Acnelyse Cream 20 g Retinoic Acid

1. What is ACNELYSE and what is it used for?

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

Retinoic acid (tretinoin), the active ingredient of ACNELYSE, when applied to the skin, stimulates the regeneration of cells of the epidermis, the top layer of 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 the blood circulation in the skin and strengthens the skin texture by tightening the pores. It also stimulates the production of collagen in the skin and compresses and thins the top layer of the skin.

• ACNELYSE is supplied in 20 gram aluminum tubes.

• ACNELYSE is in the form of a light yellow, homogeneous cream.

• Thanks to these features, ACNELYSE is used in the treatment of acne vulgaris, which manifests itself as various skin lesions.

2. How to use ACNELYSE?

ACNELYSE is applied to the skin once a day at night.

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

During the first weeks of treatment, there may be an increase in inflammatory lesions (skin disorders). The reason for this is the effect of the drug on the lesions (disorders in the skin) 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 the treatment should be interrupted temporarily. Normal application frequency should be restarted after the irritation has passed. If irritation persists, treatment should be discontinued.

Treatment results appear after 2-3 weeks, but more than 6 weeks may be required for full benefit.

After the lesions (in skin disorders) begin to improve, the drug can be used less frequently.
Application route and method

ACNELYSE should be applied in a thin layer to the washed and thoroughly dried problematic skin area and gently massaged with fingertips.

Hands should be washed before and after applying ACNELYSE.

Patients using ACNELYSE may use cosmetics; however, the skin should be thoroughly cleaned before treatment.
different age groups

Use in children
Use in the elderly

In children and adolescents over 12 years of age, the adult dose is administered.
Use in the elderly:

In the use of individuals aged 65 and over, the same dose is applied to adults.

3. What are the possible side effects?

Like all medicines, there may be side effects in people who are sensitive to the ingredients of ACNELYSE.

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

• Hypersensitivity reactions including difficulty in breathing, swelling of the face, tongue and lips

These are all very serious side effects.

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

Side effects are classified as shown in the following categories:

It can be seen in at least one of 10 patients.

It can be seen less than one in 10 patients, but more than one in 100 patients.

It can be seen less than one in 100 patients, but more than one in 1,000 patients.

It can be seen less than one in 1,000 patients, but more than one in 10000 patients.

It can be seen in less than one in 10,000 patients.

It cannot be estimated from the available data.

Very common Common

Unusual:

Rare Very rare Unknown
very common

• Itching

• rash

• Skin irritation

• Stinging sensation

• Skin dryness

• Redness

• Peeling
Widespread

• Discoloration of the skin

light sensitivity
Rare

• Allergy-related itching, redness and formation of fluid-filled blisters on the skin

• Itchy rash with widespread redness
Very rare:

• Scar formation,

• Hypersensitivity reactions including difficulty in breathing, swelling of the face, tongue and lips