Name
PROCTOZETA 15 mg/g + 10 mg/g rectal cream
Lidocaine hydrochloride and hydrocortisone acetate


What is it and what is it used for?
PROCTOZETA is a combination of two active ingredients: lidocaine hydrochloride and hydrocortisone acetate. Lidocaine hydrochloride belongs to a group of medicines called local anaesthetics that relieve pain, while hydrocortisone acetate, which belongs to a group of medicines called corticosteroids, reduces inflammation and swelling.

This medicine is indicated:
- for the treatment of internal and external hemorrhoids;
- in case of inflammation (eczema), irritation (erythema), lesions (fissures), itching and burning in the anal area due to the presence of hemorrhoids;
- before and after surgery on the anus or lower intestine (anorectal surgery).

Talk to your doctor if you do not feel better or if you feel worse after a few days.


What you need to know before taking the medicine
Do not use PROCTOZETA:
- if you are allergic to lidocaine hydrochloride, hydrocortisone acetate, similar medicines (amide-type local anaesthetics, cortisone) or any of the other ingredients of this medicine (listed in section 6);
- if you have or think you have an infection caused by fungi (mycotic infection);
- if you suffer from an infection caused by a virus, such as skin tuberculosis, herpes simplex, chickenpox, or by a bacterium;
- if the person who is to use this medicine is under 12 years of age (See the section "Children");
- if you are pregnant or breastfeeding (See section "Pregnancy and breastfeeding").


Warnings and precautions
Talk to your doctor or pharmacist before using PROCTOZETA.

This medicine should not be applied to the eyes.

The safety of medicines containing lidocaine as the active ingredient depends on the dose, the correct application of the product, and compliance with all precautions.

Your doctor will determine the dose based on your age and health. Specifically, it is recommended to use the lowest effective dose to achieve the desired results.
If you are elderly or have an acute illness, your doctor should prescribe a lower dose.

If you have an infection, this medicine may worsen your symptoms. Therefore, tell your doctor who will determine the most appropriate treatment for you.

Use this medicine with great caution and tell your doctor if you experience:
- severe trauma (injuries);
- a serious infection that spreads throughout the body (sepsis);
- extensive skin lesions.

During treatment with PROCTOZETA, avoid applying excessive doses of the product to very large areas of skin and using the medicine for long periods or in close intervals. These precautions are necessary because corticosteroids (hydrocortisone) can pass through the skin and consequently cause serious side effects. In particular, you may experience:
- during treatment, typical symptoms of Cushing's disease, such as sudden weight gain, increased body hair (hirsutism), hair loss, irregular menstrual cycles in women, loss of muscle tone, irritability, fatigue, and difficulty concentrating;
- after stopping treatment, a reduced production of some hormones called glucocorticosteroids.
Therefore, if you must use this medicine in high doses and on large areas of skin, your doctor should frequently monitor your blood levels of certain hormones and, if necessary, may decide to discontinue treatment, reduce the frequency of applications, or prescribe a similar but less potent medicine. Once treatment with PROCTOZETA is stopped, blood hormone levels usually return to normal (restoration of HPA axis function); only in some cases is the administration of other medications (systemic corticosteroids) necessary.

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

Lidocaine also passes through damaged skin and mucous membranes very easily. Therefore, use the medicine with great caution in these cases.

Stop treatment immediately after obtaining the desired effect.

Stop treatment and tell your doctor if you experience an allergic reaction (sensitization), bleeding, or irritation or burning of the skin following use of this medicine, especially over prolonged periods.

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

Children The use of this medicine is contraindicated in children under 12 years of age.


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

If PROCTOZETA is applied as directed, penetration through the skin is minimal and consequently side effects are also reduced.

The following side effects may occur due to the passage of the medicine through the skin (systemic effect):

Frequency not known (the frequency of which cannot be estimated from the available data):
- irritation and dryness of the skin, thinning of the skin and mucous membranes (atrophy), burning, itching;
- allergic reactions, even severe ones (anaphylactic shock);
- dizziness, drowsiness, visual disturbances, anxiety, tremors, changes in consciousness, convulsions, stopping breathing (respiratory arrest);
- slow heartbeat (bradycardia), low blood pressure (hypotension), reduced heart rate (myocardial depression) and even complete blockage (cardiac arrest);
- 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.