MEGANEST 40 mg/mL + 10 micrograms/mL Injectable Solution

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Meganest40 mg/ml + 10 micrograms/ml solution for injection

articaine/epinephrine

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 further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet (see section 4).

Contents of the pack:

1. What Meganest 40 mg/ml + 10 micrograms/ml solution for injection is and what it is used for.
2. What you need to know before you are given Meganest 40 mg/ml + 10 micrograms/ml solution for injection.
3. How to use Meganest 40 mg/ml + 10 micrograms/ml solution for injection.
4. Possible side effects.

5. Storage of Meganest 40 mg/ml + 10 micrograms/ml solution for injection.

1. Package contents and additional information

1. What Meganest 40 mg/ml + 10 micrograms/ml solution for injection is and what it is used for

Meganest is used to numb (anesthetize) the oral cavity during dental procedures.

This medicine contains two active substances:

• articaine, a local anesthetic that prevents pain.
• epinephrine, a vasoconstrictor that narrows the blood vessels at the injection site and, therefore, prolongs the effect of articaine. It also reduces bleeding during surgery.

Your dentist will administer Meganest 40 mg/ml + 5 micrograms/ml solution for injection or Meganest 40 mg/ml + 10 micrograms/ml solution for injection.

Meganest 40 mg/ml + 5 micrograms/ml solution for injection and Meganest 40 mg/ml + 10 micrograms/ml solution for injection are indicated in children over 4 years (around 20 kg body weight), adolescents, and adults.

Depending on the type of dental procedure performed, the dentist will choose one of the two medicines:

• Meganest 40 mg/ml + 5 micrograms/ml solution for injection is usually used for simple and short dental procedures.
• Meganest 40 mg/ml + 10 micrograms/ml solution for injection is more suitable for longer procedures or with possible significant bleeding.

2. What you need to know before you are given Meganest 40 mg/ml + 10 micrograms/ml solution for injection

Do not useMeganestif you have any of the following conditions:

• allergy to articaine, or to epinephrine or to any of the other ingredients of this medicine (listed in section 6).
• allergy to other local anesthetics.
• uncontrolled epilepsy.

Warnings and precautionsConsult your dentist before starting to use Meganest if you have any of the following conditions:

• severe heart rhythm disorders (e.g., second and third degree AV block).
• acute heart failure (acute weakness of the heart, e.g., unexpected chest pain at rest or after a heart attack).
• low blood pressure.
• abnormally fast heartbeats.
• heart attack in the last 3-6 months.
• coronary revascularization graft in the last 3 months.
• you are taking medications for high blood pressure called beta-blockers, such as propranolol. There is a risk of hypertensive crisis (very high blood pressure) or severe slowing of the heart rate (see section "Use of Meganest solution for injection with other medicines").
• very high blood pressure.
• you are taking medications for depression and Parkinson's disease (tricyclic antidepressants). These medications can enhance the effects of epinephrine.
• epilepsy.
• lack of a natural chemical called cholinesterase in the blood (plasma cholinesterase deficiency).
• kidney problems.
• severe liver problems.
• a disease called Myasthenia Gravis that causes muscle weakness.
• porphyria that causes both neurological complications and skin problems.
• if you are using other local anesthetics that cause reversible loss of sensitivity (including volatile anesthetics, such as halothane).
• if you are taking medications called antiplatelet or anticoagulant to prevent the narrowing or hardening of blood vessels in the arms and legs.
• if you are over 70 years old.
• you have or have had any heart problems.
• you have uncontrolled diabetes.
• a severe case of overactive thyroid (thyrotoxicosis).
• a tumor called pheochromocytoma.
• a disease called glaucoma that affects the eyes.
• inflammation or infection of the area where you will receive the injection.
• reduced oxygen levels in the body's tissues (hypoxia), high potassium levels in the blood (hyperkalemia), and metabolic disorders such as too much acid in the blood (metabolic acidosis).

Use ofMeganestwith other medicines

Tell your dentist if you are taking, have recently taken, or might take any other medicines.

It is very important to inform your dentist if you are taking any of the following medicines:

• Other local anesthetics that cause reversible loss of sensitivity (including volatile anesthetics, such as halothane).
• Sedatives (such as benzodiazepines, opioids), for example, to reduce anxiety before the dental procedure.
• Medicines for the heart and blood pressure (such as guanadrel, guanethidine, propranolol, nadolol).
• Tricyclic antidepressants for treating depression (such as amitriptyline, desipramine, imipramine, nortriptyline, maprotiline, and protriptyline).
• COMT inhibitors for treating Parkinson's disease (such as entacapone or tolcapone).
• MAO inhibitors for treating depressive or anxiety disorders (such as moclobemide, phenelzine, tranylcypromine, linezolid).
• Medicines for irregular heartbeats (such as digitalis, quinidine).
• Medicines for migraine attacks (such as methysergide or ergotamine).
• Sympathomimetic vasopressors (such as cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline), used to raise blood pressure: if taken in the 24 hours prior to the planned dental treatment, it should be postponed.
• Neuroleptic drugs (such as phenothiazines).

