Madecassol Care Ointment

Initial treatment of skin conditions secondarily infected by neomycin-susceptible bacteria: small lacerations, abrasions, sutured wounds, superficial burns of second degree or less

Apply an appropriate amount to the affected area 1–2 times a day. Do not exceed the recommended dose.

1. The following persons should not take (use) this medicine.

1) Patients with hypersensitivity to this medicine or its ingredients, or a history thereof

2) Persons with a previous history of hypersensitivity to aminoglycoside antibiotics such as streptomycin, kanamycin, gentamicin and neomycin, or to bacitracin

3) Patients with wounds on or around the eyes

4) Patients with wounds on the breast area (there is a risk of it passing to the infant during breastfeeding)

2. Do not do the following while using this medicine.

1) Avoid prolonged continuous use, as renal impairment, hearing loss, etc. may occur.

3. The following persons should consult a doctor, dentist or pharmacist before taking (using) this medicine.

1) Pregnant and breastfeeding women (the safety of administration during pregnancy has not been established; therefore, in pregnant women or women who may be pregnant, avoid use in large amounts or over wide areas for long periods, and administer it only if the therapeutic benefit is judged to outweigh the risk.)

4. In the following cases, stop taking (using) this medicine immediately and consult a doctor, dentist or pharmacist. When consulting, bring this package insert with you if possible.

1) Microbial substitution (superinfection): in rare cases, infections by bacteria not susceptible to this medicine may occur; in such cases, stop using it.

2) Sensitization may occur, so observe carefully and stop using it if signs of sensitization (itching, reddening from congestion, swelling, papules, blisters, etc.) appear. The risk of sensitization may increase particularly with prolonged continuous use of 8 days or more, so do not use it continuously for long periods. Sensitization may be harmful if antibiotics of the same class are later given systemically.

5. Other precautions when taking (using) this medicine

1) Follow the prescribed dosage and administration carefully.

2) When it is used in children, use it under the guidance and supervision of a parent or guardian.

3) Stop using it if the symptoms do not improve or get worse.

4) Once the symptoms improve, stop using it as soon as possible.

5) When symptoms of infection caused by streptococci appear, systemic antibiotic therapy is required.

6) Prolonged continuous use carries a risk of the emergence of resistant bacteria.

7) Do not use it in the eyes. If it gets into the eyes, rinse immediately with water. If the symptoms are severe, get treatment from an ophthalmologist.

8) Do not use it for purposes other than treatment, such as after applying makeup or shaving.

6. Storage precautions

1) Keep out of the reach of children.

2) Taking the medicine out of its original container and storing it in another container may cause accidents through misuse or reduce its quality, so keep it in its original container, tightly closed.