Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
levodopa, Quantity: 50 mg; carbidopa monohydrate, Quantity: 13.5 mg (Equivalent: carbidopa, Qty 12.5 mg); entacapone, Quantity: 200 mg
Sandoz Pty Ltd
carbidopa monohydrate,Entacapone,Levodopa
Tablet, film coated
Excipient Ingredients: hypromellose; mannitol; titanium dioxide; magnesium stearate; povidone; maize starch; sucrose; iron oxide red; glycerol; iron oxide yellow; polysorbate 80; croscarmellose sodium
Oral
30 tablets, 250 tablets, 100 tablets, 10 Tablets
(S4) Prescription Only Medicine
L.C.E. SANDOZ 50/12.5/200 is indicated for the management of patients with Parkinson's disease who are experiencing motor fluctuations.
Visual Identification: Brownish- or greyish-red, round, biconvex tablets marked with 'LCE 50' on one side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2013-11-14
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 Lue koko asiakirja
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 Lue koko asiakirja