Telmisartan Bristol Labs Tablets 20mg

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

TELMISARTAN

متاح من:

Bristol Laboratories Limited

ATC رمز:

C09CA07

INN (الاسم الدولي):

TELMISARTAN

الشكل الصيدلاني:

TABLET

تركيب:

TELMISARTAN 20 milligram(s)

نوع الوصفة الطبية :

POM

المجال العلاجي:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

الوضع إذن:

Authorised

تاريخ الترخيص:

2016-05-05

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TELMISARTAN 20MG TABLETS TELMISARTAN 40MG TABLETS TELMISARTAN 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 blood
supply to the
heart or legs, or have had a str

خصائص المنتج

Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Telmisartan Bristol Laboratories 20 mg tablets
Telmisartan Bristol Laboratories 40 mg tablets
Telmisartan Bristol Laboratories 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
Page 2 of 24
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).
_C