OCSAAR PLUS

Ország: Izrael

Nyelv: angol

Forrás: Ministry of Health

Aktív összetevők:

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Beszerezhető a:

ORGANON PHARMA ISRAEL LTD., ISRAEL

ATC-kód:

C09DA01

Gyógyszerészeti forma:

TABLETS

Összetétel:

LOSARTAN POTASSIUM 50 MG; HYDROCHLOROTHIAZIDE 12.50 MG

Az alkalmazás módja:

PER OS

Recept típusa:

Required

Gyártó:

ORGANON LLC, USA

Terápiás csoport:

LOSARTAN AND DIURETICS

Terápiás terület:

LOSARTAN AND DIURETICS

Terápiás javallatok:

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.

Engedély dátuma:

2023-05-31

Betegtájékoztató

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),
−

Termékjellemzők

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