OLAMLO HCT 40/10/25 olmesartan medoxomil/amlodipine/hydrochlorothiazide 40/10/25 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydrochlorothiazide, Quantity: 25 mg; amlodipine besilate, Quantity: 13.9 mg; olmesartan medoxomil, Quantity: 40 mg

Available from:

Accord Healthcare Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; pregelatinised maize starch; povidone; lactose monohydrate; isopropyl alcohol; silicified microcrystalline cellulose; 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:

Olamlo HCT 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: Brick red, oval, bevel-edged, film-coated tablets debossed with OC5 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: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2019-11-21

Patient Information leaflet

OLAMLO HCT
1
OLAMLO HCT
_Olmesartan medoxomil, amlodipine (as besilate) and
hydrochlorothiazide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OLAMLO HCT. 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 OLAMLO HCT
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 OLAMLO HCT IS
USED FOR
OLAMLO HCT is used to treat high
blood pressure which is sometimes
called hypertension.
Ever
yone 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 OLAMLO HCT WORKS_
OLAMLO HCT 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. OLAMLO
HCT blocks the action of
angiotensin-II and therefore relaxes
your blood vessels. This helps lower
your blood pressure.
OLAMLO HCT 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 blood vessels and
increases the supply of blood and
oxygen to the heart.
OLAMLO HCT also co
ntains
hydrochloro

Summary of Product characteristics

OLAMLO HCT tablet PI V1.0
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AUSTRALIAN PRODUCT INFORMATION
OLAMLO HCT 20/5/12.5
OLAMLO HCT 40/5/12.5
OLAMLO HCT 40/5/25
OLAMLO HCT 40/10/12.5
OLAMLO HCT 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
OLAMLO HCT 20/5/12.5 mg
contains 20 mg olmesartan medoxomil, 5 mg amlodipine as
besilate and 12.5 mg hydrochlorothiazide.
OLAMLO HCT 40/5/12.5 mg
contains 40 mg of olmesartan medoxomil, 5 mg amlodipine as
besilate and 12.5 mg hydrochlorothiazide.
OLAMLO HCT 40/5/25 mg
contains 40 mg of olmesartan medoxomil, 5 mg amlodipine as
besilate and 25 mg hydrochlorothiazide.
OLAMLO HCT 40/10/12.5 mg
contains 40 mg of olmesartan medoxomil, 10 mg amlodipine as
besilate and 12.5 mg hydrochlorothiazide.
OLAMLO HCT 40/10/25 mg
contains 40 mg of olmesartan medoxomil, 10 mg amlodipine as
besilate and 25 mg hydrochlorothiazide.
For the full list of excipients, see
Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Film-coated tablet
.
OLAMLO HCT 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.
OLAMLO HCT 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.
OLAMLO HCT 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.
OLAMLO HCT 40/10/12.5 mg
is a brick red, round, bevel-edged, film-coated tablets debossed
with “OC4” on one side and plain on other side.
OLAMLO HCT 40/10/25 mg
is a brick red, oval, bevel-edged, film-coated tablets debossed
with “OC5” on one side and plain on other side.
OLAMLO HCT tablet PI V1.0
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38
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
OLAMLO HCT is indicated for the treatment of hypertension, either as
replacement for
olmesartan medoxomil, am