PRITOR/AMLODIPINE 40 mg/5 mg telmisartan 40 mg/amlodipine (as besilate) 5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

telmisartan, Quantity: 40 mg; amlodipine besilate, Quantity: 6.935 mg (Equivalent: amlodipine, Qty 5 mg)

Available from:

Boehringer Ingelheim Pty Ltd

INN (International Name):

amlodipine besilate,Telmisartan

Pharmaceutical form:

Tablet, multilayer

Composition:

Excipient Ingredients: magnesium stearate; meglumine; sorbitol; sodium hydroxide; microcrystalline cellulose; povidone; colloidal anhydrous silica; maize starch; pregelatinised maize starch; Colour

Administration route:

Oral

Units in package:

14 tablets, 7 tablets, 30 tablets, 56 tablets, 98 tablets, 28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of hypertension. Treatment should not be initiated with this fixed-dose combination. (see DOSAGE AND ADMINISTRATION)

Product summary:

Visual Identification: Oval, biconvex, bilayered uncoated tablets, white to off white and blue, debossed with company logo and 'A1' on white layer and plain on blue layer; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2013-06-05

Patient Information leaflet

PRITOR
®
/AMLODIPINE
_TABLETS_
_telmisartan/amlodipine besilate_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Pritor/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 benefits and
risks. Your doctor has weighed the
risks of you taking this medicine
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from your
pharmacist, doctor, or from
www.medicines.org.au and may
contain important information about
the medicine and its use of which
you should be aware.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PRITOR/
AMLODIPINE IS USED FOR
Pritor/Amlodipine is used to lower
high blood pressure (hypertension).
Everyone has blood pressure. This
pressure helps get your blood all
around your body. Your blood
pressure may be different 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 or 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 PRITOR/AMLODIPINE_
_WORKS_
Pritor/Amlodipine contains
telmisartan and amlodipine (as the
besilate salt) in one single tablet.
These two active ingredients help to
reduce blood pressure in different
ways:
•
Telmisartan belongs to a group of
medicines called angiotensin II
receptor blockers. Angiotensin II
is a substance in the body which
causes blood vessels to narrow,
thu

Summary of Product characteristics

PRITOR/AMLODIPINE PI0144-09
1
AUSTRALIAN PRODUCT INFORMATION – PRITOR
®
/AMLODIPINE (TELMISARTAN/AMLODIPINE)
TABLET
1 NAME OF THE MEDICINE
telmisartan and amlodipine (as besilate)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
PRITOR/AMLODIPINE is available in four tablet strengths for oral
administration, containing 40 mg
or 80 mg telmisartan and 5 mg or 10 mg amlodipine (as besilate), in
the following combinations:
•
PRITOR/AMLODIPINE 40 mg/5 mg containing telmisartan 40 mg/amlodipine 5
mg
•
PRITOR/AMLODIPINE 40 mg/10 mg containing telmisartan 40 mg/amlodipine
10 mg
•
PRITOR/AMLODIPINE 80 mg/5 mg containing telmisartan 80 mg/amlodipine 5
mg
•
PRITOR/AMLODIPINE 80 mg/10 mg containing telmisartan 80 mg/amlodipine
10 mg
Excipients with known effect:
•
Each PRITOR/AMLODIPINE 40/5 mg and 40/10 mg tablet contains 168.64 mg
of sorbitol
•
Each PRITOR/AMLODIPINE 80/5 mg and 80/10 mg tablet contains 337.28 mg
of sorbitol
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
PRITOR/AMLODIPINE 40 mg/5 mg tablets are oval, biconvex shaped two
layer tablets, white to
off white on one side and blue on the other side. The white side is
debossed with Boehringer
Ingelheim company logo and ‘A1’. The blue side is plain. Each
tablet contains 40 mg telmisartan
and 5 mg amlodipine.
PRITOR/AMLODIPINE 40 mg/10 mg tablets are oval, biconvex shaped two
layer tablets, white to
off white on one side and blue on the other side. The white side is
debossed with Boehringer
Ingelheim company logo and ‘A2’. The blue side is plain. Each
tablet contains 40 mg telmisartan
and 10 mg amlodipine.
PRITOR/AMLODIPINE 80 mg/5 mg tablets are oval, biconvex shaped two
layer tablets, white to
off white on one side and blue on the other side. The white side is
debossed with Boehringer
Ingelheim company logo and ‘A3’. The blue side is plain. Each
tablet contains 80 mg telmisartan
and 5 mg amlodipine.
PRITOR/AMLODIPINE 80 mg/10 mg tablets are oval, biconvex shaped two
layer tablets, white to
off white