PROSPECTO: INFORMATION FOR THE USER

Meganest40 mg/ml + 10 micrograms/ml injectable solution

articaína/ epinephrine

Read the entire prospect carefully before starting to use the medication because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect (see section 4).

1.What isMeganest 40 mg/ml + 10 micrograms/ml injectable solutionand for what it is used.

2.What you need to know before you are administeredMeganest 40 mg/ml + 10 micrograms/ml injectable solution.

3.How to useMeganest 40 mg/ml + 10 micrograms/ml injectable solution.

4.Possible adverse effects.

5Storage ofMeganest 40 mg/ml + 10 micrograms/ml injectable solution.

6.Contents of the package and additional information

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

This medication contains two active principles:

• articaine, a local anesthetic that prevents pain.
• adrenaline, 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 administerMeganest 40 mg/ml + 5 micrograms/ml injectable solutionorMeganest 40 mg/ml + 10 micrograms/ml injectable solution.

Meganest 40 mg /ml + 5 micrograms/ml injectable solution and Meganest 40 mg/ml + 10 micrograms/ml injectable solutionare indicated for children over 4years (approximately 20kg of body weight), adolescents, and adults.

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

• Meganest 40 mg/ml + 5 micrograms/ml injectable solutionis usually used for simple and short dental procedures.
• Meganest 40 mg/ml + 10 micrograms/ml injectable solutionis more suitable for longer procedures or those with significant bleeding risks.

No useMeganestif you suffer from any of the following conditions:

• allergy to articaine, or to adrenaline or to any of the other components of this medication (listed in section 6).
• allergy to other local anesthetics.
• uncontrolled epilepsy with medication.

Warnings and precautionsConsult your dentist before starting to useMeganest if you suffer from any of the following conditions:

• severe heart rhythm disorders (e.g., AV block of second and third degree).
• acute heart failure (acute cardiac weakness, e.g., unexpected chest pain at rest or after a myocardial infarction [i.e., heart attack]).
• low blood pressure.
• abnormally rapid heartbeats.
• myocardial infarction in the last 3-6months.
• coronary revascularization graft in the last 3months.
• you are taking blood pressure medications called beta-blockers, such as propranolol. There is a risk of hypertensive crisis (very high blood pressure) or severe bradycardia (slow heart rate) (see section "Use ofMeganest injectable solutionwith other medications").
• very high blood pressure.
• you are taking antidepressants and Parkinson's disease medications (tricyclic antidepressants) simultaneously. These medications can intensify the effects of adrenaline.
• epilepsy.
• deficiency of a natural chemical substance called plasma cholinesterase in the blood.
• 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 antiplatelet or anticoagulant medications to prevent the narrowing or hardening of blood vessels in arms and legs.
• if you are over 70years old.
• you have or have had any heart problems.
• you have uncontrolled diabetes.
• severe hyperthyroidism (thyrotoxicosis).
• a tumor called pheochromocytoma.
• a disease called closed-angle glaucoma that affects the eyes.
• inflammation or infection of the area where you will receive the injection.
• reduced oxygen levels in the body tissues (hypoxia), high potassium levels in the blood (hyperkalemia), and metabolic disorders resulting from excessive acid in the blood (metabolic acidosis).

Use ofMeganestwith other medications

Inform your dentist if you are taking, have recently taken, or may need to take any other medication.

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

• 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.
• Heart and blood pressure medications (such as guanadrel, guanetidina, propranolol, nadolol).
• Tricyclic antidepressants for treating depression (such as amitriptiline, desipramine, imipramine, nortriptiline, maprotiline, and protriptiline).
• COMT inhibitors for treating Parkinson's disease (such as entacapona or tolcapona).
• MAO inhibitors for treating depressive or anxiety disorders (such as moclobemida, fenelzina, tranilcipromina, linezolid).
• Medications for irregular heartbeats (e.g., digitals, quinidina).
• Medications for migraines (such as metisergida or ergotamina).
• Adrenergic vasopressors (such as cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline), used to raise blood pressure: if taken in the 24hours before the planned dental treatment, it should be postponed.
• Neuroleptics (e.g., phenothiazines).

Use ofMeganestwith food

Avoid eating, even chewing gum, until you have recovered normal sensitivity. Otherwise, there is a risk of biting your lips, cheeks, or tongue, especially in children.

Pregnancy and lactationand fertility

If you are pregnant or breastfeeding, think you may be, or plan to become pregnant, consult your dentist or doctor before using this medication.

Your dentist or doctor will decide if you can takeMeganest 40 mg/ml + 5 micrograms/ml injectable solution or Meganest 40 mg/ml + 10 micrograms/ml injectable solutionduring pregnancy.

