Protopic ointment (tacrolimus 0.03% and 0.1%) – not marketed in Serbia: information and alternatives

Protopic is an ointment for use on the skin containing tacrolimus, an immunomodulating medicine from the group of topical calcineurin inhibitors (ATC D11AH01). It contains no corticosteroids. It is available in two strengths: 0.03% (0.3 mg/g) and 0.1% (1 mg/g).

In the European Union, according to the official product information of the European Medicines Agency (EMA), Protopic is used to treat moderate to severe atopic dermatitis (eczema) when topical corticosteroids have not worked well enough or are not tolerated, and for maintenance treatment in frequent flares. All information on this page comes from the official documents listed in the sources.

What is Protopic ointment, what is it used for and which authorised alternatives exist in Serbia?

Key facts about the medicine

What is Protopic used for in the EU?

According to the Summary of Product Characteristics (EMA):

• Protopic 0.1% – adults and adolescents aged 16 and over with moderate to severe atopic dermatitis who have not responded adequately to, or are intolerant of, topical corticosteroids.
• Protopic 0.03% – the same indication in adults and adolescents aged 16 and over, and in children aged 2 years and over who have not responded adequately to conventional therapy. In children aged 2 to 16 years only the 0.03% strength is used.
• Maintenance treatment – in patients with 4 or more flares per year who responded to up to 6 weeks of treatment, to prevent new flares.
• The medicine is not used in children under 2 years.

How is it used?

The ointment is applied as a thin layer to affected skin. The official documents describe application twice daily until the lesions clear, and for maintenance once daily twice a week (for example Monday and Thursday), with a review by the doctor after 12 months. The treated area is not covered with a dressing.

This describes the official product information and is not an individual recommendation – the strength, frequency and duration of use are decided by the doctor according to the official instructions.

Important safety information from the official documents

• Contraindication: hypersensitivity to tacrolimus, to macrolide antibiotics in general (e.g. azithromycin, clarithromycin, erythromycin) or to the excipients.
• Sun exposure and solaria should be avoided; it is not used together with UVB or PUVA therapy.
• It is not applied to skin with an active infection or to lesions suspected to be malignant or pre-malignant.
• It is not recommended in skin barrier defects (e.g. Netherton syndrome, generalised erythroderma) or in weakened immunity.
• Enlarged lymph nodes at the start of or during treatment should be assessed by a doctor.
• Emollients should not be applied to the same area within 2 hours before or after the ointment.
• Avoid contact with the eyes and mucous membranes.
• The most common side effects are burning and itching at the application site; local skin infections (e.g. herpes, folliculitis) and facial flushing or a feeling of warmth after drinking alcohol are also common.
• Pregnancy: do not use unless clearly necessary; breastfeeding is not recommended during treatment.

What is available in Serbia?

Replacement of a medicine is always decided by the doctor. Even when the active substance is the same, the doctor decides on the strength, frequency of application and duration of treatment.

Related information

• Atopic dermatitis – treatment and the best creams
• Tips for proper sun protection

For additional care and support with eczema and dermatitis, see also the Eczema and Psoriasis – Care for Dry, Irritated and Atopic Skin category – products in this category do not replace the medicine you have been prescribed.

Composition, packaging and manufacturer

• Active substance: tacrolimus (as monohydrate), 0.3 mg or 1 mg per 1 g of ointment.
• Marketing authorisation holder in the EU: LEO Pharma A/S, Industriparken 55, Ballerup, Denmark.
• Packs in the EU: tubes of 10 g, 30 g and 60 g.
• Authorised alternative in Serbia (Talim): excipients propylene carbonate, hard paraffin, white beeswax, liquid paraffin and white soft paraffin; marketing authorisation holder and manufacturer Galenika a.d. Belgrade.

Storage

• Protopic (EMA): do not store above 25 °C.
• Talim (ALIMS): store below 30 °C in the original package.
• Keep out of the sight and reach of children.

Frequently asked questions

Can Protopic be bought in Serbia?

No. Protopic has no marketing authorisation in Serbia and is not listed in the National Register of Medicines, so it cannot be obtained in Serbian pharmacies.

Is Talim the same as Protopic?

Talim ointment contains the same active substance (tacrolimus) in the same strengths, 0.03% and 0.1%, and has the same main indication – moderate to severe atopic dermatitis. It is a different manufacturer and a different medicine, dispensed on prescription, and the doctor decides on switching and the strength.

Is Elidel a replacement for Protopic?

Not fully. Elidel cream contains pimecrolimus, a related substance from the same group, but it is intended for mild to moderate eczema. The doctor assesses whether Elidel is a suitable option.

Can I drink alcohol or go in the sun while using Protopic?

Alcohol during treatment commonly causes flushing of the face or skin and a feeling of warmth. Sun exposure and solaria should be avoided, and the skin protected with clothing and a high-SPF cream.

Sources

• EMA – Protopic: Summary of Product Characteristics and package leaflet
• EMA – Protopic EPAR
• ALIMS – Patient leaflet, Talim® 0.3 mg/g ointment (August 2023, Serbian)
• ALIMS – Patient leaflet, Talim® 1 mg/g ointment (August 2023, Serbian)
• ALIMS – New authorisations and renewals 1 July – 31 August 2023 (Talim, Serbian)
• ALIMS – Patient leaflet, Elidel® cream (May 2020, Serbian)
• ALIMS – National Register of Medicines 2021 (Serbian)

Sources checked on: 23 October 2026.