Telmisartan Rowex 80 mg Tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Telmisartan

Disponible depuis:

Rowex Ltd

Code ATC:

C09CA; C09CA07

DCI (Dénomination commune internationale):

Telmisartan

Dosage:

80 milligram(s)

forme pharmaceutique:

Tablet

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Angiotensin II antagonists, plain; telmisartan

Statut de autorisation:

Marketed

Date de l'autorisation:

2011-03-25

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TELMISARTAN ROWEX 20 MG TABLETS
TELMISARTAN ROWEX 40 MG TABLETS
TELMISARTAN ROWEX 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 Rowex is and what it is used for
2. What you need to know before you take Telmisartan Rowex
3. How to take Telmisartan Rowex
4. Possible side effects
5. How to store Telmisartan Rowex
6. Contents of the pack and other information
1. WHAT TELMISARTAN ROWEX IS AND WHAT IT IS USED FOR_ _
Telmisartan Rowex 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 Rowex blocks the effect of
angiotensin II so that the
blood vessels relax, and your blood pressure is lowered.
Telmisartan Rowex 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.
TELMISARTAN ROWEX IS ALSO USED TO reduce cardiovascular events (i.e.
heart attack or stroke) in adults
who are at risk because they hav

Résumé des caractéristiques du produit

Health Products Regulatory Authority
01 November 2018
CRN008PHF
Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Telmisartan Rowex 80mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg telmisartan.
Excipient(s) with known effect
Each tablet contains 306.761 mg lactose (as lactose anhydrous and
lactose
monohydrate) and 3.88 mg (0.169 mmol) sodium (as sodium hydroxide).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, oblong, plane tablet, scored on one side and debossed with
‘80’ on the other
side.
The tablets are 14.7-15.0 mm long and 8.2-8.6 mm wide.
The tablet with a score line can be divided into equal doses.
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
Health Products Regulatory Authority
01 November 2018
CRN008PHF
Page 2 of 21
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 effect