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

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

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

Tillgänglig från:

Boehringer Ingelheim Pty Ltd

INN (International namn):

amlodipine besilate,Telmisartan

Läkemedelsform:

Tablet, multilayer

Sammansättning:

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

Administreringssätt:

Oral

Enheter i paketet:

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

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

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

Produktsammanfattning:

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

Bemyndigande status:

Registered

Tillstånd datum:

2011-02-18

Bipacksedel

TWYNSTA
®
_TABLETS_
_telmisartan/amlodipine besilate_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Twynsta.
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 TWYNSTA IS USED
FOR
Twynsta 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 TWYNSTA WORKS_
Twynsta 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,
thus increasing blood pressure.
Telmisartan works by blocking
the e

Produktens egenskaper

TWYNSTA PI0134-11
1
AUSTRALIAN PRODUCT INFORMATION – TWYNSTA
® (TELMISARTAN/AMLODIPINE) TABLET
1 NAME OF THE MEDICINE
telmisartan and amlodipine (as besilate)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
TWYNSTA 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:
•
TWYNSTA 40/5 mg containing telmisartan 40 mg/amlodipine 5 mg
•
TWYNSTA 40/10 mg containing telmisartan 40 mg/amlodipine 10 mg
•
TWYNSTA 80/5 mg containing telmisartan 80 mg/amlodipine 5 mg
•
TWYNSTA 80/10 mg containing telmisartan 80 mg/amlodipine 10 mg
Excipients with known effect:
•
Each TWYNSTA 40/5 mg and 40/10 mg tablet contains 168.64 mg of
sorbitol
•
Each TWYNSTA 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
TWYNSTA 40/5 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.
TWYNSTA 40/10 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.
TWYNSTA 80/5 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.
TWYNSTA 80/10 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 ‘A4’. The blue side is plain. Each tablet