PROTOPIK ungv. 0.03%

Ingredients:

1 g Protopic 0,03% ointment contains 0,3 mg tacrolimus (tacrolimus) as tacrolimus monohydrate 0.03%. inactive ingredients: white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin.

Indications:

Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. Treatment of moderate to severe atopic dermatitis in children (2 and older) who do not respond adequately to conventional therapies such as topical corticosteroids.

Dosage and administration:

Therapy should be intermittent rather than continuous. Protopic ointment should be applied in a thin layer to the affected skin surface. Can be used on any part of the body including the face, neck and locations of the coils with the exception of mucous membranes. Protopic ointment should not be applied under occlusion! With Protopic to treat all skin areas affected by clearing, after which treatment was discontinued. Usually one week after initiation of treatment is an improvement. If after two weeks of treatment no signs of improvement should be given other treatment options. Protopic can be used for short-term or long-term treatment interruption. At the first sign of recurrence of disease symptoms (redness), treatment should be resumed.

Children (2 years and above 2 years): Treatment should be started twice daily for up to 3 weeks. Then the frequency of administration should be reduced to once daily until clearance of the lesion

Adults (16 years and above 16 years): Protopic is available in two strengths, Protopic 0,03% and Protopic 0,1% ointment. Treatment should be started with Protopic 0,1% twice daily and continued until clearance of the lesion. If symptoms recur, you need to restart treatment with Protopic 0,1% twice daily. You can attempt to reduce the frequency of application or to use the lower strength Protopic 0,03% ointment if clinical condition allows.

Contraindications:

Hypersensitivity to macrolides to tacrolimus or any of the excipients.

 Special warnings and precautions for use:

Protopic should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that causes immunosuppression.

Do not use in children under 2 years of age!

During the use of Protopic ointment skin exposure to sunlight should be minimized and should avoid the use of ultraviolet (UV) light from a solarium, therapy with UVB or UVA in combination with psoralens (PUVA).;

Protopic ointment should not be applied to lesions that are considered potentially malignant or pre-malignant.;

You should not apply emollients earlier than two hours of applying Protopic ointment.;

Concomitant use of other topical preparations has not been tested. (For more information prochetete full summary!)

Pregnancy and lactation:

Protopic ointment should not be used during pregnancy unless clearly necessary. Breast-feeding during treatment with Protopic ointment is not recommended.

Packing:

10 g, 30 g and 60 g ointment in the laminated tube with an inner layer of low density polyethylene with a white polypropylene screw cap. Not all pack sizes are marketed.