COMTAN entacapone 200mg tablet bottle

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

entacapone, Quantity: 200 mg

Inapatikana kutoka:

Sandoz Pty Ltd

Dawa fomu:

Tablet, film coated

Tungo:

Excipient Ingredients: sucrose; mannitol; glycerol; iron oxide yellow; hypromellose; microcrystalline cellulose; magnesium stearate; croscarmellose sodium; polysorbate 80; iron oxide red; hydrogenated vegetable oil; titanium dioxide

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

60 Tablets, 100 Tablets, 30 Tablets

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

COMTAN is indicated in the management of Parkinson's disease as an adjunct to levodopa/dopa decarboxylase inhibitor therapy in patients who are experiencing motor fluctuations (see CLINICAL TRIALS).

Bidhaa muhtasari:

Visual Identification: Brownish-orange film-coated tablets, length 17.2-17.5mm, breadth 8-8.2mm, marked with the word "COMTAN".; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Idhini hali ya:

Licence status A

Idhini ya tarehe:

1999-05-12

Taarifa za kipeperushi

COMTAN®
1
COMTAN
®
_entacapone _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Comtan.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP-TO-DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP-TO-
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT COMTAN IS USED
FOR
Comtan is used to treat the symptoms
of Parkinson's disease in people who
are already taking a medicine called
levodopa. When levodopa on its own
does not control the symptoms,
Comtan can be added.
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.
Comtan is always used together with
levodopa. Levodopa works by
increasing the level of dopamine in
the brain and Comtan works by
making the effect of levodopa last
longer. Together, Comtan and
levodopa help 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your d

Tabia za bidhaa

220705-comtan-pi
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION
COMTAN
® (ENTACAPONE) TABLET
1.
NAME OF THE MEDICINE
Entacapone.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg entacapone.
Patients with rare hereditary problems of fructose intolerance,
glucose-galactose malabsorption
or sucrase-isomaltase insufficiency should not take this medicine.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Comtan is a brownish-orange film-coated tablets, length 17.2-17.5mm,
breadth 8-8.2mm,
marked with the word "COMTAN”.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Comtan is indicated in the management of Parkinson's disease as an
adjunct to levodopa/dopa
decarboxylase inhibitor therapy in patients who are experiencing motor
fluctuations (see
Section 5.1 Pharmacodynamic properties – Clinical Trials)
_._
4.2.
D
OSE AND METHOD OF ADMINISTRATION
Comtan is used in combination with levodopa preparations, either
levodopa/carbidopa or
levodopa/benserazide. It can be used with both standard and
sustained-release preparations of
levodopa. Other antiparkinsonian drugs may be used simultaneously.
Entacapone
enhances the effects of levodopa.
Hence, to reduce levodopa-related dopaminergic
adverse reactions (e.g. dyskinesias, nausea, vomiting and
hallucinations) it is often
necessary
to adjust levodopa dosage within the first few days to first few weeks
after initiating treatment
with Comtan. The daily dose of levodopa should be reduced by about 10
to 30% by extending
the dosing intervals and/or by reducing the amount of levodopa per
dose.
Entacapone increases the bioavailability of levodopa from standard
levodopa/benserazide
preparations slightly more (5 – 10%) than from standard
levodopa/carbidopa preparations.
Hence, patients who are taking standard levodopa/benserazide
preparations may need a larger
reduction in their levodopa dose when Comtan is initiated.
If
Comtan
treatment
is
discontinued,
it
is
necessary
to
adjust
the
dosing
of
other
antiparkinsoni