CoAprovel 300mg25mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Hydrochlorothiazide; Irbesartan

זמין מ:

Sanofi

קוד ATC:

C09DA04

INN (שם בינלאומי):

Hydrochlorothiazide; Irbesartan

כמות:

25mg ; 300mg

טופס פרצבטיות:

Tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: ; GTIN: 5000283652724

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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
medicine (listed in section 6)
• if you are ALLERGIC to hydrochlorothiazide or any other
s

מאפייני מוצר

OBJECT 1
COAPROVEL 300MG/25MG TABLETS
Summary of Product Characteristics Updated 13-Oct-2017 | SANOFI
1. Name of the medicinal product
CoAprovel 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.
Excipient with known effect:
Each film-coated tablet contains 53.3 mg of lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Pink, biconvex, oval-shaped, with a heart debossed on one side and the
number 2788 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 diureti