Olmesartan medoxomil 40 mg film-coated tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Olmesartan medoxomil

Disponible depuis:

McDermott Laboratories Ltd., T/A Gerard Laboratories

Code ATC:

C09CA; C09CA08

DCI (Dénomination commune internationale):

Olmesartan medoxomil

Dosage:

40 milligram(s)

forme pharmaceutique:

Film-coated tablet

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Angiotensin II antagonists, plain; olmesartan medoxomil

Statut de autorisation:

Marketed

Date de l'autorisation:

2015-01-09

Notice patient

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTAN MEDOXOMIL 10 MG FILM-COATED TABLETS
OLMESARTAN MEDOXOMIL 20 MG FILM-COATED TABLETS
OLMESARTAN MEDOXOMIL
40 MG FILM-COATED TABLETS
olmesartan medoxomil
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 Olmesartan medoxomil is and what it is used for
2.
What you need to know before you take Olmesartan medoxomil
3.
How to take Olmesartan medoxomil
4.
Possible side effects
5.
How to store Olmesartan medoxomil
6.
Contents of the pack and other information
1.
WHAT OLMESARTAN MEDOXOMIL IS AND WHAT IT IS USED FOR
Olmesartan medoxomil belongs to a group of medicines called
angiotensin-II receptor antagonists.
They lower blood pressure by relaxing the blood vessels.
This medicine is used for the treatment of high blood pressure (also
known as ‘hypertension’)
in
adults and
in children and adolescents aged 6 to less than 18 years. High blood
pressure can damage blood
vessels in organs such as the heart, kidneys, brain and eyes. In some
cases this may lead to a heart
attack, heart or kidney failure, stroke or blindness. Usually high
blood pressure has no symptoms. It is
important to have your blood pressure checked to prevent damage
occurring.
High blood pressure can be controlled with medicines such as
olmesartan medoxomil tablets. Your
doctor has probably also recommended that you make some changes in
your lifestyle to help lower
your blood pressure (for example losing weight, giving up smoking,
reducing the amount of alcohol
you drink

Résumé des caractéristiques du produit

Health Products Regulatory Authority
26 July 2022
CRN00CTVY
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan medoxomil 40 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Olmesartan medoxomil
Each film-coated tablet contains 40 mg of olmesartan medoxomil
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, film coated, oval, biconvex beveled edge tablets debossed with
'M' on one side of the tablet and 'O4' on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
Treatment of hypertension in children and adolescents from 6 to less
than 18 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The recommended starting dose of olmesartan medoxomil is 10 mg once
daily. In patients whose blood pressure is not
adequately controlled at this dose, the dose of olmesartan medoxomil
may be increased to 20 mg once daily as the optimal
dose. If additional blood pressure reduction is required, olmesartan
medoxomil dose may be increased to a maximum of 40 mg
daily or hydrochlorothiazide therapy may be added.
The antihypertensive effect of olmesartan medoxomil is substantially
present within 2 weeks of initiating therapy and is
maximal by about 8 weeks after initiating therapy. This should be
borne in mind when considering changing the dose regimen
for any patient.
_Elderly (65 years or older)_
No adjustment of dosage is generally required in elderly people (see
below for dose recommendations in patients with renal
impairment). If up-titration to the maximum dose of 40 mg daily is
required, blood pressure should be closely monitored.
_Renal impairment_
The maximum dose in patients with mild to moderate renal impairment
(creatinine clearance of 20 – 60 ml/min) is 20 mg
olmesartan medoxomil once daily, owing to limited experience of higher
dosages in this patient group. The use of olmesartan
medoxomil in patients with severe renal impairment (creat