FINACE GEL 30G 15%

FINACEA 15% GEL

active ingredients

1 g of Finacea Gel contains 150 mg (15%) of azelaic acid. Excipients with known effects: Benzoic acid 1 mg/g gel; Propylene glycol 0.12 g/g of gel. For the full list of excipients, see the paragraph 6.1.

Excellent

Benzoic acid (E210), Carbomeres, Detox, Lecithin, Polysorbate 80, propylene glycol, purified water, Sodium hydroxide, Triglycerides with medium chain.

Therapeutic indications

For the relief of the forms of acne papulo-pustolosa of mild to moderate degree, at face level. For topical treatment of papulo-pustolosa rosacea.

Contraindications

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

Population

Finacea 15% Gel is exclusively for skin use. Population: Finacea Gel must be applied to the skin area to be treated twice a day (in the morning and in the evening), making it penetrate with a light massage. The sufficient amount of product for the whole face is about 2.5 cm, which corresponds to 0.5 g gel. Pediatric population: Use in teenagers (12-18 years) for the treatment of vulgar acne. Dose adjustment is not required when Finacea Gel is administered to teenagers between 12-18 years. The safety and effectiveness of Finacea Gel for the treatment of vulgar acne in children under the age of 12 have not been established. The safety and effectiveness of Finacea Gel for the treatment of papulo-pustolose rosacea in children under the age of 18 have not been established. 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. Method of administration: Before applying Finacea Gel, thoroughly wash the skin with water and dry it. You can also use a delicate skin cleanser. Avoid the use of occlusive clothing or bandages and wash your hands after applying the gel. In case of skin irritation (see paragraph 4.8 "Unwanted Effects"), decrease the amount of gel for each application, or reduce the frequency of use of Finacea Gel at once a day until the disappearance of the irritative phenomenon. If necessary, suspend treatment for a few days. It is important to use Finacea Gel with continuity throughout the duration of treatment. The duration of treatment with Finacea Gel may vary from patient to patient and also depends on the severity of the skin pathology. Water: in general, an obvious improvement after 4 weeks is observed. To achieve optimal results, the treatment with Finacea Gel can be protracted for several months in accordance with the clinical outcome. If you have no improvement after 1 month or in case of acne exacerbation, suspend the use of Finacea Gel and consider other therapeutic alternatives. Rosacea: in general, an obvious improvement after 4 weeks is observed. To achieve optimal results, the treatment with Finacea Gel can be protracted for several months in accordance with the clinical outcome. In case you have no improvement after 2 months or in case of exacerbation of rosacea, suspend the use of Finacea Gel and consider other therapeutic alternatives.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Only for external use. It is necessary to pay attention during the use of Finacea gel 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 Finacea Gel. Finacea Gel contains 1 mg of benzoic acid per gram. Benzoic acid can cause local irritation. Finacea Gel contains 120 mg propylene glycol per gram. It is recommended to avoid the concomitant use of alcohol-based detergents, dyes and astringent products, products with abrasive or exfoliating action (peeling) in patients using Finacea Gel for the treatment of rosacea. During post-marketing surveillance, asthma worsening was rarely reported in patients treated with azelaic acid.

Interactions

No interaction studies have been conducted. The composition of Finacea Gel does not imply for the individual components any unwanted interaction that could adversely affect product safety. During controlled clinical studies conducted drug-specific interactions were not observed.

Effects

The undesirable effects observed most frequently during clinical studies and during post-marketing surveillance, included itching, burning and pain in the application site. The frequency of unwanted effects observed in clinical studies and post-marketing surveillance listed below in the table, were 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 Raro Immune system disorders       Hypersensitivity (which may occur with one or more of the following adverse reactions: angioedema, swelling of the eyes, swelling of the face, dispnea)asthma skinning (see paragraph 4.4) Pathologies of skin and subcutaneous tissue     Contact dermatitis, acne* Skin irritation, hives Systemic pathologies and conditions for administration Burn in the application site, pain in the application site itching on the application site Skin rash on the application site, paresthesia on the application site, dryness on the application site, edema on the application site* Erythema on the application site, exfoliation on the application site****, feeling of heat on the application site***, discoloration in the application site** urticaria on the application site*, discomfort in the application site*   *for rosacea indication. ** for acne indication. 1 These adverse reactions were reported during the post-register use of Finacea Gel. Generally, local skin irritation decreases during treatment. Pediatric population. Treatment of vulgar acne in teenagers aged 12-18 years: In 4 phase II and II/III clinical studies that included adolescents aged 12-17 years (120/383; 31%), the total incidence of adverse events for Finacea Gel was similar for groups aged 12-17 (40%), aged ≥18 years (37%) and for the entire population of patients (38%). This similarity was also found for the age group 12-20 years (40%). 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 well-controlled studies relating to the topical administration 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”). It must be given caution when prescribing azelaic acid to pregnant women.

Nursing:

It is not known whether azelaic acid is excreted in human milk in vivo. However, an in vitro test 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 azelaic acid levels present in basal milk, since azelaic acid is not concentrated in milk and less than 4% of azelaic acid applied topically is absorbed at a systemic level, not increasing exposure to algeological azelaic acid above the levels. However, caution is required in case of administration of Finacea Gel to a nursing woman. Babies should not come into contact with the skin/breast treated with the product.

Fertility:

Data on the effects of Finacea Gel 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