Proctosedyl Hydrocortisone Acetate Rectal Cream 20 gr

WARNINGS
Use the lowest effective dosage. Clinical cases suggest that the administration of products containing benzocaine can cause methaemoglobinemia referable to an 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 (shortness of breath), fatigue and tachycardia occurring during treatment may indicate a potentially life-threatening methaemoglobinaemia 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 is obtained, it is necessary minimize the frequency of application and 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 cure the infection with other measures.
PHARMACOTHERAPEUTIC CATEGORY
Substances for treatments of hemorrhoids and anal fissures for topical use.
STORAGE
This medicine does not require any special storage conditions.
CONTRAINDICATIONS / SECONDARY EFFECT
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.
NAME
PROCTOSEDYL
EXCIPIENTS
Rectal cream: cholesterin, liquid paraffin, macrogol 300, macrogol1540, macrogol 4000, polysorbate 80, propylene glycol, talc, white vaseline, purified water. Suppositories: medium chain glycerides, solid glyceridisemysithetics (Witepsol E85, Witepsol H15).
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 AND BREASTFEEDING
During pregnancy and / or lactation the medicine should be used only in case of necessity, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus.
INDICATIONS
Symptomatic treatment of hemorrhoids, internal or external, especially in the inflammatory phases; anal itching.
INTERACTIONS
No interaction studies have been performed.
DOSAGE
Rectal cream: for endorectal and perianal applications. Apply lapomata 2 times a day in acute forms; subsequently space out the applications, depending on the evolution of the symptoms. Suppositories: 1-2 suppositories per di '. Use only for short periods of treatment.
ACTIVE PRINCIPLES
Rectal cream: hydrocortisone acetate, amyline, benzocaine, aesculin, benzalkonium chloride. Suppositories: hydrocortisone acetate, benzocaine, aesculin, benzalkonium chloride.