PROCTOZETA*CR 30G 15+10MG/G

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, cortisone), 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 an infection caused by a virus, such as cutaneous tuberculosis, herpes simplex, chickenpox, or by a bacterium;
- if the person who needs to use this medicine is under 12 years of age (See 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 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 condition. 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 its symptoms. Therefore, inform your doctor, who will determine the most suitable treatment 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 avoid using the medicine for long periods or at close intervals. These precautions are necessary because corticosteroids (hydrocortisone) can pass through the skin, and consequently, serious side effects may 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 cycle in women, loss of muscle tone, irritability, fatigue, and difficulty concentrating;
- after stopping treatment, a reduced production of certain hormones called glucocorticosteroids.
Therefore, if you need to use this medicine in high doses and on large areas of skin, your doctor should subject you to frequent checks of certain hormone levels in your blood, and if necessary, may decide to stop treatment, reduce the frequency of applications, or prescribe a similar but less potent medicine. Usually, once PROCTOZETA treatment is stopped, blood hormone levels 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 may, in any case, lead to positive anti-doping test results.

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 prescribed, the passage through the skin is minimal, and consequently, the 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 (frequency 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, including severe ones (anaphylactic shock);
- dizziness, drowsiness, visual disturbances, anxiety, tremors, altered state of consciousness, convulsions, respiratory arrest;
- reduced heart rate (bradycardia), low blood pressure (hypotension), reduced heart activity (myocardial depression) leading to complete arrest (cardiac arrest);
- blurred vision.
Adherence to the instructions in the package leaflet reduces the risk of side effects.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.