Proctolyn Rectal Cream 30g,Proctolyn Crema Rettale 30g,Recordati spa

“Contraindications. Hypersensitivity to active substances or any of the excipients, tuberculosis, mycosis, herpes simplex, viral diseases with skin localization.
Dosage: Rectal cream is applied in an amount sufficient to cover the affected part, massaging gently and repeating the application 2-3 times a day.
The use of Proctolyn is not recommended for children under 12 years of age due to a lack of data on safety and effectiveness.
Active Ingredients:
1 gram of rectal cream contains 0.1 mg fluocinolone acetonide and 10 mg ketocaine hydrochloride (equivalent to 8.9 mg ketocaine). Excipients with known effects: one gram of rectal cream contains 1.5 mg of methyl parahydroxybenzoate, 0.5 mg of propyl parahydroxybenzoate, 70 mg of propylene glycol, 50 mg of stearyl alcohol, 50 mg of cetyl alcohol.
Excipients: citric acid rectal cream; menthol; methyl parahydroxybenzoate; propyl para-hydroxybenzoate; propylene glycol; stearyl alcohol; cetyl alcohol; Vaseline oil; sorbitan monostearate; polysorbate 60; purified water.
Storage:
Does not require special storage conditions.
Warnings:
Topical use of cortico in excessive doses and for prolonged periods may result in systemic absorption. The use, especially in case of long-term use, of topical products may cause sensitization phenomena. If skin infection is present, appropriate covering therapy should be instituted. The product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed ones). This medicine also contains stearyl alcohol and cetyl alcohol, which may cause local skin reactions (eg contact dermatitis). Due to the presence of propylene glycol, the product may cause skin irritation.
Undesirable effects:
During topical cortisone therapy, especially for intensive and long-term treatment, the following side effects may occur: burning sensation, itching, irritation.
Overdose: No cases of overdose have been registered.
Pregnancy and breastfeeding:
Topical use of cortico during pregnancy in laboratory animals may cause disturbances in fetal development. There is insufficient data on the use of fluocinolone acetonide in pregnant women. Therefore, the drug should be used only if necessary, after assessing the expected benefit to the mother in relation to the possible risk to the fetus. When administered systemically, cortico are excreted in breast milk. Topical cortico should be used with caution during breast-feeding.
Packaging: 30 g”