くすりのしおり

Internal
Revised: 5/2018

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 :
Concerta Tablets 18mg
 Active ingredient:
Methylphenidate hydrochloride
 Dosage form:
yellow tablet, diameter 5.3 mm, length 12 mm
 Print on wrapping:
(Face)コンサータ18mg, alza18, (Back)concerta18mg, コンサータ18mg

Effects of this medicine

This medicine increases neurotransmitters (dopamine, noradrenaline) that transmit information between nerve cells in the brain and activates nerve function to raise the concentration level or improve symptoms such as impulsiveness and restlessness.
It is usually used to treat Attention Deficit/Hyperactivity Disorder (AD/HD).

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 undue anxiety/stress/excitability, glaucoma, hyperthyroidism, tachyarrhythmia, angina pectoris, motor tic, Tourette's syndrome (including past history and family history), depression or pheochromocytoma.
    If you have epilepsy (including past history), hypertension, cardiac failure, myocardial infarction, cerebrovascular disorder, psychiatric disorder (schizophrenia, psychotic disorder, bipolar disorder), history of drug dependence/alcohol abuse, cardiac structural abnormality or gastrointestinal obstruction.
  • 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))
  • For patients under 18 years old: In general, initially take 18 mg of the active ingredient once a day in the morning. For maintenance dose, take 18 to 45 mg at a time once a day in the morning. The dosage may be increased by 9 mg or 18 mg per day with more than one week interval. The dosage should be adjusted according to the symptoms, but it will not exceed 54 mg per day.
    For patients 18 years and older: In general, initially take 18 mg of the active ingredient once a day in the morning. The dosage may be increased by 9 mg or 18 mg per day with more than one week interval. The dosage should be adjusted according to the symptoms, but it will not exceed 72 mg per day.
    This medicine contains 18 mg of the active ingredient per tablet. In principle, avoid taking this medicine in the afternoon in both cases. Strictly follow the instructions.
  • Since this medicine is a sustained-release preparation, do not crack, crunch or dissolve the tablet. Take with water.
  • If you miss a dose, take the missed dose as soon as possible. However, in principle, avoid taking this medicine in the afternoon. 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

  • Regular blood tests may be required when using over a long period.
  • The medicine may cause dizziness, drowsiness, visual disturbance, etc. Avoid driving a car or operating machinery.
  • The outer shell of the medicine will be excreted with stool. This is normal, and there is no need to be concerned.
  • Avoid food and beverages including alcohol if possible, as the adverse effects of the medicine may be strengthened.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include decreased appetite, insomnia, weight loss, headache, abdominal pain, nausea, tic, fever, sleep disorder, palpitation, and thirst. 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.
  • fever, wide area of flushed skin, intense itching [exfoliative dermatitis]
  • cold sweat, pressurized feeling/constricted feeling/pain in the chest [angina pectoris]
  • intense muscle stiffness, fever, difficulty in swallowing [neuroleptic malignant syndrome]
  • paralysis of the arm and leg on one side, impaired speech, temporary conscious disorder  [cerebrovascular disorder (vasculitis, cerebral infarction, cerebral hemorrhage, stroke)]
  • loss of appetite, general malaise, vomit, jaundice [liver failure, liver dysfunction]
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. You should never give away this medicine to other people.
  • Do not store the remainder but return it to the pharmacy where you received it or to the medical institution where it was prescribed.
  • When bringing this medicine into or from Japan, a copy of prescription or doctor's certificate may be required depending on the amount. Please consult your doctor or pharmacist for details.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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