Lidoproctene

Package leaflet: Information for the user

LIDOPROCTENE 1.5% / 1% cream

Lidocaine hydrochloride and hydrocortisone acetate
Equivalent medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LIDOPROCTENE is and what it is used for

LIDOPROCTENE 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 surgery on the anus or the final portion of the intestine (anorectal surgery).

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

2. What you need to know before using LIDOPROCTENE

Do not use LIDOPROCTENE

• if you are allergic to lidocaine hydrochloride, hydrocortisone acetate, medicines of similar type (amide-type local anesthetics, 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 (mycotic infection);
• if you have an infection caused by a virus, such as cutaneous tuberculosis, herpes simplex, chickenpox, or by a bacterium;
• 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 LIDOPROCTENE.
This medicine must not be applied to the eyes.
The safety of medicines containing lidocaine as the active substance 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 lowest effective dose necessary to achieve the desired results.
If you are elderly or suffer from an illness (in the acute phase), 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 this case.
Use this medicine with great caution and inform your doctor if you have:

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

During treatment with LIDOPROCTENE, avoid applying excessive doses of the product over large areas of skin, and do not use the medicine for prolonged periods or at closely spaced 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, increased hair growth (hirsutism), hair loss, irregular menstrual cycle 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 must use this medicine at high doses and over large skin areas, your doctor should perform frequent checks of certain hormone levels in your blood. If necessary, your doctor may decide to discontinue treatment, reduce the frequency of applications, or prescribe a similar but less potent medicine. Usually, after stopping treatment with LIDOPROCTENE, hormone levels return to normal (restoration of HPA axis function); only in some cases is administration of other medicines (systemic corticosteroids) required. Also, the passage of lidocaine through damaged skin and mucous membranes is significantly increased. Therefore, in these cases, use the medicine with extreme caution.

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 those engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

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

Other medicines and LIDOPROCTENE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Use this medicine with caution and inform your doctor if you are taking the following medicines:

• cimetidine, used for stomach problems;
• beta-blockers (such as propranolol) for heart conditions and lowering blood pressure;
• digitalis preparations 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 for treating allergies;
• diphenylhydantoin for treating epilepsy;
• anti-inflammatory medicines used to relieve pain and inflammation (such as salicylates and phenylbutazone);
• oral hypoglycemic agents and insulin for the treatment of diabetes.
  Prolonged use of this medicine over large skin areas may cause 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 facilitates the passage 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 and breastfeeding
If you are pregnant, suspect you may be pregnant, planning 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 LIDOPROCTENE except in cases of absolute necessity;
• if you are breastfeeding, do not use this medicine.

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

LIDOPROCTENE contains cetyl stearyl alcohol and methyl parahydroxybenzoate
This medicine contains cetyl stearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis), and methyl parahydroxybenzoate, which may cause allergic reactions (including delayed-type reactions).

3. How to use LIDOPROCTENE

Use this medicine exactly 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, with gentle massage, 2 or more times a day.
If you need to apply this medicine inside the anus, use the provided rectal cannula.

If you use more LIDOPROCTENE than you should
Following the rapid absorption of lidocaine into the bloodstream or the use of excessive doses of this medicine,
serious toxic effects may occur.
In particular, using an excessive dose of this medicine may cause the following symptoms: tremors,
seizures, depression, severe breathing difficulties (respiratory failure), low blood pressure (hypotension),
reduced heart rate (bradycardia), and a deep state of 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). The symptoms are spontaneously reversible and treatment is symptomatic. It may be necessary to restore the body's fluid and electrolyte balance (hydro-electrolytic balance). In cases of chronic toxicity, the doctor will need to gradually withdraw hydrocortisone.

The doctor will determine the most appropriate treatment depending on the severity of the symptoms.
In case of accidental ingestion/ingestion of LIDOPROCTENE, contact your doctor or go immediately
to the nearest hospital.

If you forget to use LIDOPROCTENE
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 everybody will experience them.
If LIDOPROCTENE is applied as directed, passage through the skin is minimal and, consequently, side effects are also 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 the available data)

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

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, consult your doctor or pharmacist.
You may also report side effects directly via the national reporting system at 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 LIDOPROCTENE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Store this medicine in its original packaging, protected from light and away from direct sources of heat.
Store at a temperature not exceeding 30°C.
After first opening the container, the medicine should be used within 12 months. After this period, any remaining medicine must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What LIDOPROCTENE contains

• The active substances are: lidocaine hydrochloride and hydrocortisone acetate. 100 g of cream contain 1.5 g of lidocaine hydrochloride and 1 g of hydrocortisone acetate.
• The other components are: glyceryl monostearate, hamamelis fluid extract, cetylstearyl alcohol, macrogol cetostearyl ether, octyldodecanol, methyl parahydroxybenzoate (E218), imidurea, purified water.

Description of the appearance of LIDOPROCTENE and contents of the pack
Tube containing 30 g of cream.
Marketing Authorization Holder and Manufacturer
Laboratorio Chimico Farmaceutico A. Sella s.r.l., Via Vicenza, 67 - 36015 Schio (VI)