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DANDRAZOL 2% SHAMPOO

Active substance(s): KETOCONAZOLE / KETOCONAZOLE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Dandrazol 2% Shampoo

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION Ketoconazole 20mg/g. For excipients see 6.1

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PHARMACEUTICAL FORM Shampoo. Clear, pink solution.

4. 4.1

CLINICAL PARTICULARS Therapeutic indications Prevention and treatment of infections in which the yeast Pityrosporum is likely to be involved, such as dandruff, seborrhoeic dermatitis and pityriasis versicolor.

4.2

Posology and method of administration Adults and children: Shake the bottle well. Wash the hair or affected areas of the skin with Dandrazol 2% Shampoo. Leave in contact for 3-5 minutes before rinsing thoroughly. * Seborrhoeic dermatitis and dandruff: Treatment of: Use Dandrazol 2% Shampoo twice weekly for 2-4 weeks. Prophylaxis of: Use Dandrazol 2% Shampoo once every 1-2 weeks. * Pityriasis versicolor (POM product only): Treatment of: Use Dandrazol 2% Shampoo once daily for a maximum of 5 days.

Prophylaxis of: As patches of pityriasis versicolor become more apparent on exposure to the sun, Dandrazol 2% Shampoo may be used once daily for a maximum of 3 days in a single treatment course before exposure to sunshine.

4.3

Contraindications Hypersensitivity to ketoconazole or any of the other ingredients of the preparation.

4.4

Special warning and precautions for use To prevent a rebound effect after stopping prolonged treatment with topical corticosteroids, it is recommended to continue applying the topical corticosteroid together with Dandrazol 2% Shampoo and to subsequently and gradually withdraw the steroid therapy over a period of 2-3 weeks. Seborrhoeic dermatitis and dandruff are often 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.

4.5

Interaction with other medicinal products and other forms of interaction Topical corticosteroids: To prevent a rebound effect after stopping prolonged treatment with topical corticosteroids, it is recommended to continue applying the topical corticosteroid together with Dandrazol 2% Shampoo and to subsequently and gradually withdraw the steroid therapy over a period of 2-3 weeks.

4.6

Pregnancy and lactation Since no ketoconazole is detected in plasma following topical administration, pregnancy and lactation are not a contraindication for the use of Dandrazol 2% Shampoo.

4.7

Effects on ability to drive and use machines None known

4.8

Undesirable effects Seborrhoeic dermatitis and dandruff are often associated with increased hair shedding, and this has also been reported, although rarely, with the use of ketoconazole containing shampoos. As with other shampoos, a local burning sensation, itching, irritation and oily/dry hair may occur, but are rare, when using shampoos containing ketoconazole. In some patients with permanently waved, permed hair, use of ketoconazole containing shampoos results in loss of the curl. In rare instances, mainly in patients with chemically damaged hair or grey hair, discolouration of the hair has been observed.

4.9

Overdose 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.

5. 5.1.

PHARMACOLOGICAL PROPERTIES Pharmacodynamic Properties ATC Code: D01A C08 (Topical use). Ketoconazole is an imidazole-dioxolane antimycotic. Ketoconazole has a potent antimycotic activity against pathogenic dermatophytes and yeasts including Pityrosporum spp.

5.2.

Pharmacokinetic properties 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 410 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.

5.3.

Preclinical safety data 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.

6. 6.1

PHARMACEUTICAL PARTICULARS List of excipients Sodium laureth sulphate Disodium laureth sulphosuccinate 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

6.2

Incompatibilities None known

6.3

Shelf life 2 years Special precautions for storage Do not store above 25 C

6.4

6.5

Nature and contents of container White opaque HDPE bottle with PP closure. Pack sizes 60, 80, 100, 120, 125, 150ml (Dandrazol 2% Shampoo).

6.6

Instructions for use and handling No special instructions

7.

MARKETING AUTHORISATION HOLDER Transdermal Limited Grimwade Avenue Croydon Surrey CR0 5DJ United Kingdom

8.

MARKETING AUTHORISATION NUMBER PL 14308/0004

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30/01/2009

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DATE OF REVISION OF THE TEXT
13/07/2012

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Source: Medicines and Healthcare Products Regulatory Agency

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