L.C.E. SANDOZ 200/50/200 levodopa 200 mg, carbidopa (as carbidopa monohydrate) 50 mg and entacapone 200 mg film-coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Sandoz Pty Ltd

INN (International Name):

carbidopa monohydrate,Entacapone,Levodopa

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: mannitol; titanium dioxide; sucrose; magnesium stearate; croscarmellose sodium; glycerol; povidone; iron oxide red; maize starch; hypromellose; polysorbate 80

Administration route:

Oral

Units in package:

10 tablets, 100 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

L.C.E. SANDOZ 200/50/200 is indicated for the management of patients with Parkinson's disease who are experiencing motor fluctuations.

Product summary:

Visual Identification: dark brownish red oval tablets marked with 'LCE200' on one side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-11-14

Patient Information leaflet

L.C.E. SANDOZ®
1
L.C.E. SANDOZ®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING L.C.E. SANDOZ?
L.C.E. SANDOZ contains the active ingredient levodopa, carbidopa
monohydrate and entacapone. L.C.E. SANDOZ is used to
treat the symptoms of Parkinson’s disease.
For more information, see Section 1. Why am I using L.C.E. SANDOZ?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE L.C.E. SANDOZ?
Do not use L.C.E. SANDOZ if you have ever had an allergic reaction to
levodopa, carbidopa or entacapone or any of the
ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I use L.C.E. SANDOZ?
in the
full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with L.C.E. SANDOZ and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE L.C.E. SANDOZ?
•
People with moderate to severe Parkinson’s disease usually take from
3 to 7 tablets of L.C.E. SANDOZ each day.
•
TAKE ONLY ONE L.C.E. SANDOZ TABLET AT EACH DOSE.
•
Do not take 2 or more L.C.E. SANDOZ tablets at any one time. Do not
break the tablets into halves. More instructions can
be found in Section 4. How do I use L.C.E. SANDOZ?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING L.C.E. SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
L.C.E. SANDOZ.
•
If you become pregnant, tell your doctor immediately. You should not
take this medicine while you are
pregnant.
•
Visit your doctor regularly so they can check on your progress.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine or reducing the dose suddenly without
talking to your doctor.
DRIVING OR USING
MACHINES

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
L.C.E. SANDOZ (LEVODOPA/CARBIDOPA
MONOHYDRATE/ENTACAPONE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Levodopa/carbidopa monohydrate/entacapone.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
L.C.E. SANDOZ film-coated tablets are available in six strengths, each
containing a 4:1 ratio of
levodopa to carbidopa monohydrate combined with 200 mg of entacapone
in a standard 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 and 200/50/200 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
L.C.E. SANDOZ 50 mg/12.5 mg/200 are round, biconvex tablets marked
with ‘LCE 50’ on one side.
L.C.E. SANDOZ 75/18.75/200 are oval tablets marked with ‘LCE 75’
on one side.
L.C.E. SANDOZ 100/25/200 are oval tablets marked with ‘LCE 100’ on
one side.
L.C.E. SANDOZ 125/31.25/200 are oval tablets marked with ‘LCE 125’
on one side.
L.C.E. SANDOZ 150/37.5/200 are elongated-ellipse shaped tablets marked
with ‘LCE 150’ on one
side.
L.C.E. SANDOZ 200/50/200 are oval tablets marked with ‘LCE 200’ on
one side.
L.C.E. SANDOZ strengths 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200
mg are brownish- _or_
greyish-red, film-coated tablets. L.C.E. SANDOZ strength 200/50/200 mg
is a dark brownish-red film-
coated tablet. L.C.E. SANDOZ strengths 75/18.75/200 mg and
125/31.25/200 mg are light brownish
red, film-coated tablets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
L.C.E. SANDOZ is indicated for the management of patients with
Parkinson’s disease who are
experiencing motor fluctuations.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The optimum daily dosage of L.C.E. SANDOZ must be determined by
careful titration in each patient.
The daily dose should preferably be optimised using one of the six
available tablet strengths
(50/12.5/200 mg, 75/18.75/200 mg, 100/25/200 mg, 125/31.25/200 mg,
150/37.5/200 mg, or
200/50/200 mg levodopa/carbidopa monohydrate/entacapone).
2
Patients should be instructed to ta