Name
Proctolyn 0.1 mg + 10 mg suppositories
Fluocinolone acetonide + ketocaine hydrochloride


What is it and what is it for?
Proctolyn contains two active ingredients: fluocinolone acetonide (glucocorticoid) which acts against inflammation and ketocaine hydrochloride (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);
- itching and burning in the anal area and near the anus;
- in lesions at the anal level with slow healing (anal fissures);
- in the anal area before and after surgery (ano-rectal surgery).

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

Talk to your doctor if you do not feel better or if you feel worse after a short time 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 flumethasone, triamcinolone, dexamethasone, diflucortolone, fluocinonide, diflorasone);
- if you have tuberculosis (TB);
- if you have fungal diseases (mycosis);
- if you have diseases caused by viruses ( Herpes Symplex ) and other viral diseases localized on the skin.


Warnings and precautions
Talk to your doctor or pharmacist before using Proctolyn:
- if the above-mentioned disorders have already manifested themselves 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).

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

Local application of Proctolyn in excessive doses and for prolonged periods can cause the medicine to pass into the body (systemic absorption) and cause the appearance of other side effects in addition to those at a local level.
Furthermore, the use, especially if prolonged, of local medicines can give rise to allergic reactions.
In this case, stop using Proctolyn and consult your doctor who will indicate an appropriate therapy.
In the presence of a skin infection, appropriate antibiotic therapy should be started.
Proctolyn is not for use on the eyes and should not come into contact with them.

For those who participate in sports: the use of the medicine without therapeutic need constitutes doping and may still result in a positive anti-doping test.

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


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

For intense and prolonged treatments, the following may occur:
• burning sensation;
• itching;
• irritation.
These side effects are usually temporary. If they occur, consult your doctor or pharmacist.

Blurred vision may occur, the frequency of which is unknown.

Reporting of side effects
If you experience any side effects, including any 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.