PROCTOSEDYL CREAM RETT 20G

PROCTOSEDYL

active ingredients

Proctosedyl rectal cream: 100 g rectal cream contain: acetate hydrocortisone 1 g, amileine 1 g, benzocaine 1 g, esculine 1 g, benzalconio chloride 5 mg. Known excipients: Propilene glycol. For the full list of excipients, see paragraph 6.1. Proctosedyl supposes: Each suppository contains: acetate hydrocortisone 5 mg, benzocaine 50 mg, esculine 10 mg, benzalconio chloride 0.1 mg. For the full list of excipients, see paragraph 6.1.

Excellent

Rectal cream: colesterin, liquid paraffin, macrogol 300, macrogol 1540, macrogol 4000, polysorbate 80, glycol propylene, talc, white vaseline, purified water. Supposes: medium-chain glycerides, solid semisitetic glycerides (Witepsol E85, Witepsol H15).

Therapeutic indications

Syntomatic treatment of hemorrhoids, internal or external, especially in inflammatory phases. Anal Prurito.

Contraindications

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

Population

Rectangular cream: For endorectal and perianal applications. Apply the ointment 2 times a day in acute forms; later deploy applications, depending on the evolution of symptomatology.Supposes: 1-2 times a day. Use only for short periods of treatment.

Conservation

Rectal cream: do not store at a temperature greater than 25°C. Suppose: this medicine does not require any particular condition of conservation.

Warnings

Use the effective minimum dosage. Clinical cases suggest that the administration of benzocaine-containing products can cause metaemoglobinemia to benzocaine absorption, especially in children and elderly. Symptoms such as cyanosis (pallore, greyish or bluish colouration of the skin, lips and ointal bed), headache, sturdiment, dispersion (spire affannoso), fatigue and tachycardia that occur during treatment may indicate a potentially dangerous metaemoglobinemia for the patient's life and require immediate medical treatment (see paragraph 4.9). The topical application of corticosteroids in excessive doses and for prolonged periods can give rise to generalized reactions from systemic absorption ( Cushing syndrome, hypophysi-surrene axis inhibition). Therefore, once obtained a favorable clinical effect, it is necessary to minimize the frequency of application and dosage, suspending the product as soon as possible. It is however necessary to limit the use of topical steroids at short periods of time. Also use with the appropriate cautele in subjects with damaged mucosa that could cause excessive absorption of active ingredients. Corticosteroids can only be applied to infected areas if preceded or accompanied by an 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. Rectangular cream : This medicine contains 5 mg of benzalconio chloride per 100 g of rectal cream. Benzalconio chloride can cause local irritation. This medicine contains 2.4 g of glycol propylene for 20 g of rectal cream. It can cause skin irritation. Do not use this medicine in children under 4 weeks of age with open wounds or extensive areas of damaged skin (such as burns) without having talked to your doctor or pharmacist. Supposes : Benzalconio chloride can cause local irritation. Visual disturbances : With the use of systemic and topical corticosteroids, visual disturbances can be reported. If a patient occurs with symptoms such as blurred vision or other visual disorders, it is necessary to consider referral to an ophthalmologist for the assessment of possible causes, which may include cataracts, glaucoma or rare diseases such as central serum corioretinopathy (CSCR), which were reported after the use of systemic and topic corticosteroids.

Interactions

No interaction studies have been carried out. Concurrent treatment with CYP3A inhibitors, including cobicistat-containing medicines, is believed to increase the risk of systemic side effects. The association must be avoided unless the benefit exceeds the greatest 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.

Effects

The side effects are catalogued according to the terminology for Systems and Organs according to MedDRA. Systemic pathologies and conditions for administration: Locally there may be hypersensitivity reactions with edema, redness, itching. Pathologies of the eye. Unknown frequency (frequency cannot be defined on the basis of available data) : vision, blurred (see also paragraph 4.4) Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals are required to report any adverse reaction suspected through the national reporting system of the Italian Pharmaco Agency at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Corticosteroid excess phenomena are characterized by astenia, adinamia, arterial hypertension, edemi, heart rhythm turbe, hypopotassiemia, metabolic alkalosis. Clinical cases suggest that the administration of benzocaine-containing products can cause metaemoglobinemia. Symptoms such as cyanosis (pallore, greyish or bluish colouration of the skin, lips and ointal bed), headache, sturdiness, dispersion (spire affannoso), fatigue and tachycardia that occur during treatment may indicate a potentially dangerous metaemoglobinemia for the patient's life and require immediate use of medical care. The recommended treatment includes, in addition to support therapy, the intravenous infusion of methylene blue.

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

Source: Farmadati