NIZORAL SHAMPOO FL 100G 20MG/G

NIZORAL 20 MG/G SHAMPOO

active ingredients

A gram of NIZORAL shampoo contains: Active ingredient: ketoconazole 20,00 mg. For the full list of excipients see paragraph 6.1.

Excellent

Sodium lauril ether sulphate; lauril semi-sulphurized bisodic; coconutyldiethanolamide; hydrolyzed laurdimonium (animal paste); macrogol 120 methylglucose dioleate; perfume; imidazolidinilurea; hydrochloric acid; sodium chloride; hydroxide sodium; erythrosine; purified water.

Therapeutic indications

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

Contraindications

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

Population

Population Adults and teenagers with more than 12 years Drill 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 teenagers under 12 years old Clinical studies have not been carried out to assess the safety and effectiveness of NIZORAL shampoo in infants and children under 12 years. Method of administration Topical application on scalp. Wash the affected areas with NIZORAL shampoo and let it act for 3-5 minutes before rinsing. Usually, a handful of shampoos is enough for a washing.

Conservation

Store at a temperature not exceeding 25°C.

Warnings

During treatment with NIZORAL shampoo, if administered at the same time to a topical corticosteroid, to prevent the rebound effect after suspension of a prolonged treatment with topical corticosteroids, it is recommended to continue the application of a slight amount of corticosteroids by progressively reducing it until suspending the application of corticosteroids in a period of 2-3 weeks. Due to the lack of percutaneous absorption of ketoconazole, systemic side effects should not be expected as a result of the use of the product, despite this, elderly patients, those with positive anamnesis for liver disease and those previously treated with griseofulvina, interrupting the treatment in case indicative signs of a liver reaction develop. The long-term use of the medicinal product may give rise to sensitization phenomena; in such case it is necessary to stop treatment and consult the attending physician. Avoid contact with eyes: in this case, rinse well with water.

Interactions

No interaction studies have been carried out.

Effects

Safety NIZORAL shampoo has been evaluated in 2890 subjects who participated in 22 clinical studies. NIZORAL shampoo has been administered at a topical level on scalp and/or skin. According to the safety data collected during these clinical trials, no adverse reactions with an incidence of ≥1% were reported. The following table shows the adverse reactions that have been detected following the use of NIZORAL shampoo both during clinical studies and during postmarketing experience. The frequencies are given according to the following conventional classification: Very common (≥ 1/10); Common (≥ 1/100 and Diseases of the nervous system Not common Disgeus Infections and infestations Not common Follicle Pathologies of the eye Not common Increased tearing, eye irritation Pathologies of skin and subcutaneous tissue Not common Alopecia, dry skin, abnormal hair structure, rash, burning sensation, acne, contact dermatitis, skin exfoliation, skin disorders. Notable Orticaria, alteration of hair color, eczema, angioedema. Systemic pathologies and conditions for administration Not common Erythema when applied, irritation when applied, itching when applied, reaction when applied, hypersensitivity when applied, pustula when applied. Immune system disorders Not common Hypersensitivity Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No known overdose cases. The poor percutaneous absorption of the drug makes it unlikely to occur symptoms and overdose signs. In case of accidental ingestion take support and symptomatic measures; to avoid the aspiration of the product do not cause vomiting and do not make gastric lavender.

There are no suitable clinical studies on pregnant or nursing women. After topical application of NIZORAL shampoo on 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 associated risks known with the use of NIZORAL shampoo during pregnancy and nursing.

Source: Farmadati