Xtandi Tablets 40mg

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:Xtandi Tablets 40 mg

Active ingredient:Enzalutamide

Dosage form:yellow tablet, diameter : approx. 10.1 mm, thickness : approx. 2.6 mm

Print on wrapping:(Face) イクスタンジ 40 mg, house-mark, (Back) イクスタンジ 40 mg,

house-mark

Effects of this medicine

This medicine inhibits binding of androgen (male hormone) against androgen receptors which exist in prostate tissues,

and consequently shows anti-tumor effects. It also exerts effectiveness by inhibiting multiple proliferative pathways

in prostate cancer cells.

It is usually used for the treatment of prostate cancer.

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

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

If you have: a history of convulsive disease such as epilepsy, a history of brain damage or stroke.

・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 4 tablets (160 mg of the active ingredient) at a time, once a day. Strictly follow the

instructions.

・If you miss a dose, take the missed dose as soon as possible. If you miss a dose for a whole day, skip the missed dose

and continue your regular dosing schedule from the following day. 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

・In rare cases, this medicine may cause convulsive seizure. Pay attention when you drive a car, or operate dangerous

machinery.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include hypertension, constipation, fatigue, appetite decreased,

weight loss, nausea, hot flush, and asthenia. 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.

・dizziness, tremor, muscle spasm [convulsive seizure]

・nasal bleeding, bleeding from gums, subcutaneous bleeding [thrombopenia]

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.

・Capsules may become soft in high temperature/humidity environments.

・Discard the remainder. Do not store them. Consult with your dispensing pharmacy or medical institution how to

discard.

For healthcare professional use only