Irbesartan 150mg film-coated tablets

Država: Velika Britanija

Jezik: angleščina

Source: myHealthbox

Aktivna sestavina:

irbesartan

Dostopno od:

Brown & Burk UK Ltd

Koda artikla:

C09CA04

INN (mednarodno ime):

irbesartan

Odmerek:

150mg

Farmacevtska oblika:

Film-coated tablets

Pot uporabe:

Oral use

Enote v paketu:

Pack sizes of 7,10,14,28,56,64,98 filmcoated tablets

Tip zastaranja:

POM - Prescription Only Medicine

Izdeluje:

Brown & Burk UK Ltd

Terapevtska skupina:

Angiotensin-II antagonists, plain

Terapevtske indikacije:

It 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

Status dovoljenje:

Authorised

Datum dovoljenje:

2015-05-13

Navodilo za uporabo

IRBESARTAN 75MG FILM-COATED TABLETS 
IRBESARTAN 150MG FILM-COATED TABLETS
IRBESARTAN 300MG FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
150mm
420 mm
Phramcode reading direction
Front
Phramcode reading direction
150mm

420mm
6 mm
might become) pregnant. Irbesartan is not 
recommended in early pregnancy, and must not be 
taken if you are more than 3 months pregnant, as 
it may cause serious harm to your baby if used at 
that stage (see pregnancy section).
CHILDREN AND ADOLESCENTS:
This medicinal product should not be used in 
children and adolescents because the safety and 
efficacy have not yet been fully established.
OTHER MEDICINES AND IRBESARTAN 
Tell your doctor or pharmacist if you are taking, 
have recently taken or might take any other 
medicines.
Your doctor may need to change your dose and/or to 
take other precautions if you are taking aliskiren.
Irbesartan does not usually interact with other 
medicines.
You may need to have blood checks if you take:
• potassium supplements
• salt substitutes containing potassium
• potassium-sparing medicines (such as certain 
diuretics)
• medicines containing lithium
If you take certain painkillers, called non-steroidal 
anti-inflammatory drugs, the effect of irbesartan 
may be reduced.
IRBESARTAN TABLETS WITH FOOD AND DRINK
Irbesartan Tablets can be taken with or without 
food.
PREGNANCY AND BREAST-FEEDING 
Pregnancy
You must tell your doctor if you think you are (or 
might become) pregnant. Your doctor will normally 
advise you to stop taking Irbesartan before you 
become pregnant or as soon as you know you are 
pregnant and will advise you to take another 
medicine instead of Irbesartan. Irbesartan is not 
recommended in early pregnancy, and must not be 
taken when more than 3 months pregnant, as it
may cause serious harm to your baby if used after 
the third month of pregnancy.
Breast feeding
Tell your doctor if you are breast-feeding or about 
to start breast-feeding. Irbesartan tablets are

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Irbesartan 150 mg film-coated tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each film-coated tablet contains 150 mg of irbesartan. 
Excipient: 45.00 mg of lactose monohydrate per film-coated tablet. 

Excipient(s) with known effect:lactose monohydrate 

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Film-coated tablet. 

White to off-white, oval, biconvex, film-coated tablets, engraved
with '150' on one 
face and plain on the other face. 

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 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 Tablet 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 antihypertensive
agents can be 
added. 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 
diabeti