Telmisartan Brillpharma 20 mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TELMISARTAN

Available from:

Brillpharma (Ireland) Limited Inniscarra, Main Street, Rathcoole, Co. Dublin, Ireland

ATC code:

C09CA07

INN (International Name):

TELMISARTAN 20 mg

Pharmaceutical form:

TABLET

Composition:

TELMISARTAN 20 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Withdrawn

Authorization date:

2016-05-05

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TELMISARTAN BRILLPHARMA 20MG TABLETS
TELMISARTAN BRILLPHARMA 40MG TABLETS
TELMISARTAN BRILLPHARMA 80MG 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 this medicine is and what it is used for
2.
What you need to know before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1.
WHAT THIS MEDICINE
IS AND WHAT IT IS USED FOR
Telmisartan 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 blocks the
effect of angiotensin II
so that the blood vessels relax, and your blood pressure is lowered.
Telmisartan 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 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 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 bloo

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Telmisartan Brillpharma 20 mg tablets
Telmisartan Brillpharma 40 mg tablets
Telmisartan Brillpharma 80 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg telmisartan.
Each tablet contains 40 mg telmisartan.
Each tablet contains 80 mg telmisartan.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White to off-white, round shaped, un-coated tablets about 6.95 mm in
diameter with 'C'
debossed on one side and '03 ' debossed on the other side.
White to off-white, oblong, un-coated tablets about 11.90 mm in length
and 5.80mm width
with 'C' debossed on one side and '04 ' debossed on the other side.
White to off-white, oblong, un-coated tablets about 16.10 mm in length
and 7.80mm width
with 'C' debossed on one side and '05 ' debossed on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension in adults.
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
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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 of 80 mg once daily.
Alternatively, telmisartan
may be used in combination with thiazide-type diuretics such as
hydrochlorothiazide, which
has been shown to have an additive blood pressure lowering effect with
telmisartan. 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 _