Mirpresoc 80 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Telmisartan

Available from:

Laboratorios LICONSA, S.A.

ATC code:

C09CA; C09CA07

INN (International Name):

Telmisartan

Dosage:

80 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:

2010-11-26

Patient Information leaflet

LF-Telmisartan-IE-PT.H.0266.001-003.IB.014
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MIRPRESOC 20 MG TABLETS
MIRPRESOC 40 MG TABLETS
MIRPRESOC 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 Mirpresoc is and what it is used for
2. What you need to know before you take Mirpresoc
3. How to take Mirpresoc
4. Possible side effects
5. How to store Mirpresoc
6. Contents of the pack and other information
1. WHAT MIRPRESOC IS AND WHAT IT IS USED FOR
Mirpresoc 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. Mirpresoc blocks the effect of
angiotensin II so that the blood
vessels relax, and your blood pressure is lowered.
MIRPRESOC 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.
MIRPRESOC 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 leg

Summary of Product characteristics

Health Products Regulatory Authority
25 June 2021
CRN008YZ9
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mirpresoc 80 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg of telmisartan
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
Mirpresoc 80 mg: are white, oblong tablets with LC embossed on one
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.
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 sections 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_
Renal impairment
Limited experience is available in patients with severe renal
impairment or haemodialysis.