Meganest 40 mg/ml + 5 microgramos/ml solution for injection

Package leaflet: Information for the user

Introduction

Meganest 40 mg/ml + 5 micrograms/ml solution for injection

Articaine hydrochloride/epinephrine (adrenaline)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, including any side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Meganest 40 mg/ml + 5 micrograms/ml solution for injection is and what it is used for
2. What you need to know before being administered Meganest 40 mg/ml + 5 micrograms/ml solution for injection
3. How to use Meganest 40 mg/ml + 5 micrograms/ml solution for injection
4. Possible side effects
5. How to store Meganest 40 mg/ml + 5 micrograms/ml solution for injection
6. Contents of the pack and other information

1. What Meganest 40 mg/ml + 5 micrograms/ml injectable solution 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.
• Adrenaline, a vasoconstrictor that narrows the blood vessels at the injection site, thereby prolonging the effect of articaine. It also reduces bleeding during surgery.

Your dentist will administer either Meganest 40 mg/ml + 5 micrograms/ml injectable solution or Meganest 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 solution are indicated in children over 4 years of age (approximately 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 injectable solution is usually used for simple and short dental procedures.
• Meganest 40 mg/ml + 10 micrograms/ml injectable solution is more suitable for longer procedures or those with potential for significant bleeding.

2. What you need to know before starting to administer Meganest 40 mg/ml + 5 micrograms solution for injection

Do not use Meganest if you have any of the following conditions:

• Allergy to articaine, or to adrenaline (epinephrine), or to any of the other components of this medicine (listed in section 6).
• Allergy to other local anesthetics.
• Epilepsy not properly controlled with medication.

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

• Severe heart rhythm disorders (e.g., second- or third-degree AV block).
• 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 (hypotension).
• Abnormally rapid heartbeats.
• Myocardial infarction within the last 3–6 months.
• Coronary artery bypass graft within the last 3 months.
• You are taking medications for blood pressure called beta-blockers, such as propranolol. There is a risk of hypertensive crisis (very high blood pressure) or severe slowing of the heartbeat (see section “Use of Meganest solution for injection with other medicines”).
• Very high blood pressure.
• You are simultaneously taking medications for depression and Parkinson’s disease (tricyclic antidepressants). These medicines may intensify the effects of adrenaline.
• Epilepsy.
• Deficiency of a naturally occurring chemical called cholinesterase in the blood (plasma cholinesterase deficiency).
• Kidney problems.
• Severe liver problems.
• A disease called Myasthenia Gravis that causes muscle weakness.
• Porphyria, which causes both neurological complications and skin problems.
• You are using other local anesthetics that cause reversible loss of sensation (including volatile anesthetics such as halothane).
• You are taking medications called antiplatelet agents or anticoagulants to prevent narrowing or hardening of blood vessels in the arms and legs.
• 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 closed-angle glaucoma that affects the eyes.
• Inflammation or infection at the site where the injection will be administered.
• Reduced oxygen levels in body tissues (hypoxia), high potassium levels in the blood (hyperkalemia), and metabolic disorders resulting from excess acid in the blood (metabolic acidosis).

Use of Meganest with other medicines

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

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

• Other local anesthetics that cause reversible loss of sensation (including volatile anesthetics such as halothane).
• Sedatives (such as benzodiazepines, opioids), for example, to reduce anxiety before a dental procedure.
• Medicines for heart conditions 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 (e.g., digitalis, quinidine).
• Medicines for migraine attacks (such as methysergide or ergotamine).
• Sympathomimetic vasoconstrictors (such as cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline), used to raise blood pressure: if taken within the 24 hours prior to the planned dental treatment, the procedure should be postponed.
• Neuroleptic drugs (e.g., phenothiazines).

Use of Meganest with food

Avoid eating, including chewing gum, until normal sensation has returned. Otherwise, there is a risk of biting your lips, cheeks, or tongue, especially in children.

Pregnancy and breastfeeding and fertility

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

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

Breastfeeding may be resumed 5 hours after anesthesia.

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

Driving and use of machines

If you experience adverse effects, including dizziness, blurred vision, or fatigue, you should not drive or operate machinery until you have recovered your normal faculties (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 injection contain sodium metabisulfite and sodium.

This medicine may cause severe allergic reactions and bronchospasm (sudden sensation 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 (adrenaline), which may lead to a positive result in doping control tests.

3. How to use Meganest 40 mg/ml + 5 micrograms/ml injectable solution

Only doctors and dentists are trained to administer 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 will determine the appropriate dose based on your age, weight, general health status, and the dental procedure being performed.

The lowest dose that provides effective anesthesia should be used.

