Telmisartan 40mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Telmisartan

Available from:

A A H Pharmaceuticals 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

Patient Information leaflet

TELMISARTAN 20 MG, 40 MG AND 80 MG TABLETS
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.
1. What Telmisartan Tablets are and what they are used for
2. What you need to know before you take Telmisartan Tablets
3. How to take Telmisartan Tablets
4. Possible side effects
5. How to store Telmisartan Tablets
6. Contents of the pack and other information
WHAT TELMISARTAN TABLETS ARE AND WHAT THEY ARE USED FOR
Telmisartan Tablets contains the active substance telmisartan. This
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 TABLETS ARE 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 TABLETS ARE 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Telmisartan 40mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40 mg telmisartan
Excipients with known effect:
Each tablet contains 19.20mg sorbitol (E420)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White to off white, oblong tablets with a break line on one side.
The tablet can be divided into equal halves.
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 thiazidetype 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 experience is available in patients w