Telmisartan Clonmel 80 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Telmisartan

Available from:

Clonmel Healthcare Ltd

ATC code:

C09CA; C09CA07

INN (International Name):

Telmisartan

Dosage:

80 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists, plain; telmisartan

Authorization status:

Marketed

Authorization date:

2011-06-29

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
TELMISARTAN CLONMEL 20MG FILM-COATED TABLETS
TELMISARTAN CLONMEL 40MG FILM-COATED TABLETS
TELMISARTAN CLONMEL 80MG FILM-COATED TABLETS
TELMISARTAN
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 or
nurse.

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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Telmisartan Clonmel is and what it is used for
2.
What you need to know before you take Telmisartan Clonmel
3.
How to take Telmisartan Clonmel
4.
Possible side effects
5.
How to store Telmisartan Clonmel
6.
Contents of the pack and other information
1.
WHAT TELMISARTAN CLONMEL IS AND WHAT IT IS USED FOR
Telmisartan Clonmel belongs to a class of medicines known as
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 Clonmel blocks the effect
of angiotensin II so that the blood
vessels relax, and your blood pressure is lowered.
TELMISARTAN CLONMEL
is used to treat essential hypertension (high blood pressure).
‘Essential’ means that
the high blood pressure is not caused by any other condition.
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
measure blood pressure to verify if it is
within the normal range.
TELMISARTAN CLONMEL
IS ALSO USED TO
reduce cardiovascular events (

Summary of Product characteristics

Health Products Regulatory Authority
28 October 2020
CRN009VCV
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telmisartan Clonmel 80 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80mg telmisartan.
Excipient with known effect
Each tablet contains 434.70mg lactose (as lactose monohydrate)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Yellow coloured capsule shaped film coated tablets with ‘80’
engraved on one side and ‘T’ engraved on other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension in adults.
Cardiovascular prevention
Reduction of cardiovascular morbidity in patients with:
i) manifest atherothrombotic cardiovascular disease (history of
coronary heart disease, stroke, or peripheral arterial disease) or
ii) type 2 diabetes mellitus with documented target organ damage
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment of essential hypertension
The usually effective dose is 40 mg once daily. Some patients may
already benefit at a daily dose of 20 mg. In cases where the
target blood pressure is not achieved, the dose of telmisartan can be
increased to a maximum of 80 mg once daily. When
considering raising the dose, it must be borne in mind that the
maximum antihypertensive effect is generally attained four to
eight weeks after the start of treatment (see section 5.1).
Cardiovascular prevention
The recommended dose is 80 mg once daily. It is not known whether
doses lower than 80 mg of telmisartan are effective in
reducing cardiovascular morbidity.
When initiating telmisartan therapy for the reduction of
cardiovascular morbidity, close monitoring of blood pressure is
recommended, and if appropriate adjustment of medications that lower
blood pressure may be necessary.
Telmisartan may be taken with or without food.
Special patient population
Renal impairment: No posology adjustment is required for patients with
mild to moderate renal im