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 :
SERTRALINE Tablets 25mg "SANWA"
 Active ingredient:
Sertraline hydrochloride
 Dosage form:
white to yellowish white tablet, major axis: approx. 8.4 mm, minor axis: approx. 4.1 mm, thickness: approx. 2.6 mm
 Print on wrapping:
セルトラリン錠25mg「三和」, セルトラリン, 25mg, SERTRALINE 25 "SANWA", セルトラリン25mg「三和」

Effects of this medicine

This medicine has the effects such as antidepressant or antipanic disorder by selectively inhibiting the reuptake of serotonin in the brain to increase continuous nerve transmission with increased serotonin level at the synaptic cleft.
It is usually used for the treatmnt of depression/depressed state, panic disorder and post-traumatic stress disorder.

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))
  • In general, for adults, start with 1 tablet (25 mg of sertraline) at a time, once a day and gradually increase the dosage up to 4 tablets (100 mg) at a time, once a day. The dosage may be adjusted up to 4 tablets (100 mg) daily according to the diseases, age or symptoms. Strictly follow the instructions.
  • If you miss a dose, take a dose as soon as possible. If it is almost time for 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

  • This medicine may cause drowsiness/dizziness. Pay close attention when you operate dangerous machinery such as driving a car.
  • Alcohol may intensify medicinal and medical effects of this medicine. Avoid drinking alcohol while taking this medicine.
  • Pay attention that taking any food containing St. John's wort (a kind of herb) with the medicine may enhance serotonin action.
  • This medicine may cause worsening symptoms of the disease, suicidal thoughts/suicide attempt and harming others, but these causal relationships are unknown. If any of these signs occur, consult with your doctor/pharmacist without stopping your medication. Family members should receive information about the following risks from your doctor: change in patient's behavior such as suicide, tendency to excite, acting aggressive and change in mental or physical condition due to slight irritation, and worsening of the underlying disease such as depression. After fully understanding these risks, family members should observe whether your conditions have changed or not. If family members noticed any of these conditions, contact the doctor. In addition, if you yourself notice any of them, inform your family members.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, somnolence, dry mouth, headache, diarrhea and dizziness. 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, excitation, hands/feet tremor [serotonin syndrome]
  • muscle stiffness, sweating, acute fever [neuroleptic malignant syndrome]
  • muscle spasmodically contracting, complete loss of consciousness [convulsion, coma]
  • general malaise, nausea, yellowing of the skin and the conjunctiva [liver dysfunction]
  • general malaise, decreased consciousness, convulsion [syndrome of inappropriate antidiuretic hormone secretion]
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.
  • Do not store the remainder and consult your pharmacy or medical institution how to discard it.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.