Lactation can be resumed 5hours after anesthesia.

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

Driving and operating machinery

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

Meganest Articaína/Epinefrina 40 mg/ml + 5 micrograms/ml injectable solution andMeganest Articaína/Epinefrina 40 mg/ml + 10 micrograms/ml injectable solutioncontainsodium metabisulfite and sodium.and

This medication can cause severe allergic reactions and bronchospasm (sudden feeling of choking) because it contains sodium metabisulfite.

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

Use in athletes

This medication contains articaine and epinephrine (adrenaline) that can produce a positive result in doping control tests.

Only doctors and dentists are trained to use Meganest.Meganest.

Your dentist will choose between Meganest 40 mg/ml + 5 micrograms/ml injectable solution or Meganest 40 mg/ml + 10 micrograms/ml injectable solution and determine the appropriate dose taking into account your age, weight, general health status, and dental procedure.

The lowest dose that provides effective anesthesia should be used.

This medication is administered by a slow injection into the oral cavity.

If you use moreMeganest 40 mg/ml + 5 micrograms/ml injectable solution or Meganest 40 mg/ml + 10 micrograms/ml injectable solutionthan 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. The symptoms of an overdose include acute weakness, pale skin, headache, agitation or restlessness, disorientation, loss of balance, tremors or involuntary muscle contractions, dilated pupils, blurred vision, difficulty focusing on objects clearly, speech alterations, dizziness, convulsions, stupor, loss of consciousness, coma, yawning, abnormally slow or rapid breathing that may lead to temporary respiratory arrest, inability of the heart to contract (cardiac failure).

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

If you have any other questions about the use of this medication, ask your dentist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

When you are at the dentist's office, the dentist will closely monitor the effects ofMeganest 40 mg/ml + 5 micrograms/ml injectable solution or Meganest 40 mg/ml + 10 micrograms/ml injectable solution.

• Inform your dentist, doctor or pharmacistimmediatelyif you experience any of the following severe side effects:Swelling of the face, tongue or pharynx, difficulty swallowing, hives or difficulty breathing (angioedema).
• Rash, itching, swelling of the throat and difficulty breathing: may be symptoms of an allergic reaction (hypersensitivity).
• A combination ofdrooping eyelidandpupil constriction(Horner syndrome).

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

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

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

• Swelling of the gums
• Neuropathic pain: pain due to nerve damage
• Numbness or decreased sensation inside and around the mouth
• Metals taste, alterations in taste or loss of gustatory function
• Increased, unpleasant or abnormal sensation of touch
• Increased sensitivity to heat
• Headache
• Abnormally rapid heartbeats
• Abnormally slow heartbeats
• Low blood pressure
• Swelling of the tongue, lips and gums.

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

• Burning sensation
• High blood pressure
• Swelling 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 1,000people:

• Nervousness, anxiety
• Facial nerve disorder (facial paralysis)
• Drowsiness
• Involuntary eye movement
• Diplopia, temporary blindness
• Drooping eyelid andconstrictionof thepupil(Horner syndrome)
• Enophthalmos (hollowing of the eye)
• Tinnitus, increased sensitivity of the ear
• Palpitations
• Flushes
• Bronchospasm, asthma, wheezing
• Difficulty breathing
• Exfoliation and ulceration of the gums
• Exfoliation of the injection site
• Hives.
• Involuntary muscle contraction
• Fatigue, weakness
• Chills

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

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

Frequency not known: cannot be estimated from available data:

• Extreme euphoria
• Cardiac conduction disorders, atrioventricular block
• Increased blood volume in a part of the body leading to congestion of blood vessels
• Widening or narrowing of blood vessels
• Snoring
• Difficulty swallowing
• Swelling of the cheeks and local swelling
• Thirst
• Enlargement of theskin(erythema)
• Abnormal increase in sweating
• Worsening of neuromuscular symptoms of Kearns-Sayre syndrome
• Sensation of heat or cold
• Trigeminal neuralgia

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet

You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaRAM.esBy reporting side effects, you can contribute to providing more information on the safety of this medicine.

This product does not require special conditions for conservation.

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

Do not usethis medicationafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

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

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

Medications should not be disposed of through drains or in the trash. Your dentist will know how to dispose of unused medications. By doing so, you will help protect the environment.

Composition of Meganest40 mg/ml + 10 micrograms/ml injectable solution

- The active principles are hydrochloride of articaine and adrenaline tartrate.

