Telmisartan Teva

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Telmisartan

Available from:

Teva B.V.

ATC code:

C09CA07

INN (International Name):

telmisartan

Therapeutic group:

Agents acting on the renin-angiotensin system

Therapeutic area:

Hypertension

Therapeutic indications:

Treatment of essential hypertension in adults

Product summary:

Revision: 11

Authorization status:

Withdrawn

Authorization date:

2010-01-25

Patient Information leaflet

43
B. PACKAGE LEAFLET
44
PACKAGE LEAFLET: INFORMATION FOR THE USER
TELMISARTAN TEVA 20 MG 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.
-
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 Teva is and what it is used for
2.
What you need to know before you take Telmisartan Teva
3.
How to take Telmisartan Teva
4.
Possible side effects
5.
How to store Telmisartan Teva
6.
Contents of the pack and other information
1.
WHAT TELMISARTAN TEVA IS AND WHAT IT IS USED FOR
Telmisartan Teva belongs to a class of medicines known as
angiotensin-II receptor antagonists.
Angiotensin II is a substance occurring in the body, which causes your
blood vessels to narrow, thus
increasing your blood pressure. Telmisartan Teva blocks this effect of
angiotensin II so that the blood vessels
relax, and your blood pressure is lowered.
Telmisartan Teva is used to treat essential hypertension (high blood
pressure) in adults. ‘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 attacks, heart or kidney failure, strokes 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 Teva is also used to reduce cardiovascular events (i.e.
heart attack or stroke) in adults who are at
risk because they have a reduced or blocked blood supply to the heart
or legs,

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Telmisartan Teva 20 mg tablets
Telmisartan Teva 40 mg tablets
Telmisartan Teva 80 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Telmisartan Teva 20 mg tablets
Each tablet contains 20 mg telmisartan
Telmisartan Teva 40 mg tablets
Each tablet contains 40 mg telmisartan
Telmisartan Teva 80 mg tablets
Each tablet contains 80 mg telmisartan
Excipients with known effect:
Telmisartan Teva 20 mg tablets
Each tablet contains 21.4 mg sorbitol (E420)
Telmisartan Teva 40 mg tablets
Each tablet contains 42.8 mg sorbitol (E420)
Telmisartan Teva 80 mg tablets
Each tablet contains 85.6 mg sorbitol (E420)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Telmisartan Teva 20 mg tablets
White to off white, oval shaped tablet; one side of the tablet is
debossed with the number
"93". The other side of the tablet is debossed with the number "7458".
Telmisartan Teva 40 mg tablets
White to off white, oval shaped tablet; one side of the tablet is
debossed with the number
"93". The other side of the tablet is debossed with the number "7459".
Telmisartan Teva 80 mg tablets
White to off white, oval shaped tablet; one side of the tablet is
debossed with the number
"93". The other side of the tablet is debossed with the number "7460".
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension in adults.
3
Cardiovascular prevention
Reduction of cardiovascular morbidity in adults with:
•
manifest atherothrombotic cardiovascular disease (history of coronary
heart disease, stroke, or peripheral
arterial disease) or
•
type 2 diabetes mellitus with documented target organ damage
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
_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