TACROLIM 0.03%

INSTRUCTIONS FOR USE:

Dosage

Flare Treatment: Tacrolimus may be used short-term or intermittently long-term but should not be used continuously for prolonged periods.

Adults and adolescents (≥ 16 years): Initiate treatment with tacrolimus 0.1% twice daily until lesions are cleared. If symptoms recur, restart treatment with tacrolimus 0.1% twice daily. Reduce application frequency or switch to TACROLIM 0.03% if clinical condition allows.

Children (≥ 2 years): Use tacrolimus 0.03%. Start treatment twice daily for 3 weeks, then reduce to once daily until lesions are clear.

Maintenance Treatment: Suitable for patients who responded to 6 weeks of twice-daily tacrolimus treatment.

Adults and adolescents (≥ 16 years): Use TACROLIM 0.1% ointment once daily, twice a week (e.g., Monday and Thursday). Reevaluate after 12 months. If flares recur, restart twice-daily treatment.

Children (≥ 2 years): Use TACROLIM 0.03% once daily, twice a week (e.g., Monday and Thursday). Reevaluate after 12 months, considering treatment discontinuation.

Administration

Apply a thin layer to affected areas, including face, neck, and folds, but avoid mucous membranes. Do not occlude treated areas.

CONTRAINDICATIONS

Hypersensitivity to tacrolimus, macrolides, or any excipients.

WARNINGS AND PRECAUTIONS

Minimize sun exposure and avoid UV light during treatment.

Evaluate any new skin changes on treated areas.

Avoid use in patients with compromised skin barriers or in conditions like Netherton syndrome, ichthyosis, erythroderma, or GVHD due to increased systemic absorption.

Monitor long-term use, especially in children.

Potential increased risk of lymphomas and skin malignancies with long-term systemic use of calcineurin inhibitors.

Ensure skin infections are treated prior to use.

Do not apply moisturizers within 2 hours of tacrolimus.

Avoid eye and mucous membrane contact. Rinse thoroughly if contact occurs.

Caution in patients with liver impairment due to extensive hepatic metabolism of tacrolimus.

PREGNANCY AND LACTATION

Use during pregnancy only if necessary due to potential risks.

Breastfeeding is not recommended due to excretion of tacrolimus in breast milk.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

TACROLIM 0.03% has no or negligible effect on the ability to drive and use machines.

SHELF LIFE

36 months from the manufacturing date. Use within 6 months after first opening.

STORAGE CONDITIONS

Store in a dry place below 30°C, protected from light.

Aluminum tube in a cardboard box containing 1 tube x 10 g with an instruction leaflet.