TELMISARTAN HYDROCHLOROTHIAZIDE LICONSA 80/12.5 mg/mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TELMISARTAN, HYDROCHLOROTHIAZIDE

Available from:

Laboratorios LICONSA, S.A.

ATC code:

C09DA07

INN (International Name):

TELMISARTAN, HYDROCHLOROTHIAZIDE

Dosage:

80/12.5 mg/mg

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists and diuretics

Authorization status:

Authorised

Authorization date:

2014-04-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER   
Telmisartan/Hydrochlorothiazide Liconsa 80 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 doctor 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 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    Telmisartan/Hydrochlorothiazide Liconsa is and
what it is used for   
2. 
What you need to know before you
take 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 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 

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telmisartan/Hydrochlorothiazide Liconsa 80 mg/12.5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Excipients with 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 10.5 mm approximately.
Round bilayer tablet with white and pink colour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Telmisartan/Hydrochlorothiazide Liconsa fixed dose combination (80 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 80 mg/12.5 mg may be administered once daily in patients whose
blood pressure is not adequately controlled by Telmisartan in monotherapy 80 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 in