Benetor Plus 40 mg/12.5 mg film-coated tablets

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Olmesartan medoxomil; Hydrochlorothiazide

Tillgänglig från:

Daiichi Sankyo Ireland Ltd

ATC-kod:

C09DA; C09DA08

INN (International namn):

Olmesartan medoxomil; Hydrochlorothiazide

Dos:

40 mg/12.5 milligram(s)

Läkemedelsform:

Film-coated tablet

Receptbelagda typ:

Product subject to prescription which may be renewed (B)

Terapiområde:

Angiotensin II antagonists and diuretics; olmesartan medoxomil and diuretics

Bemyndigande status:

Not marketed

Tillstånd datum:

2010-08-06

Bipacksedel

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PACKAGE LEAFLET: INFORMATION FOR THE USER
BENETOR PLUS 40 MG/12.5 MG
BENETOR PLUS 40 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.
High blood pressure can be controlled with medicines such as Benetor
Plus tablets. Your
doctor has probabl

Produktens egenskaper

Health Products Regulatory Authority
22 April 2022
CRN00CTZ7
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benetor Plus 40 mg/12.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg olmesartan medoxomil and 12.5
mg hydrochlorothiazide.
Excipient(s) with known effect
Benetor Plus 40 mg/12.5 mg film-coated tablets:
Each film-coated tablet contains 233.9 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Reddish-yellow, oval, film-coated tablets of 15 x 7 mm with C23
debossed on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Benetor Plus 40 mg/12.5 mg and 40 mg/25 mg fixed dose combinations are
indicated in adult patients whose blood pressure
is not adequately controlled on olmesartan medoxomil 40 mg alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
The recommended dose of Benetor Plus 40 mg/12.5 mg or 40 mg/25 mg is 1
tablet per day.
Benetor Plus 40 mg/12.5 mg may be administered in patients whose blood
pressure is not adequately controlled by
olmesartan medoxomil 40 mg alone.
Benetor Plus 40 mg /25 mg may be administered in patients whose blood
pressure is not adequately controlled on Benetor
Plus 40 mg/12.5 mg fixed dose combination.”
For convenience, patients receiving olmesartan medoxomil and
hydrochlorothiazide from separate tablets may be switched to
Benetor Plus 40 mg/12.5 mg and 40 mg/25 mg tablets containing the same
component doses.
Benetor Plus 40 mg/12.5 mg and 40 mg/25 mg can be taken with or
without food.
_Elderly (age 65 years or over)_
In elderly people the same dosage of the combination is recommended as
for adults.
Blood pressure should be closely monitored.
_Renal impairment_
Benetor Plus is contraindicated in patients with severe renal
impairment (creatinine clearance < 30 mL/min).
Health Products Regulatory Authority
22 April 2022
CRN00CTZ7
Page 2 of 19
The maximum dose of o