くすりのしおり

Internal
Revised: 6/2018

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 :
Salazopyrin Tablets 500mg
 Active ingredient:
Salazosulfapyridine
 Dosage form:
yellow-yellowish brown tablet with split line, diameter: 17.7 × 7.5 mm, thickness: 5.7 mm
 Print on wrapping:
サラゾピリン500mg, Salazopyrin500mg, Pfizer, KPh101

Effects of this medicine

This medicine is a sulfonamide medicine and has effect for inflammatory bowel disease by being resolved by intestinal bacteria and absorbed in the large intestine.
It is usually used to treat ulcerative colitis, regional enteritis or non-specific colitis.

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 disorder, liver disorder, renal disorder, bronchial asthma, acute intermittent porphyria, or glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • 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 4 to 8 tablets (2 to 4 g of the active ingredient) a day in 4 to 6 divided doses. Start with 16 tablets (8 g) a day according to your symptoms and gradually decrease the dosage from 3 weeks after the start of your medication to 3 to 4 tablets (1.5 to 2 g) a day. If you are receiving steroid therapy for a long period, take 4 tablets (2 g) and decrease the dose of steroid gradually. Strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as possible. If it is almost time for the next 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

  • The skin, nail, urine/sweat, etc. may change yellowish to yellowish-red color, or soft contact lens may change color. These changes do not represent change of pathology or side effect.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include urinary stone, swelling, edema, bloody urine, rash, itch, photosensitivity, serum sickness, erythema, facial hot flash 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.
  • symptoms of anemia (dizziness on standing up, headache, etc.), fever, bleeding tendency (subcutaneous bleeding, nose bleeding, etc.) [aplastic anemia, etc.]
  • high fever, reddened skin, stomatitis [toxic epidermal necrolysis, mucocutaneous-ocular syndrome, erythroderma drug eruption]
  • fever, cough/phlegm, respiratory distress  [interstitial pneumonia, drug-induced pneumonia, PIE syndrome, fibrosing alveolitis]
  • decreased urine output, edema in the limbs/face, malaise [acute renal failure, nephrotic syndrome, interstitial nephritis]
  • rash, dropping blood pressure, respiratory distress [shock, anaphylaxis]
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 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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