CARLEVENT levodopa/carbidopa/entacapone 75/18.75/200 mg tablet bottle

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

levodopa, Quantity: 75 mg; carbidopa monohydrate, Quantity: 20.25 mg (Equivalent: carbidopa, Qty 18.75 mg); entacapone, Quantity: 200 mg

Tillgänglig från:

Medis Pharma Pty Ltd

INN (International namn):

carbidopa monohydrate,Entacapone,Levodopa

Läkemedelsform:

Tablet, film coated

Sammansättning:

Excipient Ingredients: sodium sulfate; hyprolose; carmellose sodium; microcrystalline cellulose; magnesium stearate; trehalose dihydrate; powdered cellulose; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; lecithin

Administreringssätt:

Oral

Enheter i paketet:

100 tablets

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

levodopa/carbidopa/entacapone is indicated for the management of patients with Parkinson?s disease who are experiencing motor fluctuations.

Produktsammanfattning:

Visual Identification: Red, oval, biconvex coated tablet with '75' on one side and 'LEC'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

Bemyndigande status:

Licence status A

Tillstånd datum:

2013-10-03

Bipacksedel

CARLEVENT CMI V1 131004
1
Carlevent
_contains the active ingredient levodopa/carbidopa/entacapone _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about CARLEVENT.
It does not contain all of 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 CARLEVENT
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your
medicine. You may need to read it
again.
What CARLEVENT is used
for
CARLEVENT is used to treat the
symptoms of Parkinson’s disease.
Parkinson's disease is a disorder of
the nervous system. It is caused by
a lack of dopamine, a natural
substance that is produced in the
brain.
Dopamine relays messages in the
part of the brain that controls
muscle movement. When too little
dopamine is produced, problems
with movement result.
CARLEVENT contains three active
ingredients: levodopa, carbidopa
and entacapone. Levodopa is a
chemical closely related to
dopamine, which allows the body
to make its own dopamine.
Levodopa works by increasing the
level of dopamine in the brain.
Carbidopa makes sure that enough
levodopa gets to the brain where it
is needed, and entacapone makes
the effect of levodopa last longer.
CARLEVENT helps to relieve
symptoms such as shaking of the
limbs, stiffness and slowness of
movement, which make it difficult
to perform normal daily activities.
Other medicines can also be added
to help treat this condition.
Your doctor may have prescribed
CARLEVENT for another reason. Ask
your doctor if you have any
questions about why CARLEVENT
has been prescribed for you.
CARLEVENT is not recommended
for use in children under the age of
18, as there have been no studies
of its effects in children of this age
group.
CARLEVENT is available only with a
doctor's prescription.
There is no evidence that
CARLEVENT is addictive.

Produktens egenskaper

1
AUSTRALIAN
PRODUCT
INFORMATION
–
CARLEVENT
(LEVODOPA/
CARBIDOPA/ ENTACAPONE) TABLET
1
NAME OF THE MEDICINE
Levodopa, carbidopa and entacapone.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CARLEVENT tablets come in six strengths each containing a 4:1 ratio of
levodopa to carbidopa
combined with entacapone 200 mg in an immediate release formulation.
Containing levodopa, carbidopa, entacapone, the strengths are
50/12.5/200 mg, 75/18.75/200 mg,
100/25/200 mg, 125/31.25/200 mg, 150/37.5/200 mg and 200/50/200 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
_CARLEVENT 50/12.5/200_
Levodopa/Carbidopa/Entacapone
50
mg/12.5
mg/200
mg
film-
coated tablet; Red, oval, biconvex coated tablet with ‘50’ on one
side
and ‘LEC’ on the other side.
_CARLEVENT 75/18.75/200_
Levodopa/Carbidopa/Entacapone
75
mg/18.75
mg/200
mg
film-
coated tablet; Red, oval, biconvex coated tablet with ‘75’ on one
side
and ‘LEC’ on the other side.
_CARLEVENT 100/25/200_
Levodopa/Carbidopa/Entacapone 100 mg/25 mg/200 mg film-coated
tablet; Red, oval, biconvex coated tablet with ‘100’ on one side
and
‘LEC’ on the other side.
_CARLEVENT 125/31.25/200_
Levodopa/Carbidopa/Entacapone 125 mg/31.25 mg/200 mg film-
coated tablet; Red, oval, biconvex coated tablet with ‘125’ on one
side and ‘LEC’ on the other side.
_CARLEVENT 150/37.5/200_
Levodopa/Carbidopa/Entacapone
150
mg/37.5
mg/200
mg
film-
coated tablet; Red, oval, biconvex coated tablet with ‘150’ on one
side and ‘LEC’ on the other side.
_CARLEVENT 200/50/200_
Levodopa/Carbidopa/Entacapone 200 mg/50 mg/200 mg film-coated
tablet; Red, oval, biconvex coated tablet with ‘200’ on one side
and
‘LEC’ on the other side.
2
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
CARLEVENT
is
indicated
for
the
management
of
patients
with
Parkinson’s
disease
who
are
experiencing motor fluctuations.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Each
CARLEVENT
tablet
is
to
be
taken
orally
either
with
or
without
food
(see
Section
5.