Acnelyse Cream 20 g acne treatment ingredient Retinoic Acid

1.1. Therapeutic indications

1.2. Posology and application form

Posology / application frequency and duration:

ACNELYSE is applied to the lesioned area once a day and at night.

With the application, there may be a temporary feeling of warmth and stinging on the skin. If necessary, the dosage may be adjusted by interrupting treatment or by reducing the frequency of administration.

In the first weeks of treatment, there may be an increase in inflammatory lesions. The reason is that the drug is the effect on the lesions and does not require the drug to be cut off.

Treatment results occur after 2-3 weeks, but it may take up to 6 weeks to get full benefit.

The drug may be used less frequently once the lesions have improved.

ACNELYSE should be applied gently to the lesioned skin area with the fingertip.

Patients using ACNELYSE may use cosmetic materials; but the skin should be thoroughly cleaned before treatment.

Additional information on special populations:

Kidney / Liver failure: Dosage adjustment is not required.

Pediatric population: Pediatric use data are not available.

1.3. contraindications

1.4. Special use warnings and precautions

If sensitization or chemical irritation occurs, treatment should be discontinued.

During ACNELYSE use, the patient's exposure to sunlight should be minimized. Patients with sunburn should not use ACNELYSE until they are fully recovered. If contact with ultraviolet light can not be prevented, use of sunlight-blocking agents should be recommended.

ACNELYSE should not come into contact with the eyes, subcutaneous layer, nose, or face.

Topical application may cause local melting and peeling of the skin due to irritation to the application area. If local irritation continues with the same intensity, use less frequent illnesses; it is advisable to take a break for a temporary period or leave it completely.

It has been reported that eczematous causes skin irritation; For this reason, such patients should be used very carefully.

Cetyl alcohol may cause local skin reactions (eg itching, redness or bubbles filled with liquids due to contact with irritants such as contact dermatitis).

It may cause local skin reactions due to butyl hydroxy toluene (eg itching, redness, or fluid filled bubbles due to deeper irritants and allergens such as contact dermatitis) or irritation in the eyes and subcutaneous layer.

1.5. Interactions with other medicinal products and other forms of interaction

When used in combination with therapeutic soaps and cleansers, a strong drying effect occurs.

Precautions should be taken if preparations containing sulfur, resorcinol or salicylic acid are used with ACNELYSE.

1.6. Pregnancy and lactation

General advice

Pregnancy category is C

Women with childbearing potential / Contraception (Contraception)

Women with childbearing potential should have a pregnancy test before pregnancy starts to find pregnancy. If pregnancy is present, treatment should be postponed until the end of pregnancy. Tretinoin is recommended to be safeguarded with one or two contraceptive methods during the period of use.

ACNELYSE may reduce the level / effects of oral contraceptives.

Pregnancy period

Drugs containing oral tretinoin are classified as Category D throughout pregnancy due to fetotoxic and teratogenic effects. In pregnant women who use oral tretinoin, there is a high risk of delivering a deformed baby. This risk is shown in animal studies. For this reason, the use of oral tretinoin-containing medicines in pregnancy is not recommended unless prescribed by the physician for the treatment of a fatal disease.

Congenital diseases have been reported in a limited number of human and animal case reports. For this reason the risk can not be ignored.

When the physician decides that topical tretinoin pregnancies are superior to possible losses of possible benefits, they should be used only after the patient has been warned about possible adverse effects and effects of the fetus.

Lactation period

Post-administration systemic absorption of topical tretinoin has been found to be less than 2% on average in healthy volunteers, but there are reports that the mother may be able to tolerate some. For this reason, milk-giving mothers should be used only with the advice of the physician and with caution.

Reproduction ability / Fertility

1.7. Effects on vehicle and machine use

1.8. Undesirable effects

Adverse reactions that are considered to be drug related are listed below:

Frequencies are defined as: very common (> 1/10); common (> 1/100 to <1/10); uncommon (> 1 / 1,000 to <1/100); rare (> 1 / 10,000 to <1 / 1,000); very rare (<1 / 10,000), unknown (can not be estimated from the given data).

Immune system diseases

Very rare: hypersensitivity reactions including difficulty in breathing, swelling in the face, tongue and lips

Skin and subcutaneous tissue diseases

Very common: itching, rash, skin irritation, stinging sensation,

Common: Skin pigmentation changes (hypo-hyperpigmentation), skin irritation, light sensitivity,

Uncommon: Skin contact, contact, peeling,

Rare: Contact dermatitis, itchy rash with diffuse erythema Very rare: Scar formation

1.9. Overdose and treatment

Too much drive of the drug does not cause better and faster recovery; even redness and peeling of the skin may occur. The recommended dose should not be exceeded.

What is ACNELYSE and what is it used for?

ACNELYSE is a medication on 20 g aluminum tubes containing retinoic acid (tretinoin) as active ingredient.

Retinoic acid (tretinoin), the active ingredient of ACNELYSE, stimulates the renewal of epidermis cells, which are the deepest uppermost layer when applied to the skin, suppresses excessive keratin formation and stimulates the mechanisms of deep self repair.

Thanks to these features ACNELYSE is used in the treatment of the following conditions:

Acne vulgaris (acne),

Psoriasis (psoriasis),

Ichthyosis (fish scales),

Hyperkeratosis (increased skin thickness)

1.How to use ACNELYSE

Instructions for proper use and dose / application frequency

ACNELYSE is applied to the lesioned area once a day and at night.

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

There may be an increase in inflammatory lesions in the first weeks of treatment. The reason is that the drug is the effect on the lesions and does not require the drug to be cut off.

Treatment results occur after 2-3 weeks, but it may take up to 6 weeks to get full benefit.

The drug may be used less frequently once the lesions have improved.