OCSAAR 50 MG

Země: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktivní složka:

LOSARTAN POTASSIUM

Dostupné s:

ORGANON PHARMA ISRAEL LTD., ISRAEL

ATC kód:

C09CA01

Léková forma:

TABLETS

Složení:

LOSARTAN POTASSIUM 50 MG

Podání:

PER OS

Druh předpisu:

Required

Výrobce:

ORGANON LLC, USA

Terapeutické skupiny:

LOSARTAN

Terapeutické oblasti:

LOSARTAN

Terapeutické indikace:

Hypertension: Ocsaar 50 mg is indicated for the treatment of hypertensionHeart failure: Ocsaar 50 mg 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 Ocsaar 50 mg is not recommended.Renal protection in Type-2 diabetic patients with proteinuria: Ocsaar 50 mg 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. Ocsaar 50 mg 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 Ocsaar 50 mg on the primary deposite endpoint was largely driven by reduction in the risk of stroke.

Datum autorizace:

2021-07-31

Informace pro uživatele

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) – 1986
This medicine is to be supplied upon doctor's prescription only
OCSAAR
® 50 MG
TABLETS
EACH TABLET CONTAINS:
Losartan Potassium 50 mg
For a list of inactive ingredients refer to section 6.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
This leaflet contains concise information about OCSAAR. 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.
1. WHAT OCSAAR IS AND WHAT IT IS USED FOR?
OCSAAR is indicated for the treatment of heart failure.
OCSAAR is also indicated for the treatment of hypertension (high blood
pressure) and 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).
OCSAAR also provides kidney protection by delaying the worsening of
kidney disease in Type-2 diabetic
patients with protein in their urine (proteinuria).
THERAPEUTIC GROUP:
OCSAAR is an angiotensin II receptor antagonist.
2. BEFORE YOU TAKE OCSAAR
2.1 DO NOT TAKE OCSAAR IF:
−
you are allergic (hypersensitive) to losartan or to any of the other
ingredients of this medicine (listed in
section 6)
−
you are more than 3 months pregnant (It is also better to avoid OCSAAR
in early pregnancy - see
section 2.5 “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.
2.2 SPECIAL WARNINGS CONCERNING USE OF OCSAAR
Talk to your doctor or pharmacist before taking the medicine.
You must tell your doctor if you think you are (or might become)
pregnant. OCSAAR is not recommended in
early pregnancy, and must not be taken if you are more than 3 months
pregnant, as it may cause serious
harm to your baby if u

Charakteristika produktu

1
1.
NAME OF THE MEDICINAL PRODUCT
OCSAAR
®
50
MG
TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each OCSAAR 50 mg tablet contains 50 mg of losartan potassium.
Each OCSAAR 50 mg tablet contains 25.5 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
White, oval film-coated tablets marked 952 on one side and scored on
the other.
The score line is not intended for breaking the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYPERTENSION
: Ocsaar 50 mg is indicated for the treatment of hypertension
HEART FAILURE
: Ocsaar 50 mg 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 Ocsaar 50 mg is not
recommended.
RENAL PROTECTION IN TYPE-2 DIABETIC PATIENTS WITH PROTEINURIA
:
Ocsaar 50 mg 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
:
Ocsaar 50 mg 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 Ocsaar 50 mg 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 with other a