Use ofMeganestwith food

Avoid eating, even chewing gum, until you have regained normal sensitivity. Otherwise, there is a risk that you may bite your lips, cheeks, or tongue, especially in children.

Pregnancy and breast-feedingand fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your dentist or doctor for advice before taking this medicine.

Your dentist or doctor will decide whether you can take Meganest 40 mg/ml + 5 micrograms/ml solution for injection or Meganest 40 mg/ml + 10 micrograms/ml solution for injection during pregnancy.

Breast-feeding can be resumed 5 hours after anesthesia.

No adverse effects on fertility are expected with the doses used in a dental procedure.

Driving and using machines

If you experience side effects, including dizziness, blurred vision, or fatigue, do not drive or operate machinery until you have recovered (usually within 30 minutes after the dental procedure).

Meganest Articaine/Epinephrine 40 mg/ml + 5 micrograms/ml solution for injection and Meganest Articaine/Epinephrine 40 mg/ml + 10 micrograms/ml solution for injectioncontainsodium metabisulfiteand sodium.

This medicine may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sodium metabisulfite.

This medicine also contains less than 23 mg of sodium per dose, which is essentially "sodium-free".

Use in athletes

This medicine contains articaine and epinephrine that may produce a positive result in doping tests.

3. How to use Meganest 40 mg/ml + 10 micrograms/ml solution for injection

Only doctors and dentists are trained to use Meganest.

Your dentist will choose between Meganest 40 mg/ml + 5 micrograms/ml solution for injection or Meganest 40 mg/ml + 10 micrograms/ml solution for injection and determine the appropriate dose based on your age, weight, general health, and dental procedure.

The lowest dose that provides effective anesthesia should be used.

This medicine is administered by slow injection into the oral cavity.

If you use moreMeganest 40 mg/ml + 5 micrograms/ml solution for injection or Meganest 40 mg/ml + 10 micrograms/ml solution for injectionthan you should

It is unlikely that you will be given too much of this injection, but if you start to feel unwell, tell your dentist. Symptoms of an overdose include acute weakness, pale skin, headache, agitation or restlessness, disorientation, loss of balance, tremors or involuntary twitching, dilated pupils, blurred vision, speech difficulties, dizziness, convulsions, stupor, loss of consciousness, coma, yawning, abnormally slow or fast breathing that can lead to temporary respiratory arrest, inability of the heart to contract (heart failure).

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you have any further questions on the use of this medicine, ask your dentist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

When you are in the dentist's office, the dentist will closely monitor the effects of Meganest 40 mg/ml + 5 micrograms/ml solution for injection or Meganest 40 mg/ml + 10 micrograms/ml solution for injection.

• Tell your dentist, doctor, or pharmacistimmediatelyif you experience any of the following serious side effects:Swelling of the face, tongue, or pharynx, difficulty swallowing, hives, difficulty breathing (angioedema).
• Rash, itching, swelling of the throat, and difficulty breathing: may be symptoms of an allergic reaction (hypersensitivity).
• A combination of drooping eyelid and constricted pupil (Horner's syndrome).

These side effects are rare (may affect up to 1 in 1,000 people).

In other patients, other side effects not listed above may also occur.

Common side effects: may affect up to 1 in 10 people:

• Gingivitis
• Neuropathic pain: pain due to nerve damage
• Numbness or decreased sensation inside and around the mouth
• Metallic taste, altered taste, or loss of taste
• Increased, unpleasant, or abnormal sensation
• Increased sensitivity to heat
• Headache
• Abnormally fast heartbeats
• Abnormally slow heartbeats
• Low blood pressure
• Swelling of the tongue, lips, and gums.

Uncommon side effects: may affect up to 1 in 100 people:

• Burning sensation
• High blood pressure
• Inflammation of the tongue and mouth
• Nausea, vomiting, diarrhea
• Rash, itching
• Pain in the neck or at the injection site

Rare side effects: may affect up to 1 in 1,000 people:

• Nervousness, anxiety
• Facial nerve disorder (facial paralysis)
• Somnolence
• Involuntary eye movement
• Double vision, temporary blindness
• Drooping eyelid and constricted pupil (Horner's syndrome)
• Sinking of the eyeball into the orbit (enoftalmia)
• Ringing in the ears, increased sensitivity of the ear
• Palpitations
• Hot flashes
• Wheezing (bronchospasm, wheezing), asthma
• Difficulty breathing
• Exfoliation and ulceration of the gums
• Exfoliation at the injection site
• Hives.
• Involuntary muscle contraction
• Fatigue, weakness
• Chills

