くすりのしおり

Internal
Revised: 11/2016

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 :
Zaditen Dry Syrup 0.1%
 Active ingredient:
Ketotifen fumarate
 Dosage form:
white dry syrup
 Print on wrapping:
ザジテンドライシロップ

Effects of this medicine

This medicine shows anti-anaphylactic/antihistaminic effect and suppresses the action of histamine and inflammatory materials, which cause allergy. It consequently relieves the hypersensitivity of tissues such as airway or nasal membrane.
It is usually used to treat bronchial asthma, allergic rhinitis, dermatitis, hives, etc. It is not effective for immediately relieving an asthma attack which has already developed.

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: convulsive diseases such as epilepsy or its 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 children, take 0.03 g (0.03 mg of ketotifen) per kg of body weight [0.6 g (0.6 mg) for 20 kg of body weight], at a time, twice a day after breakfast and before bedtime. The dosage should be adjusted according to the age or symptoms.
    Age-based normal daily dose are: 0.8 g (0.8 mg) for 6 months to less than 3 years old, 1.2 g (1.2 mg) for 3 to less than 7 years old and 2.0 g (2.0 mg) for 7 years old or more. Strictly follow the instructions.
  • If you miss a dose, take a dose as soon as possible. However, if it is 5 hours or less before the next dose, skip the missed dose and continue 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. Avoid operating dangerous machinery, etc.
  • Avoid taking food or beverage containing alcohol as possible, since it may intensify drowsiness.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include drowsiness, rash, hives, edema, cystitis-like symptoms (frequent urination, pain in urination, hematuria, etc.) and transient loss of consciousness. 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.
  • convulsion (muscle spasmodically contracting) [convulsion]
  • loss of concentration, uneasiness, sleeplessness [excitement]
  • loss of appetite, general malaise, yellowness in skin or conjunctiva [hepatic 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 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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