Nizoral 20mg/g shampoo 100g

Nizoral 20mg/g Shampoo is an antifungal treatment based on ketoconazole , indicated for the treatment of seborrheic dermatitis , dandruff and scalp infections caused by fungi and yeasts . Thanks to its targeted action, it helps eliminate flaking, itching and excess sebum, restoring the natural balance of the scalp.

Its delicate formulation allows for effective application without attacking the skin, making it suitable for frequent washing. Nizoral acts in depth to combat fungal proliferation and prevent relapses, ensuring healthier hair and a rebalanced scalp. The 100g format is ideal for prolonged and targeted treatment.

ACTIVE INGREDIENTS

Active ingredients contained in Nizoral 20mg/g shampoo 100g - What is the active ingredient in Nizoral 20mg/g shampoo 100g?

One gram of NIZORAL shampoo contains: Active ingredient: ketoconazole 20.00 mg. Excipient with known effect: 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 full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Nizoral 20mg/g shampoo 100g - What does Nizoral 20mg/g shampoo 100g contain?

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

DIRECTIONS

Therapeutic indications Nizoral 20mg/g shampoo 100g - Why is Nizoral 20mg/g shampoo 100g used? What is it used for?

Treatment of scalp infections involving the 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 SIDE EFFECTS

Contraindications Nizoral 20mg/g shampoo 100g - When should Nizoral 20mg/g shampoo 100g not be used?

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

DOSAGE

Quantity and method of taking Nizoral 20mg/g shampoo 100g - How to take Nizoral 20mg/g shampoo 100g?

Dosage Adults and adolescents over 12 years Treatment of dandruff: 2 times a week for 2-4 weeks. Treatment of seborrheic dermatitis: 2 times a week for 2-4 weeks. Paediatric population Children and adolescents under 12 years No clinical studies have been conducted to evaluate the safety and efficacy of NIZORAL shampoo in infants and children under 12 years. Method of administration Topical application to the scalp. Wash the affected areas with NIZORAL shampoo and leave for 3-5 minutes before rinsing. Usually, a handful of shampoo is sufficient for one wash.

CONSERVATION

Storage Nizoral 20mg/g shampoo 100g - How is Nizoral 20mg/g shampoo 100g stored?

Store at a temperature not exceeding 25°C.

WARNINGS

Warnings Nizoral 20mg/g shampoo 100g - About Nizoral 20mg/g shampoo 100g it is important to know that:

During treatment with NIZORAL shampoo, if administered simultaneously with 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 light quantity 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, systemic side effects are not to be expected following the use of the product, despite this, elderly patients, those with a history of liver disease and those previously treated with griseofulvin should be treated with great caution, interrupting the treatment if signs indicative of a hepatic reaction develop. Use of the medicine, especially if prolonged, may give rise to sensitization phenomena; in this case it is necessary to interrupt the treatment and consult the attending physician. Avoid contact with the eyes: in this case, rinse well with water. Important information about some of the ingredients: This medicinal product contains a fragrance (bouquet 2 perfume) which contains alpha-isomethyl ionone, amyl cinnamal, amyl cinnamyl alcohol, benzyl alcohol, benzyl benzoate, benzyl cinnamate, cinnamal, cinnamyl alcohol, citral, citronellol, eugenol, evernia prunastri (oak moss) extract, geraniol, hexyl cinnamal, hydroxycitronellal, limonene and linalool, which may cause allergic reactions. This medicinal product contains benzyl alcohol which may cause mild local irritation. This medicinal product contains benzoic acid which may cause local irritation. This medicinal product contains butylated hydroxytoluene which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

INTERACTIONS

Interactions Nizoral 20mg/g shampoo 100g - Which medicines or foods can modify the effect of Nizoral 20mg/g shampoo 100g?

No interaction studies have been performed.

SIDE EFFECTS

Like all medicines, Nizoral 20mg/g shampoo 100g can cause side effects - What are the side effects of Nizoral 20mg/g shampoo 100g?

The safety of NIZORAL shampoo has been 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 ≥1% were reported. The following table reports the adverse reactions that have been observed following the use of NIZORAL shampoo both during clinical studies and during post-marketing experience. The 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).

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. 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

Overdose Nizoral 20mg/g shampoo 100g - What are the risks of Nizoral 20mg/g shampoo 100g in case of 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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Nizoral 20mg/g shampoo 100g.

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 not detectable. Plasma levels are determined on the whole body after topical application of NIZORAL shampoo. There are no known risks associated with the use of NIZORAL shampoo during pregnancy and breastfeeding.

DRIVING AND USE OF MACHINERY

Taking Nizoral 20mg/g shampoo 100g before driving or using machines - Does Nizoral 20mg/g shampoo 100g affect driving or using machines?

NIZORAL shampoo does not alter the ability to drive vehicles or use machinery.