Proctosedyl - rectal cream for hemorrhoids treatment 20 g

Product Description

Active ingredients

Proctosedyl rectal cream 100 g of rectal cream contain: hydrocortisone acetate 1 g, amylein 1 g, benzocaine 1 g, esculin 1 g, benzalkonium chloride 5 mg. Proctosedyl suppositories Each suppository contains: hydrocortisone acetate 5 mg, benzocaine 50 mg, esculin 10 mg, benzalkonium chloride 0.1 mg. For the full list of excipients, see section 6.1.

Excipients

Rectal cream: cholesterol, liquid paraffin, macrogol 300, macrogol 1540, macrogol 4000, polysorbate 80, propylene glycol, talc, white soft paraffin, purified water. Suppositories: medium-chain glycerides, solid semi-synthetic glycerides (Witepsol E85, Witepsol H15).

Therapeutic indications

Symptomatic treatment of internal or external haemorrhoids, especially in the inflammatory phase. Anal itching.

Contraindications

Hypersensitivity to the active ingredients or to any of the excipients and in particular to benzocaine (and other anesthetics with a similar chemical structure) and to substances containing the para group (sulphonamides, promethazine, etc.); tubercular and viral infections of the area to be treated.

Dosage

Rectal cream For endorectal and perianal applications. Apply the ointment twice a day in acute forms; space the applications out thereafter, depending on the evolution of the symptoms. Suppositories 1–2 suppositories per day. Use only for short periods of treatment.

Warnings and precautions

Use the minimum effective dosage. Case reports suggest that the administration of products containing benzocaine may cause methemoglobinemia due to excessive benzocaine absorption, particularly in children and the elderly. Symptoms such as cyanosis (pallor, grayish or bluish discoloration of the skin, lips, and nail beds), headache, dizziness, dyspnea (shortness of breath), fatigue, and tachycardia occurring during treatment may indicate potentially life-threatening methemoglobinemia and require immediate medical attention (see section 4.9). Topical application of corticosteroids in excessive doses and for prolonged periods may result in generalized reactions from systemic absorption (Cushing's syndrome, inhibition of the pituitary-adrenal axis). Therefore, once a favorable clinical effect has been achieved, it is necessary to minimize the frequency of application and dosage, discontinuing the product as soon as possible. In any case, it is necessary to limit the use of topical steroids to short periods of time. Also use with appropriate caution in subjects with damaged mucous membranes that could cause excessive absorption of the active ingredients. Corticosteroids can be applied to infected areas only if preceded or accompanied by appropriate antibacterial or antifungal therapy. If therapy is unsuccessful, treatment must be suspended and the infection adequately treated with other measures.

Interactions

No interaction studies have been performed.

Undesirable effects

Undesirable effects are classified according to the MedDRA System Organ Class. Systemic disorders and conditions related to the administration site: Hypersensitivity reactions may occur locally with edema, redness, and itching. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as 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 national reporting system of the Italian Medicines Agency. Website: www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

During pregnancy and/or breastfeeding, the medicine should be used only if necessary, after weighing the expected benefit for the mother against the possible risk to the fetus.