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

If you are given more Meganest 40 mg/ml + 5 micrograms/ml injectable solution or Meganest 40 mg/ml + 10 micrograms/ml injectable solution than you should

It is unlikely that you will be given too much of this injection, but if you begin to feel unwell, inform your dentist immediately. Symptoms of overdose include severe weakness, pale skin, headache, agitation or restlessness, disorientation, loss of balance, involuntary tremors or shivering, pupil dilation, blurred vision, difficulty focusing clearly, speech disturbances, dizziness, seizures, stupor, loss of consciousness, coma, yawning, abnormally slow or rapid breathing which may lead to temporary respiratory arrest, and inability of the heart to contract (cardiac failure).

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

While you are at the dentist, the dentist will closely monitor the effects of Meganest 40 mg/ml + 5 microgram/ml injectable solution or Meganest 40 mg/ml + 10 microgram/ml injectable solution.

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

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

Other patients may also experience other adverse effects not listed above.

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

• Gum inflammation
• Neuropathic pain: pain due to nerve injury
• Numbness or reduced sense of touch inside and around the mouth
• Metallic taste, taste disturbances, or loss of taste function
• Increased, unpleasant, or abnormal sense of touch
• Increased sensitivity to heat
• Headache
• Abnormally rapid heartbeat
• Abnormally slow heartbeat
• Low blood pressure
• Swelling of the tongue, lips, and gums

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

• Burning sensation
• High blood pressure
• Swelling of the tongue and mouth
• Nausea, vomiting, diarrhea
• Rash, itching
• Neck pain or injection site pain

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

• Nervousness, anxiety
• Facial nerve disorder (facial paralysis)
• Drowsiness
• Involuntary eye movements
• Double vision, temporary blindness
• Drooping eyelid and pupil constriction (Horner's syndrome)
• Sunken eyeball within the orbit (enophthalmos)
• Ringing in the ears, increased ear sensitivity
• Palpitations
• Flushing
• Wheezing (bronchospasm, whistling or hissing sounds in the bronchi), asthma
• Difficulty breathing
• Exfoliation and ulceration of the gums
• Exfoliation at the injection site
• Urticarial wheals
• Involuntary muscle contractions
• Fatigue, weakness
• Chills

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

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

Frequency not known: cannot be estimated from available data:

• Extreme sense of well-being (euphoria)
• Heartbeat coordination problems (conduction disorders, atrioventricular block)
• Increased blood volume in a part of the body leading to blood vessel congestion
• Widening or narrowing of blood vessels
• Hoarseness
• Difficulty swallowing
• Swelling of the cheeks and local swelling
• Burning mouth syndrome
• Skin redness (erythema)
• Abnormal increase in sweating
• Worsening of neuromuscular symptoms in Kearns-Sayre syndrome
• Sensation of heat or cold
• Jaw locking

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet.

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

5. Storage of Meganest 40 mg/ml + 5 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 medicine after the expiry date stated on the container. 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 colour.

Cartridges are for single use only. Use immediately after opening the cartridge. Any unused solution should be discarded.

Medicines must not be disposed of via wastewater or household waste. Your dentist will know how to dispose of medicines you no longer use. This helps protect the environment.

6. Contents of the pack and other information

Composition of Meganest 40 mg/ml + 5 micrograms/ml solution for injection

• The active substances are articaine hydrochloride and adrenaline tartrate.

• Each 1.8 ml cartridge of Meganest 40 mg/ml + 5 micrograms/ml solution for injection contains 72 mg of articaine hydrochloride and 9 micrograms of adrenaline (as adrenaline tartrate).

• Each millilitre of Meganest 40 mg/ml + 5 micrograms/ml solution for injection contains 40 mg of articaine 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 injections.

Appearance of the product and contents of the pack

Meganest 40 mg/ml + 5 micrograms/ml solution for injection is a colourless, translucent solution.

Pack containing 50 cartridges of 1.8 ml.

Pack containing 1 cartridge of 1.8 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

The latest revision of this leaflet was in February 2020

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

This information is intended for healthcare professionals only:

Dosage

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

For routine procedures, the normal dose for adult patients is 1 cartridge, although less than one cartridge may be sufficient for effective anaesthesia. According to the dentist's judgment, additional cartridges may be required for more extensive procedures, without exceeding the recommended maximum dose.

For most routine dental procedures, Meganest 40 mg/ml + 5 micrograms/ml solution for injection is preferred.

For more complex procedures, such as those requiring pronounced haemostasis, Meganest 40 mg/ml + 10 micrograms/ml solution for injection is preferred.

Concomitant use of sedatives to reduce patient anxiety:

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

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

Children (aged 4 to 11 years)

The safety of Meganest 40 mg/ml + 5 micrograms/ml solution for injection in children aged 4 years and younger has not been established. No data are available.

