Proctolyn 0, 1 mg + 10 mg 10 suppositories

Proctolyn 0.1 mg + 10 mg 10 suppositories is an antihemorrhoidal drug specifically formulated for the local treatment of internal and external hemorrhoids , anal fissures, eczema, erythema, anal and perianal itching and burning. Thanks to its composition based on fluocinolone acetonide and ketocaine hydrochloride , Proctolyn suppositories works effectively to quickly relieve pain, inflammation and anal discomfort , providing targeted and long-lasting relief.

Proctolyn rectal suppositories are also indicated for pre- and post-operative treatment in anorectal surgery , helping to reduce inflammation and promote a rapid recovery of well-being in the treated area. The presence of fluocinolone acetonide guarantees an anti-inflammatory and anti-itch action, while ketocaine hydrochloride performs an effective local anesthetic action, reducing the pain and discomfort associated with hemorrhoids, fissures and other anal conditions.

Proctolyn suppositories are the ideal solution for those seeking a complete treatment of anal symptoms such as itching, burning, pain and inflammation , thanks to its combined action and ease of use. The product is particularly suitable for those requiring rapid and localized intervention against anal disorders, improving the quality of life and daily comfort.

ACTIVE INGREDIENTS

Active ingredients contained in Proctolyn 0.1 mg + 10 mg 10 suppositories - What is the active ingredient of Proctolyn 0.1 mg + 10 mg 10 suppositories?

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

EXCIPIENTS

Composition of Proctolyn 0.1 mg + 10 mg 10 suppositories - What does Proctolyn 0.1 mg + 10 mg 10 suppositories contain?

Rectal cream citric acid menthol methyl parahydroxybenzoate propyl parahydroxybenzoate propylene glycol stearyl alcohol cetyl alcohol vaseline oil sorbitan monostearate polysorbate 60 purified water Suppositories citric acid menthol propylene glycol polysorbate 60 sorbitan monostearate colloidal silica semi-synthetic glycerides

DIRECTIONS

Therapeutic indications Proctolyn 0.1 mg + 10 mg 10 suppositories - Why is Proctolyn 0.1 mg + 10 mg 10 suppositories used? What is it used for?

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

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Proctolyn 0.1 mg + 10 mg 10 suppositories - When should Proctolyn 0.1 mg + 10 mg 10 suppositories not be used?

Hypersensitivity to the active substances or to any of the excipients listed in paragraph 6.1. Tuberculosis, mycosis, Herpes Symplex, viral diseases with cutaneous localization.

DOSAGE

Quantity and method of taking Proctolyn 0.1 mg + 10 mg 10 suppositories - How to take Proctolyn 0.1 mg + 10 mg 10 suppositories?

Rectal cream Enough to cover the affected area, massaging lightly and repeating the application 2-3 times a day. For internal application, use the special cannula inserted into the tube. Suppositories 1 suppository in the morning and 1 in the evening. Rectal cream and suppositories can be used for combined treatments . Paediatric population The use of Proctolyn is not recommended in children under 12 years of age, due to the lack of data on safety and efficacy.

CONSERVATION

Storage Proctolyn 0.1 mg + 10 mg 10 suppositories - How is Proctolyn 0.1 mg + 10 mg 10 suppositories stored?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Proctolyn 0.1 mg + 10 mg 10 suppositories - About Proctolyn 0.1 mg + 10 mg 10 suppositories it is important to know that:

Topical application of corticosteroids in excessive doses and for prolonged periods may cause systemic absorption. Use, especially if prolonged, of products for topical use may give rise to sensitization phenomena. In the presence of a skin infection, appropriate cover therapy should be instituted. Visual disturbances Visual 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, it is necessary to consider referral to an ophthalmologist for evaluation of possible causes which may include cataracts, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR), which have been reported after the use of systemic and topical corticosteroids. Important information about some of the excipients : Proctolyn rectal cream contains • methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (including delayed reactions); • stearyl alcohol and cetyl alcohol which may cause localized skin reactions (e.g. contact dermatitis).

INTERACTIONS

Interactions Proctolyn 0.1 mg + 10 mg 10 suppositories - Which medicines or foods can modify the effect of Proctolyn 0.1 mg + 10 mg 10 suppositories?

Concomitant treatment with CYP3A inhibitors, including cobicistat-containing medicinal products, is expected to increase the risk of systemic side effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side effects, in which case patients should be monitored for systemic corticosteroid side effects.

SIDE EFFECTS

Like all medicines, Proctolyn 0.1 mg + 10 mg 10 suppositories can cause side effects - What are the side effects of Proctolyn 0.1 mg + 10 mg 10 suppositories?

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 paragraph 4.4), with an unknown frequency. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .

OVERDOSE

Overdose Proctolyn 0.1 mg + 10 mg 10 suppositories - What are the risks of Proctolyn 0.1 mg + 10 mg 10 suppositories in case of overdose?

No cases of overdose have been reported.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Proctolyn 0.1 mg + 10 mg 10 suppositories.

Pregnancy Topical administration of corticosteroids during pregnancy in laboratory animals may cause abnormalities in fetal development. There are no adequate data from the use of fluocinolone acetonide in pregnant women. Therefore, the medicinal product should be used only if clearly needed, after weighing the expected benefit for the mother against the possible risk to the fetus. Breastfeeding When administered systemically, corticosteroids are excreted in breast milk. It is not known whether this is also the case when administered topically. Therefore, topical corticosteroids should be used with caution during breastfeeding.

DRIVING AND USE OF MACHINERY

Taking Proctolyn 0.1 mg + 10 mg 10 suppositories before driving or using machines - Does Proctolyn 0.1 mg + 10 mg 10 suppositories affect driving or using machines?

Proctolyn does not alter the ability to drive vehicles or use machinery.