Nizoral 20mg/g shampoo 100g

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 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).

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS FOR USE

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 tearing, 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.