Skinoren 20% - dermatological cream for acne treatment 30 g

Product Description

Medication for the treatment of acne.

Indications

Skinoren 20% cream is indicated for the treatment of acne (acne vulgaris) in its various forms, characterized by the presence of comedones, papules, pustules, and small nodules.

Composition

Active ingredients

1 g of Skinoren cream contains 200 mg (20%) of azelaic acid. Excipients with known effects: benzoic acid, propylene glycol. For a full list of excipients, see section 6.1.

Excipients

Benzoic acid (E210), cetearyl octanoate + isopropyl myristate (PCL Liquid), glycerol 85%, glyceryl stearate + cetearyl alcohol + cetyl palmitate + cocoglycerides (CUTINA CBS), propylene glycol, purified water, stearoyl macrogolglycerides.

Directions for use and dosage

Method of administration: Cutaneous use. Dosage. Skinoren cream should be applied to the affected areas of the skin twice daily (morning and evening), massaging it in gently.

Approximately 2.5 cm of cream is sufficient to treat the entire face. Before applying Skinoren cream, wash the skin thoroughly with water and dry it. You can also use a gentle skin cleanser. It is important to use Skinoren cream regularly throughout the entire treatment period. The duration of treatment with Skinoren cream may vary from patient to patient and depending on the severity of the condition. For optimal results, Skinoren cream should be used continuously for several months.

There is clinical experience with the continuous application of Skinoren cream for up to a year. In patients with acne, a noticeable improvement is generally observed after about 4 weeks. If skin irritation occurs, reduce the amount of cream per application, or reduce the frequency of use of Skinoren cream to once a day until the irritation subsides.

If necessary, discontinue treatment for a few days. After a short period of treatment without noticeable results, a medical evaluation is necessary.

Pediatric population: Use in adolescents (12-18 years). No dosage changes are expected when Skinoren cream is used in adolescents aged 12 to 18 years. The safety and efficacy of Skinoren cream in children under 12 years of age have not been established.

Geriatric population: No specific studies have been conducted in patients aged 65 years and over.

Patients with liver disease: No specific studies have been conducted in patients with liver disease.

Patients with kidney disease: No specific studies have been conducted in patients with kidney disease.

Warnings

For external use only. Care should be taken when using Skinoren cream to avoid contact with eyes, mouth, and other mucous membranes, and patients should be adequately instructed accordingly. In case of accidental contact, rinse the affected eyes, mouth, and/or mucous membranes with plenty of water. If eye irritation persists, consult a doctor.

Wash hands after each application of Skinoren cream.

Skinoren cream contains 2 mg of benzoic acid per gram. Benzoic acid may cause local irritation.

Skinoren cream contains 125 mg of propylene glycol per gram. Minimize the concomitant use of cosmetic preparations, alcoholic or aggressive cleansers, dyes, astringent or abrasive substances, or exfoliating agents during treatment.

During post-marketing surveillance, worsening of asthma has been reported rarely in patients treated with azelaic acid.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Undesirable effects

The most frequently observed adverse reactions in clinical studies and post-marketing surveillance include burning, itching, and erythema at the application site. The frequencies of adverse reactions observed during clinical trials and post-marketing surveillance and listed in the following table are defined according to the MedDRA frequency convention: Very common (≥1/10) Common (≥1/100, <1/10) Uncommon (≥1/1,000, <1/100) Rare (≥1/10,000, <1/1,000) Very rare (<1/10,000) Not known (frequency cannot be estimated from the available data)

¹ The following additional adverse reactions have been reported during post-marketing use of Skinoren cream. Symptoms of local skin irritation generally resolve during the course of treatment.

Paediatric population In clinical studies involving adolescents aged 12-18 years (454/1,336; 34%), the local tolerability of Skinoren cream was shown to be similar in the paediatric and adult populations.

Pregnancy and breastfeeding

• Pregnancy: There are no adequate and controlled studies with topical application of azelaic acid in pregnant women. Animal studies indicate the possibility of effects on pregnancy, embryonic-fetal development, parturition, or postnatal development. However, the no-adverse effect levels observed in animal studies were 3-32 times the maximum recommended human dose based on body surface area. Caution should be exercised when prescribing azelaic acid during pregnancy.
• Breastfeeding: It is not known whether azelaic acid is excreted in human milk in vivo. However, an in vitro test using equilibrium dialysis has shown that the drug can pass into breast milk. The distribution of azelaic acid in breast milk, however, is not expected to cause a significant change from baseline azelaic acid levels in milk. Since azelaic acid is not concentrated in milk and less than 4% of topically applied azelaic acid is absorbed systemically, there is no increase in exposure to endogenous azelaic acid above physiological levels. However, caution should be exercised when administering Skinoren cream during breastfeeding. Infants should not come into contact with skin/breasts treated with the product.
• Fertility: No data are available on the effects of Skinoren cream on human fertility. Results from animal studies have shown no effects on fertility in male or female rats.

Format

30 g