Informations for option: Ketoconazole 2% Shampoo, show other option

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1. Ketoconazole 2% Shampoo
2. Ketoconazole 2% Shampoo

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Ketoconazole 20 mg/g Shampoo

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Ketoconazole 2 % (20 mg/g).

For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Shampoo.

Clear, reddish solution.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Treatment of seborrhoeic dermatitis in the scalp in adults and adolescents.

4.2    Posology and method of administration

For topical use.

The affected areas are to be washed with the shampoo and rinsed after 3-5 minutes.

Seborrhoeic dermatitis:

Treatment:    Twice weekly for 2-4 weeks.

Prophylaxis:    Once a week or every two weeks.

Ketoconazole shampoo 2 % is for use in adolescents and adults.

4.3    Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Seborrhoeic dermatitis is often associated with increased loss of hair which has also been reported -although in rare cases - in treatment with Ketoconazole shampoo. Avoid contact with 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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Ketoconazole Shampoo, to prevent any potential rebound effect.

4.5    Interaction with other medicinal products and other forms of interaction

The systemic absorption of topically applied ketoconazole is minimal and systemic interaction with other medicinal products is unlikely.

4.6    Fertility, pregnancy and lactation

There are no adequate and well-controlled studies in pregnant or lactating women. Studies in animals have shown reproductive toxicity in high doses, indicating that ketoconazole may cause harmful effects with respect to foetal development. However, 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.

Ketoconazole has not been found in plasma after chronic shampooing, and lactation may continue during treatment.

There are no known risks associated with the use of Ketoconazole shampoo in pregnancy or lactation.

4.7    Effects on ability to drive and use machines

Ketoconazole shampoo has no or negligible influence on the ability to drive and use machines.

4.8    Undesirable effects

The safety of ketoconazole shampoo 2% was evaluated in 2980 subjects who participated in 22 clinical trials. Ketoconazole shampoo 2% 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 adverse drug reactions (ADRs) that have been reported with the use of ketoconazole shampoo 2% 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 form the available clinical trial data).

System Organ Class	Adverse Drug Reactions
	Frequency Category
	Uncommon (> 1/1,000 to <1/100)	Not Known
Nervous System Disorders	Dysgeusia
Infections and Infestations	Folliculitis
Eye Disorders	Eye irritation Increased lacrimation
Skin and Subcutaneous Tissue Disorders	Acne Alopecia Dermatitis contact Dry skin Hair texture abnormal Rash Skin burning sensation Skin disorder Skin exfoliation	Urticaria Hair colour changes
General Disorders and Administration Site Conditions	Application site erythema Application site irritation Application site hypersensitivity Application site pruritus Application site pustules Application site reaction

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 (www.mhra.gov.uk/yellowcard).

4.9 Overdose

When Ketoconazole shampoo is only used for topical administration, no overdose is expected.

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.

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Imidazole derivates and triazole, ATC code: D 01 AC 08

The active substance of Ketoconazole shampoo is ketoconazole which is an imidazole compound.

Ketoconazole is an antimycotic with fungistatic effect on e.g. Trichophyton, Epidermophyton, Microsporum spp. and yeast fungi (Candida, Pityrosporum) when topically applied. Ketoconazole shampoo relieves itching and squamation, usually occuring in case of seborrhoeic dermatitis.

5.2 Pharmacokinetic properties

Percutaneous absorption of Ketoconazole shampoo is negligible since the concentration in the blood - even after long-term use - was below the detection limit of the analysis method (< 5 ng/ml). Therefore, no systemic effect is to be expected.

5.3 Preclinical safety data

There are no preclinial safety data considered relevant with regards to the assessment of the safety of topically applied ketoconazole.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium lauryl ether sulphate

Disodium monolauryl ether sulphosuccinate

Magrogol 120 methyl glucose dioleate

Macrogol 7 glyceryl cocoate

Imidurea

Laurdimonium hydroxypropyl hydrolysed animal collagen

Coconut fatty acid diethanolamide

Sodium hydroxide

Sodium chloride

Ponceau 4R (E124)

Hydrochloric acid, concentrated Purified water

23/11/2008

DATE OF REVISION OF THE TEXT

26/03/2014