Benetor 20 mg film-coated tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Olmesartan medoxomil

Διαθέσιμο από:

Daiichi Sankyo Ireland Ltd

Φαρμακολογική κατηγορία (ATC):

C09CA; C09CA08

INN (Διεθνής Όνομα):

Olmesartan medoxomil

Δοσολογία:

20 milligram(s)

Φαρμακοτεχνική μορφή:

Film-coated tablet

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

Angiotensin II antagonists, plain; olmesartan medoxomil

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

2003-09-19

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BENETOR
® 10 MG, 20 MG, 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 Benetor is and what it is used for
2.
What you need to know before you take Benetor
3.
How to take Benetor
4.
Possible side effects
5.
How to store Benetor
6.
Contents of the pack and other information
1.
WHAT BENETOR IS AND WHAT IT IS USED FOR
Benetor belongs to a group of medicines called angiotensin-II receptor
antagonists. They lower blood
pressure by relaxing the blood vessels.
Benetor 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 Benetor
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 and reducing the
amount of salt in your diet). Your doctor may also have urged you to
take regular exercise, such as
walking or swimming. It is important to follow this advice from your
doctor.

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
31 March 2022
CRN00CTZ3
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benetor 20 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Olmesartan medoxomil
Each film-coated tablet contains 20 mg olmesartan medoxomil
Excipient with known effect:
Benetor 20 mg film-coated tablets: each film-coated tablet contains
123.2 mg lactose monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablets.
White, circular, film-coated tablets with C13 and C14 respectively
debossed on one 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 over)_
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 u