Irbesartan 75mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IRBESARTAN

Available from:

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

ATC code:

C09CA04

INN (International Name):

IRBESARTAN 75 mg

Pharmaceutical form:

TABLET

Composition:

IRBESARTAN 75 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Authorised

Authorization date:

2013-11-26

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
IRBESARTAN 75 MG TABLETS
IRBESARTAN 150 MG TABLETS
IRBESARTAN 300 MG TABLETS
Irbesartan
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 Irbesartan is and what it is used for
2.
What you need to know before you take Irbesartan
3.
How to take Irbesartan
4.
Possible side effects
5.
How to store Irbesartan
6.
Contents of the pack and other information
1.
WHAT IRBESARTAN IS AND WHAT IT IS USED FOR
Irbesartan belongs to a group of medicines known as angiotensin-II
receptor antagonists.
Angiotensin-II is a substance produced in the body which 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. Irbesartan slows the decrease
of kidney function in patients
with high blood pressure and type 2 diabetes.
IRBESARTAN IS USED IN ADULT PATIENTS
•
to treat high blood pressure
_(essential hypertension) _
•
to protect the kidney in patients with high blood pressure, type 2
diabetes and laboratory
evidence of impaired kidney function.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IRBESARTAN
DO NOT TAKE IRBESARTAN
•
if you are
ALLERGIC
to irbesartan or any other ingredients of
this medicine (listed in section 6)
•
if you are
MORE THAN 3 MONTHS PREGNANT.
(It is also better to avoid Irbesartan in early
pregnancy – see pregnancy section)
•
if you have diabetes or impair

Summary of Product characteristics

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13 SUMMARY OF PRODUCT CHARACTERSTICS
1.
NAME OF THE MEDICINAL PRODUCT
Irbesartan 75 mg tablets
Irbesartan 150 mg tablets
Irbesartan 300 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg of irbesartan.
Each tablet contains 150 mg of irbesartan.
Each tablet contains 300 mg of irbesartan.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Irbesartan 75 mg tablets:
White to off-white, biconvex oval shaped uncoated tablets debossed
with ‘H 28’ on one side and
plain on other side. The size is 10.8 mm X 5.7 mm.
Irbesartan 150 mg tablets:
White to off-white, biconvex oval shaped uncoated tablets debossed
with ‘H 29’ on one side and
plain on other side. The size is 13.70 mm X 7.00 mm.
Irbesartan 300 mg tablets:
White to off-white, biconvex oval shaped uncoated tablets debossed
with ‘H 30’ on one side and
plain on other side. The size is 17.30 mm X 9.50 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Irbesartan is indicated in adults for the treatment of essential
hypertension.
It is also indicated for the treatment of renal disease in adult
patients with hypertension and type 2
diabetes mellitus as part of an antihypertensive medicinal product
regimen (see sections 4.3, 4.4, 4.5
and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The usual recommended initial and maintenance dose is 150 mg once
daily, with or without food.
Irbesartan at a dose of 150 mg once daily generally provides a better
24 hour blood pressure control
than 75 mg. However, initiation of therapy with 75 mg could be
considered, particularly in
haemodialysed patients and in the elderly over 75 years.
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In patients insufficiently controlled with 150 mg once daily, the dose
of Irbesartan can be increased
to 300 mg, or other antihypertensive agents can be added (see sections
4.3, 4.4, 4.5 and 5.1). In
particular, the addition of a diuretic such as hydrochlorothiazide has
been shown to have an additive
effect with Irbesartan (see section 4.5 ).
In hy