Lidocaine hydrochloride and hydrocortisone acetate Marco Viti

Package leaflet: Information for the user

LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI 15 mg/g + 10 mg/g

rectal cream
Lidocaine hydrochloride and hydrocortisone acetate
Please read this leaflet carefully before using this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your
doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after a few days.

Contents of this leaflet:

1. What LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI is and what it is used for
2. What you need to know before using LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI
3. How to use LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI
4. Possible side effects
5. How to store LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI
6. Contents of the pack and other information

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

LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI is a combination of two active substances: lidocaine hydrochloride and hydrocortisone acetate. Lidocaine hydrochloride belongs to a group of medicines called local anaesthetics, which 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 haemorrhoids;
• in cases of inflammation (eczema), irritation (erythema), lesions (fissures), itching and burning in the anal area due to haemorrhoids;
• before and after surgical procedures on the anus or the terminal portion of the intestine (anorectal surgery).

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

2. What you should know before using LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI

Do not use LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI

• if you are allergic to lidocaine hydrochloride, hydrocortisone acetate, medicines similar to them (local anesthetics of the amide type, corticosteroids), or to any of the other ingredients of this medicine (listed in section 6);
• if you have or think you may have a fungal infection (fungal infection);
• if you have 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 the active ingredient depends on the dose, correct application of the product, and adherence to all precautions.
Your doctor will determine the appropriate dose based on your age and general health condition. In particular, it is recommended to use the lowest effective dose necessary to achieve the desired results.
If you are elderly or suffering from an acute illness, your doctor should prescribe a lower dose.
If you have an infection, this medicine may worsen its symptoms. Therefore, inform your doctor, who will determine the most appropriate therapy in such cases.
Use this medicine with great caution and inform your doctor if you have:

• severe trauma;
• a serious systemic infection (sepsis);
• extensive skin lesions.

During treatment with LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI, avoid applying excessive amounts of the product over large areas of skin, and do not use the medicine for prolonged periods or at short intervals. These precautions are necessary because corticosteroids (hydrocortisone) may pass through the skin, potentially leading to serious adverse effects. In particular, you may experience:

• during treatment, symptoms typical of Cushing's disease, such as sudden weight gain, excessive hair growth (hirsutism), hair loss, irregular menstrual cycle in women, muscle weakness, 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 over large skin areas, your doctor should perform frequent checks of certain hormone levels in your blood and, if necessary, may decide to discontinue treatment, reduce the frequency of applications, or

prescribe a similar but less potent medicine. Usually, after stopping treatment with LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI, hormone levels in the blood return to normal (restoration of HPA axis function);
only in some cases is administration of additional medicines (systemic corticosteroids) required.
Contact your doctor if you experience blurred vision or other visual disturbances.
The absorption of lidocaine through damaged skin and mucous membranes is very high. Therefore, use this medicine with extreme caution in such cases.
Discontinue treatment immediately after achieving the desired effect.
Stop treatment and inform your doctor if you develop an allergic reaction (sensitization), bleeding, or skin irritation and burning following the use of this medicine, especially after prolonged use.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Children
This medicine is contraindicated in children under 12 years of age.

Other medicines and LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Use this medicine with caution and inform your doctor if you are taking any of the following medicines:

• cimetidine, used for stomach problems;
• beta-blockers (such as propranolol) for heart conditions and lowering blood pressure;
• digitalis, used for certain heart disorders;
• other medicines similar to lidocaine (such as tocainide), used to induce anesthesia;
• barbiturates, used to induce anesthesia and treat seizures (antiepileptics);
• antihistamines, used to treat allergies;
• phenytoin, used to treat epilepsy;
• anti-inflammatory medicines used to relieve pain and inflammation (such as salicylates and phenylbutazone);
• oral hypoglycemic agents and insulin, used to treat diabetes.

Some medicines may enhance the effects of LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).
Prolonged use of this medicine over large skin areas may lead to a condition characterized by the presence of sugar in the urine (glycosuria) and increased blood sugar levels (postprandial hyperglycemia). Moreover, if the cream is applied under an occlusive dressing (non-breathable bandage), which enhances the penetration of the medicine through the skin, excessive amounts of the medicine may enter the bloodstream and its elimination through urine may be reduced (decreased urinary excretion of 17-KS and 17-OHCS).

