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STALEVO (LEVODOPA WITH CARBIDOPA AND ENTACAPONE) TABLETS: INFORMATION FOR PATIENTS

The patient should be instructed to take Stalevo (Levodopa, Carbidopa, Entacapone) tablets only as prescribed. The patient should be informed that Stalevo is a standard-release formulation of carbidopa-levodopa combined with entacapone that is designed to begin release of ingredients within 30 minutes after ingestion. It is important that Stalevo be taken at regular intervals according to the schedule outlined by the physician. The patient should be cautioned not to change the prescribed dosage regimen and not to add any additional antiparkinsonian medications, including other carbidopa-levodopa preparations, without first consulting the physician.

Patients should be advised that sometimes a "wearing-off" effect may occur at the end of the dosing interval. The physician should be notified for possible treatment adjustments if such response poses a problem to patient's everyday life.

Patients should be advised that occasionally, dark color (red, brown, or black) may appear in saliva, urine, or sweat after ingestion of Stalevo. Although the color appears to be clinically insignificant, garments may become discolored.

The patient should be advised that a change in diet to foods that are high in protein may delay the absorption of levodopa and may reduce the amount taken up in the circulation. Excessive acidity also delays stomach emptying, thus delaying the absorption of levodopa. Iron salts (such as in multi-vitamin tablets) may also reduce the amount of levodopa available to the body. The above factors may reduce the clinical effectiveness of the levodopa, carbidopa-levodopa and Stalevo therapy.

NOTE: The suggested advice to patients being treated with Stalevo is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

Patients should be informed that hallucinations can occur.

Patients should be advised that they may develop postural (orthostatic) hypotension with or without symptoms such as nausea, dizziness, syncope, and sweating. Hypotension may occur more frequently during initial therapy or when total daily levodopa dosage is increased. Accordingly, patients should be cautioned against rising rapidly after sitting or lying down, especially if they have been doing so for prolonged periods, and especially at the initiation of treatment with Stalevo.

Patients should be advised that they should neither drive a car nor operate other complex machinery until they have gained sufficient experience on Stalevo to gauge whether or not it affects their mental and/or motor performance adversely. Because of the possible additive sedative effects, caution should be used when patients are taking other CNS depressants in combination with Stalevo.

Patients should be informed that nausea may occur, especially at the initiation of treatment with Stalevo (Carbidopa, Levodopa and Entacapone).

Patients should be informed that diarrhea may occur with Stalevo and it may have a delayed onset. Sometimes prolonged diarrhea may be caused by colitis (inflammation of the large intestine). Patients with diarrhea should drink fluids to maintain adequate hydration and monitor for weight loss. If diarrhea associated with Stalevo is prolonged, discontinuing the drug is expected to lead to resolution, if diarrhea continues after stopping Stalevo, further diagnostic investigations may be needed.

Patients should be advised of the possibility of an increase in dyskinesia.

Carbidopa-levodopa combination and entacapone are known to affect embryo-fetal development in the rabbit and in the rat, respectively. Accordingly, patients should be advised to notify their physicians if they become pregnant or intend to become pregnant during therapy.

Carbidopa and entacapone are known to be excreted into maternal milk in rats. Because of the possibility that carbidopa, levodopa and entacapone may be excreted into human maternal milk, patients should be advised to notify their physicians if they intend to breast-feed or are breast-feeding an infant.

There have been reports of patients experiencing intense urges to gamble, increased sexual urges, and other intense urges and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone, that are generally used for the treatment of Parkinson's disease, including Stalevo. Although it is not proven that the medications caused these events, these urges were reported to have stopped in some cases when the dose was reduced or the medication was stopped. Prescribers should ask patients about the development of new or increased gambling urges, sexual urges or other urges while being treated with Stalevo. Patients should inform their physician if they experience new or increased gambling urges, increased sexual urges or other intense urges while taking Stalevo. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking Stalevo.

Manufactured and distributed by Novartis, Orion Corporation pharmaceutical companies and their divisions.

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