CAREDIESS SHAMP2FL 60ML10MG/G

CAUTION

active ingredients

A gram of shampoo contains 10 mg of cyclopirox. Excipients with known effect: Benzoic acid and benzoate sodium 1.678 mg/ml (see paragraph 4.4). For excipients, see paragraph 6.1.

Excellent

Dodecil-di(ossiethylene) sulphate sodium, 27% solution⁽¹⁾; Dodecil-poli(ossiethylene)-3-2-solfosuccinato disodium, 33% solution⁽²⁾; Macrogolauriletere; Sodium chloride; Purified water; 1) composed of: dodecil-di(ossiethylene) sulphate sodium; purified water; benzoic acid (E210). 2) composed of: dodecil-poli(ossiethylene)-3-2-sulfosuccinato disodium; sodium benzoate (E211), purified water.

Therapeutic indications

Carediesse is indicated for the treatment of seborrheic derrnatis of the scalp.

Contraindications

Carediesse should not be used in case of hypersensitivity ascertained to cyclopirox, cyclopyroxolamine or any of the excipients listed in paragraph 6.1.

Population

For skin use. For initial treatment of seborrheic dermatitis symptoms, Carediesse applies to scalp once or twice a week, depending on severity, for 4 weeks. For subsequent prophylaxis of symptoms, treatment can be continued for another 12 weeks. The use of Carediesse should be limited to a maximum of 16 weeks of continuous use. Pediatric population: Carediesse’s safety and effectiveness in children have not been investigated. There are no available data. Methods of administration: The contents of a dosing cap (about 5 ml) of Carediesse should be applied on wet hair and on the scalp frying until the formation of foam. The latter should then be thoroughly massaged on the scalp. If the hair is longer than the shoulders, it should be used up to two double shampoo caps (about 10 ml). Carediesse should be allowed to act for 3 minutes and then rinse with water.

Conservation

Do not store at temperature above 30°C.

Warnings

It is necessary to inform patients, during the use of Carediesse, to avoid contact with eyes. In case of bumpy contact with the eyes, rinse them with plenty of water. This medicine contains 0.525 mg benzoate sodium and 1,08 mg benzoic acid for 1 g shampoo, which is equivalent to a total of 1.678 mg/ml (corresponding to 0.548 mg/ml sodium and 1,13 mg/ml benzoic acid). Benzoic acid / benzoate salt can cause local irritation. Benzoic acid / benzoate salt can increase hetero in infants (up to 4 weeks of age). In case of irritation or sensitization after prolonged use of the product, the treatment should be suspended and other appropriate therapy should be established. Changes in hair color were observed, especially in patients with hair damaged by chemical agents (e.g. caused by hair coloring) or white or gray hair.

Interactions

There are no known cases of interactions between cyclopirox and other medicines.

Effects

Immune disorders. Rari (>1/10.000 a Pathologies of skin and subcutaneous tissue. Not common (>1/1.000 to Reporting 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 workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.agenziafarmaco.gov.it/content/comesegnalare-una-sospetta-reazione-avversa.

Overdosing

There is no experience of overdose with preparations containing cyclopirox. However, important systemic effects are not expected if Carediesse is used too frequently. In case of accidental ingestion, establish adequate therapy.

Pregnancy: For cyclopirox there are no clinical data related to pregnancy exposure. Animal studies show no direct or indirect harmful effects on pregnancy, embryo/fetal development or childbirth. However, there is no sufficient data on the possible long-term effects on post-natal development (see paragraph 5.3). You should use caution when the medicine is prescribed to pregnant women. Nursing: It is not known whether cyclopirox is excreted in breast milk in humans. So women breastfeeding should not use Carediesse. Fertility: No studies have been conducted on the effects of cyclopyrox on human fertility. Reduced fertility index was found in rats at the dose of 5 mg/kg after oral administration (see paragraph 5.3)

Source: Farmadati