Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
levodopa, Quantity: 100 mg; carbidopa monohydrate, Quantity: 27 mg (Equivalent: carbidopa, Qty 25 mg); entacapone, Quantity: 200 mg
Teva Pharma Australia Pty Ltd
carbidopa monohydrate,Entacapone,Levodopa
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; lactose; hyprolose; povidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; glycerol; polysorbate 80; allura red AC aluminium lake; carmine
Oral
10, 28, 30, 50, 60, 90, 98, 100, 130, 150, 175, 200, 250
(S4) Prescription Only Medicine
LECTEVA (Levodopa/carbidopa/entacapone) is indicated for the management of patients with Parkinson?s disease who are experiencing motor fluctuations.
Visual Identification: Oblong, biconvex, pale red tablet, marked with 100 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
Licence status A
2016-04-07
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 Прочитајте комплетан документ
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 Прочитајте комплетан документ