This information is intended for use by health professionals

1. Name of the medicinal product

Nizoral™ Dandruff Shampoo

2. Qualitative and quantitative composition

Ketoconazole 2% w/w.

For full list of excipients, see section 6.1.

3. Pharmaceutical form

Pink viscous shampoo.

4. Clinical particulars
4.1 Therapeutic indications

In the prevention and treatment of the scalp conditions dandruff and seborrhoeic dermatitis.

4.2 Posology and method of administration

Posology

Adults and adolescents aged over 12:

Wash affected areas and leave for 3 to 5 minutes before rinsing.

Treatment:

Wash the hair every 3 or 4 days for 2 to 4 weeks.

Prophylaxis:

Use once, every 1 to 2 weeks.

Do not use more often than directed.

Paediatric population

The safe and effective use of Nizoral 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.

4.3 Contraindications

Known hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Nizoral Dandruff Shampoo, to prevent any potential rebound effect.

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

None Known.

4.6 Fertility, pregnancy and lactation

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 Dandruff Shampoo to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of Nizoral Dandruff Shampoo on the whole body. There are no known risks associated with the use of Nizoral Dandruff Shampoo in pregnancy or lactation.

4.7 Effects on ability to drive and use machines

None likely.

4.8 Undesirable effects

The safety of Nizoral Dandruff Shampoo was evaluated in 2890 subjects who participated in 22 clinical trials. Nizoral 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 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

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

4.9 Overdose

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.

5. Pharmacological properties
5.1 Pharmacodynamic properties

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.

5.2 Pharmacokinetic properties

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.

5.3 Preclinical safety data

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.

6. Pharmaceutical particulars
6.1 List of excipients

Sodium lauryl ether sulphate

Disodium monolauryl ether sulphosuccinate

Coconut fatty acid diethanolamide

Laurdimonium hydrolysed animal collagen

Macrogol 120 methyl glucose dioleate

Sodium chloride

Concentrated hydrochloric acid

Imidurea

Sodium hydroxide

Erythrosine sodium (E127)

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

High-density polyethylene bottle containing 60 ml, 100 ml or 120ml Nizoral Dandruff Shampoo.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Not applicable.

7. Marketing authorisation holder

Thornton & Ross Ltd.,

Linthwaite, Huddersfield,

HD7 5QH, UK

8. Marketing authorisation number(s)

PL 00240/0452

9. Date of first authorisation/renewal of the authorisation

20/08/2008

10. Date of revision of the text

30/01/2019