くすりのしおり

Internal
Published: 5/2016

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 :
HYDANTOL D COMBINATION TABLETS
 Active ingredient:
Phenytoin
Phenobarbital
Caffeine and sodium benzoate
 Dosage form:
white tablet, diameter: 9.1 mm, thickness: 3.8 mm
 Print on wrapping:
Hydantol D, ヒダントールD配合錠, ヒダントールD

Effects of this medicine

This medicine contains antiepileptic medicines phenytoin and phenobarbital as active ingredients, and combines caffeine and sodium benzoate, which relieve or prevent drowsiness. This medicine suppresses transmission of hyper-excitement of nerve and shows hypnotic, sedative and anticonvulsive effects.
It is usually used to treat convulsive seizures in epilepsy, autonomic seizures or psychomotor seizures.

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 acute intermittent porphyria, fragile health/decreased respiratory functions, aftereffects of trauma (head injury) or progressive arteriosclerosis, heart/liver/renal/pulmonary disorder, alcohol poisoning, neurosis, hypothyroidism, blood disorder, diabetes mellitus,or tendency to drug dependence or its medical history.
  • 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, take 6 to 12 tablets a day, in several divided doses. The dosage may be adjusted according to your disease, age/symptoms. Strictly follow the instructions.
  • If you miss a dose, take the missed dose when you remember. 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

  • The medicine may cause drowsiness; or decline of ability to pay attention, to concentrate or reflex movement. Avoid driving a car or operating dangerous machinery after taking the medicine.
  • Pay attention that alcohol (drinking) may intensify medicinal effects.
  • Avoid taking any food containing St. Johns wort with this medicine, since it may diminish medicinal effects.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include drowsiness, dizziness, double vision (seeing two images of a single object), shivering of limbs, generalized red rash, gum swelling and excessive hair growth. 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, bloodshot eyes, generalized skin redness and swelling of the skin with rash or blisters [toxic epidermal necrolysis, mucocutaneous ocular syndrome, erythroderma (exfoliative dermatitis)]
  • rash, fever, swelling in lymph nodes [hypersensitivity syndrome]
  • fever, red rash of the skin, muscle/joint pain [SLE (systemic lupus erythematosus)-like symptoms]
  • being unable to stop taking the medicine despite trying to stop it [dependence]
  • anemia, nose or gum bleeding, dizziness [aplastic anemia, blood disorder such as pancytopenia]
  • general malaise, nausea, yellow discoloration of the skin and the white of eyes [fulminant hepatitis, liver dysfunction, jaundice]
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 light and moisture. Store at room temperature (1 to 30 degrees Celsius).
  • Discard the remainder. Do not store them. Ask the pharmacist or medical institution on how to discard the remainder.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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