SKINOREN CREAM 30G 20%

SKINOREN 20% CREAM

active ingredients

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 paragraph 6.1.

Excellent

Benzoic acid (E210) Cetearil octanoate + Isopropyl miristate (PCL Liquid) Glycerol 85% Glyceryl stearate + cetearil alcohol + cetil palmitato + cocoglycerides (CUTINA CBS) Propylene glycol Purified water Stearoil macrogolglycerides

Therapeutic indications

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

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Method of administration Skin use. Population Skinoren cream should be applied on areas to treat skin twice a day (morning and evening) making it penetrate with a light massage. Approximately 2.5 cm of cream are enough to treat the whole face. Before applying Skinoren cream thoroughly wash the skin with water and dry it. It is also possible to use a delicate skin cleanser. It is important to use Skinoren cream regularly throughout the duration of treatment. The duration of treatment with Skinoren cream may vary from patient to patient and depending on the severity of the pathology. To achieve optimal results, Skinoren cream must be used for several months continuously. There are clinical experiences related to the continuous application of Skinoren cream up to a year. In patients with acne, an obvious improvement is generally observed after about 4 weeks. In case of skin irritation (see section 4.8 “Unwanted Effects”), decrease the amount of cream for each application, or reduce the frequency of use of Skinoren cream at once a day until the disappearance of the irritative phenomenon. If necessary, suspend treatment for a few days. After a short period of treatment without appreciable results, a medical evaluation is required. Pediatric population Use in teenagers (12 - 18 years). There are no variations in posology when Skinoren cream is applied in teenagers with an age between 12 and 18 years. The safety and effectiveness of Skinoren cream in children under 12 years has not been proven. Geriatric population No targeted studies have been conducted on patients aged 65 or over. Patients with liver disease No targeted studies have been conducted on patients with liver disease. Patients with kidney disease No targeted studies have been conducted on patients with kidney disease.

Conservation

Do not store at temperature above 25°C.

Warnings

Only for external use. It is necessary to pay attention during the use of Skinoren cream to avoid contact with eyes, mouth and other mucous membranes, and to properly instruct patients in this regard (see paragraph 5.3 “Preclinical safety data”). In case of accidental contact, the eyes, mouth and/or mucous membranes concerned must be washed with plenty of water. If the eye irritation persists, consult a doctor. Wash your hands after every 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. Maximum limit the concomitant use of cosmetic preparations, alcoholic or aggressive detergents, dyes, astringent or abrasive substances or exfoliating agents during treatment. During post-marketing surveillance, asthma has rarely been worsened in patients treated with azelaic acid (see paragraph 4.8).

Interactions

No interaction studies have been conducted.

Effects

The most frequently observed side effects in clinical studies and post-marketing surveillance include burning, itching, and erythema at the application site. The frequency of undesirable effects observed during clinical studies and post-marketing surveillance listed in the next table are defined in accordance with the MedDRA Frequency Convention: Very common (≥1/10) Common (≥1/100, Classification for systems and organs Very common Town Not common Rare Immune system pathologies       Hypersensitivity to the drug (which may occur with one or more of the following adverse reactions: angioedema1, contact dermatitis1, eye swelling1, face swelling1)       Weighting of asthma (see section 4.4) Pathologies of skin and subcutaneous tissue     Sebortion Orticaria1, Cheilite     Skin depigmentation Rash1     Water   General and related pathologies Burning in the place of application Pain in the place of application Approximate opinion Sensation of heat in the application site Prurito in the application location Desquamation in the place of application Dermatitis in the application location Vesicles in the place of application Eritema in the application location Dryness in the application location Fastidium in the application location Eczema in the application location   Discoloration in the place of application Description Ulcer in the application location   Irritation in the application location     ¹ The following additional adverse reactions were reported during the post-register use of Skinoren cream. Generally, the symptoms of local skin irritation regress during treatment. Pediatric population In clinical studies that involved adolescents with an age between 12-18 years (454/1336; 34%), the local tolerability of Skinoren cream proved similar in the pediatric and adult population. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals are required to report any adverse reaction suspected through the national reporting system Italian Pharmaco Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

Given the very low toxicity of azelaic acid, locally and systematically, it is unlikely that an intoxication occurs.

Pregnancy

There are no adequate and controlled studies relating to the topical application of azelaic acid in pregnant women. Animal studies indicate the possibility of effects related to pregnancy, embryo-fetal development, childbirth or post-birth development. However, dose levels without harmful effects observed in animals in the study were 3-32 times the recommended maximum dose for man calculated on the body surface area. (see paragraph 5.3 ”Preclinical Security Data”). Caution should be observed when prescribing azelaic acid in pregnancy.

Food

It is not known if in live azelaic acid is excreted in breast milk. However a test in vitro performed with dialysis technique to balance 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 compared to the basal levels of azelaic acid present in milk. Since azelaic acid is not concentrated in milk and less than 4% of azelaic acid applied topically is absorbed at systemic level, there is no increase in exposure to endogenous azelaic acid above physiological levels. However it should be paid attention when Skinoren cream is given during breastfeeding. Babies should not come into contact with the skin/breast treated with the product.

Fertility

Data on the effects of Skinoren cream on human fertility are not available. The results obtained by animal studies have shown no effect on fertility in male or female rats (see paragraph 5.3 Safety preclinical data).

Source: Farmadati