APO-OLMESARTAN/AMLODIPINE/HCTZ 20/5/12.5 olmesartan medoxomil/amlodipine/hydrochlorothiazide 20/5/12.5 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydrochlorothiazide, Quantity: 12.5 mg; amlodipine besilate, Quantity: 6.95 mg; olmesartan medoxomil, Quantity: 20 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: pregelatinised maize starch; silicified microcrystalline cellulose; isopropyl alcohol; magnesium stearate; lactose monohydrate; povidone; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black

Administration route:

Oral

Units in package:

10 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

APO-OLMESARTAN/AMLODIPINE/HCTZ 20/5/12.5 mg is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination. This fixed dose combination is not indicated for initial therapy.

Product summary:

Visual Identification: Off white to peach, round, bevel-edged, film-coated tablets debossed with OC1 on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2019-11-21

Patient Information leaflet

APO-OLMESARTAN/ AMLODIPINE/ HCTZ
1
APO-OLMESARTAN/
AMLODIPINE/ HCTZ
_olmesartan medoxomil, amlodipine (as besilate) 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 this medicine. 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 APO-
OLMESARTAN/ AMLODIPINE/
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
USED FOR
APO-OLMESARTAN/
AMLODIPINE/ HCTZ 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 THIS MEDICINE WORKS _
This medicine 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. This
medicine blocks the action of
angiotensin-II and therefore relaxes
your blood vessels. This helps lower
your blood pressure.
This medicine 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

Summary of Product characteristics

APO-OLMESARTAN/AMLODIPINE/HCTZ tablet PI V1.0
Page 1 of 40
AUSTRALIAN PRODUCT INFORMATION
APO-OLMESARTAN/AMLODIPINE/HCTZ 20/5/12.5
APO-OLMESARTAN/AMLODIPINE/HCTZ 40/5/12.5
APO-OLMESARTAN/AMLODIPINE/HCTZ 40/5/25
APO-OLMESARTAN/AMLODIPINE/HCTZ 40/10/12.5
APO-OLMESARTAN/AMLODIPINE/HCTZ 40/10/25
(olmesartan medoxomil/amlodipine (as besilate) and
hydrochlorothiazide)
FILM-COATED TABLET
1
NAME OF THE MEDICINE
Olmesartan medoxomil, amlodipine (as besilate) and
hydrochlorothiazide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APO-OLMESARTAN/AMLODIPINE/HCTZ
20/5/12.5
MG
contains
20
mg
olmesartan
medoxomil, 5 mg amlodipine as besilate and 12.5 mg
hydrochlorothiazide.
APO-OLMESARTAN/AMLODIPINE/HCTZ
40/5/12.5
MG
contains
40
mg
of
olmesartan
medoxomil, 5 mg amlodipine as besilate and 12.5 mg
hydrochlorothiazide.
APO-OLMESARTAN/AMLODIPINE/HCTZ
40/5/25
MG
contains
40
mg
of
olmesartan
medoxomil, 5 mg amlodipine as besilate and 25 mg hydrochlorothiazide.
APO-OLMESARTAN/AMLODIPINE/HCTZ
40/10/12.5
MG
contains
40
mg
of
olmesartan
medoxomil, 10 mg amlodipine as besilate and 12.5 mg
hydrochlorothiazide.
APO-OLMESARTAN/AMLODIPINE/HCTZ
40/10/25
MG
contains
40
mg
of
olmesartan
medoxomil, 10 mg amlodipine as besilate and 25 mg hydrochlorothiazide.
EXCIPIENTS WITH KNOWN EFFECT
Contains lactose. For the full list of excipients, see SECTION 6.1
LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
FILM-COATED TABLET.
APO-OLMESARTAN/AMLODIPINE/HCTZ 20/5/12.5 MG is an off white to peach,
round, bevel-
edged, film-coated tablets debossed with “OC1” on one side and
plain on other side.
APO-OLMESARTAN/AMLODIPINE/HCTZ 40/5/12.5 MG is a light yellow, round,
bevel-edged,
film-coated tablets debossed with “OC2” on one side and plain on
other side.
APO-OLMESARTAN/AMLODIPINE/HCTZ 40/5/25 MG is a light yellow, oval,
bevel-edged,
film-coated tablets debossed with “OC3” on one side and plain on
other side.
APO-OLMESARTAN/AMLODIPINE/HCTZ 40/10/12.5 MG is a brick red, round,
bevel-edged,
film-coated tablets debossed with “OC4” on one side and plain on
oth