くすりのしおり

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Revised: 5/2017

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 :
WAKOBITAL SUPPOSITORIES 15
 Active ingredient:
Phenobarbital sodium
 Dosage form:
white to pale yellowish white spindle-shaped suppository, length: approximately 22.7 mm
 Print on wrapping:
15mg, ワコビタール, TAKATA

Effects of this medicine

This medicine exerts suppressive action on central nerve to show sedative/hypnotic/antiepileptic actions.
It is usually used for hypnogenesis when taking medicine is difficult, sedation of anxiety/tension and improvement of febrile convulsion and convulsive seizure of epilepsy in children.

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.
  • 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 children, insert 4 to 7 mg of the active ingredient per kilogram of body weight per day into the rectum. The dosage should be adjusted according to the symptoms and purpose. This preparation contains 15 mg of the active ingredient in a piece. Strictly follow the instructions.
  • If you are instructed to use this medicine persistently and miss a dose, use the missed 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 use two doses at one time.
  • If you accidentally use more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop using this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • Pay attention to the child's condition while using this medicine since it may cause drowsiness or decrease in attention/concentration/reflex movement.
  • Avoid taking hypericum perforatum (Saint John's wort)-contained supplements, etc. since it may weaken the effects of the medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include loose stool, pain in anal area, urinary incontinence, rash, jaundice, drowsiness, lightheadedness and diarrhea. 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, erythema (red rash), bloodshot eyes [toxic epidermal necrolysis, oculomucocutaneous syndrome, erythroderma (exfoliative dermatitis)]
  • rash, fever, swelling of lymph nodes [hypersensitivity syndrome]
  • unable to stop taking this medicine despite trying to stop [dependence]
  • sore throat, nose bleeding, gum bleeding [granulocytopenia, thrombopenia]
  • general malaise, loss of appetite, yellowing of the skin and the white of eyes [hepatic 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 it in the refrigerator away from direct sunlight and moisture.
  • Discard the remainder. Do not store them. Ask the pharmacist and the medical institution how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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