ULTRAPROCT * UNG RETT 30G

ULTRAPROCT * UNG RETT 30G

Therapeutic indications

The association contained in the Ultraproct allows the polysymptomatic treatment of the 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.

Dosage and method of use

•SuppositoriesOne 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 ointmentA thin layer of rectal ointment is usually applied twice a day. On 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 one application per day 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 apply it after the stool has been evacuated. A small amount of cream can then be applied into the rectum by lightly squeezing the tube (for use and cleaning of the applicator see section 6.6). 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 under the direct supervision of the doctor.

Contraindications

Hypersensitivity to the active substances, especially cincocaine, or to any of the excipients. Tuberculous and luetic processes in the region to be treated, smallpox, chicken pox, pusto | and vaccines.

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 periods of treatment (more than 4 weeks), local symptoms such as skin atrophy may occur. In rare cases, allergic skin reactions may occur. Eye disorders: Frequency not known (frequency cannot be estimated from the available data): blurred vision (see also section 4.4)Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine | e is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sosp etta-adverse-reaction.

Special 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 may 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.Visual disturbancesVisual disturbances may be reported with the use of systemic and topical corticosteroids. If a patient presents with symptoms such as blurred vision or other visual disturbances, referral to an ophthalmologist should be considered for evaluation of possible causes, which may include cataracts, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR), which are have been reported after use of systemic and topical corticosteroids. Ultraproct Rectal Ointment: The excipients (Macrogol-400-monoricinoleate, hydrogenated castor oil, refined castor oil and Citrus Rose fragrance oil) in Ultraproct can reduce the effectiveness of latex products such as condoms. Ultraproct suppositories: the excipient (glycerides of saturated fatty acids) in Ultraproct can reduce the effectiveness of latex products such as condoms.

Pregnancy and breastfeeding

PregnancyExperimental animal studies with corticosteroids have shown reproductive toxicity. Some epidemiological studies suggest that there may be an increased risk of cleft palate in infants from women treated with systemic corticosteroids during the first trimester of pregnancy. Ultraproct should not be used during the first trimester of pregnancy unless the benefits justify the potential risk to the fetus.Feeding timeThere are no data on the passage of substances into breast milk, therefore consult your doctor before use.

Expiry and retention

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

Interactions with other drugs

Concomitant treatment with CYP3A inhibitors, including cobicistat-containing medicines, 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 from corticosteroids; in this case it is necessary to monitor patients to verify the absence of systemic undesirable effects due to corticosteroids.

Overdose

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

Active principles

Each suppository contains fluocortolone pivalate 0.612 mg, fluocortolone caproate 0.630 mg, cincocaine hydrochloride 1 mg. For the full list of excipients see section 6.1. Each g of rectal ointment contains 0.918 mg fluocortolone pivalate, 0.945 mg fluocortolone caproate, 5 mg cinchocaine hydrochloride. Excipients with known effect: Hydrogenated castor oil. For the full list of excipients see section 6.1.

Excipients

Rectal ointment: Macrogol-400-monoricinoleate; hydrogenated castor oil; 2-octyldodecanol; refined castor oil; Citrus Rose scented oil.Suppositories: glycerides of saturated fatty acids.