くすりのしおり

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Revised: 5/2014

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 :
RECTOS Enema Ointment 50mg
 Active ingredient:
Diclofenac sodium
 Dosage form:
white to slightly yellow enema ointment, (cap) opaque orange/(body) opaque white
 Print on wrapping:

Effects of this medicine

This medicine shows anti-inflammatory effects by suppressing prostaglandin synthesis which causes inflammation to ease swelling/pain caused by inflammation and bring down fever.
It is usually used to reduce pain and inflammation caused by rheumatoid arthritis, osteoarthritis, low back pain, afterbirth pain and after surgery. It is also used to bring down fever emergently caused by acute upper respiratory tract inflammation if other antipyretics can not be expected to be affective or can not be administered.

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 peptic ulcer, blood abnormality, liver/renal disorder, hypertension, cardiac dysfunction, proctitis, rectal bleeding, hemorrhoid or influenza encephalitis/encephalopathy.
    If you have aspirin-induced asthma or a history of it.
  • If you are pregnant, possibly 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, instill 25 to 50 mg of the active ingredient at a time into the rectum, 1 to 2 times a day. The dosage may be adjusted to lower amount according to disease, age and symptoms of the patient. As it may cause shock caused by hypothermia, elderly patients will start with a lower dosage. This preparation contains 50 mg of the active ingredient per enema. Strictly follow the instructions.
  • Use only to instill into the rectum. Use after defecation as much as possible. Instill carefully so as not to damage the anal area.
  • Read the instruction, <レクトス注腸軟膏の使い方(Use of RECTOS Enema Ointment> before use. (This instruction is written only in Japanese).
  • If you miss a dose, use a dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and follow your regular dosing schedule. You should never use two doses at one time.
  • If you accidentally use more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop using this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • This medicine may cause sleepiness, diziness and blurred vision. Avoid operating in potentially hazardous activities such as driving a car.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea/vomiting, abdominal pain, diarrhea, loose stool, irritation of rectal mucosa and edema. 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.
  • cold sweat, respiratory distress, hives [shock, anaphylaxis]
  • pain/tenderness in the pit of the stomach, heartburn, shock due to hemorrhage (pale face, etc.) [peptic ulcer accompanied with hemorrhagic shock or intestinal perforation]
  • blue spot, fatigability, high fever [aplastic anemia, hemolytic anemia, agranulocytosis, thrombocytopenia]
  • high fever, bloodshot eyes, red rash (whole body) [toxic epidermal necrolysis, mucocutaneous-ocular syndrome, erythroderma]
  • decreased urine output, edema of limbs and face, general malaise [acute renal failure, nephrotic syndrome]
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. Ask the pharmacist or medical facility how to discard unneeded medicine.
  • Discard the enema container with the cap on.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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