Core Safety Profile – Ketoconazole Shampoo 1% - October 2010

CORE SAFETY PROFILE

Consisting of sections 4.3 – 4.9

Ketoconazole Shampoo 1%


NAME OF THE MEDICINAL PRODUCT

Ketoconazole Shampoo 1% MEDIC BLUE

4.3 Contraindications

Ketoconazole Shampoo 1% is contraindicated in individuals with a known hypersensitivity to any of its ingredients.

4.4 Special warnings and precautions for use

As with other shampoos, avoid contact with the eyes. If this happens, however, rinse the eyes with water.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Pregnancy and lactation

There are no adequate and well-controlled studies in pregnant or lactating women. Plasma concentrations of ketoconazole were not detectable after topical administration of Ketoconazole Shampoo 1% to the scalp of non-pregnant humans. There are no known risks associated with the use of Ketoconazole Shampoo 1% in pregnancy or lactation.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8  Undesirable effects

The safety of Ketoconazole Shampoo 1% was evaluated in 1258 subjects who participated in 8clinical trials. Ketoconazole Shampoo 1% was administered topically to the scalp. Based on pooled safety data from these clinical trials, the most commonly reported (≥1% incidence) adverse drug reactions (ADRs) were (with % incidence): hair texture abnormal (2.4%) and application site pruritus (1.8%).

Including the above- ADRs the following table displays ADRs that have been reported with the use of Ketoconazole Shampoo 1% from either clinical trial or postmarketing experiences. The displayed frequency categories use the following convention:

Very common (³1/10); common (³1/100 to <1/10); uncommon (³1/1,000 to <1/100); rare (³1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated form the available clinical trial data).

System Organ Class / Adverse Drug Reactions /
Frequency Category /
Common
(³1/100to<1/10) / Uncommon
(³1/1,000to<1/100) / NotKnown /
Immune System Disorders / Hypersensitivity
Eye Disorders / Conjunctivititis
Eye irritation
Skin and Subcutaneous Tissue Disorders / Hair texture abnormal / Acne
Hair colour changes
Skin burning sensation
Skin exfoliation / Contact dermatitis
Rash generalised
Urticaria
General Disorders and Administration Site Conditions / Application site pruritus / Application site alopecia
Application site dryness
Application site hyperaesthesia
Application site folliculitis
Application site irritation
Application site pustules
Application site rash
Application site reaction
Application site tenderness

4.9 Overdose

In the event of accidental ingestion, supportive and symptomatic measures should be carried out. To avoid aspiration, emesis or gastric lavage should not be performed.

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