LIDOCAINE HYDROCORT MV*RECTAL CRM

LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI
15 mg/g + 10 mg/g rectal cream
Lidocaine hydrochloride and hydrocortisone acetate

What it is and what it is used for
LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI 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 LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI
- 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 is 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 LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI.

This medicine must not be applied to the eyes.

The safety of medicines containing lidocaine as an active ingredient depends on the dose, correct product application, 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 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 widespread infection throughout the body (sepsis);
- extensive skin lesions.

During treatment with LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI, avoid applying excessive doses of the product, on very large skin areas, and using the medicine for long periods or at close intervals. These precautions are necessary, as corticosteroids (hydrocortisone) can pass through the skin, and consequently severe 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 frequently check your blood hormone levels and, if necessary, may decide to discontinue treatment, reduce the frequency of applications, or prescribe a similar but less potent medicine. Usually, once treatment with LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI is discontinued, 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.

Discontinue treatment as soon as the desired effect is achieved.
Discontinue 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 those involved in sports: the use of the drug without therapeutic necessity constitutes doping and can still result in 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 everybody gets them.

If LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI is applied as directed, its absorption 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 (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, vision disturbances, anxiety, tremors, altered state of consciousness, convulsions, respiratory arrest;
- slowed heart rate (bradycardia), low blood pressure (hypotension), reduced heart activity (myocardial depression) up to complete block (cardiac arrest);
- blurred vision.

Adhering to the instructions in the 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.