PROCTOLYN * CR RETT 30G

  • Recordati Industria Chimica e Farmaceutica S.p.A.
  • 021925060

Proctolyn what is it for?

Therapeutic properties

Internal and external hemorrhoids; anal and perianal eczema and erythema; anal fissures; anal and perianal itching and burning; pre- and post-operative treatment in anorectal surgery.

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PROCTOLYN * CR RETT 30G

Therapeutic indications

Internal and external hemorrhoids; anal and perianal eczema and erythema; anal fissures; anal and perianal itching and burning; pre- and post-operative treatment in anorectal surgery.

Dosage and method of use

Rectal cream Just enough to cover the affected part by massaging lightly and repeating the application 2-3 times a day. For internal application, use the special cannula inserted on the tube. Suppositories 1 suppository in the morning and 1 in the evening.Rectal cream and suppositories can be used for combined treatments.Pediatric populationProctolyn is not recommended for use in children below 12 years of age due to a lack of data on safety and efficacy.

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Tbc, mycosis, Herpes Symplex, viral diseases with skin localization.

Side effects

During topical cortisone therapy, especially for intense and prolonged treatments, the following side effects may occur: burning sensation, itching, irritation. Blurred vision may occur (see also section 4.4), with an unknown frequency.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine 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 systemhttp://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Special warnings

Topical application of cortisone in excessive doses and for prolonged periods can result in systemic absorption. The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In the presence of a skin infection, appropriate coverage therapy should be instituted.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 have been reported after use of systemic and topical corticosteroids.Important information about some of the ingredients: Proctolyn rectal cream contains • methyl para-hydroxybenzoate and propyl para-hydroxybenzoate which can cause allergic reactions (including delayed type); • stearyl alcohol and cetyl alcohol which can cause localized skin reactions (eg contact dermatitis).

Pregnancy and breastfeeding

PregnancyTopical administration of corticosteroids during pregnancy in laboratory animals can cause abnormalities in fetal development. There are no adequate data from the use of fluocinolone acetonide in pregnant women. Therefore, the medicine should only be used when needed, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus.Feeding timeWhen administered systemically, corticosteroids are excreted through breast milk. It is not known whether they are even when administered topically. Therefore topical corticosteroids should be used with caution during breastfeeding.

Expiry and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

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 from corticosteroids; in this case it is necessary to monitor patients to verify the absence of systemic undesirable effects due to corticosteroids.

Overdose

No cases of overdose have been reported.

Active principles

Rectal cream One gram of rectal cream contains 0.1 mg of fluocinolone acetonide and 10 mg of ketocaine hydrochloride (equivalent to 8.9 mg of ketocaine). Excipients with known effects: One gram of rectal cream contains 1.5 mg of methyl para-hydroxybenzoate, 0.5 mg of propyl para-hydroxybenzoate, 70 mg of propylene glycol, 50 mg of stearyl alcohol, 50 mg of cetyl alcohol. Suppositories Each suppository contains 0.1 mg of fluocinolone acetonide and 10 mg of ketocaine hydrochloride (equivalent to 8.9 mg of ketocaine). Excipient with known effect: Each suppository contains 40 mg of propylene glycol. For the full list of excipients, see section 6.1.

Excipients

Rectal cream citric acid menthol methyl para-hydroxybenzoate propyl para-hydroxybenzoate propylene glycol stearyl alcohol cetyl alcohol petroleum jelly sorbitan monostearate polysorbate 60 purified water Suppositories citric acid menthol propylene glycol polysorbate 60 sorbitan monostearate colloidal silica semisynthetic glycerides

Data sheet

Packaging
0 -1 mg + 10 mg / g rectal cream 30 g
0,1 mg + 10 mg/g crema rettale 30 g
Product Type
HUMAN DRUG
ATC code
C05AA10
ATC description
Fluocinolone acetonide
Therapeutic Group
Corticosteroids
Active principle
fluocinolone acetonide + ketocaine
Class
C.
Pharmaceutical form
cream
Type of Administration
rectal
Container
gel / ointment / cream / paste / ointment in tube
Quantity
1 tube
Capacity
30 grams
Quantity of the Active Ingredient
,1MG (fluocinolone acetonide) + 10MG (ketocaina)
-1MG (fluocinolone acetonide) + 10MG (ketocaine)
Recipe required
OTC - self-medication medicine
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