SPENDOR SHAMPOO 120ML 2%

SENDOR 2% SHAMPOO

active ingredients

Each g of shampoo contains: Active ingredient: ketoconazole 20 mg Excipient with known effects: ponceau 4R (E 124). For the full list of excipients, see paragraph 6.1.

Excellent

Sodium lauril ether sulphate Disodio monolauril etere succinate Macrogol 120 (methyl oleate glucose) Macrogol 7 (Gliceril cocoato) Imidurea Lauril diimmonium hydroxypropyl hydrolyte animal collagen Dietanolammide of coconut fatty acid Sodium hydroxide Sodium chloride Ponceau 4 R (E 124)

Therapeutic indications

Treatment of seborrheic dermatitis and Pityriasis capitis (forphore).

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1.

Population

Only for skin use. Ketoconazole shampoo is used in teenagers and adults. Massage the scalp well with shampoo and wash after 3-5 min. Adults and teenagers : Hair should be treated twice a week for 2-4 weeks. Profilassi: Once a week or every week to avoid symptoms. Treatment control: In the case of long-term treatment with local corticosteroids, sometimes the rebound phenomenon can occur. To prevent this phenomenon, it is recommended to gradually suspend the use of corticosteroid, e.g. more than 2-3 weeks, while the use of SPENDOR 2% Shampoo begins simultaneously.

Conservation

Do not store at temperature above 25°C.

Warnings

Both seborrhoic dermatitis and dandruff were often associated with hair loss and this was also found, although rarely, with the use of ketoconazole shampoo. Avoid contact with eyes. If the shampoo comes in contact with the eyes wash abundantly with water. To prevent any possible rebound effect in patients in prolonged treatment with topical corticosteroids, it is recommended to gradually suspend steroid therapy in a period of 2-3 weeks during use ketoconazole shampoo 2%. SPENDOR contains the coloring ponceau 4R (E 124), which can cause allergic reactions.

Interactions

The systemic absorption of ketoconazole applied topically is minimal and it is unlikely that there are systemic interactions with other medicines. To prevent the rebound effect after the suspension of prolonged treatment with topical corticosteroids, it is recommended to continue the application of topical corticosteroid along with ketoconazole shampoo and to suspend later and gradually steroid therapy in a period of 2-3 weeks.

Effects

The safety of ketoconazole shampoo 2% was assessed in 2.890 subjects who participated in 22 clinical studies. Ketoconazole shampoo 2% was administered by topical on scalp and/or skin. Based on the safety data collected in these clinical studies, adverse reactions with an incidence ≥1% were not reported. The following table shows the adverse reactions (ADR) that have been reported with the use of Ketoconazole Shampoo 2% both from clinical studies or post-marketing experience. In this paragraph, the frequencies of unwanted effects are defined as follows: very common (≥1/10); common (≥1/100, . Undesirable effects are expected in about 4% of patients.

Classification for Systems and organs	Town (≥1/100,	Not common (≥1/1.000,	Rare (≥1/10.000,	Notable (can not be defined according to the available data)
Infections and infestations		Follicle
Immune system disorders			Hypersensitivity
Diseases of the nervous system			Disgeus
Pathologies of the eye		Increased tearing	Eye irritation
Pathologies of skin and subcutaneous tissue	Local irritation, dry and fragile hair, hair loss	Dry skin, skin rash, skin burning sensation	Acne, hair discoloration, contact allergy, skin exfoliation, skin diseases	Angioedema, hives
Systemic pathologies and conditions for administration		Erythema in the place of application, irritation in the place of application, itching in the place of application, reaction in the place of application	Hypersensitivity in the place of application, pustula in the place of application

Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

It is not expected to overdose if ketoconazole shampoo 20 mg/g is used only at topical level. In case of accidental ingestion, only support and symptomatic measures must be used. To avoid aspiration it is necessary not to consider gastric washing or eemesi.

Pregnancy

: There is no sufficient data on the use of ketoconazole in pregnant women. Animal studies have shown a toxicity of reproduction at high oral doses, indicating a harmful effect of ketoconazole on the development of fetus. Plasma concentrations of ketoconazole are not detectable after topical administration of ketoconazole shampoo 2% on the scalp of non-pregnant women. Plasma levels have been 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.

Food

: There are no adequate and well-controlled studies in nursing women. Plasma concentrations of ketoconazole are not detectable after topical administration of ketoconazole shampoo 2% on the scalp of non-pregnant women. Plasma levels have been detected after topical administration of ketoconazole shampoo 2% on the whole body. There are no known risks associated with using ketoconazole 2% lactating shampoo.

Source: Farmadati