TELMISARTAN HYDROCHLOROTHIAZIDE LICONSA 40/12.5 mg/mg Tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

TELMISARTAN, HYDROCHLOROTHIAZIDE

זמין מ:

Laboratorios LICONSA, S.A.

קוד ATC:

C09DA07

INN (שם בינלאומי):

TELMISARTAN, HYDROCHLOROTHIAZIDE

כמות:

40/12.5 mg/mg

טופס פרצבטיות:

Tablets

סוג מרשם:

Product subject to prescription which may be renewed (B)

איזור תרפויטי:

Angiotensin II antagonists and diuretics

מצב אישור:

Authorised

תאריך אישור:

2014-04-04

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
Telmisartan/Hydrochlorothiazide Liconsa 40 mg/12.5 mg tablets
telmisartan/hydrochlorothiazide
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 doctoror 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, talk to your doctoror pharmacist. This
includes any possible side effects not listed in this
leaflet. See section 4..
WHAT IS IN THIS LEAFLET
1.
What Telmisartan/Hydrochlorothiazide Liconsa is and what it is used
for
2.
What you need to know before you ake Telmisartan/Hydrochlorothiazide
Liconsa
3.
How to take Telmisartan/Hydrochlorothiazide Liconsa
4.
Possible side effects
5.
How to store Telmisartan/Hydrochlorothiazide Liconsa
6.
Contents of the pack and other information
1.
WHAT TELMISARTAN/HYDROCHLOROTHIAZIDE LICONSA IS AND WHAT IT IS USED
FOR
Telmisartan/Hydrochlorothiazide Liconsa is a combination of two active
substances, telmisartan and hydrochlorothiazide in
one tablet. Both of these substances help to control high blood
pressure.

Telmisartan belongs to a group of medicines called angiotensin II
receptor antagonists. Angiotensin-II is a substance
produced in your body which causes your blood vessels to narrow thus
increasing your blood pressure. Telmisartan blocks
the effect of angiotensin II so that the blood vessels relax, and your
blood pressure is lowered.

Hydrochlorothiazide belongs to a group of medicines called thiazide
diuretics, which cause your urine output to increase,
leading to a lowering of your blood pressure.

High blood pressure, if not treated, can damage blood vessels in
several organs, which could lead sometimes to heart
attack, heart or kidney failure, stroke, or blindness. There are
usually no symptoms of high blood pressu

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telmisartan/Hydrochlorothiazide Liconsa 40 mg/12.5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Excipientswith known effect:
Each tablet contains 49.8 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Diameter 9.25 mm approximately. Round bilayer tablet with white and yellow colour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Telmisartan/Hydrochlorothiazide Liconsa fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide) is
indicated in adults whose blood pressure is not adequately controlled on telmisartan alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_
Telmisartan/Hydrochlorothiazide Liconsa should be taken in patients whose blood pressure is not adequately controlled
by telmisartan alone. Individual dose titration with each of the two components is recommended before changing to the
fixed dose combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be
considered.
Telmisartan/Hydrochlorothiazide Liconsa 40 mg/12.5 mg may be administered once daily in patients whose
blood pressure is not adequately controlled by Telmisartan in monotherapy 40 mg
_Special populations:_
Patients with renal impairment: Periodic monitoring of renal function is advised (see section 4.4).
Patients with hepatic impairment: In patients with mild to moderate hepatic impairment the posology should not exceed
Telmisartan/Hydrochlorothiazide Liconsa 40 mg/12.5 mg once daily. Telmisartan/Hydrochlorothiazide Liconsa is not
indicated in patients with severe hepatic impairment. Thiazides should be used with caution i