REAPTAN 5/10 perindopril arginine 5mg/ amlodipine (as besilate) 10mg tablet bottl

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amlodipine besilate, Quantity: 13.87 mg; perindopril arginine, Quantity: 5 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; magnesium stearate; lactose monohydrate; microcrystalline cellulose

Administration route:

Oral

Units in package:

30 Tablets, commercial pack, 10 tablets, commercial pack, 10 Tablets, medical sample pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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, square-shaped tablet with 5/10 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:

Registered

Authorization date:

2010-11-04

Patient Information leaflet

REAPTAN
®
_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 REAPTAN.
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 REAPTAN
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 REAPTAN IS
The name of your medicine is
REAPTAN.
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.
REAPTAN has been prescribed for
you by your doctor to replace the
separate tablets of perindopril and
amlodipine you were taking.
One REAPTAN tablet replaces
separate tablets of perindopril and
amlodipine.
WHAT REAPTAN IS
USED FOR
You have been prescribed
REAPTAN if you have high blood
pressure, also known as
hypertension.
_WHY REAPTAN 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 pressure. The only way of
knowing that you have it 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. You may feel

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
REAPTAN® (PERINDOPRIL ARGININE / AMLODIPINE BESILATE)
Version: 13
1/36
AUSTRALIAN PRODUCT INFORMATION – REAPTAN
® (PERINDOPRIL
ARGININE / AMLODIPINE BESILATE) TABLETS
1
NAME OF THE MEDICINE
Perindopril arginine / Amlodipine besilate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active components of REAPTAN are perindopril arginine and
amlodipine besilate.
Each REAPTAN 5/5 tablet contains 5 mg of perindopril arginine and 5 mg
of amlodipine (as besilate
‡
)
Each REAPTAN 5/10 tablet contains 5 mg of perindopril arginine and 10
mg of amlodipine (as besilate
‡
)
Each REAPTAN 10/5 tablet contains 10 mg of perindopril arginine and 5
mg of amlodipine (as besilate
‡
)
Each REAPTAN 10/10 tablet contains 10 mg of perindopril arginine and
10 mg of amlodipine (as besilate
‡
)
Excipient with known effect: contains sugars as lactose
For the full list of excipients, _see section 6.1 - List of
excipients. _
3
PHARMACEUTICAL FORM
REAPTAN 5/5 is a white, rod-shaped tablet engraved with 5/5 on one
face and the Servier company logo
on the other face.
REAPTAN 5/10 is a white, square-shaped tablet engraved with 5/10 on
one face and the Servier company
logo
on the other face.
REAPTAN 10/5 is a white, triangular-shaped tablet engraved with 10/5
on one face and the Servier
company logo
on the other face.
REAPTAN 10/10 is a white, round tablet engraved with 10/10 on one face
and the Servier company logo
on the other face.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
REAPTAN 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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
REAPTAN (perindopril arginine/ amlodipine) 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 dose