LIDOCAINA 5% Gingival gel

Зміст інструкції

1. Lidocaina cloridrato Ogna 5% gingival gel
   1. What is Lidocaina cloridrato Ogna and what is it used for
   2. What you need to know before you are given Lidocaina cloridrato Ogna
   3. How Lidocaina cloridrato Ogna will be administered to you
   4. Possible side effects
   5. How to store Lidocaina cloridrato Ogna
   6. Contents of the pack and other information

Lidocaina cloridrato Ogna 5% gingival gel

Lidocaina cloridrato

Read this leaflet carefully before you are given 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, pharmacist or nurse.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What Lidocaina cloridrato Ogna is and what it is used for
• 2. What you need to know before you are given Lidocaina cloridrato Ogna
• 3. How you will be given Lidocaina cloridrato Ogna
• 4. Possible side effects
• 5. How to store Lidocaina cloridrato Ogna
• 6. Contents of the pack and other information

1. What is Lidocaina cloridrato Ogna and what is it used for

Lidocaina cloridrato Ogna contains the active ingredient lidocaine hydrochloride, which belongs to the group of
medicines called local anesthetics, which work by blocking pain in the area where they are applied.
Lidocaina cloridrato Ogna is indicated as a local anesthetic to treat pain in case of minor internal injuries
to the mouth (abrasions, small burns, etc.) and to provide relief in case of localized itching.

2. What you need to know before you are given Lidocaina cloridrato Ogna

You will not be given Lidocaina cloridrato Ogna

• if you are allergic to lidocaine, to other similar medicines (amide anesthetics) or to any of the other ingredients of this medicine (listed in section 6);
• if you have or suspect an infection caused by a fungus;
• if the patient is a child under 4 years of age;
• if you are pregnant or suspect you are pregnant or if you are breastfeeding. Warnings and precautionsTalk to your doctor or nurse before you are given Lidocaina cloridrato Ogna. The safety of this medicine depends on the dose used, the correct application technique and the measures to prevent any adverse effects. Too high doses may increase the occurrence of adverse effects. To reduce the occurrence of adverse effects, the doctor will use the minimum necessary dose and may reduce the dose based on age, your health conditions, if you are an elderly patient or if you suffer from certain diseases. The doctor will use this medicine with caution if:
• you suffer from severe injuries;
• you have extensive skin lesions;
• you suffer from a severe form of infection (sepsis). If this medicine is applied to areas such as the throat, mouth or tongue, you may experience a sensation of difficulty swallowing, breathing and a feeling of numbness in the tongue, which may increase the risk of biting. Prolonged use may cause allergic-type reactions (sensitization phenomena) or bleeding (hemorrhages). If these effects occur, it is necessary to stop treatment and start appropriate therapy. In these cases, a possible allergy to lidocaine should not be excluded. Avoid contact with eyes. Children and adolescentsIn children from 4 years of age, the doctor will adjust the dose according to health conditions, weight and age (see section 3 “How you will be given Lidocaina cloridrato Ogna”). Other medicines and Lidocaina cloridrato Ogna

Tell your doctor or nurse if you are taking, have recently taken or might take any other
medicine.
Lidocaina cloridrato Ogna must be given to you with caution and you should inform your doctor if you are
taking the following medicines:

• cimetidine, a medicine used to treat stomach acidity and lesions to the stomach and intestines, because it can cause an increase in lidocaine levels in the blood;
• medicines used to treat high blood pressure or heart problems (beta-blockers) such as propranolol;
• medicines used to treat heart disorders (digitalis), as it increases the risk of developing slowed heartbeats (bradycardia) and other auriculo-vestibular conduction disorders;
• other anesthetic medicines (tocainide). Pregnancy and breastfeedingIf you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before you are given this medicine. This medicine should not be given to you if you are pregnant or suspect you are pregnant or during breastfeeding. Driving and using machinesThis medicine does not impair the ability to drive or use machines. Lidocaina cloridrato Ogna contains methyl parahydroxybenzoateThis medicine contains methyl parahydroxybenzoate which may cause delayed allergic reactions.

