Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
levodopa, Quantity: 200 mg; carbidopa monohydrate, Quantity: 54 mg (Equivalent: carbidopa, Qty 50 mg); entacapone, Quantity: 200 mg
Medis Pharma Pty Ltd
carbidopa monohydrate,Entacapone,Levodopa
Tablet, film coated
Excipient Ingredients: powdered cellulose; microcrystalline cellulose; sodium sulfate; carmellose sodium; magnesium stearate; hyprolose; trehalose dihydrate; titanium dioxide; purified talc; iron oxide yellow; 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
Licence status A
2013-10-03
CARLEVENT CMI V1 131004 1 Carlevent _contains the active ingredient levodopa/carbidopa/entacapone _ CONSUMER MEDICINE INFORMATION What is in this leaflet This leaflet answers some common questions about CARLEVENT. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking CARLEVENT against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. What CARLEVENT is used for CARLEVENT 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. CARLEVENT 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. CARLEVENT 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. Your doctor may have prescribed CARLEVENT for another reason. Ask your doctor if you have any questions about why CARLEVENT has been prescribed for you. CARLEVENT is not recommended for use in children under the age of 18, as there have been no studies of its effects in children of this age group. CARLEVENT is available only with a doctor's prescription. There is no evidence that CARLEVENT is addictive. Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION – CARLEVENT (LEVODOPA/ CARBIDOPA/ ENTACAPONE) TABLET 1 NAME OF THE MEDICINE Levodopa, carbidopa and entacapone. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CARLEVENT tablets come in six strengths each containing a 4:1 ratio of levodopa to carbidopa combined with entacapone 200 mg in an immediate release formulation. Containing levodopa, carbidopa, 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 _CARLEVENT 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. _CARLEVENT 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. _CARLEVENT 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. _CARLEVENT 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. _CARLEVENT 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. _CARLEVENT 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. 2 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS CARLEVENT 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 CARLEVENT tablet is to be taken orally either with or without food (see Section 5. Read the complete document