Pharmacor Olmesartan Amlodipine 20/10 olmesartan medoxomil 20 mg / amlodipine (as besilate) 10 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amlodipine besilate, Quantity: 13.87 mg (Equivalent: amlodipine, Qty 10 mg); olmesartan medoxomil, Quantity: 20 mg

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

30's, 10's

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Olmesartan and Amlodipine Tablets are indicated for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination.

Product summary:

Visual Identification: Greyish Orange, round shaped, biconvex, film coated tablets debossed with "A24" 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:

2019-12-17

Patient Information leaflet

1
PHARMACOR OLMESARTAN AMLODIPINE
Ver-02
PHARMACOR OLMESARTAN AMLODIPINE
_Olmesartan medoxomil and amlodipine besilate_
PHARMACOR OLMESARTAN AMLODIPINE 20/5
PHARMACOR OLMESARTAN AMLODIPINE 20/10
PHARMACOR OLMESARTAN AMLODIPINE 40/5
PHARMACOR OLMESARTAN AMLODIPINE 40/10
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions
about
PHARMACOR
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
taking
PHARMACOR
OLMESARTAN
AMLODIPINE against the benefits
he/she expects it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
YOUR
TABLETS.
You may need to read it again.
WHAT PHARMACOR
OLMESARTAN
AMLODIPINE IS USED FOR
PHARMACOR
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.
HOW
PHARMACOR
OLMESARTAN
AMLODIPINE WORKS
PHARMACOR
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.
PHARMACOR
OLMESARTAN
AMLODIPINE
blocks the action of angiotensin-II
and
therefore
relaxes
your
blood
vessels.
This
helps
lower
your
blood pressure.
P

Summary of Product characteristics

PHARMACOR
OLMESARTAN AMLODIPINE Ver: 02
1
AUSTRALIAN PRODUCT INFORMATION
PHARMACOR OLMESARTAN AMLODIPINE
(OLMESARTAN MEDOXOMIL AND AMLODIPINE AS BESILATE) TABLETS
1. NAME OF THE MEDICINE
The
active
ingredients
of
PHARMACOR
OLMESARTAN
AMLODIPINE
are
olmesartan
medoxomil and amlodipine as besilate.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
PHARMACOR OLMESARTAN AMLODIPINE 20/5 (olmesartan medoxomil and
amlodipine
20/5 mg film-coated tablets)
Each
film-coated
tablet
contains
olmesartan
medoxomil
20
mg
and
amlodipine
besilate
equivalent to 5 mg amlodipine
PHARMACOR OLMESARTAN AMLODIPINE 20/10 (olmesartan medoxomil and
amlodipine
20/10 mg film-coated tablets)
Each
film-coated
tablet
contains
olmesartan
medoxomil
20
mg
and
amlodipine
besilate
equivalent to 10 mg amlodipine
PHARMACOR OLMESARTAN AMLODIPINE 40/5 (olmesartan medoxomil and
amlodipine
40/5 mg film-coated tablets)
Each
film-coated
tablet
contains
olmesartan
medoxomil
40
mg
and
amlodipine
besilate
equivalent to 5 mg amlodipine
PHARMACOR OLMESARTAN AMLODIPINE 40/10 (olmesartan medoxomil and
amlodipine
40/10 mg film-coated tablets)
Each
film-coated
tablet
contains
olmesartan
medoxomil
40
mg
and
amlodipine
besilate
equivalent to 10 mg amlodipine
For the full list of excipients, see section 6.1 List of Excipients.
PHARMACOR
OLMESARTAN AMLODIPINE Ver: 02
2
3. PHARMACEUTICAL FORM
Film-coated tablet
PHARMACOR OLMESARTAN AMLODIPINE 20/5 (olmesartan medoxomil and
amlodipine
20/5 mg film-coated tablets)
White to off white, round shaped, biconvex, film coated tablets
debossed with "A22" on one side
and plain on other side.
PHARMACOR OLMESARTAN AMLODIPINE 20/10 (olmesartan medoxomil and
amlodipine
20/10 mg film-coated tablets)
Greyish Orange, round shaped, biconvex, film coated tablets debossed
with "A24" on one side
and plain on other side.
PHARMACOR OLMESARTAN AMLODIPINE 40/5 (olmesartan medoxomil and
amlodipine
40/5 mg film-coated tablets)
Cream to light yellow, round shaped, biconvex, film coated tablets
debossed with" A23" on one
side and plain on other side.
PHARMA