TRIDOPA levodopa/carbidopa/entacapone 150/37.5/200 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

carbidopa monohydrate, Quantity: 40.5 mg (Equivalent: carbidopa, Qty 37.5 mg); entacapone, Quantity: 200 mg; levodopa, Quantity: 150 mg

Available from:

Stada Pharmaceuticals Australia Pty Ltd

INN (International Name):

carbidopa monohydrate,Entacapone,Levodopa

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Red, oval, biconvex coated tablet with '150' 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

Authorization status:

Registered

Authorization date:

2013-10-04

Patient Information leaflet

TRIDOPA
TM
1
TRIDOPA
TM
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 TRIDOPA?
TRIDOPA contains the active ingredients levodopa, carbidopa and
entacapone. TRIDOPA is used to treat the symptoms of
Parkinson’s disease.
For more information, see Section 1. Why am I using TRIDOPA? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE TRIDOPA?
Do not take if you have ever had an allergic reaction to TRIDOPA 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 take
TRIDOPA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TRIDOPA 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 TAKE TRIDOPA?
•
People with moderate to severe Parkinson’s disease usually take from
3 to 7 tablets of TRIDOPA each day.
•
TAKE ONLY ONE TRIDOPA TABLET AT EACH DOSE. Swallow the tablets whole
with a full glass of water.
More instructions can be found in Section 4. How do I take TRIDOPA? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING TRIDOPA?
THINGS YOU
SHOULD DO
•
Tell your doctor straight away if you become pregnant.
•
Remind any doctor, surgeon, dentist or pharmacist you visit that you
are using TRIDOPA.
•
Visit your doctor regularly so they can check on your progress.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine without talking to your doctor.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how TRIDOPA affects you.
LOOKING AFTER
YOUR MEDICINE
•
Store below 25°C.
For more information, see Section 5. What should I know while taking
TRIDOPA? in the full CMI.
6.
ARE THERE

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – TRIDOPA (LEVODOPA/
CARBIDOPA/ ENTACAPONE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Levodopa, carbidopa and entacapone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRIDOPA tablets come in six strengths each containing a 4:1 ratio of
levodopa to carbidopa
anhydrous combined with entacapone 200 mg in an immediate release
formulation. Containing
levodopa, carbidopa anhydrous, 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
TRIDOPA 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.
TRIDOPA 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.
TRIDOPA 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.
TRIDOPA 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.
TRIDOPA 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.
TRIDOPA 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.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
TRIDOPA 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 TRIDOPA tablet is to be taken orally either with or without food
(see _sect