, Hampshire, GU35 9QE, United Kingdom. T: 01420 478301 F: 01420 474427 W: www.uk.sandoz.com E: sandoz.artwork@me.com ARTWORK PROOF BOX Ref: Proof no. RA Approved? Colours: Dimensions: Date prepared: Date approved: Prepared by: Approved by: Fonts: 1 21/10/2009 DW 21/10/2009 RT Yes Licence application Black Black 20% 165 x 320 mm Helvetica Font size: 7pt Artwork/RA Checklist: Product name Strength/dosage PL number Storage Pack size Warnings Excipients Braille Diurelix XL belongs to a group of medicines known as sulfonamide diuretics (water tablets). The active ingredient in Diurelix XL is indapamide. Most diuretics increase the amount of urine produced by the kidneys. However, indapamide is different from other diuretics, as it only causes a slight increase in the amount of urine produced. Diurelix XL is used to treat high blood pressure (hypertension). DO NOT TAKE DIURELIX XL IF YOU: • are ALLERGIC (HYPERSENSITIVE) to indapamide or any other sulfonamide or to any of the ingredients in preparation (see Section 6 Further information) • have severe LIVER DISEASE or suffer from a condition called HEPATIC ENCEPHALOPATHY (degenerative disease of the brain) • have a severe KIDNEY DISEASE or if you are RECEIVING DIALYSIS • have LOW BLOOD POTASSIUM TAKE SPECIAL CARE WITH DIURELIX XL Before your take Diurelix XL tell your doctor if you: • have LIVER PROBLEMS • have DIABETES • suffer from GOUT • have any other HEART PROBLEMS • have problems with your KIDNEYS • if you need to have A TEST to check how well your PARATHYROID GLAND is working • have had or develop increased SENSITIVITY OF THE SKIN TO SUN (photosensitivity) Your doctor may give you blood tests to check for low sodium or potassium levels or high calcium levels. Llegiu el document complet
Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diurelix XL 1.5 mg Prolonged-release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release tablet contains 1.5 mg indapamide. Excipient(s): lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. White, round, biconvex film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use. One tablet per 24 hours, preferably in the morning, to be swallowed whole with water and not chewed. At higher doses the antihypertensive action of indapamide is not enhanced but the saluretic effect is increased. RENAL FAILURE (see sections 4.3 and 4.4) In severe renal failure (creatinine clearance below 30 ml/min), treatment is contraindicated. Thiazide and related diuretics are fully effective only when renal function is normal or only minimally impaired. ELDERLY (see section 4.4) In the elderly, the plasma creatinine must be adjusted in relation to age, weight and gender. Elderly patients can be treated with Diurelix XL when renal function is normal or only minimally impaired. Page 2 of 9 PATIENTS WITH HEPATIC IMPAIRMENT (see sections 4.3 and 4.4) In severe hepatic impairment, treatment is contraindicated. CHILDREN AND ADOLESCENTS Diurelix XL is not recommended for use in children and adolescents due to a lack of data on safety and efficacy. 4.3 CONTRAINDICATIONS • Hypersensitivity to indapamide, to other sulfonamides or to any of the excipients • Severe renal failure • Hepatic encephalopathy or severe impairment of liver function • Hypokalaemia 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Llegiu el document complet