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Dandrazol Anti-Dandruff Shampoo

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Dandrazol Anti-Dandruff Shampoo

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Ketoconazole 20mg/g.

For excipients see 6.1

3.    PHARMACEUTICAL FORM

Shampoo.

Clear, pink solution.

4.    CLINICAL PARTICULARS

4.1.    Therapeutic indications

Prevention and treatment of dandruff.

4.2    Posology and method of administration

Adolescents and Adults:

Dandrazol Anti-Dandruff Shampoo is for use in adolescents and adults.

Shake the bottle well. Wash the hair with the Shampoo. Leave in contact for 35 minutes before rinsing thoroughly.

Treatment of: Use Dandrazol Anti-Dandruff Shampoo twice weekly for 2-4 weeks.

Prophylaxis of: Use Dandrazol Anti- Dandruff Shampoo once every 1-2 weeks.

Do not use more often than directed.

4.3. Contraindications

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

4.4.    Special Warnings 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 Anti-Dandruff 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.

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 Anti-Dandruff 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 contra-indication for the use of Dandrazol Anti-DandruffShampoo.

4.7.    Effects on ability to drive and use machines

None known

4.8 Undesirable effects

Dandruff is 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.

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 national reporting system in the United Kingdom: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

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. PHARMACOLOGICAL PROPERTIES

5.1. 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    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

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

6.2. Incompatibilities

None known

6.3    Shelf life

2 years

6.4    Special precautions for storage

Do not store above 25 °C

6.5 Nature and contents of container

White opaque HDPE bottle with PP closure. Pack sizes 60, 80, 100ml.

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 14308/0006

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

30/01/2009

10 DATE OF REVISION OF THE TEXT

27/07/2015