OLMETEC PLUS olmesartan medoxomil / hydrochlorothiazide 40/25mg tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

hydrochlorothiazide, Quantity: 25 mg; olmesartan medoxomil, Quantity: 40 mg

Tilgjengelig fra:

ORGANON PHARMA PTY LTD

INN (International Name):

Hydrochlorothiazide,Olmesartan medoxomil

Legemiddelform:

Tablet, film coated

Sammensetning:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; lactose monohydrate; hyprolose; titanium dioxide; hypromellose; purified talc; iron oxide yellow; iron oxide red

Administreringsrute:

Oral

Enheter i pakken:

10 tablets, 30 tablets

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Treatment of hypertension. Treatment should not be initiated with this fixed dose combination.

Produkt oppsummering:

Visual Identification: Pinkish, oval 15 x 7mm, film-coated tablet with C25 debossed on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2006-06-26

Informasjon til brukeren

OLMETEC PLUS
®
_Olmesartan medoxomil and hydrochlorothiazide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OLMETEC PLUS.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking OLMETEC
PLUS against the benefits he/she
expects it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
OLMETEC PLUS TABLETS.
You may need to read it again.
WHAT OLMETEC PLUS
IS USED FOR
OLMETEC PLUS is used to treat
high blood pressure which is
sometimes called hypertension.
Everyone has blood pressure. This
pressure helps push blood all around
your body. Your blood pressure
changes at different times of the day,
depending on how busy or worried
you are. You have hypertension (high
blood pressure) when your blood
pressure stays higher than is needed,
even when you are calm and relaxed.
There are usually no symptoms of
hypertension. The only way of
knowing that you have hypertension
is to have your blood pressure
checked on a regular basis. If high
blood pressure is not treated it can
lead to serious health problems,
including stroke, heart disease and
kidney failure.
_HOW OLMETEC PLUS WORKS_
OLMETEC PLUS belongs to a group
of medicines known as angiotensin-II
receptor antagonists. Angiotensin-II
is a substance produced in the body
which causes blood vessels to
tighten. OLMETEC PLUS blocks the
action of angiotensin-II and therefore
relaxes your blood vessels. This
helps lower your blood pressure.
OLMETEC PLUS also contains a
diuretic which reduces the amount of
fluid in the body. This also helps to
lower blood pressure.
Your doctor may have prescribed
OLMETEC PLUS for another
reason. Ask your doctor if you have
any questions about why OLMETEC
PLUS has been prescribed for you.
OLMETEC PLUS is not addictive.
This medicine is available only with
a doctor's pre

Preparatomtale

OLMETEC PLUS
Page 1 of 26
AUSTRALIAN PRODUCT INFORMATION
OLMETEC PLUS
®
(OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE)
TABLETS
1
NAME OF THE MEDICINE
Olmesartan medoxomil and hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OLMETEC PLUS consists of olmesartan medoxomil and hydrochlorothiazide
(HCTZ).
OLMETEC PLUS 20/12.5 MG contains 20 mg of olmesartan medoxomil and
12.5 mg of
hydrochlorothiazide.
OLMETEC
PLUS
20/25 MG
contains
20 mg
of
olmesartan
medoxomil
and
25 mg
of
hydrochlorothiazide.
OLMETEC PLUS 40/12.5 MG contains 40 mg of olmesartan medoxomil and
12.5 mg of
hydrochlorothiazide.
OLMETEC
PLUS
40/25 MG
contains
40 mg
of
olmesartan
medoxomil
and
25 mg
of
hydrochlorothiazide.
Olmesartan medoxomil is a white to light yellowish-white powder or
crystalline powder. It is
practically insoluble in water and sparingly soluble in methanol.
HCTZ is a white, or almost white, crystalline powder. HCTZ is very
slightly soluble in water,
soluble in acetone, sparingly soluble in alcohol. It dissolves in
dilute solutions of alkali
hydroxides.
Excipients with known effect:
−
lactose (as monohydrate)
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
OLMETEC PLUS is available for oral use as film-coated tablets
containing 20/12.5 mg,
20/25 mg, 40/12.5 mg, or 40/25 mg olmesartan medoxomil/HCTZ.
OLMETEC PLUS (olmesartan medoxomil/hydrochlorothiazide) 20/12.5 MG is
a round tablet,
approximately 8.5 mm in diameter, reddish yellow in colour with C22
debossed on one side.
OLMETEC PLUS (olmesartan medoxomil/hydrochlorothiazide) 20/25 MG is a
round tablet,
approximately 8.5 mm in diameter, pinkish in colour with C24 debossed
on one side. Not
currently available in Australia.
OLMETEC PLUS (olmesartan medoxomil/hydrochlorothiazide) 40/12.5 MG is
an oval tablet,
approximately 15 mm x 7 mm, reddish yellow in colour with C23 debossed
on one side.
OLMETEC PLUS (olmesartan medoxomil/hydrochlorothiazide) 40/25 MG is an
oval tablet,
approximately 15 mm x 7 mm in diameter, pinkish in colour