Irbesartan 300mg Hydrochlorothiazide 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrochlorothiazide; Irbesartan

Available from:

Milpharm Ltd

ATC code:

C09DA04

INN (International Name):

Hydrochlorothiazide; Irbesartan

Dosage:

25mg ; 300mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF:

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as
yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible sideeffects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What Irbesartan and Hydrochlorothiazide is and what it is used for
2.
What you need to know before you take Irbesartan and
Hydrochlorothiazide
3.
How to take Irbesartan and Hydrochlorothiazide
4.
Possible side effects
5.
How to store Irbesartan and Hydrochlorothiazide
6.
Contents of the pack and other information
Irbesartan and Hydrochlorothiazide 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 Irbesartan and Hydrochlorothiazide work
together to lower blood pressure further than if either was given
alone.
IRBESARTAN AND HYDROCHLOROTHIAZIDE IS USED TO TREAT HIGH BLOOD
PRESSURE,
when treatment with irbesartan or hydrochlorothiazide alone did not
provide
adequate control of your blood pressure.
DO NOT TAKE IRBESARTAN AND HYDROCHLOROTHIAZIDE
•
if you are ALLERGIC to irbesartan or any of the other ingredients of
this

Summary of Product characteristics

OBJECT 1
IRBESARTAN AND HYDROCHLOROTHIAZIDE MILPHARM
300 MG/ 25 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 02-Aug-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Irbesartan and Hydrochlorothiazide Milpharm 300 mg/ 25 mg film-coated
tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 300 mg of irbesartan and 25 mg of
hydrochlorothiazide.
_Excipientwith known effect:_
Each film-coated tablet contains 256.50 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Pink coloured film-coated biconvex oval shaped tablets, debossed with
“H 37” on one side and plain on
other side. The size is 17.7 mm X 9.6 mm.
4. Clinical particulars
4.1 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 (see section
5.1).
4.2 Posology and method of administration
Posology
Irbesartan/ Hydrochlorothiazide 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/ Hydrochlorothiazide 150 mg/12.5 mg may be administered
in patients whose blood pressure
is not adequately controlled with hydrochlorothiazide or irbesartan
150 mg alone;
• Irbesartan/ Hydrochlorothiazide 300 mg/12.5 mg may be administered
in patients insufficiently
controlled by irbesartan 300 mg or by Irbesartan/ Hydrochlorothiazide
150 mg/12.5 mg.
• Irbesartan/ Hydrochlorothiazide 300 mg/25 mg may be administered
in patients insufficiently controlled
by Irbesartan/ Hydrochlorothiazide 300 mg/12.5 mg.
Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once
daily are not recommended. When
necessary, Irbesartan/ Hydrochlorothiazide may be administere