くすりのしおり

Internal
Revised: 1/2014

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 :
Inovelon Tablets 200 mg
 Active ingredient:
Rufinamide
 Dosage form:
pale red tablet with split line, major axis: about 15.2mm, minor axis: about 6.2 mm, thickness: about 4.5 mm
 Print on wrapping:
(Face) イノベロン200mg
(Back) イノベロン, 200mg, Inovelon, E262

Effects of this medicine

This medicine suppresses epilepsy seizures by acting on central nervous system.
It is usually used for the treatment of tonic and atonic seizures associated with Lennox-Gastaut syndrome.

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 have congenital short QT syndrome..
  • If you are 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 and children four years of age or older with a body weight of 30.1 kg or greater, take 400 mg of the active ingredient per day divided in two doses after meals for the first two days. Then, the daily dose should be gradually increased by increments of 400 mg or less every other day. As a maintenance dose, take 1,800 mg per day for patients with a body weight of 30.1 to 50.0 kg, 2,400 mg per day for patients with a body weight of 50.1 to 70 kg, or 3,200 mg per day for patients with a body weight of 70.1 kg or greater, divided in 2 doses after meal. The dosage may be adjusted up to maintenance dose provided that increases are achieved by increments of 400 mg per day or less and no more frequently than every other day.
    In general, for children four years of age or older with a body weight of 15.0 to 30.0 kg, take 200 mg of the active ingredient per day divided in two doses after meals for the first two days. Then, the daily dose should be gradually increased by increments of 200 mg or less every other day. As a maintenance dose, take 1,000 mg per day divided in two doses after meal. The dosage may be adjusted up to maintenance dose provided that total dosage not exceed 1,000 mg per day, and that increases are achieved by increments of 200 mg per day or less and no more frequently than every other day. Strictly follow the instructions.
  • If you miss a dose and your next regularly scheduled dose is more than 6 hours away, take a dose as soon as possible when. However, if your next regularly scheduled dose is less than 6 hours away, 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

  • The medicine may cause drowsiness and decreased attention/concentration/reflex action ability, etc. Avoid driving a car or operating dangerous machinery during the treatment.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include somnolence, loss of appetite, vomiting, constipation, and rash. 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.
  • rash, fever, swelling of lymph nodes [hypersensitivity syndrome]
  • fever, eye redness, erythema  [Stevens-Johnson syndrome]
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.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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