Rosiced rosacea cream 30g minsan 036720023

ROSICED * CREAM 30G 0.75%

Therapeutic indications

ROSICED 7.5 mg / g Cream is indicated in adults for the topical treatment of the inflammatory papulopustular manifestations of rosacea.

Dosage and method of use

Dosage:Apply and gently massage a thin layer of cream on the affected skin of the face twice a day, for a usual treatment duration of 6 to 12 weeks. If necessary, treatment can be continued (see section 4.4). In the absence of clinical improvement, therapy should be discontinued.Pediatric population:The safety and efficacy of ROSICED 7.5 mg / g cream in children has not been established; therefore ROSICED 7.5 mg / g cream should not be used in children.Method of administration:Cutaneous use. The areas to be treated must be cleansed before applying the cream. Patients can use non-comedogenic and non-astringent cosmetics after applying the cream.

Contraindications

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, - Hypersensitivity to or to medicines containing metronidazole or other 5-nitroimidazoles such as ROSICED 7.5 mg / g Cream. The only exception is cases of life-threatening infections and if other medicines have been found to be ineffective. - During the first trimester of pregnancy. - In patients with severe hepatic injury, dyshematopoiesis and central or peripheral nervous system disease, a careful risk / benefit assessment is required prior to treatment with ROSICED 7.5 mg / g Cream.

Side effects

The following spontaneous adverse reactions have been reported which are categorized by system organ class by frequency using the following convention: very common (≥ 1/10), common (≥1 / 100,

. 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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Avoid contact with eyes and mucous membranes. In case of contact, the cream should be carefully removed with water. If irritation occurs, the patient should be advised to use ROSICED 7.5 mg / g cream less frequently or to temporarily discontinue therapy and seek advice from the physician if necessary. Avoid exposure to ultraviolet light (sun baths, solariums, sun lamps), during therapy with ROSICED 7.5 mg / g cream. The recommended duration of therapy should not be exceeded. If required, the therapy can be repeated, but an interval of 6 weeks should be kept between the two treatments. ROSICED 7.5 mg / g Cream should be used with caution in patients with evidence or a history of blood dyscrasia. Unnecessary or prolonged use of this medicinal product should be avoided. Evidence suggests that metronidazole is carcinogenic in some animal species. There is no evidence so far of a carcinogenic effect in humans.Pediatric population:There are no adequate clinical studies on the efficacy and safety of ROSICED 7.5 mg / g cream in children; therefore ROSICED 7.5 mg / g cream should not be used in children.Excipients with known effects:ROSICED 7.5 mg / g cream contains 400 mg of propylene glycol in 2 g (daily dose), which may cause skin irritation.

Pregnancy and breastfeeding

Pregnancy: The safety of metronidazole use during pregnancy has not been sufficiently demonstrated. Contradicting reports are available, especially regarding the first stage of pregnancy. Some studies have indicated an increase in the rate of malformations. The risk of possible sequelae, including a carcinogenic risk, has not yet been clarified. In case of uncontrolled use of nitroimidazoles by the mother, the fetus and / or the neonate are exposed to a carcinogenic or genotoxic risk. To date, there is no proven evidence of damage to the embryo or fetus. In experimental animal studies, metronidazole did not exhibit teratogenic properties (see section 5.3). ROSICED 7.5 mg / g Cream is contraindicated during the first trimester of pregnancy. During the middle trimester and last trimester of pregnancy, ROSICED 7.5 mg / g Cream should only be administered in the event of failure of other treatments.Breastfeeding: Metronidazole passes into breast milk. Following oral administration, 100% of the plasma value can be reached. Following cutaneous application of ROSICED 7.5 mg / g Cream, plasma levels are lower than those seen after oral administration of metronidazole. Nonetheless, breastfeeding should be discontinued or treatment with ROSICED 7.5 mg / g Cream should be discontinued.

Expiration and retention

Do not store above 30 ° C. Do not refrigerate or freeze.

Interactions with other drugs

There are no known interactions with other medicinal products for cutaneous use. Interaction with systemic treatments is unlikely, because the absorption of metronidazole after cutaneous application of ROSICED 7.5 mg / g cream is low. However, it should be remembered that disulfiram-like reactions have been reported in a small number of patients taking metronidazole and alcohol at the same time. Oral metronidazole has been found to potentiate the effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.

Overdose

Overdose is extremely unlikely. The cream should be removed by rinsing with warm water. There are no data on overdose in humans. Acute oral toxicity studies with the topical gel formulation containing 0.75% metronidazole in rats showed no toxic action with doses up to 5g of finished product per kg body weight, the highest dose used. . This dose is equivalent to oral administration of 12 x 30g tubes of 0.75% metronidazole cream for an adult weighing 72 kg and 2 tubes of cream for a child weighing 12 kg.

Active principles

1 g of cream contains 7.5 mg metronidazole (0.75% m / m)Excipient with known effect:100 g of cream contain: Propylene Glycol 20 g. For the full list of excipients, see section 6.1.

Excipients

Glyceryl monolaurate, Glyceryl monomyristate, Propylene glycol, Anhydrous citric acid (pH regulator), Sodium hydroxide (pH regulator), Carbomers, Purified water.