Telmisartan/Hydrochlorothiazide Rowa 80 mg/25 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Hydrochlorothiazide; Telmisartan

Available from:

Rowa Pharmaceuticals Limited

ATC code:

C09DA; C09DA07

INN (International Name):

Hydrochlorothiazide; Telmisartan

Dosage:

80 mg/25 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:

Marketed

Authorization date:

2014-04-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Telmisartan/Hydrochlorothiazide Rowa 80 mg/25 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 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 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 import

Summary of Product characteristics

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 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 Rowa fixed dose combination (80 mg
telmisartan/25 mg hydrochlorothiazide (HCTZ)) is
indicated in adults whose blood pressure is not adequately controlled
Telmisartan/Hydrochlorothiazide Rowa 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.
1.
Telmisartan/Hydrochlorothiazide Rowa 80 mg/ 25 mg may be administered
once daily in patients whose blood
pressure is not adequately controlled by
Telmisartan/Hydrochlorothiazide Rowa 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 Rowa 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 hepatic impairment the posology
should not exceed Telmisartan/