APO-Perindopril Arginine/Amlodipine 10/5 perindopril arginine 10 mg and amlodipine (as besilate) 5 mg uncoated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

perindopril arginine, Quantity: 10 mg; amlodipine besilate, Quantity: 6.94 mg (Equivalent: amlodipine, Qty 5 mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

amlodipine besilate,perindopril arginine

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; croscarmellose sodium; colloidal anhydrous silica

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Perindopril arginine and amlodipine combination tablet is indicated as substitution therapy for the treatment of hypertension and/or stable coronary heart disease in patients already controlled with separate doses of perindopril and amlodipine, given concurrently at the same dose level. Treatment should not be initiated with this combination.

Product summary:

Visual Identification: White to off-white coloured, triangular-shaped biconvex tablets engraved with 'APO' on one side and '10/5' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-01-12

Patient Information leaflet

APO-PERINDOPRIL/AMLODIPINE 5/5, 5/10, 10/5 & 10/10 TABLETS
1
APO-PERINDOPRIL/AMLODIPINE
5/5, 5/10, 10/5 & 10/10 TABLETS
_Contains the active ingredient perindopril arginine 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 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 using this medicine
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 YOUR
MEDICINE.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Perindopril/Amlodipine 5/5, 5/10,
10/5 & 10/10 tablets. It contains the
active ingredient perindopril arginine
and amlodipine besilate.
Perindopril belongs to a group of
medicines called angiotensin
converting enzyme (ACE) inhibitors.
Amlodipine belongs to a group of
medicines called calcium channel
blockers.
Calcium channel blockers do not
change the amount of calcium in
your blood or bones.
Perindopril/Amlodipine Tablets has
been prescribed to you by your
doctor to replace the separate tablets
of perindopril and amlodipine you
were taking.
One Perindopril/Amlodipine tablet
replaces separate tablets of
perindopril and amlodipine.
You have been prescribed
Perindopril/Amlodipine tablets if you
have high blood pressure, also known
as hypertension.
_WHY PERINDOPRIL/AMLODIPINE _
_IS USED FOR HIGH BLOOD _
_PRESSURE _
Everyone has blood pressure. This
pressure helps get your blood all
around the body. Your blood
pressure may be different at different
times of the day, depending on how
busy or stressed you are.
You have high blood pressure when
your blood pressure stays higher than
is needed, even when you are calm or
relaxed.
There are usually no symptoms of
high blood

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-PERINDOPRIL ARGININE/AMLODIPINE
(PERINDOPRIL ARGININE AND AMLODIPINE (AS
BESILATE)) TABLETS
1
NAME OF THE MEDICINE
Perindopril arginine and amlodipine besilate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril arginine and amlodipine (as besilate) combination tablets
contain the following
amount of perindopril arginine and amlodipine (as besilate
1
) respectively: 5 mg/5 mg, 5 mg/10
mg, 10 mg/5 mg & 10 mg/10 mg.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
5 MG/5 MG TABLET
White to off-white coloured, oval-shaped biconvex tablets engraved
with “APO” on one side
and “5/5” on the other side.
5 MG/10 MG TABLET
White to off-white coloured, square-shaped biconvex tablets engraved
with “APO” on one side
and “5/10” on the other side.
10 MG/5 MG TABLET
White to off-white coloured, triangular-shaped biconvex tablets
engraved with “APO” on one
side and “10/5” on the other side.
10 MG/10 MG TABLET
White to off-white coloured, round-shaped biconvex tablets engraved
with “APO” on one side
and “10/10” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Perindopril arginine and amlodipine combination tablets are indicated
as substitution therapy
for the treatment of hypertension and/or stable coronary heart disease
in patients already
controlled with separate doses of perindopril and amlodipine, given
concurrently at the same
dose level. Treatment should not be initiated with this combination.
4.2
DOSE AND METHOD OF ADMINISTRATION
Perindopril Arginine/Amlodipine tablets are intended for oral
administration.
1
Amlodipine doses are given as the active base.
2
Perindopril arginine and amlodipine (as besilate) combination tablet
is available in strengths of
5 mg/5 mg, 5 mg/10 mg, 10 mg/5 mg and 10 mg/10 mg as substitution
therapy for patients
already controlled with separate doses of perindopril (5 mg or 10 mg)
and amlodipine (5 mg
or 10 mg), given concurrently at the dose level as indicated in t