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NIZORAL DANDRUFF SHAMPOO

Active substance(s): KETOCONAZOLE

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SUMMARY OF PRODUCT CHARACTERISTICS

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.
Method of administration
For topical administration

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it is recommended that the steroid therapy be gradually withdrawn over a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

4.6

Interaction with other medicinal products and other forms of interaction
None Known
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

4.8

Effects on ability to drive and use machines
None likely
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
Rare
(≥1/10,000 and <1/1,000)
(≥1/1,000 to <1/100)

Immune System
disorders
Nervous System
Disorders

Hypersensitivity
Dysgeusia

Infections and
Infestations

Folliculitis

Eye Disorders

Increased lacrimation

Skin and Subcutaneous
Tissue Disorders

General Disorders and
Administration Site
Conditions

Not Known

Alopecia
Dry skin
Hair texture abnormal
Rash
Skin burning sensation
Application site erythema
Application site irritation
Application site pruritus
Application site reaction

Eye irritation

Acne
Dermatitis contact
Skin disorder
Skin exfoliation

Angioedema
Urticaria
Hair colour
changes

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 on the scalp. Plasma levels were detected
after topical administration of Nizoral 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.

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 25ºC

6.5

Nature and contents of container
High-density polyethylene bottle containing 60ml, 100ml or 120ml Nizoral
Dandruff Shampoo
Not all pack sizes may be marketed

6.6

Special precautions for disposal
Not applicable

7

MARKETING AUTHORISATION HOLDER
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire
SL6 3UG
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 15513/0311

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
10/12/2010

10

DATE OF REVISION OF THE TEXT
13/06/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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