Lorista H 50 mg + 12.5 mg Film Coated Tablets

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
27-10-2020
Ciri produk Ciri produk (SPC)
27-10-2020

Bahan aktif:

LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE

Unit dalam pakej:

28 Tablets

Dikeluarkan oleh:

KRKA

Risalah maklumat

                                LORISTA H/ LORISTA HD FILM-COATED
TABLETS
Losartan potassium/Hydrochlorothiazide (50/12.5 mg, 100/25 mg)
_ _
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Lorista H and Lorista HD is
used for
2.
How Lorista H and Lorista HD
works
3.
Before you use Lorista H and
Lorista HD
4.
How to use Lorista H and Lorista
HD a
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Lorista H
and Lorista HD
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT LORISTA H AND LORISTA HD_ _IS
USED FOR
Lorista H and Lorista HD is a
combination of an angiotensin II
receptor antagonist (losartan) and a
diuretic (hydrochlorothiazide).
Losartan and hydrochlorothiazide work
together to lower high blood pressure.
If you have high blood pressure and a
thickening of the left ventricle, the
heart’s main pumping chamber, your
doctor has prescribed Lorista H and
Lorista HD to help lower the risk of
cardiovascular events, such as stroke.
HOW LORISTA H AND LORISTA HD_ _
WORKS
The losartan ingredient of Lorista H
and Lorista HD lowers blood pressure
by specifically blocking a substance
called angiotensin II. Angiotensin II
normally tightens your blood vessels.
The losartan ingredient of Lorista H or
Lorista HD allows them to relax. The
hydrochlorothiazide ingredient of
Lorista H and Lorista HD works by
making your kidneys pass more water
and salt. Together, losartan and
hydrochlorothiazide lower high blood
pressure. Although your doctor will be
able to tell you that the medicine is
working by measuring your blood
pressure, you probably will feel no
different while you are taking Lorista H
or Lorista HD.
WHY HAS MY DOCTOR PRESCRIBED
LORISTA H OR LORISTA HD?
Your doctor has prescribed Lorista H or
Lorista HD because you have a
condition known as hypertension or
high blood pressure. In patients with
high blood pressure and a thickening of
the left ventricle, losartan, often in
combination with hydrochlorothiazide,
reduces the risk of stroke and heart
atta
                                
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Ciri produk

                                1.3.1
Losartan potassium + Hydrochlorothiazide
SPC, Labeling and Package Leaflet
MY
SmPCPIL136939_6
30.07.2019 – Updated: 23.10.2020
Page 1 of 13
_LORISTA H _
_LORISTA HD _
Losartan potassium/Hydrochlorothiazide
NAME OF THE MEDICAL PRODUCT
Lorista H 50 mg/12.5 mg film-coated tablets
Lorista HD 100 mg/25 mg film-coated tablets
PRODUCT DESCRIPITON AND COMPOSITION
Each Lorista H film-coated tablet contains 50 mg losartan, potassium
salt, and 12.5 mg
hydrochlorothiazide.
Lorista H: Yellow, oval, slightly biconvex, one-side scored film
coated tablets. The score line is not
intended for breaking the tablet.
Each Lorista H tablet contains 59.98 mg lactose.
Each Lorista HD film-coated tablet contains 100 mg losartan, potassium
salt, and 25 mg
hydrochlorothiazide.
Lorista HD: Yellow, oval, slightly biconvex film coated tablets.
Each Lorista HD tablet contains 119.95 mg lactose.
DOSAGE FORM
Film-coated tablets
THERAPEUTICS INDICATIONS
_Hypertension_
Lorista H and Lorista HD is indicated for the treatment of
hypertension, for patients in whom
combination therapy is appropriate.
_Hypertensive Patients with left ventricular hypertrophy_
Lorista H and Lorista HD is indicated to reduce the risk of stroke in
patients with hypertension and left
ventricular hypertrophy, but there is evidence that this benefit does
not apply to black patients (see
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE, PHARMACODYNAMIC
PROPERTIES and POSOLOGY AND METHOD OF ADMINISTRATION.)
POSOLOGY AND METHOD OF ADMINISTRATION
Lorista H or Lorista HD may be administered with other
antihypertensive agents.
Lorista H or Lorista HD should be swallowed with a glass of water.
Lorista H or Lorista HD may be administered with or without food.
Fixed dose combination is not indicated for initial therapy.
Hypertension
The usual starting and maintenance dose is one Lorista H (losartan 50
mg/HCTZ 12.5 mg) tablet once
daily. For patients who do not respond adequately to Lorista H, the
dosage may be increased to 2
Lorista H tablets or 1 Lorista HD (losartan 100 mg/HC
                                
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Risalah maklumat Risalah maklumat Bahasa Melayu 27-10-2020