Proctosoll rectal cream 30g with dispensing cannula

Proctosoll rectal cream 30g with dispensing cannula is a topical treatment specifically formulated for the symptomatic treatment of uncomplicated external hemorrhoids . This rectal cream combines the effectiveness of three active ingredients: benzocaine , hydrocortisone acetate and sodium heparin , which work synergistically to relieve pain, reduce inflammation and improve local circulation. The presence of the dispensing cannula facilitates the direct and precise application of the product, ensuring practical and hygienic use. Proctosoll is ideal for those seeking rapid and targeted relief from hemorrhoidal symptoms, thanks to its advanced formulation and ease of use.

ACTIVE INGREDIENTS

Active ingredients contained in Proctosedyl rectal cream 20g - What is the active ingredient of Proctosedyl rectal cream 20g?

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. 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

Composition of Proctosedyl rectal cream 20g - What does Proctosedyl rectal cream 20g contain?

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

DIRECTIONS

Therapeutic indications Proctosedyl rectal cream 20g - Why is Proctosedyl rectal cream 20g used? What is it used for?

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

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Proctosedyl rectal cream 20g - When should Proctosedyl rectal cream 20g not be used?

Hypersensitivity to the active substances or to any of the excipients and in particular to benzocaine (and other anaesthetics 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

Quantity and method of taking Proctosedyl rectal cream 20g - How to take Proctosedyl rectal cream 20g?

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

CONSERVATION

Storage Proctosedyl rectal cream 20g - How to store Proctosedyl rectal cream 20g?

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

WARNINGS

Warnings Proctosedyl rectal cream 20g - About Proctosedyl rectal cream 20g it is important to know that:

Use the lowest effective dosage. Case reports suggest that administration of products containing benzocaine may cause methaemoglobinaemia due to excessive absorption of benzocaine, particularly in children and the elderly. Symptoms such as cyanosis (paleness, greyish or bluish colouring 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 may give rise to generalised reactions from systemic absorption (Cushing's syndrome, inhibition of the pituitary-adrenal axis). Therefore, once a favourable 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. 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 the therapy is unsuccessful, 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 under 4 weeks of age with open wounds or large areas of damaged skin (such as burns) without discussing it with 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, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes, which may include cataract, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR), which have been reported after use of systemic and topical corticosteroids.

INTERACTIONS

Interactions Proctosedyl rectal cream 20g - Which medicines or foods can modify the effect of Proctosedyl rectal cream 20g?

No interaction studies have been performed. Concomitant treatment with CYP3A inhibitors, including cobicistat-containing medicinal products, is expected to increase the risk of systemic side effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side effects, in which case patients should be monitored for systemic corticosteroid side effects.

SIDE EFFECTS

Like all medicines, Proctosedyl rectal cream 20g can cause side effects - What are the side effects of Proctosedyl rectal cream 20g?

Undesirable effects are listed according to the MedDRA System Organ Class. Systemic disorders and conditions related to the administration site: Hypersensitivity reactions may occur locally 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 . Reporting suspected adverse reactions that occur after authorisation 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 at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .

OVERDOSE

Overdose Proctosedyl rectal cream 20g - What are the risks of Proctosedyl rectal cream 20g in case of overdose?

Corticosteroid excess phenomena are characterized by asthenia, adynamia, arterial hypertension, edema, cardiac rhythm disturbances, hypokalemia, metabolic alkalosis. Case reports suggest that administration of products containing benzocaine may cause methemoglobinemia. Symptoms such as cyanosis (pallor, grayish or bluish coloration 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. Recommended treatment includes, in addition to supportive care, intravenous infusion of methylene blue.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Proctosedyl rectal cream 20g.

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

DRIVING AND USE OF MACHINERY

Taking Proctosedyl rectal cream 20g before driving or using machines - Does Proctosedyl rectal cream 20g affect driving or using machines?

Proctosedyl does not alter the ability to drive vehicles or use machines.