Nizoral 20mg/g shampoo 100g

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Treatment of scalp infections involving yeast Malassezia (formerly called Pityrosporum), such as localized seborrheic dermatitis and pityriasis capitis (dandruff). NIZORAL shampoo can be used by adults and adolescents (12-18 years).

ACTIVE INGREDIENTS

One gram of NIZORAL shampoo contains: Active ingredient: ketoconazole 20.00 mg. Excipient with known effects: each g of shampoo contains 2 mg of bouquet 2 perfume which contains 0.08 mcg of benzyl alcohol, 1.2 mcg of benzoic acid and 0.2 mcg of butylated hydroxytoluene. For the complete list of excipients see section 6.1.

EXCIPIENTS

Sodium lauryl ether sulfate; disodium monolaurylether sulfosuccinate; coccoyldiethanolamide; hydrolysed laurdimonium (animal collagen); macrogol 120 methylglucose dioleate; perfume bouquet 2; imidazolidinylurea; hydrochloric acid; sodium chloride; sodium hydroxide; erythrosine; purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

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

DOSAGE

Dosage Adults and adolescents over 12 years old Dandruff treatment: 2 times a week for 2-4 weeks. Treatment of seborrheic dermatitis: 2 times a week for 2-4 weeks. Pediatric population Children and adolescents under 12 years old No clinical studies have been carried out to evaluate the safety and effectiveness of NIZORAL shampoo in infants and children under 12 years of age. Method of administration Topical application on the scalp. Wash the affected areas with NIZORAL shampoo and leave for 3-5 minutes before rinsing. Usually, a handful of shampoo is enough for one wash.

CONSERVATION

Store at a temperature not exceeding 25°C.

WARNINGS

During treatment with NIZORAL shampoo, if administered simultaneously with a topical corticosteroid, to prevent the rebound effect after suspension of prolonged treatment with topical corticosteroids, it is recommended to continue the application of a light amount of corticosteroids, gradually reducing it until the application of corticosteroids is suspended over a period of 2-3 weeks. Given the poor percutaneous absorption of ketoconazole, no systemic side effects are to be expected following the use of the product, despite this, elderly patients, those with a positive history of liver disease and those already previously treated with griseofulvin should be treated with great caution, interrupting treatment if signs indicative of a liver reaction develop. The use of the medicine, especially if prolonged, can give rise to sensitization phenomena; in this case it is necessary to stop treatment and consult your doctor. Avoid contact with eyes: in this case, rinse well with water. Important information about some excipients: This medicine contains a fragrance (bouquet 2 perfume) which in turn contains alpha-isomethyl ionone, amyl cinnamale, amyl cinnamal alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, cinnamale, cinnamyl alcohol, citral, citronellol, eugenol, evernia prunastri (oakmoss) extract, geraniol, hexyl cinnamale, hydroxycitronellal, limonene and linalool, which may cause allergic reactions. This medicine contains benzyl alcohol which may cause mild local irritation. This medicine contains benzoic acid which may cause local irritation. This medicinal product contains butylated hydroxytoluene which may cause localized skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

INTERACTIONS

No interaction studies have been performed.

SIDE EFFECTS

The safety of NIZORAL shampoo was evaluated in 2890 subjects who participated in 22 clinical studies. NIZORAL shampoo was administered topically to the scalp and/or skin. Based on the safety data collected during these clinical studies, no adverse reactions with an incidence of ≥1% were reported. The following table reports the adverse reactions that were detected following the use of NIZORAL shampoo both during clinical studies and during postmarketing experience. Frequencies are reported according to the following conventional classification: Very common (≥ 1/10); Common (≥ 1/100 and < 1/10); Uncommon (≥ 1/1,000 and <1/100); Rare (≥ 1/10,000 and <1/1,000); Very rare (< 1/10,000); Not known (frequency cannot be estimated from the available clinical data).

Nervous system disorders.

Uncommon: Dysgeusia.

Infections and infestations.

Uncommon: Folliculitis.

Eye pathologies.

Uncommon: Increased lacrimation, eye irritation.

Pathologies of the skin and subcutaneous tissue.

Uncommon: Alopecia, dry skin, abnormal hair texture, rash, burning sensation, acne, contact dermatitis, skin exfoliation, skin disorder.

Not known: Urticaria, hair discolouration, eczema, angioedema.

Systemic pathologies and conditions relating to the administration site.

Uncommon: Application site erythema, application site irritation, application site pruritus, application site reaction, application site hypersensitivity, application site pustules.

Immune system disorders.

Uncommon: Hypersensitivity

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance 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.

OVERDOSE

There are no known cases of overdose. The poor percutaneous absorption of the drug makes the occurrence of symptoms and signs of overdose unlikely. In case of accidental ingestion, adopt supportive and symptomatic measures; To avoid aspiration of the product, do not induce vomiting and do not perform gastric lavage.

PREGNANCY AND BREASTFEEDING

There are no adequate clinical studies in pregnant or breastfeeding women. After topical application of NIZORAL shampoo to the scalp of non-pregnant women, plasma concentrations of ketoconazole are undetectable. Plasma levels are determined on the entire body after topical application of NIZORAL shampoo. There are no known risks associated with the use of NIZORAL shampoo during pregnancy and breastfeeding.

EFFECTS ON DRIVING ABILITY

NIZORAL shampoo does not affect the ability to drive or use machines.