Drug Information Sheet("Kusuri-no-Shiori")
Internal
Published: 04/2017
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approvaldetails 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:MONTELUKAST TABLETS 5mg "CEO"Active ingredient:Montelukast Sodium
Dosage form:bright grayish yellow tablet, major axis: 7.5 mm, minor axis: 5.5 mm,thickness: 2.9 mm
Print on wrapping:(face) モンテルカスト錠 5mg「CEO」, モンテルカスト, 5mg (back)
MONTELUKAST5mg「CEO」, モンテルカスト, 5mg, CEO145
Effects of this medicine
This medicine suppresses bronchoconstriction by inhibiting the action of leukotriene. It prevents episode of bronchialasthma such as cough, wheezing and breathing difficulty. In addition, it controls nasal ventilation resistance etc. andimproves symptoms of allergic rhinitis such as nasal congestion, nasal discharge and sneezing.
It is usually used to treat bronchial asthma and allergic rhinitis. In asthma, it is effective for preventing an asthma
attack, not for stopping an asthma attack that has already developed. Use other medicine to stop an asthma attack.
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 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 bronchial asthma: In general, for adult, take 2 tablets (10 mg of montelukast) at a time, once a day before
bedtime.
For allergic rhinitis: In general, for adult, take 1 to 2 tablets (5 to 10 mg of montelukast) at a time, once a day before
bedtime.
In any case, strictly follow the instructions.
・If you miss a dose, take a dose as soon as you remember. However, if it is almost time for the next dose, skip themissed dose and continue the regular dosing schedule. You should not 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
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include diarrhea, abdominal pain, nausea, heartburn, headache, liverdysfunction, dry mouth, somnolence, stomach discomfort, malaise, rash and itch. 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 indicatedin brackets. If any of these symptoms occur, stop taking this medicine and see your doctor
immediately.
・cold sweat, facial pallor, respiratory distress [anaphylaxis]
・breathing difficulty, swelling of face/tongue/pharynx [angioedema]・loss of appetite, general malaise, yellowing of the skin and conjunctiva [fulminant hepatitis, hepatitis, hepaticdysfunction, jaundice]・fever, bloodshot eyes, skin/mucosal rash/erythema/blister [toxic epidermal necrolysis, mucocutaneous ocularsyndrome, erythema multiforme]
・nasal/gum bleeding, subcutaneous bleeding in limbs [decreased platelets]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with yourdoctor 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 light, heat and moisture.
・Discard the remainder. Do not store them.
For healthcare professional use only//

For further information, talk to your doctor or pharmacist.

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