Telmisartan/Hydrochlorothiazide 40 mg/12.5 mg tablets

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Telmisartan; Hydrochlorothiazide

Prieinama:

Accord Healthcare Ireland Ltd.

ATC kodas:

C09DA; C09DA07

INN (Tarptautinis Pavadinimas):

Telmisartan; Hydrochlorothiazide

Dozė:

40 mg / 12.5 milligram(s)

Vaisto forma:

Tablet

Gydymo sritis:

Angiotensin II antagonists and diuretics; telmisartan and diuretics

Autorizacija statusas:

Marketed

Leidimo data:

2019-08-02

Pakuotės lapelis

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TELMISARTAN/HYDROCHLOROTHIAZIDE 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 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 is and what it is used for
2.
What you need to know before you take Telmisartan/Hydrochlorothiazide
3.
How to take Telmisartan/Hydrochlorothiazide
4.
Possible side effects
5.
How to store Telmisartan/Hydrochlorothiazide
6.
Contents of the pack and other information
1.
WHAT TELMISARTAN/HYDROCHLOROTHIAZIDE IS AND WHAT IT IS USED FOR
Telmisartan/Hydrochlorothiazide 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 pressure before damage occurs. Thus it is important to
regularly

Prekės savybės

Health Products Regulatory Authority
05 January 2022
CRN00CPTY
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telmisartan/Hydrochlorothiazide 40 mg/12.5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg telmisartan and 12.5 mg
hydrochlorothiazide.
Excipients with known effect:
Telmisartan Hydrochlorothiazide 40 mg/12.5 mg tablets:
Each tablet contains 0.74 mg of sodium
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Telmisartan Hydrochlorothiazide 40 mg/12.5 mg tablets are white or
almost white, 6.55 x 13.6 mm oval‑shaped and biconvex
tablets marked with TH on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Telmisartan Hydrochlorothiazide 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
Telmisartan Hydrochlorothiazide 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 40 mg/12.5 mg may be administered
once daily in patients whose blood pressure is not
adequately controlled by telmisartan 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
40 mg/12.5 mg once daily. Telmisartan Hydrochlorothiazide 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 d