APO-OLMESARTAN HCTZ 40/25 olmesartan medoxomil/hydrochlorothiazide 40/25 mg film coated tablets blister pack

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

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

Pieejams no:

Arrotex Pharmaceuticals Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

Hydrochlorothiazide,Olmesartan medoxomil

Zāļu forma:

Tablet, film coated

Kompozīcija:

Excipient Ingredients: purified water; microcrystalline cellulose; hyprolose; lactose monohydrate; magnesium stearate; hypromellose; titanium dioxide; iron oxide yellow; macrogol 4000

Ievadīšanas:

Oral

Vienības iepakojumā:

30

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

Indicated for the treatment of hypertension.,Treatment should not be initiated with this fixed dose combination.

Produktu pārskats:

Visual Identification: 40/25 mg film coated tablets are yellow film coated, oval shaped, biconvex tablets debossed with L348 on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Autorizācija statuss:

Licence status A

Autorizācija datums:

2015-02-05

Lietošanas instrukcija

APO-OLMESARTAN HCTZ TABLETS
1
APO-OLMESARTAN
HCTZ
_Olmesartan medoxomil and hydrochlorothiazide _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about olmesartan/HCTZ. 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
olmesartan/HCTZ against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
APO-Olmesartan HCTZ contains
two medicines, olmesartan and
hydrochlorothiazide (HCTZ). These
two medicines work together to treat
high blood pressure (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 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
high blood pressure. The only way of
knowing that you have high blood
pressure is to have your blood
pressure checked on a regular basis.
Untreated high blood pressure can
lead to serious health problems,
including stroke, heart disease and
kidney failure.
_HOW IT WORKS _
Olmesartan 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. Olmesartan blocks the action
of angiotensin-II and therefore
relaxes your blood vessels. This
helps lower your blood pressure.
HCTZ is a diuretic which reduces the
amount of fluid in the body. This also
helps to lower blood pressure.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed

Produkta apraksts

1
AUSTRALIAN PRODUCT INFORMATION
APO-OLMESARTAN HCTZ 20/12.5 40/12.5 40/25
(OLMESARTAN MEDOXOMIL/HYDROCHLOROTHIAZIDE)
FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Olmesartan medoxomil/hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APO-OLMESARTAN
HCTZ
20/12.5
film
coated
tablets
contain
20
mg
of
olmesartan
medoxomil and 12.5 mg of hydrochlorothiazide.
APO-OLMESARTAN
HCTZ
40/12.5
film
coated
tablets
contain
40
mg
of
olmesartan
medoxomil and 12.5 mg of hydrochlorothiazide.
APO-OLMESARTAN HCTZ 40/25 film coated tablets contain 40 mg of
olmesartan medoxomil
and 25 mg of hydrochlorothiazide.
EXCIPIENTS WITH KNOWN EFFECT
Sugars as lactose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO-OLMESARTAN HCTZ 20/12.5
Yellow film coated, round, biconvex tablets debossed with ‘346’ on
one side and ‘L’ on other
side.
APO-OLMESARTAN HCTZ 40/12.5
Yellow film coated, oval shape, biconvex tablets debossed with
‘L347’ on one side and plain
on other side.
APO-OLMESARTAN HCTZ 40/25
Yellow film coated, oval shape, biconvex tablets debossed with
‘L348’ on one side and plain
on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension.
Treatment should not be initiated with this fixed dose combination.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
ADULTS
APO-OLMESARTAN HCTZ is administered once daily, with or without food,
in patients whose
blood pressure is not adequately controlled by olmesartan medoxomil or
HCTZ alone.
APO-OLMESARTAN HCTZ is registered in the combination of 20/12.5 mg,
40/12.5 mg and
40/25 mg. Olmesartan HCTZ 20/25 mg is registered in alternative
brands.
Dosing should be individualised and dependent on the patient’s
condition. Depending on the
blood pressure response, the dose may be titrated after 4 weeks.
If blood pressure is not adequately controlled on olmesartan medoxomil
alone, HCTZ may be
added with a starting dose of 12.5 mg. Should blood pressure still
remain inadequately
controlled either up-titration o