Mepivacaine Ognar

Patient Information Leaflet

MEPIVACAINA OGNA 30 mg/ml injection solution

Mepivacaine Hydrochloride
Please read this leaflet carefully before you are given 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 nurse.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What MEPIVACAINA OGNA is and what it is used for

MEPIVACAINA OGNA contains the active substance mepivacaine hydrochloride, which belongs to a class of medicines called local anaesthetics, used to numb (anaesthetize) parts of the body (local anaesthesia) in adults and children. It can be used in all types of local anaesthesia, i.e. the type of anaesthesia that eliminates the sensation of pain in a specific area of the body without loss of consciousness.
MEPIVACAINA OGNA is indicated to induce local anaesthesia and regional trunci block anaesthesia in procedures involving the oral cavity and teeth (for stomatological and dental use). This medicinal product is particularly indicated for inducing anaesthesia in patients in whom vasoconstrictors are contraindicated, such as those suffering from high blood pressure, heart circulation problems (coronary diseases) or diabetes.

2. What you should know before being given MEPIVACAINA OGNA

MEPIVACAINA OGNA must not be administered to you if:

• you are allergic to mepivacaine or to any of the other ingredients of this medicine (listed in section 6);
• you are allergic (hypersensitive) to other medicines similar to this one (amide-type local anesthetics);
• you suffer from a neuromuscular disease characterized by muscle weakness (myasthenia gravis);
• you have low levels of cholinesterase in the blood (an enzymatic protein);
• you suffer from severe liver problems (severe hepatic insufficiency);
• you are pregnant or suspect you might be pregnant.

Warnings and precautions
Please consult your doctor or nurse before receiving MEPIVACAINA OGNA.
Serious adverse reactions, including death, have been reported following the use of local anesthetics.
This may occur even if you have never previously experienced an allergic reaction when using a local anesthetic (no history of individual hypersensitivity).
Therefore, this medicine will be administered only under strict medical supervision by trained personnel and in facilities equipped with emergency measures necessary for urgent treatment.
Local anesthesia should be avoided in infected areas and in cases of inflammation.

Other medicines and MEPIVACAINA OGNA
Inform your doctor or nurse if you are currently taking, have recently taken, or might need to take any other medicines.
No severe drug interactions are known; however, this medicine should be used with extreme caution in patients undergoing treatment with MAO inhibitors (monoamine oxidase inhibitors) or tricyclic antidepressants.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, please consult your doctor before receiving this medicine.
This medicine must not be administered if you are pregnant or suspect you might be pregnant.

Driving and using machines
At the recommended doses, this medicine does not significantly or persistently impair your ability to drive vehicles or operate machinery. However, after the procedure, please ask your doctor whether you may drive or operate machinery.

MEPIVACAINA OGNA contains sodium chloride
This medicine contains less than 23 mg (1 mmol) of sodium per dose, i.e. essentially "sodium-free".

3. How MEPIVACAINA OGNA will be administered to you

This medicine will be administered by a dentist or a nurse.
The doctor will adjust the required dose according to your needs.
The recommended dose is 1 or 3 cartridges of 1.8 ml, depending on the type of procedure.

Use in children
The dosage will be determined according to the child's age, the extent of the procedure, and will take into account the child's body weight. The maximum recommended dose is 0.025 ml of anesthetic solution per kilogram of body weight. The total dose must not exceed one cartridge per session.

If you are given more MEPIVACAINA OGNA than you should
This medicine will be administered by a doctor or nurse, so overdose is unlikely.
Accidental intravascular injection of local anesthetics may cause immediate generalized adverse effects. However, if you think you have been given too much of this medicine, inform your doctor immediately or go to the nearest hospital (see section 4 “Possible side effects”).
At the first sign of overdose, the doctor will immediately stop administering the medicine and will initiate the most appropriate therapy depending on the severity of symptoms.

If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Like other medicines used for anaesthesia, the side effects caused by MEPIVACAINA OGNA depend on the administered dose.

The following symptoms may occur, especially after administration of high doses, overdose, or inappropriate administration:

• excitation;
• tremors;
• disorientation;
• dizziness;
• pupil dilation (mydriasis);
• increased metabolism and body temperature;
• after administration of very high doses, difficulty or inability to open the mouth (trismus) and convulsions may occur;
• increased sweating;
• heart rhythm disturbances (arrhythmias);
• increased blood pressure (hypertension);
• increased breathing rate (tachypnea);
• increased bronchial dilation (bronchodilation);
• nausea, vomiting;
• slowing of the heartbeat (bradycardia);
• increased dilation of blood vessels (vasodilation);
• skin irritations (urticaria, skin rashes), itching;
• bronchospasm;
• swelling of the throat due to fluid accumulation (laryngeal edema);
• cessation of heart and respiratory function (cardiorespiratory collapse);
• severe allergic reaction (anaphylactic shock).

