CoAprovel

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

irbesartan, hydrochlorothiazide

Available from:

Sanofi Winthrop Industrie

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.

Product summary:

Revision: 49

Authorization status:

Authorised

Authorization date:

1998-10-14

Patient Information leaflet

109
B. PACKAGE LEAFLET
110
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COAPROVEL 150 MG/12.5 MG 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 possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What CoAprovel is and what it is used for
2.
What you need to know before you take CoAprovel
3.
How to take CoAprovel
4.
Possible side effects
5.
How to store CoAprovel
6.
Contents of the pack and other information
1.
WHAT COAPROVEL IS AND WHAT IT IS USED FOR
CoAprovel 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 CoAprovel work together to lower blood
pressure further than if either
was given alone.
COAPROVEL IS USED TO TREAT HIGH BLOOD PRESSURE
, when treatment with irbesartan or
hydrochlorothiazide alone did not provide adequate control of your
blood pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE COAPROVEL
DO NOT TAKE COAPROVEL
▪
if you are
ALLERGIC
to irbesartan or any of the other ingredients of this

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
CoAprovel 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 with known effect:
Each tablet contains 26.65 mg of lactose (as lactose monohydrate).
For the 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
Posology
CoAprovel 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:
▪
CoAprovel 150 mg/12.5 mg may be administered in patients whose blood
pressure is not
adequately controlled with hydrochlorothiazide or irbesartan 150 mg
alone.
▪
CoAprovel 300 mg/12.5 mg may be administered in patients
insufficiently controlled by
irbesartan 300 mg or by CoAprovel 150 mg/12.5 mg.
▪
CoAprovel 300 mg/25 mg may be administered in patients insufficiently
controlled by
CoAprovel 300 mg/12.5 mg.
Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once
daily are not recommended.
When necessary, CoAprovel may be administered with another
antihypertensive medicinal product
(see sections 4.3, 4.4, 4.5 and 5.1).
3
Special Populations
_Renal impairment_
Due to the hydrochlorothiazide component, CoAprovel 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 necessary in patients