SHAMPOO 125ML 10MG/G

NIZOBLUE 10 MG/G SHAMPOO

active ingredients

A gram of shampoo contains: Active ingredient: Ketoconazole 10 mg. Excipients with known effects: butylated hydroxytoluene (E321) 1.0 mg; benzyl alcohol 12.5 mg; methylparabene (E218) 0.01 mg; propylparabene (E216) 0.002 mg; 5 mg perfumed oil. For the full list of excipients, see paragraph 6.1.

Excellent

Sodium lauriletere sulphate, Citric acid, Sodium coconut, Coccoil monoethanolamide, Etilenglycol distearate, Poliquaternium-7 (contains methylparabene (E218) and propylparabene (E216)), Ipromellose, Tetrasodio edelato, Oil fragrant, Sodium chloride (per).

Therapeutic indications

Treatment of the affections of the scalp, such as dandruff, untuosity, itching.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. NIZOBLUE Shampoo 10 mg/g is contraindicated in individuals with known hypersensitivity to any of the ingredients. NIZOBLUE is contraindicated in children under 12 years of age.

Population

Spread on wet hair a small amount of NIZOBLUE and massage slightly. Let the product act 3 - 5 minutes, then rinse. It is recommended to perform treatment 2 - 3 times a week. The disappearance of symptoms usually occurs within 4^a week. Do not exceed the recommended doses.

Conservation

Please note: do not use the medicine after the expiry date indicated on the package.

Warnings

After prolonged treatment with corticosteroid on the scalp, before applying NIZOBLUE shampoo on the same skin area it is advisable to wait 15 days, or immediately start treatment with NIZOBLUE, continuing to apply corticosteroid in decreasing doses until the elimination of steroid therapy within 2 weeks. Given 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 treatment in case indicative signs of a liver reaction develop. The use, especially if prolonged, of the product can give rise to phenomena of sensitization; in such case it is necessary to stop the treatment. As with other shampoos, avoid contact with eyes. If this happens, rinse thoroughly with running water. Important information about some excipients: NIZOBLUE contains butylated hydroxytoluene (E321), methylparabene (E218), propylparabene (E216), benzyl alcohol and fragrant oil. Butylated hydroxytoluene (E321) can cause reactions on localized skin (e.g. contact dermatitis) or irritation to the eyes and mucosa. This medicine contains 12.5 mg of benzyl alcohol per g of shampoo. Benzyl alcohol can cause allergic reactions and mild local irritation. Methylparabene (E218) and propylparabene (E216), contained in the excipient polyquaternium-7, can cause allergic reactions (also delayed). This medicine contains a fragrance (scented oil) in turn containing alpha-isometil ionone, benzil alcohol, benzil benzoato, benzil salicylate, butilfenil methylpropional, citral, citronellol, cumarin, eugenol, geranium, hydroxycitronellal, isoeugenol, lemon and linalol. NIZOBLUE should not be used in children under 12 years of age.

Interactions

Crusade hypersensitivity or cross-sensitivity reactions may occur as a result of the contemporary use of antifungal preparations of the same class (miconazole, econazole, isoconazole).

Effects

The safety of NIZOBLUE shampoo 10 mg/g has been evaluated in 1258 subjects in 8 clinical studies in which NIZOBLUE shampoo 10 mg/g has been applied on the scalp. From the grouped data of these clinical trials it emerged that the most frequent pharmaco (ADR) Avverse reactions (≥ 1% of incidence) were: abnormal hair structure (2.4%) and itching to the application site (1.8%). Including the above ADRs, the following table shows the ADRs that were reported with the use of Ketoconazole shampoo 10 mg/g both during clinical studies and post-marketing experience. The frequencies are given according to the following conventional classification: very common (≥ 1/10), common (from ≥ 1/100 to Organic systemic classification   Adverse reactions to the Pharmaco   Frequency Town (≥1/100, Not common (≥1/1,000, Rare (≥1/10.000, Notable Immune system disorders     Joints Hypersensitivity Pathologies of the eye   Eye irritation     Pathologies of skin and subcutaneous tissue Abnormal hair structure Skin exfoliation Acne Changes in hair color Sensation of skin burning Contact dermatitis Angioedema Rash generalized Orticaria Systemic pathologies and conditions for administration Prurito to the application site Alopecia to the application site Drying to the application site Irritation to the application site Rash to the application site Hyperesthesia to the application site Follicolite to the application site Pustole to the application site Reaction to the application site Sensitivity to the application site   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

In case of accidental ingestion, support and symptomatic measures can be implemented. To avoid aspiration should not be induced emesis or practiced gastric lavender.

Pregnancy and nursing

: There are no controlled and adequate studies on the use of NIZOBLUE shampoos in pregnant women or nursing. Plasma concentrations of ketoconazole were not detected after the topical administration of Ketoconazole shampoo 10 mg/g to the scalp of non-pregnant women. Although no risks associated with the use of NIZOBLUE shampoo 10 mg/g during pregnancy or breastfeeding have been identified, it is necessary to be prudent to prescribe the medicine to pregnant women.

Source: Farmadati