Proctosoll rectal cream 30g with dispensing cannula

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

INDICATIONS

Symptomatic treatment of uncomplicated external hemorrhoids.

ACTIVE INGREDIENTS

100g of cream contain: - BENZOCAINE g: 5; - HYDROCORTISONE ACETATE g: 0.5; - SODIUM HEPARIN IU: 5,000. For excipients, see 6.1.

EXCIPIENTS

Cetostearyl alcohol, isopropyl myristate, propylene glycol, macrogol cetostearyl ether, dimethicone, isothiazolinone, levomenthol, disodium EDTA, butylated hydroxyanisole, purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity towards components or other substances closely related from a chemical point of view. Tuberculous skin lesions. Viral infections.

DOSAGE

In acute forms, particularly after evacuation, apply the cream 2-3 times a day. Do not exceed the recommended doses.

CONSERVATION

Store at a temperature not exceeding 30° C.

WARNINGS

After a short period of treatment, without appreciable results, consult your doctor. Excessive and/or prolonged application of cortisone can give rise to generalized reactions due to systemic absorption. The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case it is necessary to interrupt treatment and institute suitable therapy. The effectiveness and safety of benzocaine depend on correct dosage; it is therefore necessary to use the minimum quantity of the preparation sufficient to obtain the desired effect by applying it with caution in subjects with seriously damaged mucous membranes or the site of inflammatory processes which could cause excessive absorption of the active ingredient. High absorption of benzocaine can cause serious reactions, particularly in children and elderly patients. Proctosoll contains propylene glycol This medicinal product contains 25 mg of propylene glycol per dose equivalent to 25 mg/g. Proctosoll contains butylated hydroxyanisole. May cause localized skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes. Proctosoll contains cetostearyl alcohol. May cause localized skin reactions (e.g. contact dermatitis). Keep the medicine out of the reach of children.

INTERACTIONS

Particular attention must be paid to its use in conjunction with other anticoagulant treatments.

SIDE EFFECTS

Locally, burning sensation, irritation, dryness of the skin, folliculitis, acne eruptions, hypertrichosis, hyperpigmentation and skin atrophy may sometimes occur. If any local reaction typical of corticotherapy appears, it can be remedied by suspending the treatment.Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

There are no known symptoms of overdose.

PREGNANCY AND BREASTFEEDING

In pregnant women, use must be carried out only in case of actual need and under the direct supervision of a doctor.

EFFECTS ON DRIVING ABILITY

The product does not interfere with the ability to drive and use machines.