KETOCONAZOLE CRISTERS 2 % Gel in single-dose sachet 8Sach

Gel at 2% (foaming) in sachet-dose.

Ketoconazole................................................................................................................................ 120 mg

for one sachet-dose of 6 g.

Excipient with known effect: sodium lauryl sulfate.

Excipients:

This medicine is indicated in adults and adolescents from 12 years of age, in:

• the treatment of seborrheic dermatitis,

• the treatment of Pityriasis versicolor.

The use of KETOCONAZOLE CRISTERS 2 %, gel in sachet-dose is reserved for adults and adolescents (≥ 12 years).

The safety and efficacy of KETOCONAZOLE CRISTERS 2 %, gel in sachet-dose have not been established in children under 12 years of age. No data are available.

Dosage

Seborrheic dermatitis

1 sachet is sufficient for one application.

During the first month of treatment, the dosage is usually 2 applications per week.

A maintenance treatment may be deemed necessary by the physician; it is usually one application per week or every two weeks depending on the results obtained.

Pityriasis versicolor

Single application (in one go) the contents of 4 sachets.

Method of administration

Cutaneous application to the scalp and/or skin.

Seborrheic dermatitis

• Thoroughly wet the affected areas of skin and/or scalp.

• Apply the contents of one sachet to the affected areas.

• Lather abundantly.

• Avoid contact with the eyes.

• Leave in place for 5 minutes. For good efficacy, it is important to respect this minimum duration.

• Then rinse the skin and/or scalp thoroughly, not just the hair.

Pityriasis versicolor

Open the sachet(s) before entering the shower.

• Thoroughly wet the body, including the scalp.

• Apply the content of 4 sachets to the entire surface of the body, including the scalp, optionally using a damp glove.

• Lather abundantly, applying firm pressure to the affected areas.

• Avoid contact with the eyes.

• Leave in place for 5 minutes. For good efficacy, it is important to respect this minimum duration.

• Then rinse the skin and scalp thoroughly, and not just the hair.

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

Special warnings

When using KETOCONAZOLE CRISTERS 2 %, gel in sachet-dose in patients who have received prolonged treatment with topical corticosteroids, it is recommended to gradually discontinue the corticosteroid therapy over a period of 2 to 3 weeks in order to avoid any potential rebound effect.

Precautions for use

Avoid contact with the eyes. In case of accidental contact with the eye, rinse with water.

Excipient with known effect

This medicine contains 540 mg of sodium lauryl sulfate per sachet-dose. Sodium lauryl sulfate may cause local skin reactions (such as a stinging or burning sensation) or increase skin reactions caused by other products when applied to the same area.

Given the low systemic exposure to ketoconazole after application of KETOCONAZOLE CRISTERS 2 %, gel in sachet-dose, it is unlikely that drug interactions are clinically significant.

Pregnancy

No effect of KETOCONAZOLE CRISTERS 2 %, gel in sachet-dose during pregnancy is expected since maternal systemic exposure is negligible. KETOCONAZOLE CRISTERS 2 %, gel in sachet-dose may therefore be used during pregnancy.

Breast-feeding

No effect of KETOCONAZOLE CRISTERS 2 %, gel in sachet-dose in breastfed newborns or infants is expected, since maternal systemic exposure is negligible.

KETOCONAZOLE CRISTERS 2 %, gel in sachet-dose may therefore be used during breastfeeding.

The tolerability of ketoconazole administered to the scalp and/or skin was evaluated in 2890 patients across 22 clinical trials. Based on the pooled tolerability data from these clinical trials, no adverse reaction with an incidence ≥ 1% was reported.

The adverse effects reported with ketoconazole, either during clinical studies or after marketing, are listed below by frequency category, according to 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 data).

System Organ Class	Adverse effects
	Frequency
	Uncommon (≥ 1/1 000 to <1/100)	Rare (≥ 1/10 000 to < 1/1000)	Not known
Immune system disorders		Hypersensitivity
Nervous system disorders		Dysgeusia
Infections and infestations	Folliculitis
Eye disorders	Increased lacrimation	Eye irritation
Skin and subcutaneous tissue disorders	Alopecia Dry skin Abnormal hair texture Rash Skin burning sensation	Acne Contact dermatitis Skin disorders Skin desquamation	Angioedema Urticaria Change in hair colour
General disorders and site abnormality of administration	Erythema at the application site Irritation at the application site Pruritus at the application site Reaction at the application site	Hypersensitivity at the site of application Pustules at the application site

 

Reporting of suspected adverse reactions

The reporting of suspected adverse effects after marketing authorisation of the medicine is important. It allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals report any suspected adverse effect via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/.

Ingestion

In case of accidental ingestion, treatment will be limited to supportive and symptomatic measures.

In order to avoid aspiration of gastric contents, do not perform gastric lavage or induced vomiting.

Pharmacotherapeutic class: Antifungal for topical use - imidazole and triazole derivatives, ATC code: D01AC08

Ketoconazole is an antifungal of the imidazole group. It has potent antifungal activity against:

• dermatophytes: in particular Trichophyton sp., Epidermophyton sp.., Microsporum sp.

• yeasts: in particular Candida sp. and Malassezzia furfur (Pityrosporum ovale).

In vitro and in vivo in animals, ketoconazole inhibits the synthesis of leukotrienes.

Plasma concentrations of ketoconazole are not detectable after local administration of ketoconazole to the scalp.

Low but occasionally measurable plasma levels (from 11 to 33 ng/ml with an assay detection limit of 5 ng/ml) were observed in 3 out of 6 patients with a Pityriasis versicolor after topical administration of ketoconazole over the entire body (estimated dose of 400 mg for 5 minutes).

Non-clinical data from conventional studies, including primary ocular or skin irritation, skin sensitisation and repeated-dose dermal toxicity, did not reveal any particular risk for humans.

Ketoconazole is teratogenic in rats by oral route from doses of 80 mg/kg; however, by dermal route the plasma concentrations of ketoconazole are 6000 times lower than those found by oral route for a dose of 40 mg/kg in rats.

18 months.

To be stored at a temperature not exceeding + 25°C.

No special requirements.

List I

Marketing authorisation (AMM)

CIP 3400938861457 (4 sachets). CIP 3400938861518 (8 sachets).

Price:

2,39 euros (4 sachets). 4,40 euros (8 sachets).

Social Security reimbursement at 30% (4 sachets, 8 sachets) in the indications:

• Pityriasis versicolor (4 sachets, 8 sachets)
• Seborrheic dermatitis (4Sach, 8Sach)

Collection.