CICLOPIROX OLAMINE VIATRIS 1,5 % Shampoo Bottle/100ml

Ciclopirox olamine....................................................................................................................1,50 g (1,5 % w/w)

For 100 g.

Excipient with known effect: polysorbate 80 (E433).

Treatment of seborrhoeic dermatitis of the scalp.

Dosage

Paediatric population

The safety and efficacy of the 1,5 % ciclopirox olamine shampoo in children under 12 years of age have not yet been established.

No data are available.

Method of administration

For cutaneous use only.

Use the 1,5 % ciclopirox olamine shampoo two to three times per week. Wet the hair and apply a sufficient quantity of shampoo to obtain abundant lather. Massage the scalp and adjacent areas vigorously with the fingertips. Then rinse the hair thoroughly and repeat the procedure. Leave the shampoo in contact with the scalp for a total of 3 to 5 minutes for the two applications combined.

The recommended duration of treatment is 4 weeks.

A mild shampoo may be used between applications of the 1,5 % ciclopirox olamine shampoo.

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

The 1,5 % ciclopirox olamine shampoo is for external use only.

Avoid contact with the eyes. CICLOPIROX OLAMINE VIATRIS shampoo may cause eye irritation. In case of accidental contact with the eyes, rinse with water.

The 1,5 % ciclopirox olamine shampoo may cause skin irritation. If irritation occurs and persists, discontinue treatment.

In rare cases, mainly in patients whose hair has been damaged by chemical agents (for example due to hair colouring) or in patients with grey or white hair, a change in hair colour has been observed.

Excipients

Polysorbate 80 (E433) may cause allergic reactions.

To date, there are no data on possible drug interactions. However, given the low level of systemic absorption, the occurrence of drug interactions is unlikely.

Pregnancy

There are no data on the use of ciclopirox olamine in pregnant women. Animal studies have not shown direct or indirect toxic effects on reproduction. However, there are not enough data regarding possible long-term effects on postnatal development (see section Preclinical safety).

As a precaution, it is preferable to avoid using CICLOPIROX OLAMINE VIATRIS shampoo during pregnancy.

Breast-feeding

It has not been established whether ciclopirox olamine is excreted in human breast milk. Therefore, breastfeeding women must not use CICLOPIROX OLAMINE VIATRIS shampoo.

Fertility

Animal studies in which ciclopirox olamine was administered orally or subcutaneously revealed no impairment of fertility.

The shampoo with 1,5 % ciclopirox olamine has no effect on the ability to drive vehicles and use machines.

Adverse reactions occurring either during clinical studies or spontaneously reported are presented in the table below. They are listed by organ class and by frequency, using the following conventions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to <1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000) and unknown frequency (when the frequency cannot be estimated from the available data):

*As these effects are also symptoms of the condition being treated, they will be considered adverse effects if an aggravation of symptoms is noted.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/.

In case of accidental ingestion, management in accordance with clinical indications is necessary and appropriate measures should be considered.

Pharmacotherapeutic class: antifungal for topical use, ATC code: D01AE14.

Ciclopirox olamine is an active antifungal (pyridone family) in vitro against Pityrosporum sp. (also known as Malassezia sp). These yeasts are considered the pathogenic agents responsible for dandruff and seborrheic dermatitis. Ciclopirox olamine has antibacterial activity against many gram-positive and gram-negative bacteria.

It also has anti-inflammatory activity due to inhibition of prostaglandin and leukotriene synthesis.

The shampoo containing 1,5 % ciclopirox olamine has antifungal activity in vivo against Malassezia sp.

The clinical effects of the antibacterial activity in seborrheic dermatitis are not determined.

Percutaneous absorption is very low after topical application of a cream containing 1 % ciclopirox olamine: 1,1 to 1,7 % of the applied dose was detected in the urine.

The potential risk of systemic absorption of the ciclopirox olamine contained in the rinse-off shampoo at 1,5 % ciclopirox olamine is very low.

Non-clinical data from conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenesis, and reproduction and developmental functions did not reveal any particular risk for humans.

3 years.

This medicine does not require any particular storage precautions.

No special requirements.