PROCTOSEDYL RECTAL CREAM TUBE 20 G

Name
Proctosedyl rectal cream
Hydrocortisone acetate, Amylein, Benzocaine, Esculin, Benzalkonium chloride


What is it and what is it used for?
Proctosedyl is a local antihemorrhoidal drug based on corticosteroids (a group of anti-inflammatory drugs).

Proctosedyl is used to treat the symptoms of internal or external hemorrhoids, especially during the inflammatory phase. Anal itching.


What you need to know before taking the medicine
Do not use Proctosedyl
- if you are allergic to hydrocortisone acetate, amylein, benzocaine, esculin, benzalkonium chloride or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to other anaesthetics with a chemical structure similar to benzocaine and to substances containing the para group (sulphonamides, promethazine, etc.).
- if you have tuberculosis or viral infections in the area to be treated.


Warnings and precautions
Talk to your doctor or pharmacist before using Proctosedyl.
Use with appropriate caution in subjects with damaged mucous membranes , which could cause excessive absorption of the active ingredients.
Corticosteroids can be applied to infected areas only if preceded or accompanied by appropriate antibacterial or antifungal therapy. If therapy is unsuccessful, treatment should be discontinued and the infection adequately treated with other measures.

Caution : Use the lowest effective dosage.

Case reports suggest that the administration of products containing benzocaine may cause methemoglobinemia (increased levels of methemoglobin in the blood) due to excessive benzocaine absorption, particularly in children and the elderly. Symptoms such as cyanosis (paleness, grayish or bluish discoloration of the skin, lips, and nails), headache, dizziness, dyspnea (difficulty breathing), fatigue, and tachycardia that occur during treatment may indicate potentially life-threatening methemoglobinemia (see also "If you use more Proctosedyl than you should"). If you notice any of these symptoms, notify your doctor immediately or go to the nearest hospital.

Local application of corticosteroids in excessive doses and for prolonged periods can cause generalized reactions from systemic absorption (Cushing's syndrome, inhibition of the pituitary-adrenal axis [the adrenal gland may be temporarily unable to produce adequate quantities of cortisol upon discontinuation]). Therefore, once a favorable clinical effect has been achieved, it is necessary to minimize the frequency of application and dosage, discontinuing the product as soon as possible. In any case, it is necessary to limit local use of steroids to short periods of time.

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

Anti-doping test
For those who participate in sports: the use of the drug without medical necessity constitutes doping and may result in a positive anti-doping test.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
These effects usually disappear after a short time, however if you experience any of the following symptoms you should contact your doctor or pharmacist:
local allergic reactions presenting with swelling, redness and itching.

It may occur with an unknown frequency (frequency cannot be estimated from the available data): blurred vision.

Following the instructions in the package leaflet reduces the risk of side effects.

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.