Proctosedyl Rectal Cream 20gr

"PROCTOSEDYL CREMA" is used for the treatment of internal and external hemorrhoids in the inflammatory phase and with anal itching.
Composition
Active ingredient: 1 g hydrocortisone acetate, 1 g amyline, 1 g benzocaine, 1 g aesculin, 5 mg benzalkonium chloride.
Excipients: cholesterin, liquid paraffin, macrogol 300, macrogol 1540, macrogol 4000, polysorbate 80, propylene glycol, talc, white petroleum jelly, purified water.

Indications
Symptomatic treatment of hemorrhoids, internal or external, especially in the inflammatory phases; anal itching.

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.

Dosage
Rectal cream: for endorectal and perianal applications. Apply the ointment 2 times a day in acute forms; subsequently space out the applications, according to the evolution of the symptoms. Suppositories: 1-2 suppositories per di '. Use only for short periods of treatment.

Warnings
Use the lowest effective dosage. Clinical cases suggest that the administration of products containing benzocaine may cause methemoglobinemia attributable 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. Topical application of corticosteroids in excessive doses and for prolonged periods can give rise to generalized reactions from 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, stopping 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 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.

Interactions
No interaction studies have been performed.

Side effects
Undesirable effects are categorized according to MedDRA System and Organ terminology. General disorders and administration site conditions: hypersensitivity reactions with edema, redness, itching may occur locally. 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.

Pregnancy
During pregnancy and / or lactation the medicine should be used only in case of need ', after evaluating the expected benefit for the mother in relation to the possible risk for the fetus.