Very rare side effects: may affect up to 1 in 10,000 people:

• Persistent loss of sensitivity, extensive numbness, and loss of taste

Frequency not known: cannot be estimated from the available data:

• Extreme euphoria
• Heart conduction disorders (conduction disorders, atrioventricular block)
• Increased blood flow to a part of the body leading to congestion of blood vessels
• Widening or narrowing of blood vessels
• Hoarseness
• Difficulty swallowing
• Swelling of the cheeks and local swelling
• Burning mouth syndrome
• Redness of the skin (erythema)
• Abnormal sweating
• Worsening of neuromuscular symptoms of Kearns-Sayre syndrome
• Feeling of heat or cold
• Jaw locking

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet.

You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Meganest 40 mg/ml + 10 micrograms/ml solution for injection

No special storage conditions are required.

Keep this medicine out of the sight and reach of children.

Do not use this medicineafter the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice that the solution is cloudy or has changed color.

The cartridges are for single use. Use immediately after opening the cartridge. The unused solution should be discarded.

Medicines should not be disposed of via wastewater or household waste. Your dentist will know how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Container Content and Additional Information

Meganest Composition40 mg/ml + 5 micrograms/ml injectable solution

• The active ingredients are articaína hydrochloride and adrenaline tartrate.

• Each 1.8 ml cartridge of Meganest40 mg/ml + 5 micrograms/ml injectable solution contains 72 mg of articaína hydrochloride and 9 micrograms of adrenaline (as adrenaline tartrate).
• Each milliliter of Meganest40 mg/ml + 5 micrograms/ml injectable solution contains 40 mg of articaína hydrochloride and 5 micrograms of adrenaline (as adrenaline tartrate).

• The other components (excipients) are: sodium metabisulfite, sodium chloride, sodium hydroxide or hydrochloric acid (for pH adjustment), water for injectable preparations.

Product Appearance and Container Content

Meganest40 mg/ml + 5 micrograms/ml injectable solution is a colorless and transparent injectable solution.

Container containing 50 cartridges of 1.8 ml.

Container containing 1 cartridge of 1.8 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Clarben S.A.

Av. Valdelaparra 27

28108 Alcobendas

Spain

Manufacturer

Laboratorios Clarben S.A.

C/ Eduardo Marconi, 2. Polígono Industrial Codein.

Fuenlabrada (Madrid)- 28946

Spain.

This leaflet was last revised inFebruary 2020

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es

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This information is intended only for healthcare professionals:

Posology

For all populations, the lowest dose that provides effective anesthesia should be used. The necessary dose must be determined individually.

For a routine procedure, the normal dose for adult patients is 1 cartridge, but the content of less than one cartridge may be sufficient for effective anesthesia. According to the dentist's judgment, more cartridges may be required for more extensive procedures, without exceeding the recommended maximum dose.

In the case of most routine dental procedures, it is preferable to use Meganest40 mg/ml + 5 micrograms/ml injectable solution.

For more complex procedures, such as pronounced hemostasis, it is preferable to use Meganest40 mg/ml + 10 micrograms/ml injectable solution.

Concomitant use of sedatives to reduce patient anxiety:

The maximum safe dose of the local anesthetic may be reduced in sedated patients due to an additive effect on central nervous system depression.

Adults and adolescents (between 12 and 18 years old)In adults and adolescents, the maximum dose of articaína is 7 mg/kg, with an absolute maximum dose of articaína of 500 mg. The maximum dose of articaína of 500 mg corresponds to a healthy adult weighing over 70 kg.

Children (between 4 and 11 years old)

The safety of Meganest40 mg/ml + 5 micrograms/ml injectable solution has not been established in children under 4 years of age. No data are available.

The amount to be injected must be determined based on the child's age and weight and the magnitude of the operation. The effective mean dose is 2 mg/kg and 4 mg/kg for simple and complex procedures, respectively. The lowest dose that provides effective dental anesthesia should be used. In children from 4 years old (or from 20 kg (44 lbs) body weight) and older, the maximum dose of articaína is only 7 mg/kg, with an absolute maximum dose of 385 mg of articaína for a healthy child weighing 55 kg.

Special populations

Elderly patients and patients with renal disorders:

Due to the lack of clinical data, special precautions should be taken to administer the lowest dose that provides effective anesthesia in elderly patients and in patients with renal disorders.

High plasma levels of the medication may occur in these patients, especially after repeated use. In case of re-injection, the patient should be closely monitored to identify any signs of relative overdose.

Patient with hepatic insufficiency

For patients with hepatic insufficiency, special precautions should be taken to administer the lowest dose that provides effective anesthesia, especially after repeated use, although 90% of articaína is first inactivated by non-specific plasma esterases in tissues and blood.

