くすりのしおり

Internal
Revised: 3/2015

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 :
Olopatadine Hydrochloride OD Film 5mg "MARUHO"
 Active ingredient:
Olopatadine hydrochloride
 Dosage form:
bluish white film (orally disintegrating film), maximum length: 20 mm, minimum length: 14 mm, thickness: 80 to 100μm
 Print on wrapping:
オロパタジン塩酸塩ODフィルム5mg「マルホ」,5mg

Effects of this medicine

This medicine suppresses production and release of allergic substances (histamine, etc.) in the body. It also resolves and relieves allergic symptoms in the skin and the nose by inhibiting activities of these allergic substances.
It is usually used in the treatment of allergic rhinitis, hives, and itch associated with skin diseases.

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 renal disorder or hepatic disorder.
  • 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 1 film (5 mg of the active ingredient) at a time, twice a day: one time in the morning and one time before bedtime. The dosage may be adjusted according to the disease, age or symptoms. For children 7 years old or above, take 1 film (5 mg of the active ingredient) at a time, twice a day: one time in the morning and one time before bedtime. Strictly follow the instructions.
  • This medicine melts when placed on the tongue, so it can be taken without water. It will not be absorbed from the oral mucosa so be sure to swallow the film with saliva when taken without water. However, do not take it without water when you are lying down.
  • If you miss a morning dose and notice it until noon, take a dose as soon as possible. However, if you notice it late in the day, 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 sleepiness. Avoid driving a car or operating dangerous machinery.
  • If you take the medicine for treatment of pollinosis, you need to take the medicine until the pollen season ends.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include hypersensitivity (rash, edema, itch, respiratory distress), sleepiness, malaise and dry mouth. 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.
  • general malaise, loss of appetite, nausea, yellowing in skin and white of eyes [fulminant hepatitis, 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.