PROCTOSEDYL * CREAM RETT 20G

PROCTOSEDYL * CREAM RETT 20G

Therapeutic indications

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

Dosage and method of use

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 a day. Use only for short periods of treatment.

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 (sulfonamides, promethazine, etc.); tuberculous and viral infections of the area to be treated.

Side effects

Adverse effects are categorized according to MedDRA System and Organ terminology.General disorders and administration site conditions:Locally hypersensitivity reactions may occur with edema, redness, itching. Eye disorders. Frequency not known (frequency cannot be estimated from the available data) : vision, blurred (see also section 4.4) Reporting of suspected adverse reactions. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug. 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.

Special warnings

Use the lowest effective dosage. Clinical cases suggest that the administration of products containing benzocaine may cause methemoglobinemia referable to excessive absorption of benzocaine, particularly in children and the elderly. Symptoms such as cyanosis (paleness, greyish or bluish discoloration of the skin, lips and nail bed), headache, lightheadedness, dyspnoea (wheezing), fatigue and tachycardia that occur during treatment may indicate potentially life-threatening methaemoglobinaemia. patient 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 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 minimize the frequency of application and the 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 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 can cause local irritation. This medicine contains 2.4 g of propylene glycol per 20 g of rectal cream. It can cause skin irritation. Do not use this medicine in children less than 4 weeks of age with open wounds or large areas of damaged skin (such as burns) without talking to your 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 are have been reported after use of systemic and topical corticosteroids.

Pregnancy and breastfeeding

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

Expiry and retention

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

Interactions with other drugs

No interaction studies have been performed. Concomitant treatment with CYP3A inhibitors, including medicinal products containing cobicistat, 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 from corticosteroids; in this case it is necessary to monitor patients to verify the absence of systemic undesirable effects due to corticosteroids.

Overdose

The phenomena of excess corticosteroids are characterized by asthenia, adynamia, arterial hypertension, edema, heart rhythm disturbances, hypokalemia, metabolic alkalosis. Clinical cases suggest that the administration of products containing benzocaine may cause methemoglobinemia. Symptoms such as cyanosis (paleness, greyish or bluish discoloration of the skin, lips and nail bed), headache, lightheadedness, dyspnoea (wheezing), fatigue and tachycardia that occur during treatment may indicate potentially life-threatening methaemoglobinaemia. patient and require immediate medical attention. In addition to supportive care, the recommended treatment includes intravenous infusion of methylene blue.

Active principles

Proctosedyl rectal cream: 100 g of rectal cream contain: 1 g hydrocortisone acetate, 1 g amyline, 1 g benzocaine, 1 g aesculin, 5 mg benzalkonium chloride.Excipients with known effect:Propylene glycol. For the full list of excipients, see section 6.1.Proctosedyl suppositories: Each suppository contains: 5 mg hydrocortisone acetate, 50 mg benzocaine, 10 mg aesculin, 0.1 mg benzalkonium chloride. 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 petroleum jelly, purified water.Suppositories: medium chain glycerides, solid semisithetic glycerides (Witepsol E85, Witepsol H15).