NIZORAL Shampoo Ref.[6933] Active ingredients: Ketoconazole

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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Nizoral 2% shampoo, to prevent any potential rebound effect.

Keep out of the eyes. If the shampoo should get into the eyes, they should be bathed with water.

No interaction studies have been performed.

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 Ketoconazole Shampoo 2% to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of Ketoconazole Shampoo 2% on the whole body. There are no known risks associated with the use of Ketoconazole Shampoo 2% in pregnancy or lactation.

Not relevant.

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).

Immune System disorders

Rare: Hypersensitvity

Nervous System Disorders

Rare: Dysgeusia

Infections and Infestations

Uncommon: Folliculitis

Eye Disorders

Uncommon: Increased lacrimation

Rare: Eye irritation

Skin and Subcutaneous Tissue Disorders

Uncommon: Alopecia, Dry skin, Hair texture abnormal, Rash, Skin burning sensation

Rare: Acne, Dermatitis contact, Skin disorder, Skin exfoliation

Not Known: Angioedema, Urticaria, Hair colour changes

General Disorders and Administration Site Conditions

Uncommon: Application site erythema, Application site irritation, Application site pruritus, Application site reaction

Rare: 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.