3. How Lidocaina cloridrato Ogna will be administered to you

This medicine will be administered to you by a doctor.
The doctor will apply the correct dose of this medicine directly to the area to be treated or using a
sterile gauze swab.
The dose will be adjusted by the doctor based on your health condition.
Use only for short-term treatments.
The effect of Lidocaina cloridrato Ogna appears after 3-5 minutes.

Use in adults
The recommended dose is 4 g of gel per application (equivalent to 200 mg of lidocaine hydrochloride). Do not exceed
20 g of gel per day (equivalent to 1 g of lidocaine hydrochloride).

Use in adolescents aged 12 to 18 years
The doctor will adjust the dose based on health conditions, weight and age.

Use in children aged 4 to 12 years
The recommended dose should not exceed 5 mg/kg of lidocaine hydrochloride. Do not exceed 3 doses
per day.

Use in the elderly and debilitated patients
The doctor will adjust the dose based on your condition and weight if you are an elderly person or are debilitated, suffer
from serious illnesses or if you have severe infections.

If you are given more Lidocaina cloridrato Ogna than you should
This medicine will be administered to you by a doctor, therefore it is unlikely that you will be given
an excessive dose. However, if you think you have been given an excessive dose, inform
your doctor or another healthcare professional immediately.
In case of overdose, you may experience:

• tremors;
• convulsions followed by depression, difficulty breathing (respiratory failure) and coma;
• heart disorders associated with decreased blood pressure (hypotension) and slowed heartbeat (bradycardia). If you have any questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

• rarely allergic reactions which can also be serious such as anaphylactic shock;
• skin irritation;
• excitation or depression associated with dizziness, drowsiness, visual disturbances, anxiety, tremors followed by changes in consciousness, convulsions, severe breathing difficulties (respiratory arrest);
• slowing of the heartbeat (bradycardia), changes in the heartbeat (arrhythmias, myocardial depression) up to blockage of heart activity;
• decrease in blood pressure (hypotension, hypertension). Reporting of side effectsIf 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help to provide more information on the safety of this medicine.

5. How to store Lidocaina cloridrato Ogna

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
After first opening, use within 36 months.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lidocaina cloridrato Ogna contains

• The active ingredient is lidocaine hydrochloride. 100 g of gel contains 5 g of lidocaine hydrochloride.
• The other ingredients are: polyethylene glycol 200, polyethylene glycol 1500, methyl parahydroxybenzoate, purified water. Description of the appearance of Lidocaina cloridrato OgnaPack containing 1 tube of 30 g of gel. Marketing authorisation holder and manufacturerGIOVANNI OGNA & Figli S.r.l. Via Figini, 41 - 20835 Muggiò (MB)

The following information is intended exclusively for doctors or healthcare professionals
Special warnings and precautions for use
The safety of use of products containing lidocaine depends on the dosage, a correct application technique and the adoption of precautionary measures. The medicine must be used at the minimum effective dose, appropriately reducing the dosage in relation to the age and physical condition of the patient, in the elderly and in acutely ill patients. Excessive dosage of lidocaine or a narrow interval between applications can cause high plasma levels and the manifestation of undesirable effects.
Absorption after application to damaged skin and mucous membranes is high, especially in the bronchial tree. Therefore, lidocaine gel must be used with caution in patients with severe trauma, sepsis or extensive skin lesions.
In the case of use in areas of the mouth or throat, patients must be warned that the application of a local anesthetic may interfere with swallowing and cause difficulty in aspiration.

Overdose
Treatment is symptomatic. Any convulsions can be controlled with the administration of short-acting barbiturates or benzodiazepines.

Incompatibilities
Lidocaine is incompatible with amphotericin, sodium sulfadiazine, sodium cefazolin, sodium phenytoin, mefentermine hydrochloride, alkalis, heavy metals, oxidizing agents, tannin, air and light.

For further information, consult the Summary of Product Characteristics.