Summary of Product Characteristics (SmPC) - Nizoral Anti-dandruff shampoo
1 NAME OF THE MEDICINAL PRODUCT
Nizoral™ Anti-Dandruff Treatment 2%w/w Shampoo
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ketoconazole 2% w/w.
Excipient(s) with known effect:
Sodium lauryl ether sulfate 24% 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 condition dandruff.
4.2 Posology and method of administration
For topical administration.
Ketoconazole shampoo 2% is for use in adolescents and adults: Wash affected areas and leave for 3-5 minutes before rinsing. Usually, a palmful of shampoo suffices for one wash.
Treatment:
Dandruff and seborrhoeic dermatitis: Wash hair twice weekly for 2-4 weeks.
Tinea versicolor: Once daily for a maximum of 5 days.
Prophylaxis:
Dandruff and seborrhoeic dermatitis: Use once every 1-2 weeks.
Tinea versicolor: Once daily for a maximum of 3 days before exposure to sunshine.
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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Nizoral anti-dandruff treatment 2%w/w Shampoo, to prevent any potential rebound effect.
If the scalp has not cleared within 4 weeks, a doctor or pharmacist should be consulted.
Excipient warnings:
This medicine contains 24% w/w sodium lauryl ether sulfate in each application. Sodium lauryl ether sulfate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area.
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 anti-dandruff treatment 2%w/w Shampoo to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of Nizoral anti-dandruff treatment 2%w/w Shampoo on the whole body. There are no known risks associated with the use of Nizoral anti-dandruff treatment 2%w/w Shampoo in pregnancy or lactation.
4.7 Effects on ability to drive and use machines
None likely
4.8 Undesirable effects
The safety of ketoconazole 2% shampoo was evaluated in 2890 subjects who participated in 22 clinical trials. Ketoconazole 2% 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 Ketoconazole 2% 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)
Not known (cannot be estimated form the available clinical trial data).
| 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 | Hypersensitvity | ||
| 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 |
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, 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 Anti-Dandruff Treatment 2%w/w Shampoo on the scalp. Plasma levels were detected after topical administration of Nizoral Anti-Dandruff Treatment 2%w/w Shampoo 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.
| General Disorders and Administration Site Conditions | Application site erythema Application site irritation Application site pruritus Application site reaction | Application site hypersensitivity Application site pustules |
6.1 List of excipients
Sodium lauryl ether sulfate 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 25ºC
6.5 Nature and contents of container
High-density polyethylene bottle containing 60ml or 100ml Nizoral Anti-Dandruff Treatment 2%w/w Shampoo Not all pack sizes may be marketed
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
Thornton & Ross Ltd.,
Linthwaite, Huddersfield,
HD7 5QH,
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 00240/0453
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
10/12/2010
10 DATE OF REVISION OF THE TEXT
17/08/2023