Protopic ointment is indicated for the treatment of atopic dermatitis in children from 2 years of age - Protopic ointment 0.03%, in adults and adolescents aged 16 years - Protopic ointment 0.03% and 0.1%.
Active substance: tacrolimus;
1 g of ointment contains tacrolimus (as monohydrate) 0.3 mg or 1 mg;
Excipients: white soft paraffin, mineral oil, propylene carbonate, white wax, paraffin.
Hypersensitivity to tacrolimus, macrolides or excipients.
Protopic ointment must be applied in a thin layer to the affected or those areas of the skin that are most often affected. The ointment can be applied to any part of the body (face, neck, etc.), including flexion surfaces. It is necessary to avoid getting the ointment on the mucous membranes. The ointment should be applied under occlusive dressings as this application has not been investigated.
Pregnant
Should not be applied.
Children
Applied to children aged 2 years and older.
Drivers
Does not affect.
When applied topically, overdose is unlikely.
If ingested, it is necessary to take generally accepted measures, including control of vital body functions and monitoring of the general condition. Stimulation of vomiting or gastric lavage is not recommended due to the characteristics of excipients, contains ointment.
During clinical studies, approximately 50% of patients experienced an adverse reaction in the form of skin irritation at the site of application of the ointment. Burning and itching sensations often occurred, usually of mild to moderate intensity, which mostly disappeared after the first week of treatment. Erythema was a common adverse reaction. Feeling of warmth, pain, paresthesias and rashes were also often observed. Alcohol intolerance (redness of the face or skin irritation after drinking alcoholic beverages) was common.
No formal interaction studies have been conducted with topical tacrolimus ointment.
Store at a temperature not exceeding 25 ° С out of reach of children.
Do not use after the expiration date printed on the package.
The shelf life is 3 years.