OLMEKAR HCT 40/5/25 Olmesartan medoxomil, Amlodipine (as besilate) and Hydrochlorothiazide 40 mg/5 mg/25 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amlodipine besilate, Quantity: 6.935 mg (Equivalent: amlodipine, Qty 5 mg); hydrochlorothiazide, Quantity: 25 mg; olmesartan medoxomil, Quantity: 40 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30 Tablets, 10 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

It 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: Light yellow, oval, biconvex, film coated tablets debossed with T 29 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:

2018-04-23

Patient Information leaflet

OLMEKAR HCT
_Olmesartan medoxomil, amlodipine (as besilate) and
hydrochlorothiazide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OLMEKAR 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 OLMEKAR
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 OLMEKAR HCT IS
USED FOR
OLMEKAR HCT 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 OLMEKAR HCT WORKS _
OLMEKAR 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. OLMEKAR HCT blocks
the action of angiotensin-II and
therefore relaxes your blood vessels.
This helps lower your blood
pressure.
OLMEKAR 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.
OLMEKAR HCT also contains
hydrochlorothi

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – OLMEKAR HCT
(olmesartan/amlodipine/hydrochlorothiazide) FILM COATED TABLETS
1
NAME OF THE MEDICINE
Olmesartan medoxomil, amlodipine (as besilate) and hydrochlorothiazide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OLMEKAR HCT 20/5/12.5 contains 20 mg olmesartan medoxomil, 5 mg
amlodipine as besilate
and 12.5 mg hydrochlorothiazide.
OLMEKAR HCT 40/5/12.5 contains 40 mg of olmesartan medoxomil, 5 mg
amlodipine as
besilate and 12.5 mg hydrochlorothiazide.
OLMEKAR HCT 40/5/25 contains 40 mg of olmesartan medoxomil, 5 mg
amlodipine as besilate
and 25 mg hydrochlorothiazide.
OLMEKAR HCT 40/10/12.5 contains 40 mg of olmesartan medoxomil, 10 mg
amlodipine as
besilate and 12.5 mg hydrochlorothiazide.
OLMEKAR HCT 40/10/25 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.
OLMEKAR HCT 20/5/12.5 - orange white, round, biconvex, film coated
tablets debossed with “T
21” on one side and plain on other side.
OLMEKAR HCT 40/5/12.5 - light yellow, round, biconvex, film coated
tablets debossed with
“T22” on one side and plain on other side.
OLMEKAR HCT 40/5/25 - light yellow, oval, biconvex, film coated
tablets debossed with “T29”
on one side and plain on other side.
OLMEKAR HCT 40/10/12.5 - grayish red, round, biconvex, film coated
tablets debossed with
“T24” on one side and plain on other side.
OLMEKAR HCT 40/10/25 - grayish red, oval, biconvex, film coated
tablets debossed with “T30”
on one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
OLMEKAR HCT is indicated for the treatment of hypertension, either as
replacement for
olmesartan medoxomil, amlodipine and hydrochlorothiazide being already
taken as separate
2
tablets or as add-on therapy where a patient's blood pressure is not
controlled on a dual
combination (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).
This fixed dose comb