くすりのしおり

Internal
Revised: 3/2016

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 :
AMITRIPTYLINE HYDROCHLORIDE Tablets 10mg "SAWAI"
 Active ingredient:
Amitriptyline hydrochloride
 Dosage form:
pale blue tablet, diameter: 6.1 mm, thickness: 3.7 mm
 Print on wrapping:
アミトリプチリン 塩酸塩10mg「サワイ」,SW-027,Amitriptyline Hydrochloride 10mg「SAWAI」

Effects of this medicine

This medicine relieves depressive mood by suppressing reuptake of neurotransmitters (noradrenaline, serotonin) in the brain. This medicine also increases the bladder capacity and prevents urinary incontinence by suppressing action of a substance (acetylcholine) which causes bladder to contract. It also relieves pain.
It is usually used to treat depression/depressive state in psychiatric patients, bedwetting and peripheral neuropathic pain.

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 in early recovery period of myocardial infarction.
    If you have glaucoma or urinary retention (prostate disease, etc.).
  • 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 depression/depressive state: In general, for adults, start taking 30 to 75 mg of the active ingredient a day and the dosage may be gradually increased up to 150 mg a day. Take the dosage in divided doses. On rare occasions, the dosage may be increased up to 300 mg a day. The dosage may be decreased according to the age or symptoms.
    For bedwetting: In general, take 10 to 30 mg of the active ingredient at a time, once a day before bedtime. The dosage may be decreased according to the age or symptoms.
    For peripheral neuropathic pain: In general, for adults, start taking 10 mg of the active ingredient a day. The dosage may be adjusted according to the age or symptoms, but the maximum daily dose should not exceed 150 mg.
    This medicine contains 10 mg of the active ingredient in a tablet. Strictly follow the instructions.
  • For depression/depressive state or peripheral neuropathic pain: If you miss a dose, take the missed dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and follow your next dosing schedule. You should never take two doses at one time.
    For bedwetting: If you miss a dose, skip the missed dose and follow 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

  • This medicine may cause drowsiness and decreased attention/concentration/reflex movement. Avoid operating dangerous machinery, such as driving a car.
  • Drinking alcohol may intensify medicinal effects. Refrain from drinking alcohol while taking this medicine.
  • Refrain from taking any food containing St. John's wort, since it may diminish medicinal effects.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include drowsiness, rash, hives 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.
  • remaining motionless, muscle stiffness, difficulty swallowing [malignant syndrome]
  • anxiety, excitement, fever, shivering of limbs, diarrhea [serotonin syndrome]
  • acute precordial pressure, chest pain, cold sweat [myocardial infarction]
  • facial edema, swelling inside the mouth [edema of face/tongue]
  • loss of appetite, nausea/vomiting, constipation, abdominal bloating/atony [paralytic ileus]
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 light, 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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