PROCTOLYN*RECTAL CREAM 30G

Proctolyn 0.1 mg/g + 10 mg/g rectal cream
fluocinolone acetonide + ketocaine hydrochloride

What it is and what it is used for
Proctolyn contains two active ingredients: fluocinolone acetonide (a glucocorticoid) which acts against inflammation, and ketocaine hydrochloride (a local anesthetic) which reduces sensitivity in the area where it is applied.
Proctolyn belongs to a group of medicines called "antihemorrhoidals" (against hemorrhoids) and is used:
- in the local treatment of internal and external hemorrhoids;
- in inflammation and irritation of the skin in the anal area and near the anus (eczema and erythema);
- for itching and burning in the anal area and near the anus;
- for lesions in the anus with slow healing (anal fissures);
- in the anal area before and after surgical procedures (anorectal surgery).

Proctolyn acts locally by reducing inflammation, redness (congestion), itching, anal burning and indirectly pain.

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

What you need to know before taking the medicine
Do not use Proctolyn
- if you are allergic to fluocinolone acetonide, ketocaine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to other medicines belonging to the same family (glucocorticoids such as flumetasone, triamcinolone, dexamethasone, diflucortolone, fluocinonide, diflorasone)
- if you have tuberculosis (TBC)
- if you have fungal diseases (mycoses)
- if you have viral diseases (Herpes Simplex) and other viral skin diseases.

Warnings and precautions
Talk to your doctor or pharmacist before using Proctolyn:
- if the above-mentioned disorders have occurred in the past
- if you are pregnant or breastfeeding (see section Pregnancy and breastfeeding)
- if you are a child under 12 years of age (see section Children).

Consult your doctor if you experience blurred vision or other visual disturbances.

Local application of Proctolyn in excessive doses and for prolonged periods can lead to the medicine passing into the body (systemic absorption) and cause the appearance of other side effects in addition to local ones.
Furthermore, the use, especially if prolonged, of medicines for local use can cause allergic reactions.
In this case, stop using Proctolyn and consult your doctor, who will prescribe appropriate treatment.
In the presence of a skin infection, appropriate antibiotic therapy should be started.
Proctolyn is not for ophthalmic use and should not come into contact with the eyes.

For athletes: the use of the medicine without therapeutic necessity constitutes doping and can in any case lead to positive anti-doping tests.

Children
In children under 12 years of age, Proctolyn should only be used after consulting a doctor and assessing the risks and benefits of the treatment with them.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
For intense and prolonged treatments, the following may occur:
• burning sensation
• itching
• irritation.

These side effects are generally transient. If they occur, consult your doctor or pharmacist.

Blurred vision may occur, with unknown frequency.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.