OLMESARTAN/AMLODIPINE 40/10 APOTEX olmesartan medoxomil 40 mg / amlodipine (as besilate) 10 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

olmesartan medoxomil, Quantity: 40 mg; amlodipine besilate, Quantity: 13.87 mg (Equivalent: amlodipine, Qty 10 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: silicified microcrystalline cellulose; pregelatinised maize starch; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

10 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

It is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination (see Dosage and Administration).

Product summary:

Visual Identification: Red (brownish red), round, biconvex, film-coated tablets debossed with L78 on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-06-13

Patient Information leaflet

OLMESARTAN/AMLODIPINE APOTEX
1
OLMESARTAN/
AMLODIPINE APOTEX
_Olmesartan medoxomil and amlodipine besilate _
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/Amlodipine. 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 using
Olmesartan/Amlodipine against the
benefits it is expected to 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
Olmesartan/Amlodipine 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.
Olmesartan/Amlodipine contains
olmesartan medoxomil, which
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/Amlodipine
blocks the action of angiotensin-II
and therefore relaxes your blood
vessels. This helps lower your blood
pressure.
Olmesartan/Amlodipine also contains
amlodipine besilate, a calcium
channel blocker. This reduces the
movement of calcium into the cells
of the heart and blood vessels. This
also helps to lower blood pressure as
it relaxes the bl

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION –
OLMESARTAN/AMLODIPINE APOTEX tablets
(Olmesartan medoxomil/ amlodipine besilate)
NAME OF THE MEDICINE
Olmesartan medoxomil and amlodipine besilate
QUALITATIVE AND QUANTITATIVE COMPOSITION
OLMESARTAN/AMLODIPINE 20/5 APOTEX tablets contain 20 mg olmesartan
medoxomil and 5 mg amlodipine (as besilate).
OLMESARTAN/AMLODIPINE 20/10 APOTEX tablets contain 20 mg olmesartan
medoxomil and 10 mg amlodipine (as besilate).
OLMESARTAN/AMLODIPINE 40/5 APOTEX tablets contain 40 mg olmesartan
medoxomil and 5 mg amlodipine (as besilate).
OLMESARTAN/AMLODIPINE 40/10 APOTEX tablets contain 40 mg olmesartan
medoxomil and 10 mg amlodipine (as besilate).
The tablets contain no excipients with a known effect. For the full
list of excipients, see
Section 6.1 List of excipients.
PHARMACEUTICAL FORM
OLMESARTAN/AMLODIPINE 20/5 APOTEX - white, round, biconvex,
film-coated tablets
debossed with “L75” on one side and plain on other side.
OLMESARTAN/AMLODIPINE 20/10 APOTEX - greyish-orange, round, biconvex,
film-
coated tablets debossed with “L76” on one side and plain on other
side.
OLMESARTAN/AMLODIPINE 40/5 APOTEX - light yellow, round, biconvex,
film-coated
tablets debossed with “L77” on one side and plain on other side.
OLMESARTAN/AMLODIPINE 40/10 APOTEX - red (brownish red), round,
biconvex,
film-coated tablets debossed with “L78” on one side and plain on
other side.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
OLMESARTAN/AMLODIPINE APOTEX is indicated for the treatment of
hypertension.
Treatment should not be initiated with this fixed-dose combination
(see 4.2 Dose and Method
of Administration).
4.2
DOSE AND METHOD OF ADMINISTRATION
OLMESARTAN/AMLODIPINE APOTEX is registered in four strengths:
OLMESARTAN/AMLODIPINE 20/5 APOTEX (olmesartan medoxomil 20 mg and
amlodipine as besilate 5 mg); OLMESARTAN/AMLODIPINE 20/10 APOTEX
(olmesartan
medoxomil 20 mg and amlodipine as besilate 10 mg);
OLMESARTAN/AMLODIPINE 40/5
APOTEX (olmesartan medoxomil 40 mg and amlodipine as besilate 5 mg);
OLMES