Benetor Plus 20 mg/12.5 mg film-coated tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Olmesartan medoxomil; Hydrochlorothiazide

Boleh didapati daripada:

Daiichi Sankyo Ireland Ltd

Kod ATC:

C09DA; C09DA08

INN (Nama Antarabangsa):

Olmesartan medoxomil; Hydrochlorothiazide

Dos:

20 mg/12.5 milligram(s)

Borang farmaseutikal:

Film-coated tablet

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

Angiotensin II antagonists and diuretics; olmesartan medoxomil and diuretics

Status kebenaran:

Marketed

Tarikh kebenaran:

2005-05-12

Risalah maklumat

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
BENETOR PLUS 20 MG/12.5 MG
BENETOR PLUS 20 MG/25 MG
FILM-COATED TABLETS
OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE
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 Plus is and what it is used for
2. What you need to know before you take Benetor Plus
3. How to take Benetor Plus
4. Possible side effects
5. How to store Benetor Plus
6. Contents of the pack and other information
1.
WHAT BENETOR PLUS IS AND WHAT IT IS USED FOR
Benetor Plus contains two active substances, olmesartan medoxomil and
hydrochlorothiazide,
that are used to treat high blood pressure (hypertension):

Olmesartan
medoxomil
is
one
of
a
group
of
medicines
called
angiotensin
II-receptor
antagonists. It lowers blood pressure by relaxing the blood vessels.

Hydrochlorothiazide is one of a group of medicines called thiazide
diuretics (“water tablets”).
It lowers blood pressure by helping the body to get rid of extra fluid
by making your kidneys
produce more urine.
You will only be given Benetor Plus if Benetor (olmesartan medoxomil)
alone has not adequately
controlled your blood pressure. When given together, the two active
substances in Benetor Plus
help to lower blood pressure more than if either of them were given
alone.
You may already be taking medicines to treat your high blood pressure,
but your doctor may want
you to take Benetor Plus to lower it more.
Page 2 of 10
High blood pressure can be controlled with medicines such as Benetor
Plus tablets. Your docto

Ciri produk

Health Products Regulatory Authority
22 April 2022
CRN00CTZ7
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benetor Plus 20 mg/12.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg olmesartan medoxomil and 12.5
mg hydrochlorothiazide
Excipient(s) with known effect
Benetor Plus 20 mg/12.5 mg film-coated tablets: Each film-coated
tablet contains 110.7 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Reddish-yellow, round, film-coated tablets of 8.5 mm with C22 debossed
on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Benetor Plus fixed dose combination is indicated in adult patients
whose blood pressure is not adequately controlled on
olmesartan medoxomil alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
Benetor Plus is not for use as initial therapy, but in patients whose
blood pressure is not adequately controlled by 20 mg
olmesartan medoxomil alone. Benetor Plus is administered once daily,
with or without food.
When clinically appropriate, direct change from monotherapy with 20 mg
olmesartan medoxomil to the fixed combination may
be considered, taking into account that theantihypertensive effect of
olmesartan medoxomil is maximal by about 8 weeks after
initiating therapy (see section 5.1 ). Dose titration of the
individual components is recommended:
20 mg olmesartan medoxomil/12.5 mg hydrochlorothiazide may be
administered in patients whose blood pressure is not
adequately controlled by the optimal monotherapy olmesartan medoxomil
20 mg alone.
20 mg olmesartan medoxomil/ 25 mg hydrochlorothiazide may be
administered in patients whose blood pressure is not
adequately controlled by 20 mg olmesartan medoxomil/ 12.5 mg
hydrochlorothiazide.
_Elderly people (age 65 years or over)_
In elderly people the same dosage of the combination is recommended as
for adults.
_Renal impairment_
When Benetor Pl