Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
LOSARTAN POTASSIUM
DEXCEL PHARMA TECHNOLOGIES LTD
C09CA01
TABLETS
LOSARTAN POTASSIUM 50 MG
PER OS
Required
DEXCEL LTD, ISRAEL
LOSARTAN
LOSARTAN
Hypertension: Losardex 50 is indicated for the treatment of hypertensionHeart failure: Losardex 50 is indicated for the treatment of heart failure, usually in addition to diuretics and/or digitalis, if use of an ACE inhibitor is not appropriate.Switching patients with heart failure who are stable on an ACE inhibitor to Losardex 50 is not recommended.Renal protection in Type-2 diabetic patients with proteinuria: Losardex 50 is indicated to delay the progression of renal disease as measured by a reduction in the combined incidence of doubling of serum creatinine, end stage renal disease (need for dialysis or renal transplantation) or death; and to reduce proteinuria.Reduction in the risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy. Losardex 50 is indicated to reduce the risk of cardiovascular morbidity and mortality as measured by the combined incidence of cardiovascular death, stroke, and myocardial infarction in hypertensive patients with left ventricular hypertrophy.The benefit of Losardex 50 on the primary deposite endpoint was largely driven by reduction in the risk of stroke.
2013-03-31
PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine can be sold with a physician’s prescription only LOSARDEX ® TABLETS 12.5, 50 MG LOSARDEX ® CAPLETS, 100 MG Each tablet/caplet contains Losartan Potassium at a dosage of 12.5, 50 or 100 mg respectively. Inactive ingredients and allergens in the medicine - see section 6 "Additional information" and in section 2 "Important information about some of the ingredients of this medicine". READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about the medicine. 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 medical condition seems similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? LOSARDEX is used for the treatment of heart failure. LOSARDEX 50 and LOSARDEX 100 are also indicated for the treatment of high blood pressure to help lower the risk of cardiovascular events, such as stroke, in patients with high blood pressure and a thickening of the left ventricle (the heart’s main pumping chamber). LOSARDEX 50 and LOSARDEX 100 also provide kidney protection by delaying the worsening of kidney disease in Type-2 diabetic patients with protein in their urine (proteinuria). THERAPEUTIC GROUP: belongs to angiotensin II receptor blockers group. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are hypersensitive (allergic) to the active ingredient (losartan) or to any of the other ingredients of this medicine (see section 6). • You are more than 3 months pregnant (it is also better to avoid LOSARDEX in early pregnancy - see section “Pregnancy and breast - feeding”). • Your liver function is severely impaired. • You have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren. SPECIAL WARNINGS CONCERNING USE OF THE MEDICINE • Talk to your doctor or pharmacis Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT LOSARDEX 100 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each caplet contains 100 mg of losartan potassium. Each caplet contains approximately 220 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Caplets LOSARDEX 100 are white, film-coated, biconvex caplets, scored on both sides. The caplet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension: LOSARDEX 100 is indicated for the treatment of hypertension. Heart failure: LOSARDEX 100 is indicated for the treatment of heart failure, usually in addition to diuretics and/or digitalis, if use of an ACE inhibitor is not appropriate. Switching patients with heart failure who are stable on an ACE inhibitor to LOSARDEX 100 is not recommended. Renal protection in Type-2 diabetic patients with proteinuria: LOSARDEX 100 is indicated to delay the progression of renal disease as measured by a reduction in the combined incidence of doubling of serum creatinine, end stage renal disease (need for dialysis or renal transplantation) or death; and to reduce proteinuria. Reduction in the risk of cardiovascular morbidity and mortality in hypertensive patients with left ventricular hypertrophy: LOSARDEX 100 is indicated to reduce the risk of cardiovascular morbidity and mortality as measured by the combined incidence of cardiovascular death, stroke, and myocardial infarction in hypertensive patients with left ventricular hypertrophy. The benefit of LOSARDEX 100 on the primary deposite endpoint was largely driven by reduction in the risk of stroke. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Hypertension The usual starting and maintenance dose is 50 mg once daily for most patients. The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy. Some patients may receive an additional benefit by increasing the dose to 100 mg once daily (in the morning). Losartan may be administered alone or with other Baca dokumen lengkapnya