FINACEA * GEL 30G 15%

FINACEA * GEL 30G 15%

Therapeutic indications

For the relief of mild to moderate forms of papulo-pustular acne on the face. For the topical treatment of papulo-pustular rosacea.

Dosage and method of use

Finacea 15% Gel is for cutaneous use only.Dosage: 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 amount of product sufficient for the whole face is approximately 2.5 cm, which corresponds to 0.5 g of gel.Pediatric population: Use in adolescents (12-18 years) for the treatment of acne vulgaris. No dose adjustment is required when Finacea Gel is administered to adolescents aged 12-18 years. The safety and efficacy of Finacea Gel for the treatment of acne vulgaris in children under the age of 12 have not been established. The safety and efficacy of Finacea Gel for the treatment of papulopustular rosacea in children under the age of 18 have not been established.Geriatric population: No targeted studies have been conducted in patients aged 65 and over.Patients with liver disease: No targeted studies have been conducted in patients with liver disease.Patients with kidney disease: No targeted studies have been conducted in patients with kidney disease.Method of administration: Before applying Finacea Gel, wash the skin thoroughly with water and dry it. You can also use a mild skin cleanser. Avoid using occlusive clothing or bandages and wash your hands after applying the gel. In case of skin irritation (see section 4.8 "Undesirable effects"), decrease the quantity of gel for each application, or reduce the frequency of use of Finacea Gel to once a day until the irritation disappears. If necessary, stop the treatment for a few days. It is important to use Finacea Gel continuously for the duration of the treatment. The duration of treatment with Finacea Gel may vary from patient to patient and also depends on the severity of the skin disease.Acne: in general, a noticeable improvement is observed after 4 weeks. For best results, Finacea Gel treatment can be continued for several months according to the clinical outcome. In case there is no improvement after 1 month or in case of acne exacerbation, stop using Finacea Gel and consider other therapeutic alternatives.Rosacea: in general there is a noticeable improvement after 4 weeks. For best results, Finacea Gel treatment can be continued for several months according to the clinical outcome. In case there is no improvement after 2 months or in case of rosacea exacerbation, stop using Finacea Gel and consider other therapeutic alternatives.

Contraindications

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

Side effects

The most frequently observed side effects in clinical trials and post-marketing surveillance included itching, burning and pain at the application site. The frequencies of undesirable effects observed in clinical trials and post-marketing surveillance and listed below in the table were defined according to the MedDRA frequency convention: Very common (≥1 / 10); Common (≥1 / 100,

* for rosacea indication. ** for the acne indication. ¹ These adverse reactions have been reported during post-registration use of Finacea Gel. Generally, local skin irritation subsides during the course of treatment.Pediatric population. Treatment of acne vulgaris in adolescents aged 12-18 years: In 4 phase II and II / III clinical trials that included adolescents aged 12-17 years (120/383; 31%), the incidence Total adverse events for Finacea Gel were similar for age groups 12-17 years (40%), age groups ≥18 years (37%) and for the entire patient population (38%). This similarity was also found for the 12-20 year age group (40%).Reporting of suspected adverse reactions. Reporting 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 Finacea gel 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 Finacea Gel. Finacea Gel contains 1 mg of benzoic acid per gram. Benzoic acid can cause local irritation. Finacea Gel contains 120 mg of propylene glycol per gram. It is advisable to avoid the concomitant use of alcohol-based cleansers, tinctures and astringent products, products with abrasive or exfoliating (peeling) action in patients who use Finacea Gel for the treatment of rosacea. During post-marketing surveillance, worsening of asthma has rarely been reported in patients treated with azelaic acid.

Pregnancy and breastfeeding

Pregnancy:There are no adequate and well controlled studies related to the topical administration 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 exercised when prescribing azelaic acid to pregnant women.Feeding time:It is not known whether azelaic acid is excreted in human milk in vivo. However, an in vitro test performed with equilibrium dialysis technique showed 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 milk azelaic acid levels, as azelaic acid is not concentrated in milk and less than 4% of the acid. Topically applied azelaic is absorbed systemically, not increasing exposure to endogenous azelaic acid above physiological levels. However, caution is required when Finacea Gel is administered to a nursing woman. Newborns should not come into contact with the skin / breasts treated with the product.Fertility:There are no data on the effects of Finacea Gel 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

This medicine does not require any special storage conditions.

Interactions with other drugs

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

Overdose

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

Active principles

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

Excipients

Benzoic acid (E210), Carbomers, Disodium edetate, Lecithin, Polysorbate 80, Propylene glycol, Purified water, Sodium hydroxide, Medium chain triglycerides.