Telmisartan/Hydrochlorothiazide Rowex 80 mg/25 mg coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Telmisartan; Hydrochlorothiazide

Available from:

Rowex Ltd

ATC code:

C09DA07

INN (International Name):

Telmisartan; Hydrochlorothiazide

Dosage:

80 mg/25 milligram(s)

Pharmaceutical form:

Coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

telmisartan and diuretics

Authorization status:

Marketed

Authorization date:

2013-07-04

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TELMISARTAN/HYDROCHLOROTHIAZIDE ROWEX 40 MG/12.5 MG COATED TABLETS
TELMISARTAN/HYDROCHLOROTHIAZIDE ROWEX 80 MG/12.5 MG COATED TABLETS
TELMISARTAN/HYDROCHLOROTHIAZIDE ROWEX 80 MG/25 MG COATED 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 Rowex is and what it is used
for
2. What you need to know before you take
Telmisartan/hydrochlorothiazide Rowex
3. How to take Telmisartan/hydrochlorothiazide Rowex
4. Possible side effects
5. How to store Telmisartan/hydrochlorothiazide Rowex
6. Contents of the pack and other information
1. WHAT TELMISARTAN/HYDROCHLOROTHIAZIDE ROWEX IS AND WHAT IT IS USED
FOR
Telmisartan/hydrochlorothiazide Rowex 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
someti

Summary of Product characteristics

Health Products Regulatory Authority
24 June 2019
CRN008L6F
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telmisartan/hydrochlorothiazide Rowex 80 mg/25 mg Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 80 mg telmisartan and 25 mg
hydrochlorothiazide.
Excipient(s) with known effect:
Contains 306.8 mg lactose.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Coated tablet.
Yellow, oval, biconvex coated tablet debossed with 80 on one side and
with 25 on the other side (15.4 mm x 8.0 mm).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Telmisartan/hydrochlorothiazide Rowex fixed dose combination (80 mg
telmisartan/25 mg hydrochlorothiazide) is indicated in
adults whose blood pressure is not adequately controlled on
Telmisartan/hydrochlorothiazide Rowex 80 mg/12.5 mg (80 mg
telmisartan/12.5 mg hydrochlorothiazide) or adults who have been
previously stabilised on telmisartan and
hydrochlorothiazide given separately.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Telmisartan/hydrochlorothiazide Rowex 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 Rowex 80 mg/25 mg may be
administered once daily in patients whose blood pressure is
not adequately controlled by Telmisartan/hydrochlorothiazide Rowex 80
mg/12.5 mg or in patients who have been previously
stabilised on telmisartan and hydrochlorothiazide given separately.
Telmisartan/hydrochlorothiazide Rowex 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 impairm