LOSARDEX 50
البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
نشرة المعلومات
(PIL)
14-06-2020
خصائص المنتج
(SPC)
27-02-2023
تقرير التقييم الجمهور
(PAR)
19-02-2020
العنصر النشط:
LOSARTAN POTASSIUM
متاح من:
DEXCEL PHARMA TECHNOLOGIES LTD
ATC رمز:
C09CA01
الشكل الصيدلاني:
TABLETS
تركيب:
LOSARTAN POTASSIUM 50 MG
طريقة التعاطي:
PER OS
نوع الوصفة الطبية :
Required
المصنعة من قبل:
DEXCEL LTD, ISRAEL
المجموعة العلاجية:
LOSARTAN
المجال العلاجي:
LOSARTAN
الخصائص العلاجية:
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.
تاريخ الترخيص:
2023-03-31
نشرة المعلومات
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
اقرأ الوثيقة كاملة
خصائص المنتج
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
اقرأ الوثيقة كاملة
