くすりのしおり

Internal
Revised: 12/2016

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 :
CYMBALTA Capsules 20mg [pain associated with each disease]
 Active ingredient:
Duloxetine hydrochloride
 Dosage form:
light reddish white/pale yellowish white and opaque capsule, length: 14.3 mm
 Print on wrapping:
(Face) サインバルタ 20mg, (Back) サインバルタ 20mg 031 20

Effects of this medicine

This medicine acts on inhibitory pathway of pain in central nervous system and inhibits the reuptake of serotonin and noradrenaline, thereby exhibiting analgesic effect.
It is usually used for the treatment of pain associated with diabetic neuropathy, fibromyalgia, chronic low back pain and osteoarthritis.

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 hepatic disorder, renal disorder, or narrow-angle glaucoma.
  • 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))
  • Pain associated with diabetic neuropathy: In general, for adults, start taking 20 mg of duloxetine once a day after breakfast. After taking 20 mg daily for one week or more, the dosage is increased to 40 mg daily. The dosage can be increased up to 60 mg daily, when this medicine exhibits an insufficient effectiveness after taking 40 mg daily for one week or more.
    Pain associated with fibromyalgia, chronic low back pain and osteoarthritis: In general, for adults, start taking 20 mg of duloxetine once a day after breakfast. After taking 20 mg daily for one week or more, the dosage is increased to 40 mg daily. Furthermore, after taking 40 mg daily for one week or more, the dosage is increased to 60 mg daily.
    This product contains 20 mg of duloxetine per capsule. Strictly follow the instructions.
  • If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose. 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. Sudden discontinuation of taking this medicine may cause adverse events.

Precautions while taking this medicine

  • Take extra care when driving a car or operating dangerous machinery, because this medicine may induce drowsiness, dizziness, etc. If you become aware of these symptoms, do not drive a car or operate dangerous machinery.
  • Alcohol may enhance the effects or the adverse reactions of this medicine.
  • Pay attention to the foods containing hypericum perforatum (St. John's wort), because they carry the risk of enhancing action of serotonin.
  • The following symptoms may appear: anxiety, irritability, impatience, excitability, panic attacks, insomnia, disturbance of mood or in the body by slight stimulations, hostility, aggression, impulsive behavior, restlessness, continued abnormally growing elation, etc. You may have symptoms such as suicidal ideation, suicide attempt. If any of these symptoms are observed, consult with your doctor.
  • In the elderly, pay attention to falls, because they may be caused by dizziness etc.
  • If you are breastfeeding, avoid breastfeeding while taking this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, somnolence, dry mouth, headache, constipation, diarrhea, dizziness, pain in abdomen, insomnia, malaise, loss of appetite, hyperglycemia, vomiting, weight gain, discomfort in abdomen, rash, itch, hives, contact dermatitis, light-sensitive reactions (exaggerated sunburn caused by sunlight, itch, pigmentation), angioedema and skin vasculitis. 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.
  • anxiety, irritability, sweating  [serotonin syndrome]
  • muscle stiffness, increased pulse, fever  [syndrome malin (neuroleptic malignant syndrome)]
  • increased body weight without edema over a short period, convulsion, disturbance of consciousness  [syndrome of inappropriate antidiuretic hormone secretion (SIADH)]
  • malaise, loss of appetite, yellowness in skin or in the white of eyes  [hepatic function disorder, hepatitis, jaundice]
  • high fever, blister, inflammation in mucous membrane of eyes, mouth, etc.  [mucocutaneous ocular syndrome]
  • dyspnea (breathing difficulty), convulsion, hives  [anaphylactic reaction]
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 the medicine out of the reach of infants and children. Store it at room temperature (1 to 30 degrees Celsius) away from direct sunlight and moisture.
  • Discard the remainder. Do not store them. For disposal methods, consult the pharmacy or the medical institution from which you have received the medicine.
  • [To family members] If patients show behavioral changes such as suicidal ideation and aggression, or depression or depressive states, keep in close contact with your doctor.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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