くすりのしおり

External
Revised: 3/2018

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 :
Rozex Gel 0.75%
 Active ingredient:
Metronidazole
 Dosage form:
colorless to faint yellow, viscous and homogenous gel
 Print on wrapping:

Effects of this medicine

This medicine demonstrates antibacterial action against several species of Gram-negative and Gram-positive anaerobic bacteria that produce malodorous substances (putrescine, cadaverine) in the cutaneous ulcer sites.
It is usually used for sterilization of cancerous skin ulcer and improvement of its associated smell.

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: a blood disorder, an organic disorder in the brain or spinal cord.
  • 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, apply an appropriate amount according to the symptoms and lesion size: after cleaning up the area, put the medicine on gauze, etc., and apply to the affected area, or apply the medicine directly to the affected area, and cover with gauze, etc., once or twice a day as needed. Strictly follow the instructions.
  • If the applied area is extensive, systemic adverse drug reactions such as peripheral nerve disorders (motor paralysis, sensory paralysis, numbness in hands and feet, and pain in hands and feet), central nervous system disorders (headache, phonation difficulty, tremor of hands and feet, decreased mental concentration, and amnesia/loss of memory ability), decreased white blood cell, and decreased neutrophil (fever and sore throat) may develop. If you feel some abnormalities, consult with your doctor or pharmacist.
  • Pay close attention when replacing gauze, etc. as irritation of the affected areas may cause bleeding at ulceration sites.
  • If irritative symptoms occur, reduce frequency of the application, temporarily stop the application, or seek medical advice.
  • Do not lick or drink this medicine.
  • If you miss a dose, apply as soon as possible.
  • If you accidentally applied more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop applying this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • Avoid drinking alcohol while using this medicine, because some cases show psychological symptom, colicky abdominal pain, vomiting or flushing.
  • Avoid UV exposure (sunbathing or sunlamps, etc.) while using this medicine. UV exposure may decrease efficacy.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include bleeding from ulcer sites. 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.
No pertinent entries.
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

  • Handle this medicine sanitarily. Keep out of reach of infants and children. Store at room temperature (1 to 30 degrees Celsius) away from direct sunlight and moisture. This medicine may turn yellowish brown by long time storage.
  • Do not freeze.
  • Discard any unused leftover amount. Do not keep it.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.