Kyowa Kirin "Nouriast" tabs 20 mg x30/x100

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.

Brand name:NOURIAST Tablets 20mg

Active ingredient:Istradefylline

Dosage form:yellowish brown tablet, diameter 7.1 mm, thickness 3.3 mm

Print on wrapping:KH131 ノウリアスト 20mg

Effects of this medicine

This medicine weakens the action of adenosine, a neurotransmitter in the brain, and consequently improves "wearing-off" phenomenon (a state of the onset of parkinsonian symptoms) caused by the decreased effects of other concomitant antiparkinsonian medicines resulting from their long-term use.

It is usually used to improve wearing-off phenomenon in patients with Parkinson’s disease on the treatment with levodopa-containing products.

Before using this medicine, be sure to tell your doctor and pharmacist

・If you have previously experienced any allergic reaction (itch, rash etc.) to any medicines.

If you are a patient with hepatic disorder.

・If you are pregnant, possibly pregnant, or breastfeeding.

・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

・Your dosing schedule prescribed by your doctor is<<            to be written by a healthcare professional>>

・In general, for adults, take 1 tablet (20mg of the active ingredient) at a time, once a day, in conjunction with levodopa-containing products. Depending on your symptoms, the dose may be increased up to 2 tablets (40mg) at a time. Strictly follow the instructions.

・If you missed a dose, take a dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and follow your regular dosing schedule. You should never take two doses at one time.

・If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.

・Do not stop taking this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

・This medicine may cause sudden onset of sleep and somnolence (falling into a half-doze) without any signs, orthostatic hypotension (dizziness on standing up), dizziness, loss of consciousness, and syncope. Avoid engaging in dangerous activities, such as driving a car, operating machinery, or working at heights.

・If shortness of breath, breathlessness, or dry cough without phlegm occurs, consult with your doctor or pharmacist.

・Note that smoking may weaken the action of the medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include dyskinesia (involuntary movement), constipation, visual hallucination or hallucination (seeing things or hearing sound that do/dose not actually exist), somnolence, nausea, and weight decreased. If any of these symptoms occur, consult with your doctor or pharmacist.

The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.

・seeing things or hearing sound that do/does not actually exist, groundless belief in something untrue [visual hallucination, hallucination, auditory hallucination, somatic hallucination, delusion, persecutory delusion]

・disturbed consciousness [delirium]

・vague sense of fear [anxiety disorder]

・having no energy, being depressed, loss of sleep [aggravation of depression/depression]

・elation, excitement, being overexcited [mania, agitation]

・uncontrollable craving/desire [impulse-control disorder]

The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

・Keep out of the reach of children. Store away from direct sunlight, heat and moisture.

・Discard the remainder. Do not store them.