Irbesartan 300mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Irbesartan

Available from:

Accord Healthcare Ltd

ATC code:

C09CA04

INN (International Name):

Irbesartan

Dosage:

300mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050502; GTIN: 5055565704011

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
IRBESARTAN 75MG FILM-COATED TABLETS
IRBESARTAN 150MG FILM-COATED TABLETS
IRBESARTAN 300MG FILM-COATED 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 further questions, please 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, call 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 Tablets are and what they are used for
2. What you need to know before you take Irbesartan Tablets
3. How to take Irbesartan Tablets
4. Possible side effects
5. How to store Irbesartan Tablets
6. Contents of the pack and other information
1. WHAT IRBESARTAN TABLETS ARE AND WHAT THEY ARE USED FOR
Irbesartan Tablets belong 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 Tablets
prevents the binding of angiotensin -II to these
receptors, causing the blood vessels to relax and the blood pressure
to lower. Irbesartan Tablets slows the decrease of
kidney function in patients with high blood pressure and type 2
diabetes.
Irbesartan Tablets 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 TABLETS
DO NOT TAKE IRBESARTAN TABLETS:

If you are allergic to Irbesartan or any of the other ingredients of
this medicine (listed in section 6)..

If you are more than

Summary of Product characteristics

OBJECT 1
IRBESARTAN ACCORD 300 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 22-Dec-2017 | Accord
Healthcare Limited
1. Name of the medicinal product
Irbesartan Accord 300 mg Film-coated Tablets
2. Qualitative and quantitative composition
Each film - coated tablet contains 300 mg Irbesartan.
Excipient: 101.44 mg of lactose monohydrate per tablet.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film– coated tablet
White to off white, oval, biconvex, film coated tablet debossed 'I
300' on one side and plain on other side.
4. Clinical particulars
4.1 Therapeutic indications
Irbesartan Accord is indicated in adults for the treatment of
essential hypertension.
It is also indicated for the treatment of renal disease in adults
patients with hypertension and type 2
diabetes mellitus as part of an antihypertensive medicinal product
regimen. (See section 5.1)
Irbesartan can be used alone or in combination with other
antihypertensive agents (see sections 4.3, 4.4,
4.5 and 5.1).
4.2 Posology and method of administration
Posology
Irbesartan can be used alone or in combination with other
antihypertensive agents (see sections 4.3, 4.4,
4.5 and 5.1).
The usual recommended initial and maintenance dose is 150 mg once
daily, with or without food.
Irbesartan Tablets 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.
In patients insufficiently controlled with 150 mg once daily. The dose
of Irbesartan Tablets can be
increased to 300 mg, or other anti-hypertensive agents can be added.
In particular, the addition of a
diuretic such as hydrochlorothiazide has been shown to have an
additive effect with Irbesartan Tablets.
(See section 4.5).
In hypertensive type 2 diabetic patients, therapy should be initiated
at 150 mg irbesartan once daily and
titrated up to 300 mg once daily as the preferred maintenance dose