Երկիր: Ավստրալիա
Լեզու: անգլերեն
Աղբյուրը: Department of Health (Therapeutic Goods Administration)
entacapone, Quantity: 200 mg; levodopa, Quantity: 200 mg; carbidopa monohydrate, Quantity: 54 mg (Equivalent: carbidopa, Qty 50 mg)
Stada Pharmaceuticals Australia Pty Ltd
carbidopa monohydrate,Entacapone,Levodopa
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; powdered cellulose; trehalose dihydrate; hyprolose; carmellose sodium; sodium sulfate; magnesium stearate; titanium dioxide; iron oxide yellow; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; lecithin
Oral
100 tablets
(S4) Prescription Only Medicine
levodopa/carbidopa/entacapone is indicated for the management of patients with Parkinson?s disease who are experiencing motor fluctuations.
Visual Identification: Red, oval, biconvex coated tablet with '200' 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
Registered
2013-10-04
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 Կարդացեք ամբողջական փաստաթուղթը
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 Կարդացեք ամբողջական փաստաթուղթը