Irbesartan/ Hydrochlorothiazide Aurobindo 150mg/12.5mg film-coated Tablets

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

HYDROCHLOROTHIAZIDE, IRBESARTAN

Διαθέσιμο από:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

Φαρμακολογική κατηγορία (ATC):

C09DA04

INN (Διεθνής Όνομα):

HYDROCHLOROTHIAZIDE 12.5 mg IRBESARTAN 150 mg

Φαρμακοτεχνική μορφή:

FILM-COATED TABLET

Σύνθεση:

HYDROCHLOROTHIAZIDE 12.5 mg IRBESARTAN 150 mg

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2013-12-03

Φύλλο οδηγιών χρήσης

Page
1
of
8
PACKAGE LEAFLET: INFORMATION FOR THE USER
IRBESARTAN/ HYDROCHLOROTHIAZIDE AUROBINDO 150 MG/ 12.5 MG FILM-COATED
TABLETS
IRBESARTAN/ HYDROCHLOROTHIAZIDE AUROBINDO 300 MG/ 12.5 MG FILM-COATED
TABLETS
IRBESARTAN/ HYDROCHLOROTHIAZIDE AUROBINDO 300 MG/ 25 MG 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
sideeffects not listed in this leaflet See section 4.
WHAT IS IN THIS LEAFLET:
1. What Irbesartan/ Hydrochlorothiazide Aurobindo is and what it is
used for
2. What you need to know before you take Irbesartan/
Hydrochlorothiazide Aurobindo
3. How to take Irbesartan/ Hydrochlorothiazide Aurobindo
4. Possible side effects
5. How to store Irbesartan/ Hydrochlorothiazide Aurobindo
6. Contents of the pack and other information
1. WHAT IRBESARTAN/ HYDROCHLOROTHIAZIDE AUROBINDO IS AND WHAT IT IS USED
FOR
Irbesartan/ Hydrochlorothiazide Aurobindo 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
Aurobin

Αρχείο Π.Χ.Π.

Page
1
of
20
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Irbesartan/ Hydrochlorothiazide Aurobindo 150 mg/ 12.5 mg film-coated
tablets
Irbesartan/ Hydrochlorothiazide Aurobindo 300 mg/ 12.5 mg film-coated
tablets
Irbesartan/ Hydrochlorothiazide Aurobindo 300 mg/ 25 mg film-coated
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
150 mg/12.5 mg
Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
_Excipient with known effect: _
Each film-coated tablet contains 131.85 mg of lactose monohydrate.
300 mg/12.5 mg
Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of
hydrochlorothiazide.
_Excipient with known effect: _
Each film-coated tablet contains 276.20 mg of lactose monohydrate.
300 mg/25 mg
Each film-coated tablet contains 300 mg of irbesartan and 25 mg of
hydrochlorothiazide.
_Excipient: _
Each film-coated tablet contains 256.50 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
150 mg/ 12.5 mg
Peach coloured film-coated biconvex oval shaped tablets, debossed with
“H 35” on one side and
plain on other side. The size is 14 mm X 7.6 mm.
300 mg/ 12.5 mg
Peach coloured film-coated biconvex oval shaped tablets, debossed with
“H 36” on one side and
plain on other side. The size is 17.7 mm X 9.6 mm.
300 mg/ 25 mg
Pink coloured film-coated biconvex oval shaped tablets, debossed with
“H 37” on one side and
plain on other side. The size is 17.7 mm X 9.6 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Page
2
of
20
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
Irbesartan/ Hydrochlorothiazide can be taken once daily, with or
without food.
Dose titration with the individual components (i.e. irbesartan and
hydrochlorothiazide) may be
recommended.
When cl