This information is intended for use by health professionals

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 or affected areas of the skin with the Shampoo. Leave in contact for 3-5 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 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-Dandruff Shampoo.

4.7 Effects on ability to drive and use machines

None known

4.8 Undesirable effects

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

System Organ Class

Adverse Drug Reactions

Frequency Category

Uncommon

(≥1/1,000 to <1/100)

Rare

(≥1/10,000 and <1/1,000)

Not Known

Immune System disorders

Hypersensitivity

Nervous System Disorders

Dysgeusia

Infections and Infestations

Folliculitis

Eye Disorders

Increased lacrimation

Eye irritation

Skin and Subcutaneous Tissue Disorders

Alopecia

Dry skin

Hair texture abnormal

Rash

Skin burning sensation

Acne

Dermatitis contact

Skin disorder

Skin exfoliation

Angioedema

Urticaria

Hair colour changes

General Disorders and Administration Site Conditions

Application site erythema

Application site irritation

Application site pruritus

Application site reaction

Application site hypersensitivity

Application site pustules

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.

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 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.

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 Special precautions for disposal and other handling

No special instructions

7. Marketing authorisation holder

Transdermal Limited

Merlin House

Brunel Road

Theale

Reading RG7 4AB

United Kingdom

8. Marketing authorisation number(s)

PL 14308/0006

9. Date of first authorisation/renewal of the authorisation

30/01/2009

10. Date of revision of the text

15/11/2019