Tolura

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Telmisartan

Available from:

Krka, d.d., Novo mesto 

ATC code:

C09CA07

INN (International Name):

telmisartan

Therapeutic group:

Angiotensin II antagonists, plain

Therapeutic area:

Hypertension

Therapeutic indications:

HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients with:manifest atherothrombotic cardiovascular disease (history of coronary heart disease or peripheral arterial disease) or;type 2 diabetes mellitus with documented target organ damage.

Product summary:

Revision: 11

Authorization status:

Authorised

Authorization date:

2010-06-04

Patient Information leaflet

44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
TOLURA 40 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 Tolura is and what it is used for
2.
What you need to know before you take Tolura
3.
How to take Tolura
4.
Possible side effects
5.
How to store Tolura
6.
Contents of the pack and other information
1.
WHAT TOLURA IS AND WHAT IT IS USED FOR
Tolura 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. Tolura blocks the effect of angiotensin II so that the
blood vessels relax, and your
blood pressure is lowered.
TOLURA 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.
TOLURA 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 stroke or
have high risk diabetes. Your doctor can tell you if you are at high
risk for su

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tolura 40 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg telmisartan.
Excipients with known effect:
Each tablet contains 149.8 mg sorbitol (E420) and 57 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
40 mg: white to almost white, biconvex, oval tablets
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.
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
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.
3
_Special populations_
Patients with renal impairment
Limited experience is available in patients with severe renal
impai