Telmisartan/Hydrochlorothiazide Chemo Ibérica 80 mg/12.5 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Telmisartan; Hydrochlorothiazide

Available from:

Chemo Iberica S.L.

ATC code:

C09DA; C09DA07

INN (International Name):

Telmisartan; Hydrochlorothiazide

Dosage:

80 mg/12.5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists and diuretics; telmisartan and diuretics

Authorization status:

Not marketed

Authorization date:

2014-02-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Telmisartan/Hydrochlorothiazide Chemo Ibérica 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 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 X
4.
Possible side effects
5.
How to store Telmisartan/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 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. The

Summary of Product characteristics

Health Products Regulatory Authority
13 May 2020
CRN009LVN
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telmisartan/Hydrochlorothiazide Chemo Ibérica 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 Chemo Ibérica 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 Chemo Ibérica 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/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 Chemo Ibérica 40 mg/12.5 mg once
daily. Telmisartan/Hydrochlorothiazide Chemo Ibérica is
not indicated in patients with severe hepatic impairment. Thiazides
should be used with caution in patients with impaired
hepatic function (see section 4.4).
_Elderly patients: _
No dosage ad