Hartan 50mg film-coated tablets

Country: Malaysia

Language: English

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

Active ingredient:

LOSARTAN POTASSIUM

Available from:

STADPHARM SDN. BHD.

INN (International Name):

LOSARTAN POTASSIUM

Units in package:

3x10'stablet Tablets

Manufactured by:

STELLAPHARM J.V. Co., LTD. - BRANCH 1

Patient Information leaflet

Page 1 of 2
HARTAN 50MG FILM-COATED TABLETS
Active ingredient: Losartan potassium 50 mg
_Consumer Medication Information Leaflet _
_(RiMUP) _
WHAT IS IN THIS LEAFLET
1.
What Hartan 50mg film-coated tablets
is used for
2.
How Hartan 50mg film-coated tablets
works
3.
Before you use Hartan 50mg film-
coated tablets
4.
How to use Hartan 50mg film-coated
tablets
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Hartan
50mg film-coated tablets
8.
Product description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
WHAT HARTAN 50MG FILM-COATED TABLETS
IS USED FOR

Treat hypertension (high blood pressure).

Reduce the risk of
stroke (a
sudden
attack of weakness affecting one side of
the body) in patients with high blood
pressure and left
ventricular
hypertrophy
(a
thickening
of
the
left
ventricle of the heart).

To slow the worsening of diabetic kidney
disease
(nephropathy)
in
the
patients
with type 2 diabetes who have or had
high blood pressure.
HOW HARTAN 50MG FILM-COATED TABLETS
WORKS
Losartan belongs to a group of medicines
known
as
angiotensin-II
receptor
antagonists. Angiotensin II is a chemical
in your body, which tightens your blood
vessels making it harder for the blood to
pass through them and causes your blood
pressure to increase.
Losartan blocks this effect, causing the
blood vessels to relax and so lowers your
blood pressure.
BEFORE YOU USE HARTAN 50MG FILM-COATED
TABLETS
- _When you must not use it _

You are allergic to losartan potassium or
any of the other ingredients of this drug.

You are more than 3 months pregnant.
_If you think any of these apply to you, or if _
_you are in any doubt at all, consult your _
_doctor before taking this drug. _
_ _
_-_
_ _
_Before you start to use it _
_If any of the situations mentioned below _
_apply to you, you should tell your doctor _
_before taking this drug: _

If you have renal artery stenosis
(narrowing of the kidney artery).

If you have kidney or liver dysfunction.

If
you
have
volume
depletion
(

Summary of Product characteristics

HARTAN 50MG FILM-COATED TABLETS
COMPOSITION
Active ingredient: One tablet contains 50 mg losartan potassium.
PHARMACODYNAMICS
Losartan and its principal active metabolite block the vasoconstrictor
and
aldosterone-secreting
effects
of
angiotensin
II
by
selectively
blocking the binding of angiotensin II to the AT1 receptor found in
many
tissues, (e.g., vascular smooth muscle, adrenal gland).
The active metabolite is 10 to 40 times more potent by weight than
losartan and appears to be a reversible, non-competitive inhibitor of
the
AT1 receptor.
Neither losartan nor its active metabolite inhibits ACE (kininase II,
the
enzyme that converts angiotensin I to angiotensin II and degrades
bradykinin); nor do they bind to or block other hormone receptors or
ion
channels known to be important in cardiovascular regulation.
PHARMACOKINETICS
Losartan is readily absorbed from the gastrointestinal tract following
oral
administration, but undergoes substantial first-pass metabolism
resulting in
a systemic bioavailability of about 33%. It is metabolised to an
active
carboxylic
acid
metabolite
E-3174
(EXP-3174),
which
has
greater
pharmacological activity than losartan; some inactive metabolites are
also
formed. Metabolism is primarily by cytochrome P450 isoenzymes CYP2C9
and CYP3A4. Peak plasma concentrations of losartan and E-3174 occur
about 1 hour and 3 to 4 hours, respectively, after an oral dose.
Both losartan and E-3174 are more than 98% bound to plasma proteins.
Losartan
is
excreted
in
the
urine,
and
in
the
faeces
via
bile,
as
unchanged drug and metabolites. Following oral dosing about 4% of the
dose is excreted unchanged in urine and about 6% is excreted in urine
as the active metabolite. The terminal elimination half-lives of
losartan
and E-3174 are about 1.5 to 2.5 hours and 3 to 9 hours, respectively.
INDICATIONS

_ Hypertension: _
HARTAN 50MG FILM-COATED TABLETS is indicated for the treatment of
hypertension.

_ Hypertensive patients with left ventricular hypertrophy: _
HARTAN 50MG FILM-COATED TABLETS is indicated