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 following 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 MEPIVACAINA 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 and applies to the product in its original
intact packaging, properly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MEPIVACAINA OGNA contains

• The active substance is mepivacaine hydrochloride. Each ml of injectable solution contains 30 mg of mepivacaine hydrochloride.
• The other components are sodium chloride and water for injections.

Description of the appearance of MEPIVACAINA OGNA and contents of the pack
Injectable solution
The cartridge is available in the following packaging:
Carton box containing 50 cartridges of 1.8 ml.
Marketing Authorization Holder
GIOVANNI OGNA & Figli S.r.l.
Via Figini, 41 - 20835 Muggiò (MB)
Manufacturer
Pierrel S.p.A.
Strada Statale Appia n. 46/48 - 81043 Capua (CE)

Package leaflet: information for the physician
The following information is intended exclusively for physicians or healthcare professionals
Special warnings and precautions for use
Prior to administration, the physician must assess the patient's general health and circulatory status; he/she must also obtain information regarding concomitant therapies and any previous allergic reactions. Any overdose of local anaesthetic must be avoided, and two maximum doses must never be administered without an interval of at least 24 hours between them. In any case, the lowest effective dose and concentration should be used to achieve the desired effect. The anaesthetic solution should be injected cautiously in small increments, following a preliminary aspiration after approximately 10 seconds. Especially when infiltrating highly vascularized areas, it is advisable to wait approximately 2 minutes before proceeding with the actual loco-regional block. The patient must be kept under close monitoring, and administration must be stopped immediately at the first sign of alarm (e.g., changes in consciousness).
Warning: Immediate availability of emergency equipment, medications, and trained personnel is essential, as rare but serious reactions, sometimes with fatal outcome, have been reported following the use of local anaesthetics, even in the absence of a history of individual hypersensitivity.
Patients with advanced hepatic impairment or severe renal insufficiency.
Data from lidocaine use suggest that in patients with advanced liver disease (Child class C), clearance may be reduced by approximately 50%. A clinically significant reduction in mepivacaine clearance is expected only in patients with severe renal insufficiency (CrCl <30 mL/min) not undergoing haemodialysis.
A reduced clearance is not expected to influence the occurrence of toxicity episodes caused by high plasma concentrations of mepivacaine after single doses in surgical anaesthesia.
However, in chronic renal failure, the renal excretion of the metabolite PPX is impaired, and accumulation may occur following repeated administrations.

Dosage and method of administration
Adults
Disinfect the cartridge diaphragm before use with 70% ethyl alcohol or 90% pharmaceutical-grade isopropyl alcohol.
Cartridges must not be immersed in any type of solution.
Based on the above considerations and the active substance concentration per cartridge, the maximum amount that can be administered in a single session should be calculated as follows:
Mepivacaine 30 mg/ml: maximum dosage of 3 cartridges of 1.8 ml.
Mepivacaine HCl: 3 x 54.00 mg = 162.00 mg, equivalent to 2.7 mg/kg of anaesthetic for a 60 kg patient.
Under no circumstances should the dose exceed 300 mg of mepivacaine per session.

Children
The recommended maximum dose is 0.025 ml of anaesthetic solution per kg of body weight. The total dose must not exceed one cartridge per session. The maximum dose of mepivacaine HCl that can be administered to a child (in mg) can be calculated as follows: child's weight (kg) × 1.33.

Special populations

• Hepatic impairment: In patients with impaired liver function, dose reduction is not required for surgical anaesthesia. In patients with Child class C hepatic impairment, when prolonged blocks involving repeated administrations are used, repeated doses of mepivacaine should be reduced by 50%, and the total dose over 24 hours must not exceed 750 mg of mepivacaine ().
• Renal impairment: In patients with renal dysfunction, dose reduction for surgical anaesthesia within 24 hours is not necessary.

Overdose
At the first sign of alarm, administration must be stopped immediately. The patient should be placed in a horizontal position, airway patency ensured, and oxygen administered in case of severe dyspnoea, or artificial ventilation performed (Ambu bag). The use of analeptics should be avoided, as they may worsen the condition by increasing oxygen consumption. Seizures, if present, may be controlled with intravenous diazepam 10–20 mg; barbiturates are not recommended as they may exacerbate bulbar depression. Circulatory support may be achieved with appropriate intravenous doses of corticosteroids. Diluted alpha- and beta-adrenergic vasoconstrictors (e.g., mefentermine, metaraminol, and others) or atropine sulphate may be added. Sodium bicarbonate, administered intravenously at an appropriate concentration, may be used as an antiacidotic agent.
For further information, consult the Summary of Product Characteristics.