IRB-H 15012.5 (Irbesartan and Hydrochlorothiazide Tablets 15012.5 mg)

País: Malàisia

Idioma: anglès

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

ingredients actius:

HYDROCHLOROTHIAZIDE; Irbesartan

Disponible des:

HEALOL PHARMACEUTICALS SDN. BHD.

Designació comuna internacional (DCI):

HYDROCHLOROTHIAZIDE; Irbesartan

Unidades en paquete:

4x7tablet Tablets

Fabricat per:

Aurobindo Pharma Limited (Unit III),

Informació per a l'usuari

IRB-H
®
(IRBESARTAN AND HYDROCHLOROTHIAZIDE 150 MG /12.5 MG)
Pharmacode position may change as per Supplier’s m/c requirement &
additional small pharma code may ap-
pear on the front / back panel
WHAT IS IN THIS LEAFLET
1.
What
_IRB-H _
is used for
2.
How
_IRB-H _
works
3.
Before you take
_IRB-H _
4.
How to take IRB-H
_ _
5.
While you are using IRB-H
_ _
6.
Side effects
7.
Storage and Disposal of
_IRB-H _
8.
Product Description
9.
Manufacturer and Product Registration Holder
10. Date of Revision
WHAT _IRB-H _IS USED FOR:
IRB-H is used to treat high blood pressure, when treatment
with Irbesartan or hydrochlorothiazide alone did not provide
adequate control of your blood pressure.
HOW _IRB-H WORKS_
IRB-H is a combination of two active substances, Irbesartan
and hydrochlorothiazide. Irbesartan belongs to a group of
medicines
known
as
angiotensin-II
receptor
antagonists.
Angiotensin-II is a substance produced in the body that binds
to receptors in blood vessels causing them to tighten. This
results in an increase in blood pressure. Irbesartan prevents the
binding of angiotensin-II to these receptors, causing the blood
vessels to relax and the blood pressure to lower.
Hydrochlorothiazide is one of a group of medicines (called
thiazide diuretics) that causes increased urine output and so
causes a lowering of blood pressure.
The two active ingredients in IRB-H work together to lower
blood pressure further than if either was given alone.
BEFORE YOU USE _IRB-H _
_When you must not take it :_
•
if you are allergic (hypersensitive) to Irbesartan or any of
the other ingredients of IRB-H.
•
if you are
ALLERGIC
(hypersensitive) to hydrochlorothiazide
or any other sulfonamide-derived medicines.
•
if you are
MORE THAN 3 MONTHS PREGNANT
. (It is also
better to avoid IRB-H in early pregnancy – see pregnancy
section).
•
if you have severe liver or kidney problems.
•
if you have difficulty in producing urine.
•
if your doctor determines that you have
PERSISTENTLY HIGH
CALCIUM OR LOW POTASSIUM LEVELS IN YOUR BLOOD
IR

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
IRB-H
Irbesartan and Hydrochlorothiazide Tablets
_R_
_x_
_ Only_
NAME OF THE MEDICINAL PRODUCT:
Irbesartan and Hydrochlorothiazide Tablets
150/12.5 mg
(TRADE) NAME OF PRODUCT
: IRB-H 150/12.5
STRENGTH
: 150/12.5 mg
PHARMACEUTICAL FORM
: Film-coated Tablet.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Irbesartan and Hydrochlorothiazide Tablets 150/12.5 mg_
Each film-coated tablet contains Irbesartan Ph.Eur. 150 mg and
Hydrochlorothiazide Ph.Eur. 12.5 mg
DESCRIPTION
_Irbesartan and Hydrochlorothiazide Tablets 150/12.5 mg_
Peach coloured, film-coated biconvex oval shaped tablets, debossed
with “H 35” on one
side and plain on the other side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
This fixed dose combination is indicated in adult patients whose blood
pressure is not adequately
controlled on Irbesartan or hydrochlorothiazide alone.
POSOLOGY AND METHOD OF ADMINISTRATION
Irbesartan and Hydrochlorothiazide Tablets can be taken once daily,
with or without food.
Dose
titration
with
the
individual
components
(i.e.
irbesartan
and
hydrochlorothiazide)
may
be
recommended.
When clinically appropriate direct change from monotherapy to the
fixed combinations may be considered:
▪
_Irbesartan and Hydrochlorothiazide Tablets _150 mg/12.5 mg may be
administered in patients whose
blood pressure is not adequately controlled with hydrochlorothiazide
or Irbesartan 150 mg alone;
Doses higher than 300 mg Irbesartan /25 mg hydrochlorothiazide once
daily are not recommended.
When
necessary,
Irbesartan
and
Hydrochlorothiazide
Tablets
may
be
administered
with
another
antihypertensive medicinal product. (Refer Interaction with other
medicinal products and other forms of
interaction section).
_Renal impairment_
due to the hydrochlorothiazide component, Irbesartan and
Hydrochlorothiazide is not recommended for
patients with severe renal dysfunction (creatinine clearance < 30
ml/min). Loop diuretics are preferred to
thiazides in this population. No dosage adjustment is