Irbesartan 300mg Hydrochlorothiazide 12.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Irbesartan; Hydrochlorothiazide

Available from:

Lupin Healthcare (UK

ATC code:

C09DA04

INN (International Name):

Irbesartan; Hydrochlorothiazide

Dosage:

300mg ; 12.5mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050502; GTIN: 8901107024284

Patient Information leaflet

1
_Version 4, 02/2016 _
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IRBESARTAN-LUPIN COMP 150 MG/12.5 MG FILM-COATED TABLETS
IRBESARTAN-LUPIN COMP 300 MG/12.5 MG FILM-COATED TABLETS
IRBESARTAN-LUPIN COMP 300 MG/25 MG FILM-COATED TABLETS
Irbesartan/Hydrochlorothiazide
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 side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Irbesartan-Lupin comp is and what it is used for
2.
What you need to know before you take Irbesartan-Lupin comp
3.
How to take Irbesartan-Lupin comp
4.
Possible side effects
5.
How to store Irbesartan-Lupin comp
6.
Contents of the pack and other information
1.
WHAT IRBESARTAN-LUPIN COMP IS AND WHAT IT IS USED FOR
Irbesartan-Lupin comp 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-Lupin comp work together to
lower blood pressure further
than if either was given alone.
IRBESARTAN-LUPIN COMP IS USED TO TREAT HIGH BLOOD PRESSURE
, when treatment with irbesarta

Summary of Product characteristics

OBJECT 1
IRBESARTAN/HYDROCHLOROTHIAZIDE 300 MG/25 MG
FILM-COATED TABLETS
Summary of Product Characteristics Updated 09-Oct-2017 | Lupin
Healthcare (UK) Ltd
1. Name of the medicinal product
Irbesartan-Lupin comp 150 mg/12.5 mg Film-Coated Tablets
Irbesartan-Lupin comp 300 mg/12.5 mg Film-Coated Tablets
Irbesartan-Lupin comp 300 mg/25 mg Film-Coated Tablets
2. Qualitative and quantitative composition
Each Irbesartan-Lupin comp 150 mg/12.5 mg film-coated tablet contains
150 mg of irbesartan and 12.5
mg of hydrochlorothiazide.
Each Irbesartan-Lupin comp 300 mg/12.5 mg film-coated tablet contains
300 mg of irbesartan and 12.5
mg of hydrochlorothiazide.
Each Irbesartan-Lupin comp 300 mg/25 mg film-coated tablet contains
300 mg of irbesartan and 25 mg
of hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Irbesartan-Lupin comp 150 mg/12.5 mg film-coated tablets are light
peach-coloured, biconvex, oval-
shaped film coated tablets, debossed with “IT1” on one side and
plain on the other side. The tablets have
a length of 14 mm and width of 7 mm.
Irbesartan-Lupin comp 300 mg/12.5 mg film-coated tablets are light
peach-coloured, biconvex, oval-
shaped film coated tablets, debossed with “IT2” on one side and
plain on the other side. The tablets have
a length of 19 mm and width of 8.5 mm.
Irbesartan-Lupin comp 300 mg/25 mg film-coated tablets are tan,
biconvex, oval-shaped film coated
tablets, debossed with “IT3” on one side and plain on the other
side. The tablets have a length of 19 mm
and width of 8.5 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 sections
5.1).
4.2 Posology and method of administration
Posology
Irbesartan-Lupin comp can be taken once daily, with or without food.
Dose titration with the individual components (i.e. irbesartan and
hydroc