Active ingredient: 1 g ACNELYSE contains 250 mcg Retinoic acid (Tretinoin).

Excipient: Butylhydroxytoluene (E321), paraffin (vaseline flant), polysorbate 60, cetyl alcohol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol, sorbitan stearate (span 60), stearyl alcohol, purified water.

Before you start using this medicine, read this INSTRUCTIONS FOR USE carefully, because it contains important information for you.

ACNELYSE contains retinoic acid (tretinoin) as the active ingredient.

Retinoic acid (tretinoin), the active ingredient of ACNELYSE, stimulates the renewal of cells of the epidermis, the top layer of the skin, when applied to the skin, suppresses excessive keratin formation and stimulates the skin’s self-repair mechanisms.

Formulated in a special cream base that is easily accepted by the skin, ACNELYSE regulates blood circulation in the skin and strengthens the skin texture by tightening the pores. It also stimulates collagen production in the skin and tightens and thins the top layer of the skin.

ACNELYSE is presented in 20 gram aluminum tubes.

ACNELYSE is in light yellow, homogeneous cream form.

Instructions for proper use and dosage/frequency of administration

ACNELYSE is applied to the skin once a day at night, unless your doctor indicates otherwise.

There may be a temporary feeling of warmth and stinging on the skin upon application. If necessary, the dose that the patient can tolerate can be adjusted by interrupting the treatment or reducing the frequency of application.

There may be an increase in inflammatory lesions (inflammatory disorder/damage to the skin) during the first weeks of treatment. This is due to the effect of the drug on the lesions and does not require discontinuation of the drug when tolerated. However, if excessive irritation (redness, peeling or discomfort) occurs, the frequency of application should be reduced or treatment should be temporarily discontinued. Normal application frequency should be resumed once irritation subsides. If irritation persists, treatment should be discontinued.

Acne treatment results appear after 2-3 weeks, but more than 6 weeks may be required to see full benefit.

Like all medicines, ACNELYSE may have side effects in people who are sensitive to the ingredients it contains.

Side effects are classified as shown in the following categories:

If any of the following occur, stop using ACNELYSE and IMMEDIATELY inform your doctor or go to the emergency department of your nearest hospital.

These are all very serious side effects.

If you have one of these, it means you have a serious allergy to ACNELYSE. You may need emergency medical attention or hospitalization.