PROCTOZETA*CR 30G 1.5%+1%

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

What it is and what it is 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 anesthetics 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 cases 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 the last part of the intestine (anorectal surgery).

Consult 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 anesthetics, corticosteroids) or any of the other ingredients of this medicine (listed in section 6);
- if you suffer or think you suffer from a fungal infection (mycotic infection);
- if you suffer from a viral infection, such as cutaneous tuberculosis, herpes simplex, chickenpox, or a bacterial infection;
- if the person who needs to use this medicine is under 12 years old (See section "Children");
- if you are pregnant or breastfeeding (See section "Pregnancy and breastfeeding").

Warnings and precautions
Consult your doctor or pharmacist before using PROCTOZETA.

This medicine must not be applied to the eyes.

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

Your doctor will determine the dose based on your age and health conditions. In particular, it is recommended to use the minimum effective dose to achieve the desired results.
If you are elderly and suffer from an illness (in the acute phase), your doctor should prescribe a lower dose.

If you suffer from an infection, this medicine can worsen your symptoms. Therefore, inform your doctor who will establish the most suitable therapy in this case.

Use this medicine with great caution and inform your doctor if you have:
- severe trauma (injuries);
- a severe systemic infection (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 at close intervals. These precautions are necessary because corticosteroids (hydrocortisone) can pass through the skin, and consequently, severe side effects can occur. In particular, you may experience:
- during treatment, typical symptoms of Cushing's disease, such as sudden weight gain, increased hair growth (hirsutism), hair loss, irregular menstrual cycles in women, loss of muscle tone, irritability, fatigue, and difficulty concentrating;
- after discontinuation of treatment, reduced production of certain hormones called glucocorticosteroids.
Therefore, if you need to use this medicine at high doses and on large areas of skin, your doctor should monitor your blood hormone levels frequently and, if necessary, may decide to stop treatment, reduce the frequency of applications, or prescribe a similar but less potent medicine. Usually, once treatment with PROCTOZETA is stopped, hormone levels in the blood return to normal (restoration of HPA axis function); only in some cases is the administration of other medicines (systemic corticosteroids) necessary.

Contact your doctor if you experience blurred vision or other visual disturbances.
The passage of lidocaine through damaged skin and mucous membranes is also very high. Therefore, in these cases, use the medicine with great caution.

Stop treatment immediately after achieving the desired effect.

Stop treatment and inform your doctor if you experience an allergic reaction (sensitization), bleeding, or skin irritation and burning after using this medicine, especially for prolonged periods.

For athletes: the use of the drug without therapeutic necessity constitutes doping and can still lead to positive anti-doping tests.

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 everyone experiences them.

If PROCTOZETA is applied as directed, its passage 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 unknown (whose frequency cannot be estimated from the available data)
- skin irritation and dryness, thinning of the skin and mucous membranes (atrophy), burning, itching;
- allergic reactions, including severe ones (anaphylactic shock);
- dizziness, drowsiness, visual disturbances, anxiety, tremors, altered state of consciousness, seizures, respiratory arrest;
- decreased heart rate (bradycardia), low blood pressure (hypotension), decreased heart activity (myocardial depression) up to complete block (cardiac arrest);
- blurred vision.
Adhering to the instructions in the package leaflet reduces the risk of side effects.

Reporting of side effects
If you get 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.