Telmisartan/Hydrochlorothiazide Rowa 40 mg/12.5 mg tablets

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Telmisartan; Hydrochlorothiazide

Mevcut itibaren:

Rowa Pharmaceuticals Limited

ATC kodu:

C09DA; C09DA07

INN (International Adı):

Telmisartan; Hydrochlorothiazide

Doz:

40 mg/12.5 milligram(s)

Farmasötik formu:

Tablet

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

Angiotensin II antagonists and diuretics; telmisartan and diuretics

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

2014-04-04

Bilgilendirme broşürü

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

Ürün özellikleri

Health Products Regulatory Authority
15 September 2022
CRN00CR4X
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telmisartan/Hydrochlorothiazide Rowa 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:
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 Rowa fixed dose combination (40 mg
telmisartan/12.5 mg hydrochlorothiazide (HCTZ)) is
indicated in adults whose blood pressure is not adequately controlled
on telmisartan alone.
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.
1.
Telmisartan/Hydrochlorothiazide Rowa 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
_Renal impairment_
Periodic monitoring of renal function is advised (see section 4.4).
_Hepatic impairment_
In patients with mild to moderate hepatic impairment the posology
should not exceed Telmisartan/Hydrochlorothiazide Rowa
40 mg/12.5 mg once daily. Telmisartan/Hydrochlorothiazide Rowa 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 _
No dosage adjustment is necessary.
_ _
_Paediatric population _
The safety and efficacy of Telmisartan/Hydrochlorothiazide Rowa in
child