APX-PERINDOPRIL ARGININE/ AMLODIPINE 10/10 perindopril arginine 10 mg/ amlodipine 10 mg uncoated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amlodipine besilate, Quantity: 13.87 mg; perindopril arginine, Quantity: 10 mg

Available from:

Servier Laboratories (Aust) Pty Ltd

INN (International Name):

amlodipine besilate,perindopril arginine

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: colloidal anhydrous silica; microcrystalline cellulose; lactose monohydrate; magnesium stearate

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

APX-PERINDOPRIL ARGININE/ AMLODIPINE 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, round tablet with 10/10 on one face and servier logo on the other face; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2013-06-21

Patient Information leaflet

APX-PERINDOPRIL ARGININE/ AMLODIPINE
1
APX-PERINDOPRIL
ARGININE/
AMLODIPINE
_5/5; 5/10; 10/5; 10/10 _
_Perindopril/amlodipine [pronounced per-in-do-pril/ am-load-i-peen] _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about APX-
PERINDOPRIL ARGININE/
AMLODIPINE.
It does not contain all the available
information about this medicine.
Reading this leaflet 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 APX-
PERINDOPRIL ARGININE/
AMLODIPINE 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 APX-
PERINDOPRIL
ARGININE/
AMLODIPINE IS
The name of your medicine is APX-
PERINDOPRIL ARGININE/
AMLODIPINE.
The medicine contains the active
ingredient perindopril arginine.
Perindopril belongs to a group of
medicines called angiotensin
converting enzyme (ACE) inhibitors.
It also contains the active ingredient
amlodipine besilate. 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.
APX-PERINDOPRIL ARGININE/
AMLODIPINE has been prescribed
for you by your doctor to replace the
separate tablets of perindopril and
amlodipine you were taking.
One APX-PERINDOPRIL
ARGININE/ AMLODIPINE tablet
replaces separate tablets of
perindopril and amlodipine.
WHAT APX-
PERINDOPRIL
ARGININE/
AMLODIPINE IS USED
FOR
You have been prescribed APX-
PERINDOPRIL ARGININE/
AMLODIPINE if you have high
blood pressure, also known as
hypertension.
_WHY APX-PERINDOPRIL _
_ARGININE/ 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 p

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
APX-PERINDOPRIL ARGININE/ AMLODIPINE (PERINDOPRIL ARGININE /
AMLODIPINE BESILATE)
Version: 1
1/37
AUSTRALIAN PRODUCT INFORMATION – APX-PERINDOPRIL ARGININE/
AMLODIPINE (PERINDOPRIL ARGININE / AMLODIPINE BESILATE) TABLETS
1
NAME OF THE MEDICINE
Perindopril arginine / Amlodipine besilate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active components of APX-PERINDOPRIL ARGININE/ AMLODIPINE are
perindopril arginine and
amlodipine besilate.
Each APX-PERINDOPRIL ARGININE/ AMLODIPINE 5/5 tablet contains 5 mg of
perindopril arginine and 5 mg
of amlodipine (as besilate
‡
)
Each APX-PERINDOPRIL ARGININE/ AMLODIPINE 5/10 tablet contains 5 mg of
perindopril arginine and 10
mg of amlodipine (as besilate
‡
)
Each APX-PERINDOPRIL ARGININE/ AMLODIPINE 10/5 tablet contains 10 mg
of perindopril arginine and 5
mg of amlodipine (as besilate
‡
)
Each APX-PERINDOPRIL ARGININE/ AMLODIPINE 10/10 tablet contains 10 mg
of perindopril arginine and 10
mg of amlodipine (as besilate
‡
)
Excipient with known effect: sugars as lactose
For the full list of excipients, _see section 6.1 - List of
excipients. _
3
PHARMACEUTICAL FORM
APX-PERINDOPRIL ARGININE/ AMLODIPINE 5/5 is a white, rod-shaped tablet
engraved with 5/5 on one face
and the Servier company logo
on the other face.
APX-PERINDOPRIL ARGININE/ AMLODIPINE 5/10 is a white, square-shaped
tablet engraved with 5/10 on
one face and the Servier company logo
on the other face.
APX-PERINDOPRIL ARGININE/ AMLODIPINE 10/5 is a white,
triangular-shaped tablet engraved with 10/5 on
one face and the Servier company logo
on the other face.
APX-PERINDOPRIL ARGININE/ AMLODIPINE 10/10 is a white, round tablet
engraved with 10/10 on one face
and the Servier company logo
on the other face.
‡
Amlodipine doses are given as active base
AUSTRALIAN PRODUCT INFORMATION
APX-PERINDOPRIL ARGININE/ AMLODIPINE (PERINDOPRIL ARGININE /
AMLODIPINE BESILATE)
Version: 1
2/37
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
APX-PERINDOPRIL ARGININE/ AMLODIPINE is indicated as s