Telmisartan/Hydrochlorothiazide Liconsa 80 mg/25 mg tablets

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Telmisartan; Hydrochlorothiazide

Tillgänglig från:

Laboratorios LICONSA, S.A.

ATC-kod:

C09DA; C09DA07

INN (International namn):

Telmisartan; Hydrochlorothiazide

Dos:

80 mg/25 milligram(s)

Läkemedelsform:

Tablet

Terapiområde:

Angiotensin II antagonists and diuretics; telmisartan and diuretics

Bemyndigande status:

Not marketed

Tillstånd datum:

2014-02-28

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
Telmisartan/Hydrochlorothiazide Chemo Ibérica 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 yourdoctor or 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 yourdoctor or pharmacist. This
includes any possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Telmisartan/Hydrochlorothiazide Chemo Ibérica is and what it is
used for
2.
What you need to know before you take Telmisartan/Hydrochlorothiazide
Chemo Ibérica .
3.
How to take Telmisartan/Hydrochlorothiazide Chemo Ibérica.
4.
Possible side effects
5.
How to storeTelmisartan/Hydrochlorothiazide Chemo Ibérica.
6.
Contents of the pack and other information
1.
WHAT TELMISARTAN/HYDROCHLOROTHIAZIDE CHEMO IBÉRICA IS AND WHAT IT IS
USED FOR
Telmisartan/Hydrochlorothiazide Chemo Ibérica 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.

Produktens egenskaper

Health Products Regulatory Authority
04 April 2022
CRN00CR20
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telmisartan/Hydrochlorothiazide Liconsa 80 mg/25 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
Excipients with known effect:
Each tablet contains 99.67 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Diameter 12 mm approximately.
Round bilayer tablets with white and yellow colour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Telmisartan/Hydrochlorothiazide Chemo Ibérica fixed dose combination
(80 mg telmisartan/25 mg hydrochlorothiazide(HCTZ))
is indicated in patients whose blood pressure is not adequately
controlled on Telmisartan/Hydrochlorothiazide Chemo Ibérica
80 mg/12.5 mg (80 mg telmisartan/12.5 mg HCTZ) or adults who have been
previously stabilised on telmisartan and HCTZ
given separately.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The fixed dose combination 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 Chemo Ibérica 80 mg/25 mg may be
administered once daily in patients whose blood
pressure is not adequately controlled by
Telmisartan/Hydrochlorothiazide Chemo Ibérica 80 mg/12.5 mg (80 mg
telmisartan/12.5 mg HCTZ) or in patients who have been previously
stabilised on telmisartan and HCTZ given separately.
_ _
Telmisartan/Hydrochlorothiazide Chemo Ibérica is also available at
the dose strengths 40 mg/12.5 mg and 80 mg/12.5 mg.
_Renal impairment: _
Periodic monitoring of renal function is advised (see section 4.4).
_Hepatic impairment: _
In patients with mild to moderate he