Irbesartan 150mg tablets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Irbesartan

Disponível em:

Sandoz Ltd

Código ATC:

C09CA04

DCI (Denominação Comum Internacional):

Irbesartan

Dosagem:

150mg

Forma farmacêutica:

Tablet

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 02050502; GTIN: 5050650098020

Características técnicas

IRBESARTAN SANDOZ 150 MG FILM- COATED TABLETS
Summary of Product Characteristics Updated 26-Oct-2016 | Sandoz
Limited
1. Name of the medicinal product
Irbesartan Sandoz 150 mg film- coated tablets
2. Qualitative and quantitative composition
Each film- coated tablet contains 150 mg irbesartan.
Excipient with known effect:
12.925 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 '150' 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 section s 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
stud