Proctosedyl rectal cream 20g

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Symptomatic treatment of hemorrhoids, internal or external, especially in the inflammatory phases. Anal itching.

ACTIVE INGREDIENTS

Proctosedyl rectal cream: 100 g of rectal cream contains: hydrocortisone acetate 1 g, amylein 1 g, benzocaine 1 g, aesculin 1 g, benzalkonium chloride 5 mg. Excipients with known effect: Propylene glycol. For the full list of excipients, see section 6.1. 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: cholesterin, liquid paraffin, macrogol 300, macrogol 1540, macrogol 4000, polysorbate 80, propylene glycol, talc, white petrolatum, purified water. Suppositories: medium chain glycerides, solid semisitetic glycerides (Witepsol E85, Witepsol H15).

CONTRAINDICATIONS AND SIDE EFFECTS

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.); tuberculous and viral infections in the area to be treated.

DOSAGE

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

CONSERVATION

Rectal cream: do not store above 25°C. Suppositories: this medicine does not require any special storage conditions.

WARNINGS

Use the minimum effective dosage. Clinical cases suggest that the administration of products containing benzocaine may cause methemoglobinemia attributable to excessive absorption of benzocaine, particularly in children and the elderly. Symptoms such as cyanosis (pallor, greyish or bluish discoloration of the skin, lips and nail beds), headache, dizziness, dyspnoea (shortness of breath), fatigue and tachycardia occurring during treatment may indicate potentially life-threatening methaemoglobinaemia and require immediate medical attention (see section 4.9). Topical application of corticosteroids in excessive doses and for prolonged periods can give rise to generalized reactions due to systemic absorption (Cushing's syndrome, inhibition of the pituitary-adrenal axis). Therefore, once a favorable clinical effect has been obtained, it is necessary to reduce the frequency of application and dosage to a minimum, discontinuing the product as soon as possible. It is in any case necessary to limit the use of topical steroids to short periods of time. Furthermore, use with appropriate caution in subjects with damaged mucous membranes which could cause excessive absorption of the active ingredients. Corticosteroids can be applied to infected areas only if preceded or accompanied by suitable antibacterial or antifungal therapy. In case of failure of the therapy it is necessary to suspend the treatment and adequately treat the infection with other measures. Rectal cream : This medicine contains 5 mg of benzalkonium chloride per 100 g of rectal cream. Benzalkonium chloride may cause local irritation. This medicine contains 2.4 g of propylene glycol per 20 g of rectal cream. May cause skin irritation. Do not use this medicine in children younger than 4 weeks of age with open wounds or large areas of damaged skin (such as burns) without talking to their doctor or pharmacist. Suppositories : Benzalkonium chloride may cause local irritation. Visual disturbances : Visual disturbances may be reported with the use of systemic and topical corticosteroids. If a patient presents with symptoms such as blurred vision or other visual disturbances, referral to an ophthalmologist should be considered for evaluation of possible causes, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR), which have been reported after the use of systemic and topical corticosteroids.

INTERACTIONS

No interaction studies have been performed. Concomitant treatment with CYP3A inhibitors, including cobicistat-containing medicinal products, is thought to increase the risk of systemic side effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic side effects due to corticosteroids; in this case it is necessary to monitor patients to verify the absence of systemic side effects due to corticosteroids.

SIDE EFFECTS

Undesirable effects are classified according to MedDRA System Organ Terminology. Systemic disorders and conditions relating to the administration site: Hypersensitivity reactions with edema, redness, itching may occur locally. Eye pathologies. Frequency not known (frequency cannot be estimated from the available data) : vision, blurred (see also section 4.4) Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous 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 at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

The phenomena caused by excess corticosteroids are characterized by asthenia, adynamia, arterial hypertension, edema, cardiac rhythm disorders, hypokalemia, metabolic alkalosis. Case reports suggest that administration of benzocaine-containing products may cause methemoglobinemia. Symptoms such as cyanosis (pallor, greyish or bluish discoloration of the skin, lips and nail beds), headache, dizziness, dyspnea (shortness of breath), fatigue and tachycardia that occur during treatment may indicate potentially life-threatening methemoglobinemia and require immediate medical attention. The recommended treatment includes, in addition to supportive therapy, intravenous infusion of methylene blue.

PREGNANCY AND BREASTFEEDING

During pregnancy and/or breastfeeding the medicine must be used only if necessary, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus.

EFFECTS ON DRIVING ABILITY

Proctosedyl does not affect the ability to drive or use machines.