Converide 300mg/12.5mg film-coated Tablets

Country: Malta

Language: English

Source: Malta Medicines Authority

Active ingredient:

IRBESARTAN, HYDROCHLOROTHIAZIDE

Available from:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC code:

C09DA04

INN (International Name):

IRBESARTAN 300 mg HYDROCHLOROTHIAZIDE 12.5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

IRBESARTAN 300 mg HYDROCHLOROTHIAZIDE 12.5 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Authorised

Authorization date:

2019-02-05

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CONVERIDE 150 MG/12.5MG FILM-COATED TABLETS
CONVERIDE 300 MG/12.5MG FILM-COATED TABLETS
CONVERIDE 300 MG/25MG 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 Converide is and what it is used for
2.
What you need to know before you take Converide
3.
How to take Converide
4.
Possible side effects
5.
How to store Converide
6.
Contents of the pack and other information
1.
WHAT CONVERIDE IS AND WHAT IT IS USED FOR
Converide 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 Converide work together to lower blood
pressure further than if either
was given alone.
CONVERIDE
IS
USED
TO
TREAT
HIGH
BLOOD
PRESSURE
,
when
treatment
with
irbesartan
or
2
hydrochlorothiazide alone did not provide adequate control of your
blood pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CONVERIDE
DO NOT TAKE CONVERIDE:
-
if you ar

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Converide 150 mg/12.5 mg film-coated tablets
Converide 300mg/12.5mg film-coated tablets
Converide 300mg/25mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Converide 150 mg/12.5 mg film-coated tablets: Each film-coated tablet
contains 150 mg of irbesartan
and 12.5 mg of hydrochlorothiazide.
Converide 300mg/12.5mg film-coated tablets: Each film-coated tablet
contains 300 mg of irbesartan
and 12.5 mg of hydrochlorothiazide.
Converide 300mg/25mg film-coated tablets: Each film-coated tablet
contains 300 mg of irbesartan and
25 mg of hydrochlorothiazide.
Excipient with known effect: lactose monohydrate.
Converide 150 mg/12.5 mg film-coated tablets: Each film-coated tablet
contains 26.65 mg of lactose
(as lactose monohydrate)
Converide 300mg/12.5mg film-coated tablets: Each film-coated tablet
contains 65.8 mg of lactose (as
lactose monohydrate)
Converide 300mg/25mg film-coated tablets: 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.
Converide 150 mg/12.5 mg film-coated tablets: White, round, convex,
film- coated tablets with
diameter 9.5 mm.
Converide 300mg/12.5mg film-coated tablets: Pink, convex, film coated
capsule-shaped tablets, scored
on one side, embossed “MC” on the other side, with dimensions 17.5
x 8 mm.
Converide 300mg/25mg film-coated tablets: White, convex, film coated
capsule-shaped tablets, scored
on one side, embossed “MC” on the other side, with dimensions 17.5
x 8 mm.
2
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
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
Converide c