Држава: Израел
Језик: Енглески
Извор: Ministry of Health
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
ORGANON PHARMA ISRAEL LTD., ISRAEL
C09DA01
TABLETS
LOSARTAN POTASSIUM 50 MG; HYDROCHLOROTHIAZIDE 12.50 MG
PER OS
Required
ORGANON LLC, USA
LOSARTAN AND DIURETICS
LOSARTAN AND DIURETICS
Ocsaar plus is indicated for the treatment of hypertension, for patients in whom combination therapy is appropriate. To reduce the risk of stroke in patients with hyperfension adn left ventricular hypertrophy.
2023-05-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACIST'S REGULATIONS (PREPARATIONS) – 1986 This medicine is to be supplied under doctor's prescription only OCSAAR ® PLUS TABLETS EACH TABLET CONTAINS: Losartan Potassium 50 mg Hydrochlorothiazide 12.5 mg For a list of inactive and allergenic ingredients see section “Important information about some of the ingredients of OCSAAR PLUS” and section 6 “FURTHER INFORMATION”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • This leaflet contains concise information about OCSAAR PLUS. If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their ailment seems similar to yours. OCSAAR PLUS is not intended for children and adolescents under 18 years of age. 1. WHAT OCSAAR PLUS IS INTENDED FOR? OCSAAR PLUS is intended for the treatment of hypertension, and to reduce the risk of stroke in patients with high blood pressure and a thickening of the left ventricle (the heart’s main pumping chamber). THERAPEUTIC GROUP: OCSAAR PLUS is a combination of an angiotensin II receptor antagonist (losartan) and a thiazide diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Hydrochlorothiazide works by making the kidneys pass more water and salt. This also helps to reduce blood pressure. 2. BEFORE YOU TAKE OCSAAR PLUS DO NOT TAKE OCSAAR PLUS IF YOU: − are allergic (hypersensitive) to losartan, hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6), − are allergic to other sulfonamide-derived substances (e.g. other thiazides, some antibacterial drugs such as co-trimoxazole, ask your doctor if you are not sure), − Прочитајте комплетан документ
1 1. NAME OF THE MEDICINAL PRODUCT OCSAAR ® PLUS TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide (HCTZ). Each tablet contains 63.13 mg lactose monohydrate. OCSAAR PLUS contains 4.24 mg (0.108 mEq) of potassium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet OCSAAR PLUS tablets are yellow, oval, film-coated tablet with “717” debossed on one side and scored on the other. The score line is not intended for breaking the tablet. No information is available regarding crushing/chewing/splitting of the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OCSAAR PLUS is indicated for the treatment of hypertension, for patients in whom combination therapy is appropriate. OCSAAR PLUS is indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Hypertension Losartan and hydrochlorothiazide is not for use as initial therapy, but in patients whose blood pressure is not adequately controlled by losartan potassium or hydrochlorothiazide alone. Dose titration with the individual components (losartan and hydrochlorothiazide) is recommended. When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled. The usual maintenance dose of OCSAAR PLUS is one tablet of OCSAAR PLUS once daily. For patients who do not respond adequately to OCSAAR PLUS, the dosage may be increased to two tablets of OCSAAR PLUS once daily. The maximum dose is two tablets of OCSAAR PLUS once daily. In general, the antihypertensive effect is attained within three to four weeks after initiation of therapy. _ _ _ _ REDUCTION IN THE RISK OF STROKE IN PATIENTS WITH HYPERTENSION AND LEFT VENTRICULAR HYPERTROPHY The usual starting dose is 50 mg of losartan once daily. If goal blood pressure is not reached with losartan 50 mg, thera Прочитајте комплетан документ