Irbesartan 300mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Irbesartan

Available from:

Sandoz 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: 5050650098037

Summary of Product characteristics

IRBESARTAN SANDOZ 300 MG FILM- COATED TABLETS
Summary of Product Characteristics Updated 27-Oct-2016 | Sandoz
Limited
1. Name of the medicinal product
Irbesartan Sandoz 300 mg film- coated tablets
2. Qualitative and quantitative composition
Each film- coated tablet contains 300 mg irbesartan.
Excipient with known effect:
25.850 mg of lactose monohydrate per tablet.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film- coated tablet
White, oval biconvex film- coated tablets, debossed with '300' on one
side and scored on the other side.
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
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. 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.
In patients insufficiently controlled with 150 mg once daily, the dose
of irbesartan can be increased to 300
mg, or other anti-hypertensive 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 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 for
treatment of renal disease.
The demonstration of renal benefit of irbesartan in hypertensive type
2 diabetic patients is based on
studi