CoAprovel 150mg12.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrochlorothiazide; Irbesartan

Available from:

Sanofi

ATC code:

C09DA04

INN (International Name):

Hydrochlorothiazide; Irbesartan

Dosage:

12.5mg ; 150mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050502; GTIN: 5000283642824

Patient Information leaflet

Code :
688043-G620854
Update :
V5- 21/09/2017
PA code :
194557
Product/Item type :
PRO CO-APROVEL
150/12,5
Country :
GB
Artwork by :
M.PACHO
Format :
170 x 310 mm
(Plegado 170 X 34,5 mm)
Laetus Code :
969
Colours :
1
BLACK
Fonts :
Ocean Sans Pro San (8pt)
Assembly Card :
M-B421
Reason of change:
TRANSFER
SANOFI-AVENTIS
RIELLS PACKAGING TEAM
688043-G620854
170 x 310 mm
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 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 wa

Summary of Product characteristics

OBJECT 1
COAPROVEL 150MG/12.5MG TABLETS
Summary of Product Characteristics Updated 13-Oct-2017 | SANOFI
1. Name of the medicinal product
CoAprovel 150 mg/12.5 mg film-coated tablets.
2. Qualitative and quantitative composition
Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
Excipient with known effect:
Each film-coated tablet contains 38.5 mg of lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Peach, biconvex, oval-shaped, with a heart debossed on one side and
the number 2875 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).
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