GSL: General Sales Licence
This information is intended for use by health professionals
Nizoral™ anti-dandruff Shampoo
Ketoconazole 2% w/w.
For full list of excipients, see section 6.1.
Pink viscous shampoo
In the prevention and treatment of the scalp condition dandruff.
Adults and adolescents aged over 12:
Wash affected areas and leave for 3 to 5 minutes before rinsing.
Wash the hair every 3 or 4 days for 2 to 4 weeks.
Use once, every 1 to 2 weeks.
Do not use more often than directed.
The safe and effective use of Nizoral anti-dandruff Shampoo in infants and children under the age of 12 years has not been established.
Method of administration
For topical administration. Usually, a palmful of shampoo suffices for one wash.
Known hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Keep out of the eyes. If the shampoo should get into the eyes, they should be bathed with water.
In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Nizoral anti-dandruff Shampoo, to prevent any potential rebound effect.
If the scalp has not cleared within 4 weeks, a doctor or pharmacist should be consulted.
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 Nizoral anti-dandruff Shampoo to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of Nizoral anti-dandruff Shampoo on the whole body. There are no known risks associated with the use of Nizoral anti-dandruff Shampoo in pregnancy or lactation.
The safety of Nizoral Anti-Dandruff Shampoo was evaluated in 2890 subjects who participated in 22 clinical trials. Nizoral Anti-Dandruff Shampoo was administered topically to the scalp and/or skin. Based on pooled safety data from these clinical trials, there were no ADRs reported with an incidence ≥1%.
The following table displays ADRs that have been reported with the use of Nizoral Anti-Dandruff Shampoo from either clinical trial or postmarketing 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
(≥1/1,000 to <1/100)
(≥1/10,000 and <1/1,000)
Immune System disorders
Nervous System Disorders
Infections and Infestations
Skin and Subcutaneous Tissue Disorders
Hair texture abnormal
Skin burning sensation
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 reactionsReporting 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
In the event of accidental ingestion, supportive and symptomatic 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: D01AC08
Ketoconazole is a synthetic 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.
Plasma concentrations of ketoconazole were not detectable after topical administration of NIZORAL® SHAMPOO 2% on the scalp. Plasma levels were detected after topical administration of NIZORAL® SHAMPOO 2% on the whole body.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Sodium lauryl ether sulphate
Disodium monolauryl ether sulphosuccinate
Coconut fatty acid diethanolamide
Laurdimonium hydrolysed animal collagen
Macrogol 120 methyl glucose dioleate
Concentrated hydrochloric acid
Erythrosine sodium (E127)
Store below 25°C
High-density polyethylene bottle containing 60 ml or 100 ml Nizoral anti-dandruff Shampoo.
Not all pack sizes may be marketed.
Thornton & Ross Ltd.,
HD7 5QH, UK