• Eachcartridge of 1.8ml of injectable solution ofMeganest40 mg/ml + 10 micrograms/ml injectable solutioncontains 72 mg of hydrochloride of articaine and 18micrograms of adrenaline (as tartrate of adrenaline).
• Each milliliter ofMeganest40 mg/ml + 10 micrograms/ml injectable solutioncontains 40mg of hydrochloride of articaine and 0.01milligrams of adrenaline (as tartrate of adrenaline).

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

Aspect of the product and content of the package

Meganest40 mg/ml + 10 micrograms/ml injectable solutionisan injectable solution, colorless and transparent.

Package containing 50 cartridges of 1.8 ml.

Package containing 1 cartridge of 1.8 ml.

It may not be marketed all package sizes.

Holder of the marketing authorization and responsible for the manufacture

Holder of the marketing authorization:

Laboratorios Clarben S.A.

C/ Asura 111

28043 Madrid

Spain

Responsible for the Manufacture

Laboratorios Clarben S.A.

C/ Eduardo Marconi, 2. Industrial Codein.

Fuenlabrada (Madrid)- 28946

Spain.

Last review of this leaflet was inFebruary 2020

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

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This information is intended solely for healthcare professionals:

Dosage

For all populations, the lowest effective dose should be used. The required 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 dental anesthesia. According to the dentist's judgment, it may be necessary to use more cartridges for more extensive procedures, without exceeding the recommended maximum dose.

For most routine dental procedures, it is preferable to useMeganest40 mg/ml + 5 micrograms/ml injectable solution.

For more complex procedures, such as pronounced hemostasis, it is preferable to useMeganest40 mg/ml + 10 micrograms/ml injectable solution.

Concomitant use of sedatives to reduce patient anxiety:

The maximum safe dose of 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 of age)

In adults and adolescents, the maximum dose of articaine is 7 mg/kg, with a maximum absolute dose of articaine of 500 mg. The maximum dose of articaine of 500 mg corresponds to a healthy adult of more than 70 kg of body weight.

Children (between 4 and 11 years of age)

The safety ofMeganest40 mg/ml + 10 micrograms/ml injectable solutionin children under 4 years has not been established. There are no available data.

The amount to be injected should be determined by 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 effective dose should be used. In children of 4 years (or over 20 kg (44 lbs) of body weight) and older, the maximum dose of articaine is only 7 mg/kg, with a maximum absolute dose of 385 mg of articaine for a healthy child of 55 kg of body weight.

Special populations

Older patients and patients with renal disorders:

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

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

Patients with liver insufficiency

Special precautions should be taken to administer the lowest effective dose, especially after repeated use, although 90% of articaine is first inactivated by non-specific esterases in tissues and blood.

Patients with plasma cholinesterase deficiency

Elevated plasma levels of the drug may occur in patients with plasma cholinesterase deficiency or under treatment with cholinesterase inhibitors, as the product is inactivated in 90% by plasma esterases. Therefore, the lowest effective dose should be used.

Administration form

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 drug

This drug should only be used by a doctor or 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 a resuscitation team and appropriate medication are available to apply immediate treatment for any emergency respiratory or cardiovascular.

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

When usingMeganest40 mg/ml + 10 micrograms/ml injectable solutionfor infiltration or regional anesthetic block, the injection should always be administered slowly and with prior aspiration.

Special warnings

Adrenaline reduces blood flow in the gums, which may cause local tissue necrosis.

There have been rare cases of prolonged or irreversible nerve damage and taste loss after mandibular block analgesia.

Precautions for use

Risk associated with accidental intravascular injection:

An accidental intravascular injection may cause high levels of adrenaline and articaine in the systemic circulation. This may be associated with severe adverse reactions, such as convulsions, followed by central nervous system and cardiovascular depression and coma, which progresses to respiratory and cardiac 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 the intravascular injection has not occurred.

Risk associated with intraneural injection:

An accidental intraneural injection may 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 withdrawn slightly whenever the patient feels a discharge during injection or if the injection is particularly painful. If nerve damage occurs due to the needle, the neurotoxic effect may be exacerbated by the possible chemical neurotoxicity of articaine and the presence of adrenaline, as it may reduce perineural blood flow and prevent local elimination of articaine.

Treatment of overdose

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

According to the severity of the symptoms of overdose, the doctor or dentist should implement protocols that anticipate the need to protect 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 occur, the injection of local anesthetic should be stopped immediately. If necessary, place the patient in a supine position.

The symptoms of CNS (convulsions, CNS depression) should be treated immediately with appropriate airway support/respiratory support and administration of anticonvulsant drugs.

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

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

Special precautions for elimination and other manipulations

This drug 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 a part of the cartridge is used, the rest should be discarded.

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