Olmetec Plus 40mg/12.5mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Herunterladen Gebrauchsinformation (PIL)
17-06-2018
Herunterladen Fachinformation (SPC)
17-06-2018

Wirkstoff:

Olmesartan medoxomil; Hydrochlorothiazide

Verfügbar ab:

Daiichi Sankyo UK Ltd

ATC-Code:

C09DA08

INN (Internationale Bezeichnung):

Olmesartan medoxomil; Hydrochlorothiazide

Dosierung:

40mg ; 12.5mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 02050502; GTIN: 5015494401252

Gebrauchsinformation

                                Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMETEC PLUS 40 MG/12.5 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 Olmetec Plus is and what it is used for
2. What you need to know before you take Olmetec Plus
3. How to take Olmetec Plus
4. Possible side effects
5. How to store Olmetec Plus
6. Contents of the pack and other information
1. WHAT OLMETEC PLUS IS AND WHAT IT IS USED FOR
Olmetec
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 Olmetec Plus if Olmetec (olmesartan medoxomil)
alone has not
adequately controlled your blood pressure. When given together, the
two active substances in
Olmetec 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 Olmetec Plus to lower it more.
High blood pressure can be controlled with medicines such as Olmetec
Plus tablets. Your
doctor has probably also recommended that y
                                
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Fachinformation

                                OBJECT 1
OLMETEC PLUS 40 MG/12.5 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 16-Oct-2017 | Daiichi
Sankyo UK Limited
1. Name of the medicinal product
Olmetec Plus 40 mg/12.5 mg film-coated tablets
2. Qualitative and quantitative composition
Olmetec Plus 40 mg/12.5 mg film-coated tablets:
Each film-coated tablet contains 40 mg olmesartan medoxomil and 12.5
mg hydrochlorothiazide.
Excipient(s) with known effect
Olmetec 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.
Olmetec Plus 40 mg/12.5 mg 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.
Olmetec 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 Olmetec Plus 40 mg/12.5 mg or 40 mg/25 mg is 1
tablet per day.
Olmetec Plus 40 mg/12.5 mg may be administered in patients whose blood
pressure is not adequately
controlled by olmesartan medoxomil 40 mg alone.
Olmetec Plus 40 mg/25 mg may be administered in patients whose blood
pressure is not adequately
controlled on Olmetec Plus 40 mg/12.5 mg fixed dose combination.
For convenience, patients receiving olmesartan medoxomil and
hydrochlorothiazide from separate tablets
may be switched to Olmetec Plus 40 mg/12.5 mg and 40 mg/25 mg tablets
containing the same
component doses.
Olmetec 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_
Olmetec Plus is contraindicated in patients with severe renal
impairment (crea
                                
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