Teli H Tablets 40mg12.5mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TELMISARTAN; HYDROCHLOROTHIAZIDE

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

TELMISARTAN; HYDROCHLOROTHIAZIDE

Unit dalam pakej:

30 Tablets; 60 Tablets; 100 Tablets; 30 Tablets; 60 Tablets; 100 Tablets

Dikeluarkan oleh:

CADILA PHARMACEUTICALS LIMITED

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
TELI H TABLETS 40MG/12.5MG
Telmisartan BP 40mg, Hydrochlorothiazide BP 12.5mg
1
WHAT IS IN THIS LEAFLET
1.
What
_Teli H _
is used for
2.
How
_Teli H _
works
3.
Before you use
_Teli H_
4.
How to use
_Teli H_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Teli H_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT
_TELI H _
IS USED FOR
_Teli H _
is a combination of two active
substances,
Telmisartan
and
Hydrochlorothiazide in one tablet.
Both of these substances help to control
high blood pressure.
_Teli _
_H _
is
used
to
treat
high
blood
pressure
(essential
hypertension)
in
patients
whose
blood pressure is not
controlled
enough
when
either
telmisartan
or
hydrochlorothiazide
is
used alone.
HOW
_TELI H _
WORKS
•
Telmisartan belongs to a group of
medicines
called
angiotensin
II
receptor antagonists. Angiotensin-II
is
a
substance
produced
in
your
body
which
causes
your
blood
vessels
to
narrow
thus
increasing
your
blood
pressure.
Telmisartan
blocks the effect of angiotensin II so
that
the
blood
vessels
relax,
and
your blood pressure is lowered.
•
Hydrochlorothiazide belongs to a
group of medicines called thiazide
diuretics, which cause your urine
output to
increase, leading to a
lowering of your blood pressure.
High blood pressure, if not treated, can
damage blood vessels in several organs,
which could lead sometimes to heart
attack, heart or kidney failure, stroke, or
blindness.
There
are
usually
no
symptoms
of
high
blood
pressure
before
damage
occurs.
Thus
it
is
important to regularly measure blood
pressure to verify if it is
within the
normal range.
BEFORE YOU USE
_TELI H_
-
_When you must not use it_
•
if you are allergic (hypersensitive)
to
telmisartan
or
any
other
ingredients
included
in
_Teli _
_H_
_ _
tablets (see “Product Description”
for a list of other ingredients).
•
if you are allergic (hypersensitive)
to hydrochlorothiazide or to any
other
sulfonamide-derived
medicines.
•
if

Ciri produk

For the use only of a Registered Medical
Practitioner or a Hospital or a Laboratory
NAME OF THE MEDICINAL PRODUCT
Teli H 40 mg/12.5 mg tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
bi-layered
tablet
contains
40
mg
telmisartan
BP
and
12.5
mg
hydrochlorothiazide BP
PHARMACEUTICAL FORM
Tablet
PRODUCT DESCRIPTION
Biconvex, bilayered, oval shaped, uncoated tablets. One layer is pink
and other
layer is white and may contain pink specks.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Telmisartan 40 mg+hydrochlorothiazide 12.5mg is indicated in patients
whose blood pressure is not adequately controlled on telmisartan
alone.
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
Telmisartan+hydrochlorothiazide should be taken in patients whose
blood
pressure is not adequately controlled by telmisartan alone. Individual
dose
titration with each of the two components is recommended before
changing to the
fixed
dose
combination. When
clinically
appropriate,
direct
change
from
monotherapy to the fixed combination may be considered.
Telmisartan 40 mg+hydrochlorothiazide 12.5mg may be administered in
patients
whose blood pressure is not adequately controlled by telmisartan
monotherapy or
hydrochlorothiazide monotherapy.
SPECIAL POPULATIONS
RENAL IMPAIRMENT
: Due to the hydrochlorothiazide component, Teli H
should not be used in patients with severe renal dysfunction
(creatinine
clearance <30 mL/min). Loop diuretics are preferred to thiazides in
this
population. Experience in patients with mild to moderate renal
impairment is
modest but has not suggested adverse renal effects and dose adjustment
is not
considered necessary. Periodic monitoring of renal function is
advised.
HEPATIC IMPAIRMENT
: In patients with mild to moderate hepatic impairment the
posology should not exceed telmisartan 40mg + hydrochlorothiazide
12.5mg
once daily. Telmisartan + hydrochlorothiazide is not indicated in
patients
with severe hepatic impairment. Thiazides should be used with caution
in
patients with impaired hepatic