Spendor 2% shampoo 120 ml - dermatitis and dandruff

Product Description

Medical shampoo for dermatitis

Indications

Spendor is a medicinal shampoo useful in the treatment of seborrheic dermatitis and Pityriasis capitis (dandruff).

Composition

Active ingredients

Each g of shampoo contains: ketoconazole 20 mg

Excipient with known effects: ponceau 4R (E 124). For the full list of excipients, see section 6.1.

Excipients

Sodium lauryl ether sulfate Disodium monolauryl ether succinate Macrogol 120 (methyl glucose dioleate) Macrogol 7 (Glyceryl cocoate) Imidurea Lauryl diimmonium hydroxypropyl hydrolysate of animal collagen Coconut fatty acid diethanolamide Sodium hydroxide Sodium chloride Ponceau 4 R (E 124) Concentrated hydrochloric acid Purified water

Directions for use and Dosage

For cutaneous use only. Ketoconazole shampoo is used in adolescents and adults. Massage the scalp well with the shampoo and wash after 3-5 minutes. Adults and adolescents: The hair should be treated twice a week for 2-4 weeks. Prophylaxis: Once a week or every week to prevent the recurrence of symptoms. Treatment monitoring: In case of long-term treatment with local corticosteroids, a rebound phenomenon may sometimes occur. To prevent this phenomenon, it is recommended to gradually discontinue the use of the corticosteroid, e.g., over 2-3 weeks, while simultaneously initiating the use of Spendor 2% shampoo.

Warnings

Read the package leaflet carefully before starting treatment.

Both seborrheic dermatitis and dandruff have often been associated with hair loss, and this has also been reported, although rarely, with the use of ketoconazole shampoo. Avoid contact with eyes. If the shampoo comes into contact with your eyes, rinse thoroughly with water. To prevent any possible rebound effect in patients undergoing prolonged treatment with topical corticosteroids, it is recommended to gradually discontinue steroid therapy over a period of 2-3 weeks while using 2% ketoconazole shampoo. SPENDOR contains the colorant Ponceau 4R (E 124), which may cause allergic reactions.

Pregnancy and breastfeeding

Pregnancy: There are insufficient data on the use of ketoconazole in pregnant women. Animal studies have shown reproductive toxicity at high oral doses, which indicates a harmful effect of ketoconazole on the development of the fetus. Plasma concentrations of ketoconazole are not detectable after topical administration of 2% ketoconazole shampoo to the scalp of non-pregnant women. Plasma levels have been detected after topical administration of 2% ketoconazole shampoo to the whole body. There are no known risks associated with the use of ketoconazole shampoo 2% during pregnancy.

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

Storage

Do not store above 25°C.

Format

120 ml bottle