LIDOPROCTENE 1,5%/1% Cream

Зміст інструкції

1. LIDOPROCTENE 1,5% / 1% cream
   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

LIDOPROCTENE 1,5% / 1% cream

Lidocaine hydrochloride and hydrocortisone acetate
Equivalent medicine

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 you use 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 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 case 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.

2. What you need to know before using LIDOPROCTENE

Do not use LIDOPROCTENE

• if you are allergic to lidocaine hydrochloride, hydrocortisone acetate, similar medicines (local anesthetic agents of the amide type, corticosteroids) or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from or think you may suffer from a fungal infection (mycotic infection);
• if you suffer from an infection caused by a virus, such as cutaneous tuberculosis, simple herpes, varicella, or by a bacterium;
• if the person who needs to use this medicine is less than 12 years old (See the “Children” section);
• if you are pregnant or if you are breastfeeding (See the “Pregnancy and breastfeeding” section).

Warnings and precautions
Consult your doctor or pharmacist before using LIDOPROCTENE.
This medicine should not be applied to the eyes.
The safety of medicines containing lidocaine as the active ingredient depends on the dose, the correct application of the product and compliance with all precautions.
The doctor will establish the dose based on age and your 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 an acute phase), your doctor should prescribe a lower dose.
If you suffer from an infection, this medicine may worsen the symptoms. Therefore, inform your doctor who will establish the most appropriate therapy in this case.
Use this medicine with great caution and inform your doctor if you have:

• severe trauma (injuries);
• a severe infection spreading throughout the body (sepsis);
• extensive skin lesions.

During treatment with LIDOPROCTENE, avoid applying excessive doses of the product to very large areas of the 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 serious side effects may occur. 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 stopping treatment, a reduced production of some hormones called glucocorticosteroids. Therefore, if you need to use this medicine at high doses and on large areas of the skin, your doctor should subject you to frequent checks of hormone levels in the blood and, if necessary, may decide to stop treatment, reduce the frequency of applications or prescribe a similar medicine, but less potent. Usually, once treatment with LIDOPROCTENE 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. 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 obtaining the desired effect.
Stop treatment and inform your doctor if you experience an allergic reaction (sensitization), bleeding or irritation and burning of the skin following the use of this medicine, especially for prolonged periods.
For athletes: the use of the drug without therapeutic necessity constitutes doping and may in any case result in a positive doping test.

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

Other medicines and LIDOPROCTENE
Tell 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 propanolol) for the treatment of heart problems and to lower blood pressure;
• digitalis used for some heart disorders;
• other medicines similar to lidocaine (such as tocainide) used to induce anesthesia;
• barbiturates used to induce anesthesia and for the treatment of convulsions (antiepileptics);
• antihistamines for the treatment of allergies;
• diphenylhydantoin for the treatment of epilepsy;
• anti-inflammatory drugs used to relieve pain and inflammation (such as salicylates and phenylbutazone);
• oral hypoglycemic agents and insulin for the treatment of diabetes. Long-term use of this medicine on large areas of the skin can cause a condition characterized by the presence of sugars in the urine (glycosuria) and increased blood sugar levels (postprandial hyperglycemia). In addition, if the cream is applied under a non-breathable bandage, which facilitates the passage of the medicine through the skin, an excessive amount of medicine in the blood and a reduced elimination through the urine (decrease in urinary excretion of 17-KS and 17-OHCS) may occur.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Since glucocorticoids, including hydrocortisone contained in this medicine, 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 operating machinery
This medicine does not impair the ability to drive vehicles 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 reactions).

3. How to use LIDOPROCTENE

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
Apply a small amount of cream to the affected area, with a gentle massage, 2 or more times a day.
If you need to apply this medicine inside the anus, use the appropriate rectal cannula.

If you use more LIDOPROCTENE than you should
Following the rapid passage of lidocaine into the blood or the use of excessive doses of this medicine, serious toxic effects may occur.
In particular, the use of an excessive dose of this medicine can cause the following symptoms: tremors,
convulsions, depression, severe difficulty breathing (respiratory failure), lowering of the
blood pressure (hypotension), slowing of the heart rate (bradycardia) and a deep state of
unconsciousness (coma).
Following the use of the medicine for prolonged periods of time, a reduction in the levels of
some hormones in the blood may occur (secondary adrenal insufficiency) (See the paragraph “Warnings and
precautions”). In this case, the doctor, if necessary, may decide to stop the treatment, reduce
the frequency of applications or prescribe a similar medicine (corticosteroid), but less
potent. The symptoms are spontaneously reversible and the treatment is symptomatic. It may be necessary
to rebalance the amount of fluids and salts in the body (fluid and electrolyte balance). In case of chronic toxicity,
the doctor will have to slowly remove the hydrocortisone from the body.
The doctor will establish the most appropriate therapy based on the severity of the symptoms.
In case of ingestion/accidental intake 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 a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 passage of the medicine through the skin
(systemic effect):

Frequency not known(the frequency of which 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, convulsions, respiratory arrest (respiratory failure);
• reduction of heartbeats (bradycardia), lowering of blood pressure (hypotension), reduction of heart activity (myocardial depression) up to complete block (cardiac arrest).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 the first opening of the container, the medicine must be used within 12 months. After this period, any remaining medicine must be disposed of.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What LIDOPROCTENE contains

• The active ingredients are: lidocaine hydrochloride and hydrocortisone acetate. 100 g of cream contains 1.5 g of lidocaine hydrochloride and 1 g of hydrocortisone acetate.
• The other ingredients 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 authorisation holder and manufacturer
Laboratorio Chimico Farmaceutico A. Sella s.r.l., Via Vicenza, 67 - 36015 Schio (VI)