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Since glucocorticoids, including hydrocortisone contained in this medicine, may have harmful effects on pregnancy and/or the fetus/newborn:

• if you are pregnant, do not use LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI except when strictly necessary;
• if you are breastfeeding, do not use this medicine.

Driving and using machines
This medicine does not impair your ability to drive or operate machinery.

LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI contains cetyl alcohol and parahydroxybenzoates
This medicine contains cetyl alcohol, which may cause local skin reactions (e.g., contact dermatitis), and parahydroxybenzoates, which may cause allergic reactions (including delayed-type reactions).

3. How to use LIDOCAINA CLORIDRATO E IDROCORTISONE ACETATO MARCO VITI

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply a small amount of cream to the affected area, gently massaging it in, two or more times a day.
If you need to apply this medicine inside the anus, first pierce the safety seal and screw on the rectal cannula provided in the package. After applying the cream, remove the cannula from the tube and clean it.

If you use more LIDOCAINA CLORIDRATO E IDROCORTISONE ACETATO MARCO VITI than you should
Serious toxic effects may occur due to the rapid absorption of lidocaine into the bloodstream or from using excessive doses of this medicine.
In particular, using too high a dose of this medicine may cause the following symptoms: tremors, convulsions, depression, severe breathing difficulties (respiratory failure), low blood pressure (hypotension), reduced heart rate (bradycardia), and deep unconsciousness (coma).

Prolonged use of this medicine may lead to reduced levels of certain hormones in the blood (secondary adrenal insufficiency) (see section “Warnings and precautions”). In such cases, the doctor may decide, if necessary, to discontinue treatment, reduce the frequency of applications, or prescribe a similar but less potent medicine (corticosteroid). Symptoms are spontaneously reversible and treatment is symptomatic. Rebalancing body fluids and electrolytes (hydro-electrolytic balance) may be required. In cases of chronic toxicity, the doctor will need to gradually withdraw hydrocortisone from the body.
The doctor will determine the most appropriate treatment depending on the severity of symptoms.

In case of accidental ingestion/overdose of LIDOCAINA CLORIDRATO E IDROCORTISONE ACETATO MARCO VITI, contact your doctor or go immediately to the nearest hospital.

If you forget to use LIDOCAINA CLORIDRATO E IDROCORTISONE ACETATO MARCO VITI
Do not use a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI is applied as directed, absorption through the skin is minimal and, consequently, side effects are reduced.
The following side effects may occur due to the medicine passing through the skin (systemic effect):
Frequency not known (frequency cannot be estimated from available data)

• skin irritation and dryness, thinning of the skin and mucous membranes (atrophy), burning, itching;
• allergic reactions, even severe ones (anaphylactic shock);
• dizziness, drowsiness, visual disturbances, anxiety, tremors, altered consciousness, seizures, respiratory depression (respiratory arrest);
• reduced heart rate (bradycardia), low blood pressure (hypotension), reduced heart activity (myocardial depression) up to complete blockage (cardiac arrest);
• blurred vision . .

Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATE MARCO VITI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
After first opening the container, the medicine should be used within 3 months.
After this period, any remaining medicine must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What LIDOCAINA CLORIDRATO E IDROCORTISONE ACETATO MARCO VITI contains

• The active substances are: lidocaine hydrochloride and hydrocortisone acetate. 1 g of rectal cream contains 15 mg of lidocaine hydrochloride and 10 mg of hydrocortisone acetate.
• The other components are: purified water, white soft paraffin, liquid paraffin, cetylstearyl alcohol, sorbitan stearate, polysorbate 60, methyl parahydroxybenzoate, propyl parahydroxybenzoate.

Description of the appearance of LIDOCAINA CLORIDRATO E IDROCORTISONE ACETATO MARCO VITI and contents of the pack
30 g tube of rectal cream.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Marco Viti Farmaceutici S.p.A. - Via Mentana, 38 – 36100 Vicenza – Italy
Manufacturer
Zeta Farmaceutici S.p.A. - Via Galvani, 10 – 36066 Sandrigo (VI) – Italy