Patient with plasma cholinesterase deficiency

High plasma levels of the medication may occur in patients with cholinesterase deficiency or under treatment with acetylcholinesterase inhibitors, since the product is 90% inactivated by plasma esterases. Therefore, the lowest dose that provides effective anesthesia should be used.

Method of Administration

Infiltration and perineural use in the oral cavity.

If there is inflammation and/or infection at the injection site, local anesthesia should be injected with caution. The injection speed should be very slow (1 ml/min).

Precautions to be taken before handling or administering the medication

This medication should only be used by a doctor or a dentist with sufficient training and familiar with the diagnosis and treatment of systemic toxicity, or under their supervision. Before inducing regional anesthesia with local anesthetics, it should be ensured that resuscitation equipment and adequate medication are available to provide immediate treatment for any respiratory or cardiovascular emergency. The patient's level of consciousness should be monitored after each injection of local anesthesia.

When using Meganest40 mg/ml + 5 micrograms/ml injectable solution for infiltration or regional anesthetic block, the injection should always be administered slowly and with prior aspiration.

Special Warnings

Adrenaline reduces blood flow to the gums, which can cause local tissue necrosis.

Very rare cases of prolonged or irreversible nerve damage and taste loss have been reported after mandibular block anesthesia.

Precautions for Use

Risk associated with accidental intravascular injection:

An accidental intravascular injection can cause high levels of adrenaline and articaína in the systemic circulation. This can be associated with serious adverse reactions, such as convulsions, followed by central nervous system depression and cardiorespiratory arrest, which progresses to respiratory and circulatory arrest.

Therefore, to ensure that the needle does not penetrate a blood vessel during injection, aspiration should be performed before injecting the local anesthetic. However, the absence of blood in the syringe does not guarantee that intravascular injection has not occurred.Risk associated with intraneural injection:

An accidental intraneural injection can cause the drug to move retrogradely through the nerve.

To avoid intraneural injection and prevent nerve damage when performing nerve blocks, the needle should be slightly withdrawn whenever the patient feels a sensation of discharge during injection or if the injection is particularly painful. If nerve damage occurs due to the needle, the neurotoxic effect may be worsened by the possible neurotoxicity of articaína and the presence of adrenaline, as it can reduce perineural blood flow and prevent local elimination of articaína.

Overdose Treatment

Before administering regional anesthesia with local anesthetics, it should be ensured that resuscitation equipment and adequate medication are available to provide immediate treatment for any respiratory or cardiovascular emergency.

Depending on the severity of the overdose symptoms, the doctor or dentist should implement protocols that anticipate the need to protect the airways and provide assisted ventilation.

The patient's level of consciousness should be monitored after each injection of local anesthesia.

If signs of acute systemic toxicity appear, the injection of the local anesthetic should be stopped immediately. If necessary, the patient should be placed in a supine position.

The symptoms of the CNS (convulsions, CNS depression) should be treated immediately with adequate respiratory support and the administration of anticonvulsant medications.

Optimal oxygenation and ventilation, along with circulatory support and treatment of acidosis, can prevent cardiac arrest. If cardiovascular depression (hypotension, bradycardia) occurs, appropriate treatment with intravenous fluids, vasopressors, or inotropic agents should be considered. Children should be administered doses according to their age and weight.

In case of cardiac arrest, cardiopulmonary resuscitation should be performed immediately.

Special Precautions for Elimination and Other Handling

This medication should not be used if the solution is turbid or has changed color.

To avoid the risk of infection (e.g., transmission of hepatitis), the syringe and needles used to prepare the solution should always be new and sterile.

The cartridges are for single use. If only part of the cartridge is used, the rest should be discarded.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

This information is intended only for healthcare professionals

Local injection / Dental use. For exclusive use in dental anesthesia.

To avoid intravascular injection, aspiration control should always be performed in at least two planes (needle rotation of 180º), although a negative aspiration result does not rule out involuntary and unnoticed intravascular injection.

The injection speed should not exceed 0.5 ml in 15 seconds, i.e., 1 cartridge/minute.

Major systemic reactions, such as those resulting from accidental intravascular injection, can be avoided in most cases by a technical injection (after aspiration, slow injection of 0.1-0.2 ml and slow application of the rest, not before 20-30 seconds have passed).

Accidental injection may be associated with convulsions followed by central nervous system or cardiorespiratory arrest. Resuscitation equipment, oxygen, and other resuscitation medications should be available for immediate use.

Opened cartridges should not be used in other patients. Residues should be discarded.

The technical data sheet includes guidelines and recommendations to ensure correct use of the product (see Posology and method of administration; Warnings and special precautions for use)