Irbesartan Hydrochlorothiazide BMS

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

irbesartan, hydrochlorothiazide

Available from:

Bristol-Myers Squibb Pharma EEIG

ATC code:

C09DA04

INN (International Name):

irbesartan, hydrochlorothiazide

Therapeutic group:

Agents acting on the renin-angiotensin system

Therapeutic area:

Hypertension

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).

Product summary:

Revision: 8

Authorization status:

Withdrawn

Authorization date:

2007-01-19

Patient Information leaflet

86
B. PACKAGE LEAFLET
Medicinal product no longer authorised
87
PACKAGE LEAFLET: INFORMATION FOR THE USER
IRBESARTAN HYDROCHLOROTHIAZIDE BMS 150 MG/12.5 MG TABLETS
irbesartan/hydrochlorothiazide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Irbesartan Hydrochlorothiazide BMS is and what it is used for
2.
Before you take Irbesartan Hydrochlorothiazide BMS
3.
How to take Irbesartan Hydrochlorothiazide BMS
4.
Possible side effects
5.
How to store Irbesartan Hydrochlorothiazide BMS
6.
Further information
1.
WHAT IRBESARTAN HYDROCHLOROTHIAZIDE BMS IS AND WHAT IT IS USED
FOR
Irbesartan Hydrochlorothiazide BMS 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 Hydrochlorothiazide BMS work
together to lower blood
pressure further than if either was given alone.
IRBESARTAN HYDROCHLOROTHIAZIDE BMS IS USED TO TREAT HIGH BLOOD
PRESSURE
, when treatment with
irbesartan or hydrochlorothiazide alone did not provide adequate
control of your blood pressure.
2.
BEFORE YOU TAKE IRBESARTA

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Irbesartan Hydrochlorothiazide BMS 150 mg/12.5 mg tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
Excipient:
Each tablet contains 26.65 mg of lactose (as lactose monohydrate).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Peach, biconvex, oval-shaped, with a heart debossed on one side and
the number 2775 engraved on the
other side.
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
Irbesartan Hydrochlorothiazide BMS 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 BMS 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 BMS 300 mg/12.5 mg may be administered
in patients
insufficiently controlled by irbesartan 300 mg or by Irbesartan
Hydrochlorothiazide
BMS 150 mg/12.5 mg.
Irbesartan Hydrochlorothiazide BMS 300 mg/25 mg may be administered in
patients
insufficiently controlled by Irbesartan Hydrochlorothiazide BMS 300
mg/12.5 mg.
Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once
daily are not recommended.
When necessary, Irbesartan Hydrochlorothiazide BMS may be administered
with another
antihypertensive medicinal product (see section 4.5).
Renal impairment:
due to the hydrochlorothiazide component, Irbesartan
Hydrochlorothiazide BMS is
not recommended for pa