ULTRAPROCT 12SUPP

ULTRAPROCT

active ingredients

Each suppository contains fluocortolone pivalato 0,612 mg, fluocortolone caproato 0,630 mg, cincocaine hydrochloride 1 mg. For the full list of excipients see paragraph 6.1. Each g of rectal ointment contains fluocortolone pivalato 0.918 mg, fluocortolone caproate 0.945 mg, cincocaine hydrochloride 5 mg Hydrogenated castor oil. For the full list of excipients see paragraph 6.1.

Excellent

Rectal ointment: Macrogol-400-monoricinoleate; hydrogenated castor oil; 2-ottildodecanol; refined castor oil; citrus Rose scented oil. Supposes: glycerides of saturated fatty acids.

Therapeutic indications

The association contained in Ultraproct allows the polysyntomatic treatment of abnormal varicose syndrome. The ability to place both the assumptions and the rectal ointment allows to reach the internal and external venous sectors that can be involved simultaneously in the varicose phenomenon. Internal and external hemorrhoids, anal spiders, proctitis.

Contraindications

Hypersensitivity to active ingredients, especially cincocaine, or any of the excipients. Tubercular and luetic processes in the region to be treated, smallpox, chickenpox, vaccine pustos.

Population

• Supposes Usually a suppository is sufficient per day. After the complete disappearance of the disorders, it is recommended to continue the treatment for a week with the use of 1 supposed 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 faster disappearance of symptomatology. In order to avoid relapses, the treatment should be protracted with a daily application for a few days after the complete disappearance of the disorders. The intrarectal introduction of the rectal ointment can be practiced by means of the special cannula attached to the packaging, taking care to perform the application after the evacuation of the feces. A small amount of cream can then be applied in the rectum by slightly pressing the tube (for use and cleaning of the applicator see paragraph 6.6). The duration of treatment should not, when possible, exceed four weeks. Pediatric patients: in the early childhood the product should be administered in cases of actual need under the direct control of the doctor.

Conservation

Rectal ointment: keep at a temperature below 25°C. Suppose: keep in the refrigerator (2°C - 8°C).

Warnings

In the case of mycosis present in the area to be treated, are indicated antifungal topical. The use, especially if prolonged, of products for topical use can give rise to phenomena of sensitization. In this case it is necessary to stop treatment and establish suitable therapy. In the case of topical applications on extended surfaces, on loose skin or in the presence of occlusive bandage, corticosteroids could be absorbed in quantities to cause systemic undesirable effects. Avoid contact with eyes. It is recommended to wash your hands thoroughly after use. If the suppositories had become soft for the heat, they will have to be immersed in cold water, before opening the enclosure, until they have resumed a sufficient consistency. Visual disturbances With the use of systemic and topical corticosteroids, visual disturbances can be reported. If a patient occurs with symptoms such as blurred vision or other visual disorders, it is necessary to consider referral to an ophthalmologist for the assessment of possible causes, which may include cataracts, glaucoma or rare diseases such as central serum corioretinopathy (CSCR), which were reported after the use of systemic and topic corticosteroids. Ultraproct rectal ointment: excipients (Macrogol-400-monoricinoleate, hydrogenated castor oil, refined castor oil and Citrus Rose perfume oil) in Ultraproct can reduce the effectiveness of latex products such as prophylactics. Supposed Ultraproct: the excipient (glycerides of saturated fatty acids) in Ultraproct can reduce the effectiveness of latex products such as prophylactics.

Interactions

Concurrent treatment with CYP3A inhibitors, including cobicistat-containing medicines, is believed to increase the risk of systemic side effects. The association must be avoided unless the benefit exceeds the greatest risk of systemic side effects due to corticosteroids; in this case it is necessary to monitor patients to verify the absence of systemic side effects due to corticosteroids.

Effects

Rare cases of local irritation with burning. Awareness cases in subjects prepared, 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 occurrence of systemic absorption secondary phenomena plausible. In the case of these, it could be traceable to the classical secondary effects of corticosteroids, even of very small entities. For prolonged treatment periods (more than 4 weeks) symptoms may occur locally such as skin atrophy. In rare cases allergic reactions may occur at the skin level. Eye pathologies: Notable frequency (frequency cannot be defined on the basis of available data): blurred vision (see also paragraph 4.4) Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction through the national reporting system http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sosp ect-reaction-adversa.

Overdosing

No known overdose cases from Ultraproct. In accordance with the results obtained from acute toxicity studies carried out with fluocortolone esters, no risk of intoxication is expected as a result of a single rectal or perianal application of Ultraproct, not even following an involuntary overdose. In the case of accidental oral intake systemic effects, dose-dependent, may be caused by the active ingredient with anesthetic action, cincocaine, and may occur with symptoms at the expense of the SNC (convulsions, inhibition or arrest of respiratory functions) and cardiocirculatory disorders (depression or cessation of cardiac functions).

Pregnancy Experimental studies on animals with corticosteroids have evidenced reproductive toxicity. Some epidemiological studies suggest that there could be an increased risk of palatoschisis in infants treated with systemic corticosteroids during the first trimester of pregnancy. Ultraproct should not be used during the first trimester of pregnancy unless benefits justify the potential risks to the fetus. Food There is no data about the passage of substances into breast milk, so consult your doctor before use.

Source: Farmadati