Fatima Gel 2.5%

Acne vulgaris (common acne)

Adjust the dose according to the treatment response and the patient's tolerance.

Wash the affected area clean and apply this medicine, usually 1–2 times a day, patting it on lightly.

At the start of treatment, apply it once a day (before bedtime); check how the patient adapts, and if the patient adapts well, increase to twice a day (morning and evening).

1. Do not administer to the following patients.

1) Patients with inflammation

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

2. Administer with caution to the following sites.

1) Dry or oily atopic skin (in this case, choose a preparation with a low concentration and a suitable base)

2) Eroded skin

3) This medicine contains propylene glycol; administer it with caution to patients who are hypersensitive to this ingredient or have a history of allergy.

3. Side effects

1) Contact dermatitis, allergic contact dermatitis and severe erythema that leaves scars may occur.

2) This medicine may bleach hair and colored fabrics.

3) Severe or persistent irritation may occur; if such symptoms occur, stop administration and consult a doctor or pharmacist.

4) Sensitivity to sunlight may increase.

5) Temporary facial edema, dermatitis and skin rash may occur.

6) A mild burning sensation after the first use, and redness or peeling a few days after the start of treatment, may occur.

7) Sudden dryness and peeling of the skin may appear after 1–2 weeks; this peeling is a normal part of the treatment process and decreases within 1–2 days if treatment is stopped temporarily.

4. General precautions

1) To minimize irritation, note the following.

① Do not apply it to skin that has already become irritated during prior treatment.

② Do not use it together with other therapeutic topical keratolytics or cleansers.

③ Use a mild facial cleanser (face washing: at most twice a day), and do not use cosmetics containing perfume or alcohol.

④ At the beginning of and during treatment, it is advisable to avoid exposure to sunlight and to use a sunscreen preparation.

⑤ Do not use UV lamps.

⑥ Take particular care in people with fair skin and on areas where the skin is delicate.

2) Mild irritation may occur, especially at the beginning of treatment. If it remains minor, it does not mean skin intolerance or allergy. This can be checked before treatment by testing the patient's sensitivity with a "test application" (applying it repeatedly to a small area of skin for 10–15 consecutive days).

3) If irritation occurs, lengthen the interval between applications or use a lower concentration; if the irritation is excessive, stop using it and give other appropriate treatment.

5. Interactions

Do not use it together with other topical acne medicines (including acne medicines containing vitamin A derivatives).

6. Use in pregnant and breastfeeding women

1) The safety of this medicine in pregnant women has not been established; administer it with caution only if the therapeutic benefit is judged to outweigh the risk, and do not apply it in the last month of pregnancy in particular.

2) It is not known whether this medicine passes into breast milk; apply it with caution only if the therapeutic benefit is judged to outweigh the risk.

7. Use in children

Safety and efficacy in children have not been established.

8. Treatment of overdose

1) If severe scaling, erythema or edema appears, stop using it.

2) Cold compresses may be applied to relieve the side effects quickly. If the reaction is judged to be related to overdose rather than allergic in nature, it may be tried again carefully at a reduced dose after the symptoms and signs have disappeared.

9. Precautions for application

1) This medicine is for external use only.

2) Apply it taking care not to let it come into contact with the eyes, nose, mouth or other mucous membranes. If it gets into the eyes, rinse them thoroughly with plenty of water. If irritation persists, consult a doctor or pharmacist.

3) Do not apply it to wounds or pre-existing skin lesions.

10. Storage precautions

Keep out of the reach of children.