Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
LOSARTAN POTASSIUM HYDROCHLOROTHIAZIDE
Laboratorios LICONSA, S.A.
100/25 Milligram
Film Coated Tablet
2008-05-02
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Losartan Potassium/Hydrochlorothiazide Liconsa 100 mg/25 mg film-coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg of losartan potassium, equivalent to 91.52 mg of losartan, and 25 mg of hydrochlorothiazide. Excipient: 140.61 mg of lactose monohydrate/film-coated tablet For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Round, yellow, film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of essential hypertension in patients whose blood pressure is not adequately controlled by losartan 50 mg/ hydrochlorothiazide 12.5 mg once daily. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Method of administration_ The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water). Losartan potassium/Hydrochlorothiazide may be administered with or without food. The combination of 100 mg losartan potassium / 25 mg hydrochlorothiazide is not recommended as initial therapy. One losartan potassium / hydrochlorothiazide tablet once daily is recommended for those patients who do not respond adequately to a combination of 50 mg losartan potassium / 12.5 mg hydrochlorothiazide given once daily. In general, the antihypertensive effect is attained within three to four weeks after initiation of therapy. _Use in the elderly: _No initial dose adjustment is necessary. Experience is limited in this population. _Use in renal impairment_: No initial dosage adjustment is necessary in patients with mild to moderate renal impairment (i.e. creatinine clearance 30-50 ml/min). Losartan potassium/Hydrochlorothiazide is not recommended for patients on dialysis. It is contraindicated in patients with severe renal impairment (i.e. c Lugege kogu dokumenti