Dandrazol Anti-Dandruff Shampoo

Prevention and treatment of dandruff.

Adults and Adolescents aged over 12:

For use in adults and children over 12 years.

Shake the bottle well. Wash the hair or affected areas of the skin with the Shampoo. Leave in contact for 3-5 minutes before rinsing thoroughly.

Do not use more than directed.

Paediatric population

Safe and effective use in infants and children under the age of 12 years has not been established.

Method of administration

For topical administration.

Known hypersensitivity to the active substance ketoconazole or to any of the excipients listed in section 6.1.

To prevent a rebound effect after stopping prolonged treatment with topical corticosteroids, it is recommended to continue applying the topical corticosteroid together with ketoconazole 2% shampoo and to subsequently and gradually withdraw the steroid therapy over a period of 2-3 weeks.

Dandruff is associated with increased hair shedding, and this has also been reported, although rarely, with the use of ketoconazole containing shampoos (see Undesirable Effects).

Keep out of the eyes. If the shampoo should get into the eyes, they should be bathed with cold water.

If the scalp has not cleared within 4 weeks, a doctor or pharmacist should be consulted.

This medicine contains 380 mg sodium laureth sulfate in 1 g. Sodium laureth sulfate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area.

None known

Since no ketoconazole is detected in plasma following topical administration to the scalp, pregnancy and lactation are not a contra-indication for the use of ketoconazole 2% shampoo.

There are no adequate and well-controlled studies in pregnant or lactating women. Data on a limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole on pregnancy or on the health of the foetus/newborn child. Animal studies have shown reproductive toxicity at doses that are not relevant to the topical administration of ketoconazole. No effects on the breastfed newborn/infant are anticipated. See Pharmacokinetic properties, section 5.2.

Plasma concentrations of ketoconazole were not detectable after topical administration of ketoconazole 2% shampoo to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of ketoconazole 2% shampoo on the whole body. There are no known risks associated with the use of ketoconazole 2% shampoo in pregnancy or lactation.

None known

The following table displays ADRs that have been reported with the use of Ketoconazole 2% Shampoo from either clinical trial or post marketing experiences. The displayed frequency categories use the following convention:

Very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available clinical trial data).

Table 1: Adverse Drug Reactions

Reporting of suspected adverse reactions

Reporting suspected adverse reactions 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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

In the event of accidental ingestion, only supportive measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.

Pharmacotherapeutic group: Imidazole and triazole derivatives.

ATC Code: D01A C08 (Topical use).

Ketoconazole is an imidazole-dioxolane antimycotic, active against yeasts, including Malassezia and dermatophytes. Its broad spectrum of activity is already well known.

Ketoconazole also has a direct anti-inflammatory action independent from its antifungal activity which may contribute to symptom relief in dandruff and seborrhoeic dermatitis.

Ketoconazole does not appear to be appreciably absorbed systemically following topical application of a 2% shampoo to skin. Ketoconazole was not detected in plasma of patients receiving topical application of 2% shampoo 4-10 times weekly for 6 months, or in patients using 2% shampoo 2-3 times weekly for an average of 16 months. Following a single topical application, substantial amounts of the drug were detected in hair 12 hours after application; however only 5% of the applied ketoconazole was detected in hair keratin. Following repeated (twice weekly for 2 months) application, 20% of the applied dose was detected in hair keratin.

In vitro studies using ketoconazole in a microbial system (i.e., Ames test) have not shown the drug to be mutagenic. In addition, there was no evidence of mutagenicity in any stage of germ cell development in a dominant lethal mutation test in mice who received single oral doses of ketoconazole as high as 80 mg/kg. There was no evidence of carcinogenicity in a long-term feeding study in mice and rats. Hepatotoxicity featured prominently in high dose toxicology studies in animals and occurs in about 1 in 10,000 patients.

Sodium laureth sulfate

Disodium laureth sulfosuccinate

PEG-120 Methyl glucose dioleate

PEG-7-Glyceryl Cocoate

Imidurea

Lauryldimonium hydroxypropyl hydrolysed collagen

Cocamide DEA

Sodium hydroxide

Sodium chloride

Erythrosine C.I. 45430 (E127)

Hydrochloric acid concentrated

Purified water

None known

2 years

Do not store above 25 ° C

White opaque HDPE bottle with PP closure.

Pack sizes 60, 80, 100ml.

No special instructions.