Telmisartan Mylan 20 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Telmisartan

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

C09CA; C09CA07

INN (International Name):

Telmisartan

Dosage:

20 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists, plain; telmisartan

Authorization status:

Not marketed

Authorization date:

2012-02-10

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Telmisartan Mylan 20 mg tablets
Telmisartan Mylan 40 mg tablets
Telmisartan Mylan 80 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 Telmisartan Mylan is and what it is used for
2.
What you need to know before you take Telmisartan Mylan
3.
How to take Telmisartan Mylan
4.
Possible side effects
5.
How to store Telmisartan Mylan
6.
Contents of the pack and other information
1.
WHAT TELMISARTAN MYLAN IS AND WHAT IT IS USED FOR
Telmisartan Mylan contains telmisartan, which 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 which increases your blood pressure. Telmisartan
Mylan blocks the effect of
angiotensin II so that the blood vessels relax, and your blood
pressure is lowered.
Telmisartan Mylan 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.
If high blood pressure is not treated it can damage blood vessels in
some organs, which could possibly
lead 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 Mylan is also used to reduce the risk of heart attack or
stroke in adults who are at risk
because they have

Summary of Product characteristics

Health Products Regulatory Authority
07 January 2021
CRN009ZPH
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telmisartan Mylan 20 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg telmisartan
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off white, round flat, bevelled edged tablets of 7 mm
debossed with ‘TN over 20’ on one side and ‘M’ 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:
1.
manifest atherothrombotic cardiovascular disease (history of coronary
heart disease, stroke, or peripheral arterial
disease) or
2.
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
Li