Tolura 40mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Telmisartan

Available from:

Consilient Health Ltd

ATC code:

C09CA07

INN (International Name):

Telmisartan

Dosage:

40mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050502; GTIN: 5391512452377

Patient Information leaflet

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 such events.
2.
WHAT YOU NE

Summary of Product characteristics

OBJECT 1
TOLURA 40 MG TABLETS
Summary of Product Characteristics Updated 20-May-2016 | Consilient
Health Ltd
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.
_Special populations_
Patients with renal impairment
Limited