SKINOREN * CREAM 30G 20%

SKINOREN * CREAM 30G 20%

Therapeutic indications

Treatment of acne (acne vulgaris) in its various expressions characterized by the presence of comedones, papules, pustules, small nodules.

Dosage and method of use

Method of administrationCutaneous use.DosageSkinoren cream should be applied to the areas to be treated twice a day (morning and evening) making it penetrate with a light massage. Approximately 2.5 cm of cream is enough to treat the entire face. Before applying Skinoren cream, wash the skin thoroughly with water and dry it. It is also possible to use a mild skin cleanser. It is important to use Skinoren cream regularly for the duration of the treatment. The duration of treatment with Skinoren cream may vary from patient to patient and according to the severity of the disease. For best results, Skinoren cream should be used continuously for several months. There is clinical experience with the continuous application of Skinoren cream for up to one year. In patients with acne, there is generally a noticeable improvement after about 4 weeks. In case of skin irritation (see section 4.8 "Undesirable Effects"), decrease the amount of cream for each application, or reduce the frequency of use of Skinoren cream to once a day until the irritation disappears. If necessary, stop the treatment for a few days. After a short period of treatment with no appreciable results, a medical evaluation is required.Pediatric populationUse in adolescents (12 - 18 years). There are no changes in dosage when Skinoren cream is applied in adolescents aged 12 to 18 years. The safety and efficacy of Skinoren cream in children under the age of 12 has not been proven.Geriatric populationNo targeted studies have been conducted in patients aged 65 and over.Patients with liver diseaseNo targeted studies have been conducted in patients with liver disease.Patients with kidney diseaseNo targeted studies have been conducted in patients with kidney disease.

Contraindications

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

Side effects

The most frequently observed undesirable effects in clinical trials and post-marketing surveillance include burning, itching and erythema at the application site. The frequencies of undesirable effects 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,

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The following additional adverse reactions have been reported during post-registration use of Skinoren cream. Generally, symptoms of local skin irritation subside during the course of treatment.Pediatric populationIn clinical trials involving adolescents aged 12-18 years (454/1336; 34%), the local tolerability of Skinoren cream was shown to be similar in the pediatric and adult populations.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.

Special warnings

For external use only. Care should be taken while using Skinoren cream to avoid contact with eyes, mouth and other mucous membranes, and to adequately educate patients in this regard (see section 5.3 “Preclinical safety data”). In case of accidental contact, the eyes, mouth and / or affected mucous membranes should be washed with plenty of water. If eye irritation persists, consult a doctor. Wash your hands after each application of Skinoren cream. Skinoren cream contains 2 mg of benzoic acid per gram. Benzoic acid can cause local irritation. Skinoren cream contains 125 mg of propylene glycol per gram. Limit the concomitant use of cosmetic preparations, alcoholic or aggressive detergents, dyes, astringent or abrasive substances or exfoliating agents to the maximum during the course of treatment. During post-marketing surveillance, worsening of asthma has rarely been reported in patients treated with azelaic acid (see section 4.8).

Pregnancy and breastfeeding

PregnancyThere are no adequate and controlled studies on the topical application of azelaic acid in pregnant women. Studies in animals indicate the possibility of effects related to pregnancy, embryo-fetal development, parturition or postnatal development. However, the no-adverse dose levels observed in the study animals were 3-32 times the maximum recommended human dose on body surface area. (see paragraph 5.3 "Preclinical safety data"). Caution should be observed when prescribing azelaic acid in pregnancy.Feeding timeIt is not known ifin vivoazelaic acid is excreted in breast milk. However a testin vitroperformed with equilibrium dialysis technique 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 levels of azelaic acid 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, care should be taken when Skinoren cream is administered during breastfeeding. Newborns should not come into contact with the skin / breasts treated with the product.FertilityThere are no data on the effects of Skinoren cream on human fertility. Results obtained from animal studies have shown no effects on fertility in male or female rats (see section 5.3 Preclinical safety data).

Expiration and retention

Do not store above 25 ° C.

Interactions with other drugs

No interaction studies have been conducted.

Overdose

Given the very low toxicity of azelaic acid, both locally and systemically, intoxication is unlikely.

Active principles

1 g of Skinoren cream contains 200 mg (20%) of azelaic acid. Excipients with known effects: benzoic acid, propylene glycol. For the 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