LECTEVA levodopa/carbidopa/entacapone 200 mg/50 mg/200 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levodopa, Quantity: 200 mg; carbidopa monohydrate, Quantity: 54.1 mg (Equivalent: carbidopa, Qty 50 mg); entacapone, Quantity: 200 mg

Available from:

Teva Pharma Australia Pty Ltd

INN (International Name):

carbidopa monohydrate,Entacapone,Levodopa

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; lactose; hyprolose; povidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; glycerol; iron oxide yellow; polysorbate 80; iron oxide red; iron oxide black

Administration route:

Oral

Units in package:

10, 28, 30, 50, 60, 90, 98, 100, 130, 150, 175, 200, 250

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Oblong, biconvex, brown tablet, marked with 200 on one side, plain on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-04-07

Patient Information leaflet

LECTEVA
®
_levodopa/carbidopa/entacapone_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Lecteva.
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.
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 LECTEVA IS USED
FOR
Lecteva 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.
This medicine 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.
Lecteva 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may

Summary of Product characteristics

Teva Pharma Australia Pty Limited Version 1.1
1
AUSTRALIAN PRODUCT INFORMATION – LECTEVA
(LEVODOPA/CARBIDOPA/ENTACAPONE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Levodopa/carbidopa/entacapone.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lecteva film-coated tablets are available in seven strengths, each
containing a 4:1 ratio of
levodopa to carbidopa anhydrous combined with 200 mg of entacapone in
an immediate release
formulation: 50/12.5/200 mg, 75/18.75/200 mg, 100/25/200 mg,
125/31.25/200 mg,
150/37.5/200 mg, 175/43.75/200 mg and 200/50/200 mg.
Lecteva contains carbidopa, equivalent to the stated amount of
carbidopa anhydrous present in
each strength combination.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
50/12.5/200 mg:
Round, biconvex, light brown tablet, marked with “50” on one side,
plain on
the other.
75/18.75/200 mg:
Oval, biconvex, light orange tablet, marked “75” on one side,
plain on the
other.
100/25/200 mg:
Oblong, biconvex, pale red tablet, marked with “100” on one side,
plain on
the other.
125/31.25/200 mg:
Round, biconvex, yellowish brown tablet, marked with “125” on one
side,
plain on the other.
150/37.5/200 mg:
Oval, biconvex, dark red tablet, marked with “150” on one side,
plain on the
other.
175/43.75/200 mg:
Ellipse, biconvex, pale brown tablet, marked with “175” on one
side, plain
on the other.
200/50/200 mg:
Oval, biconvex, brown tablet, marked with “200” on one side, plain
on the
other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Lecteva (Levodopa/carbidopa/entacapone) is indicated for the
management of patients with
Parkinson’s disease who are experiencing motor fluctuations.
Teva Pharma Australia Pty Limited Version 1.1
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
The optimum daily dosage of Lecteva must be determined by careful
titration in each patient. The
daily dose should preferably be optimised using one of the seven
available tablet strengths
(50/12.5/200 mg, 75/18.75/200 mg, 100/25/200 mg, 125/31