LICOLIN 75 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

IRBESARTAN

Available from:

Laboratorios LICONSA, S.A.

ATC code:

C09CA04

INN (International Name):

IRBESARTAN

Dosage:

75 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists, plain

Authorization status:

Authorised

Authorization date:

2010-11-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LICOLIN 75 MG TABLETS
LICOLIN 150 MG TABLETS
LICOLIN 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. Do not pass it on to
others. It may harm
them, even if their signs of illness are 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 Licolin 75 mg/150 mg/300 mg tablets is and what it is used for
2. What you need to know before you take Licolin 75 mg/150 mg/300 mg
tablets
3. How to take Licolin 75 mg/150 mg/300 mg tablets
4. Possible side effects
5. How to store Licolin 75 mg/150 mg/300 mg tablets
6. Content of the pack and other information
1.
WHAT LICOLIN 75 MG/150 MG/300 MG TABLETS IS AND WHAT IS USED FOR
Licolin 75 mg/150 mg/300 mg tablets 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. Licolin 75 mg/150
mg/300 mg tablets prevents the
binding of angiotensin-II to these receptors, causing the blood
vessels to relax and the blood
pressure to lower. Licolin 75 mg/150 mg/300 mg tablets slows the
decrease of kidney function
in patients with high blood pressure and type 2 diabetes.
Licolin 75 mg/150 mg/300 mg tablets is used in the treatment of high
blood pressure
(hypertension essential) and for the protection of the kidney in
hypertensive type 2 diabetic
patients with laboratory evidence of impaired renal function.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKELICOLIN 75 MG/150 MG/300 MG
TABLETS
DO NOT TAKE LICOLIN 75 MG/150 MG/300 MG TABLETS

if you are allergi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Licolin 75 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg of Irbesartan.
Excipient: 15.4 mg of lactose monohydrate per tablet.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Licolin 75 mg tablets are white, cylindrical, biconvex tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-
Treatment of essential hypertension.
-
Treatment of renal disease in patients with hypertension and type 2
diabetes mellitus as part of an antihypertensive
drug 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.
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. 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 studies where
irbesartan was used in addition to other antihypertensive agents, as
needed, to reach target blood pressure (see sections
4.3, 4.4, 4.5 and 5.1).
Special Populations
_Renal impairment:_ no dosage adjustment is necessary in patients with
impaired renal function.
A lower starting dose (75 mg) should be considered for patients
undergoing haemodialysis (see section 4.4).
_Hepatic impairment: _no