Ultraproct Fluocortolone Hemorrhoids 12 Suppositories

NAME
ULTRAPROCT

PHARMACOTHERAPEUTIC CATEGORY
Topical substances for the treatment of hemorrhoids and anal fissures.

ACTIVE PRINCIPLES
Fluocortolone pivalate, fluocortolone caproate, cinchocaine hydrochloride.

EXCIPIENTS
Rectal ointment: polyethylene glycol-400-monoricinoleate; hydrogenated castor oil; 2-octyldodecanol; castor oil; CitrusRose scented oil. Suppositories: glycerides of saturated fatty acids.

INDICATIONS
The association contained in the drug allows the polysymptomatic treatment of anorectal varicose syndrome. The availability of both suppositories and rectal ointment allows to reach the internal and external venous sectors that can be involved in the varicose phenomenon at the same time. Internal and external hemorrhoids, anal fissures, proctitis.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active ingredients, especially cincocaine, or to any of the excipients; tuberculous and luetic processes in the region to be treated, smallpox, chicken pox, vaccine pustules.

DOSAGE
Suppositories: one suppository a day is usually sufficient. After the complete disappearance of the disorders, it is recommended to continue the treatment for another week with the use of 1 suppository every 2 days. It is advisable to introduce the suppository after defecation. Rectal ointment: A thin layer of rectal ointment is usually applied twice a day. In the first day, 3-4 applications of the preparation are also recommended to obtain a more rapid disappearance of the symptoms. To avoid relapses, the treatment should be continued with an application for a few more days after the complete disappearance of the ailments. The intrarectal introduction of the rectal ointment can be carried out by means of the special cannula attached to the package, taking care to carry out the application after the evacuation of the faeces. The duration of treatment should, when possible, not exceed four weeks. Pediatric patients: in very early childhood the product should be administered in cases of real need.

STORAGE
Rectal ointment: store below 25 degrees C. Suppositories: store in the refrigerator (2 degrees C - 8 degrees C).

WARNINGS
In the case of mycosis present in the area to be treated, topical antifungals are indicated. 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. In the event of topical applications on large surfaces, on damaged skin or in the presence of an occlusive dressing, corticosteroids could be absorbed in such quantities as to cause systemic undesirable effects. Avoid contact with eyes. It is recommended to wash hands thoroughly after use. If the suppositories have become soft due to the heat, they must be immersed in cold water, before opening the wrapper, until they have regained a sufficient consistency.

INTERACTIONS
Concomitant treatment with CYP3A inhibitors, including medicinal products containing cobicistat, is thought to increase the risk of systemic side effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic side effects due to corticosteroids; in this case it is necessary to monitor the patients to verify the absence of systemic undesirable effects due to corticosteroids.

SIDE EFFECTS
Rare cases of local irritation with burning. Cases of sensitization in predisposed subjects towards one or more components of the product, especially cincocaine. The low doses of active ingredients contained in the product do not make an easy onset of secondary systemic phenomena from absorption plausible. If these occur, they could be attributable to the classic side effects of corticosteroids, albeit of a very small entity. For prolonged treatment periods (more than 4 weeks) local symptoms such as skin atrophy may occur. In rare cases, allergic skin reactions may occur. 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
Experimental studies on animals with corticosteroids have shown reproductive toxicity. Some epidemiological studies suggest that there may be an increased risk of cleft palate in newborns from women treated with systemic corticosteroids during the first quarter of pregnancy. The drug should not be used during the first trimester of pregnancy unless the benefits justify potential risks to the fetus. There are no data on the passage of substances into breast milk, therefore consult your doctor before use.