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NIZORAL * SHAMPOO FL 100G 20MG / G

  • EG SpA
  • 024964140

Anti-dandruff shampoo based on ketoconazole.

Read the package leaflet.

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NIZORAL * SHAMPOO FL 100G 20MG / G

Therapeutic 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).

Dosage and method of use

Dosage Adults and adolescents over 12 years old Treatment of dandruff: 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 the age of 12 No clinical studies have been performed to evaluate the safety and efficacy 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.

Contraindications

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

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 safety data collected during these clinical studies, no adverse reactions with incidence ≥1 were reported%. The table below lists the adverse reactions that have been detected following the use of NIZORAL shampoo both during clinical trials and during post-marketing experience. Frequencies are reported according to the following conventional classification: Very common (≥ 1/10); Common (≥ 1/100 e

Nervous system disorders
Uncommon Dysgeusia
Infections and infestations
Uncommon Folliculitis
Eye disorders
Uncommon Increased lacrimation, eye irritation
Skin and subcutaneous tissue disorders
Uncommon Alopecia, dry skin, abnormal hair structure, rash, burning sensation, acne, contact dermatitis, skin exfoliation, skin disorders.
Not known Hives, hair discolouration, eczema, angioedema.
General disorders and administration site conditions
Uncommon Application site erythema, application site irritation, application site itching, application site reaction, application site hypersensitivity, application site pustules.
Disorders of the immune system
Uncommon Hypersensitivity

Reporting of suspected adverse reactions

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

Special warnings

During treatment with NIZORAL shampoo, if administered simultaneously with a topical corticosteroid, to prevent the rebound effect after discontinuation 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 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, nevertheless elderly patients, those with a history of liver disease and those already treated previously with griseofulvin, should be treated with great caution, stopping treatment if signs suggestive of a hepatic reaction develop. Especially if prolonged use of the medicine can give rise to sensitization phenomena; in this case it is necessary to interrupt the treatment and consult the attending physician. Avoid contact with eyes: in this case, rinse well with water.

Pregnancy and breastfeeding

There are no adequate clinical studies in pregnant or lactating women. After topical application of NIZORAL shampoo to the scalp of non-pregnant women, plasma concentrations of ketoconazole are not detectable. Plasma levels are determined on the whole body after topical application of NIZORAL shampoo. There are no known associated risks with the use of NIZORAL shampoo during pregnancy and breastfeeding.

Expiry and retention

Store at a temperature not exceeding 25 ° C.

Interactions with other drugs

No interaction studies have been performed.

Overdose

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

Active principles

One gram of NIZORAL shampoo contains: Active ingredient: ketoconazole 20.00 mg. For the full list of excipients see section 6.1.

Excipients

Sodium lauryl ether sulfate; disodium lauryl semisulfosuccinate; coconuthyldiethanolamide; hydrolyzed laurdimonium (animal collagen); macrogol 120 methylglucose dioleate; perfume; imidazolidinylurea; hydrochloric acid; sodium chloride; sodium hydroxide; erythrosine; purified water.

EG SpA
024964140
10 Items