KETONOVA SHAMPOO 120ML 20MG/G

KETONOVA 20 MG/G SHAMPOO

active ingredients

Ketoconazole 2% by weight (20 mg/g) For the full list of excipients, see paragraph 6.1

Excellent

Sodium lauril ethere sulfate Monolauril ethere succinato bisodic Macrogol-120 metilglucose dioleate Macrogol-7-glyceril coconut Imidurea Hydroxypropyl laurildimonium collagen hydrolyzed animal Fenossiethanol Potassium sorbate Dietanolamide of fatty acids

Therapeutic indications

Treatment of seborrheic skin dermatitis.

Contraindications

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

Population

For topical application. Wash the affected areas with shampoo and rinse after leaving it to act for 3-5 minutes. Patients aged 15 years: Seborrheic dermatitis: Treatment: Twice a week for 2-4 weeks. Profilassi: Once a week or every 2 weeks.

Conservation

Do not store at temperature above 25°C.

Warnings

Seborrheic dermatitis and dandruff are often associated with hair loss and this has been reported, although rarely, even with the use of KETONOVA 20 mg/g shampoo. In patients who have been in prolonged treatment with topical corticosteroids, it is recommended that steroid therapy be gradually suspended during a period of 2-3 weeks while using KETONOVA 20 mg/g shampoo, to prevent a potential rebound effect. Avoid contact with eyes. If the shampoo comes in contact with the eyes, these must be rinsed with water. Shampoo should not be used in children or adolescents under the age of 15.

Interactions

The systemic absorption of ketoconazole applied by topical means is minimal and systemic interaction with other medicinal products is unlikely.

Effects

The safety of KETONOVA shampoo 20 mg/g has been evaluated in 2,890 subjects who participated in 22 clinical studies. KETONOVA shampoo 20 mg/g has been administered topically on scalp and/or skin. Based on the safety data collected by these clinical trials, no adverse reactions were reported with an incidence ≥ 1%. The following table shows adverse drug reactions (ADRs) that have been reported with the use of KETONOVA shampoo 20 mg/g both from clinical studies and post-marketing experiences. The frequency categories displayed use the following convention: Very common (≥ 1/10), common (≥ 1/100, Classification for Systems and Organs Drug adverse reactions Frequency category Not common (≥ 1/1.000, Rare (≥1/10,000 to Notable Immune system disorders   Hypersensitivity   Diseases of the nervous system   Disgeus   Infections and infestations Follicle     Pathologies of the eye Increased tearing Irritation of the eye   Pathologies of skin and subcutaneous tissue Alopecia, dry skin, abnormal hair structure, rash, skin burning sensation Acne, contact dermatitis, skin disorders, skin exfoliation Angioedema, hives, changes in hair color Systemic pathologies and conditions for administration Erythema to the application site, irritation to the application site, itching to the application site, reaction to the application site Hypersensitivity to the application site, pustula to the application site   Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring 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/come-segnalare-una-sosp ect-reaction-adversa.

Overdosing

There are no overdose cases if you use KETONOVA 20 mg/g shampoo only by topical use. In case of accidental ingestion, only support measures must be taken. To avoid aspiration, you should not induce emesis or gastric lavender.

There are no adequate and well-controlled studies on pregnant or nursing women. Plasmatic concentrations of ketoconazole after topical administration of KETONOVA 20 mg/g shampoo on the scalp of unpregnant women. Plasma levels have been detected after topical administration of KETONOVA 20 mg/g shampoo throughout the body. There are no known risks associated with the use of KETONOVA 20 mg/g pregnant and nursing shampoo.

Source: Farmadati