くすりのしおり

Internal
Published: 8/2015

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 :
Azulfidine EN Tablets 500mg
 Active ingredient:
Salazosulfapyridine
 Dosage form:
yellow to yellowish brown tablet, major axis: 18.0mm, minor axis: 9.5mm
 Print on wrapping:
(face) nothing mentioned, (back) アザルフィジンEN, 500mg, KPh 102, Azulfidine EN

Effects of this medicine

This medicine eases inflammation of rheumatoid arthritis by helping abnormal immunity return to normal. It may take 1 to 2 months until the effect of the medicine is obtained.
It is usually used to treat rheumatoid arthritis.

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: blood/liver/kidney disorder or bronchial asthma.
  • 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 tablet (500 mg of the active ingredient) at a time, twice a day (after breakfast and dinner). Strictly follow the instructions.
    If you are an elderly patient, you should especially follow your doctor's instructions.
  • This medicine is designed to dissolve in the intestine, so you must swallow it without chewing or cracking.
  • If you miss a 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 or change the dosage unless your doctor instructs you to do so.

Precautions while taking this medicine

  • This medicine may cause the skin, nails or body fluid (urine, sweat, etc.) to become yellow to yellowish red, or may turn soft contact lenses yellow. If you notice a change in color of them, consult with your doctor.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include rash, nausea/vomiting, stomachache, stomach discomfort, itch, urinary stone (backache), proteinuria/hematuria (cloudy or red urine), glycosuria (dry mouth, increased urine output), photosensitivity, flush face (red face) and hives. 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.
  • erythema, dyspnoea, light headedness [shock, anaphylaxis]
  • fever, sore throat, bleeding tendency [blood disorder such as agranulocytosis, thrombocytopenia]
  • fever, cough, dyspnoea [lung disorder such as interstitial pneumonitis, drug-induced pneumonia]
  • decreased urine output, swelling [kidney disorder such as acute renal failure, nephrotic syndrome]
  • loss of appetite, malaise, yellowing of the skin or eyes [liver disorder such as fulminant hepatitis, hepatitis]
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.

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