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Nizoral Anti-Dandruff Shampoo

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Nizoral™ Anti-Dandruff Shampoo

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Ketoconazole 2% w/w For excipients, see 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.

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.

4.3    Contraindications

Known hypersensitivity to ketoconazole or any of the excipients.

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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Nizoral Anti-Dandruff Shampoo, to prevent any potential rebound effect.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

4.7    Effects on ability to drive and use machines

None likely

4.8    Undesirable effects

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

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

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

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

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 25°C

6.5    Nature and contents of container

High-density polyethylene bottle containing 60ml or 100ml Nizoral AntiDandruff 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 15513/0312

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10/12/2010

10    DATE OF REVISION OF THE TEXT

08/07/2013