Telmisartan/Hydrochlorothiazide Clonmel 80 mg/25 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Telmisartan; Hydrochlorothiazide

Available from:

Clonmel Healthcare Ltd

ATC code:

C09DA; C09DA07

INN (International Name):

Telmisartan; Hydrochlorothiazide

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:

2014-02-21

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TELMISARTAN/HYDROCHLOROTHIAZIDE CLONMEL 40MG/12.5MG 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 Clonmel is and what it is used
for
2.
What you need to know before you take Telmisartan/Hydrochlorothiazide
Clonmel
3.
How to take Telmisartan/Hydrochlorothiazide Clonmel
4.
Possible side effects
5.
How to store Telmisartan/Hydrochlorothiazide Clonmel
6.
Contents of the pack and other information
1.
WHAT TELMISARTAN/HYDROCHLOROTHIAZIDE CLONMEL IS AND WHAT IT IS USED
FOR
Telmisartan/Hydrochlorothiazide Clonmel 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

Summary of Product characteristics

Health Products Regulatory Authority
04 February 2022
CRN00CQD3
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telmisartan/Hydrochlorothiazide Clonmel 80 mg/25 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
Each tablet contains up to 0.882 mg sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Telmisartan/Hydrochlorothiazide Clonmel 80 mg/25 mg tablets are white
or almost white, 9.0 x 17.0 mm oval‑shaped and
biconvex tablets marked with “TH” on one side and “25” on the
other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Telmisartan/Hydrochlorothiazide Clonmel fixed dose combination (80 mg
telmisartan/25 mg hydrochlorothiazide) is indicated
in adults whose blood pressure is not adequately controlled on
Telmisartan/Hydrochlorothiazide Clonmel 80 mg/12.5 mg
(80 mg telmisartan/12.5 mg hydrochlorothiazide) or patients who have
been previously stabilised on telmisartan and
hydrochlorothiazide given separately.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Telmisartan/Hydrochlorothiazide Clonmel 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 Clonmel 80 mg/25 mg may be
administered once daily in patients whose blood pressure is
not adequately controlled by Telmisartan/Hydrochlorothiazide Clonmel
80 mg/12.5 mg or in patients who have been
previously stabilised on telmisartan and hydrochlorothiazide given
separately.
Telmisartan/Hydrochlorothiazide Clonmel is also available at the dose
strengths 40 mg/12.5 mg and 80 mg/ 12.5 mg.
_Special populations_
_Elderly_
No dose adjustment is necessary.
_Renal impairment_
Pe