PROCTOSOLL * CREAM RETT 30G OTC

  • Alfasigma S.p.A.
  • 027377023

Symptomatic treatment of uncomplicated external hemorrhoids.

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PROCTOSOLL * CREAM RETT 30G OTC

Therapeutic indications

Symptomatic treatment of uncomplicated external hemorrhoids.

Dosage and method of use

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

Contraindications

Hypersensitivity to components or other closely related substances from a chemical point of view. Skin lesions of a tuberculous nature. Viral infections.

Side effects

Sometimes there may be a sensation of burning, irritation, dry skin, folliculitis, acne eruptions, hypertrichosis, hyperpigmentation and skin atrophy. If any local reactions typical of corticotherapy appear, this can be remedied by stopping the treatment. 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 ratio of the medicinal product. 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.

Special warnings

After a short period of treatment, without noticeable results, consult your doctor. The excessive application and / or for prolonged periods of cortisone can give rise to generalized reactions from 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 the treatment and institute a suitable therapy. The efficacy and safety of benzocaine depend on a 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 severely damaged mucous membranes or site of inflammatory processes that could cause excessive absorption of the active ingredient. High absorption of benzocaine can cause severe reactions, particularly in children and elderly patients. Proctosoll contains propylene glycol This medicinal product contains 25 mg propylene glycol per dose equivalent to 25 mg / g. Proctosoll contains butylhydroxyanisole May cause localized skin reactions (eg contact dermatitis) or irritation to the eyes and mucous membranes. Proctosoll contains cetostearyl alcohol May cause localized skin reactions (eg contact dermatitis). Keep this medicine out of the reach of children.

Pregnancy and breastfeeding

In pregnant women, use should only be carried out in case of real need and under direct medical supervision.

Expiration and retention

Store at a temperature not exceeding 30 ° C.

Interactions with other drugs

Particular attention in the use must be observed in conjunction with other anticoagulant treatments.

Overdose

There are no known symptoms of overdose.

Active principles

100 g 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, g Propylene glycol, macrogol cetostearyl ether, dimethicone, isothiazolinone, levomentol, disodium EDTA, butyl hydroxyanisole, purified water.

027377023

Data sheet

Packaging
crema rettale tubo da 30 g
Product Type
HUMAN DRUG
ATC code
C05AA01
ATC description
Hydrocortisone
Therapeutic Group
Corticosteroids + local anesthetics
Active principle
idrocortisone + benzocaina + eparina sodica
Class
CN
Pharmaceutical form
cream
Type of Administration
rectal
Container
gel / ointment / cream / paste / ointment in tube
Quantity
1 tube
Capacity
30 grams
Quantity of the Active Ingredient
50MG (benzocaina) + 50UI (eparina sodica) + 5MG (idrocortisone)
Recipe required
OTC - self-medication medicine
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