The amount to be injected should be determined based on the child's age, body weight, and the extent of the procedure. The effective average dose is 2 mg/kg and 4 mg/kg for simple and complex procedures, respectively. The lowest dose providing effective dental anaesthesia should be used. In children aged 4 years (or from 20 kg (44 lbs) body weight) and older, the maximum dose of articaine is only 7 mg/kg, with an absolute maximum dose of 385 mg of articaine for a healthy child weighing 55 kg.

Special populations

Elderly patients and patients with renal disorders:

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

Elevated plasma levels of the drug may occur in these patients, especially after repeated use. If re-injection is required, the patient should be closely monitored for any signs of relative overdose.

Patients with hepatic impairment

For patients with hepatic impairment, special precautions should be taken to administer the lowest dose that provides effective anaesthesia, especially after repeated use, although 90% of articaine is first inactivated by non-specific plasma and tissue esterases.

Patients with plasma cholinesterase deficiency

Elevated plasma levels of the drug may occur in patients with cholinesterase deficiency or those receiving acetylcholinesterase inhibitors, as the drug is inactivated by plasma esterases in 90%. Therefore, the lowest dose providing effective anaesthesia should be used.

Method of administration

Infiltration and perineural use in the oral cavity.

If inflammation and/or infection is present at the injection site, local anaesthesia should be administered with caution. The injection rate should be very slow (1 ml/min).

Precautions to be taken before handling or administering the medicine

This medicine should only be used by a physician or dentist with adequate training and familiar with the diagnosis and treatment of systemic toxicity, or under their supervision. Before initiating regional anaesthesia with local anaesthetics, availability of resuscitation equipment and appropriate medication must be ensured to allow immediate treatment of any respiratory or cardiovascular emergency. The patient's level of consciousness should be monitored after each local anaesthetic injection.

When using Meganest 40 mg/ml + 5 micrograms/ml solution for injection for infiltration or regional anaesthetic block, the injection must always be administered slowly and with prior aspiration.

Special warnings

Adrenaline reduces blood flow in the gums, potentially causing local tissue necrosis.

Very rare cases of prolonged or irreversible nerve injury and taste disturbance have been reported following mandibular nerve block anaesthesia.

Precautions for use

Risk associated with accidental intravascular injection:

Accidental intravascular injection may cause high systemic levels of adrenaline and articaine. This may lead to serious adverse reactions such as seizures, followed by central nervous and cardiorespiratory depression, coma, and progression to respiratory and circulatory arrest.

Therefore, to ensure the needle does not enter a blood vessel during injection, aspiration must be performed before injecting the local anaesthetic. However, the absence of blood in the syringe does not guarantee that intravascular injection has not occurred.

Risk associated with intraneural injection:

Accidental intraneural injection may cause retrograde drug spread along the nerve.

To avoid intraneural injection and prevent nerve injury during nerve blocks, the needle should always be slightly withdrawn if the patient experiences a shooting sensation or particularly painful injection. If nerve injury occurs from the needle, the neurotoxic effect may be worsened by the potential chemical neurotoxicity of articaine and the presence of adrenaline, which may reduce perineural blood flow and impair local elimination of articaine.

Management of overdose

Before administering regional anaesthesia with local anaesthetics, availability of resuscitation equipment and appropriate medication must be ensured to allow immediate treatment of any respiratory or cardiovascular emergency.

Depending on the severity of overdose symptoms, the physician or dentist should implement protocols including airway protection and assisted ventilation if needed.

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

If signs of acute systemic toxicity occur, injection of the local anaesthetic must be stopped immediately. If necessary, place the patient in the supine position.

Symptoms of CNS toxicity (seizures, CNS depression) must be treated immediately with appropriate airway/respiratory support and administration of anticonvulsant drugs.

Optimal oxygenation and ventilation, together with circulatory support and correction 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 receive age- and weight-appropriate doses.

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

Special precautions for disposal and other handling

This medicine must not be used if the solution is cloudy or has changed colour.

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

Cartridges are for single use only. If only part of the cartridge is used, the remainder must be discarded.

Disposal of unused medicine and all materials that have come into contact with it must be carried out in accordance with local regulations.

This information is intended for healthcare professionals only

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

To avoid intravascular injection, aspiration control must always be performed in at least two planes (rotating the needle by 180°), although a negative aspiration result does not rule out inadvertent intravascular injection.

The injection rate must not exceed 0.5 ml in 15 seconds, i.e., 1 cartridge per minute.

Major systemic reactions due to accidental intravascular injection can be avoided in most cases by proper injection technique (after aspiration, inject slowly 0.1–0.2 ml, then slowly administer the remainder no sooner than 20–30 seconds later).

Accidental injection may be associated with seizures followed by central nervous system or cardiorespiratory arrest. Resuscitation equipment, oxygen, and other resuscitation drugs must be immediately available.

Opened cartridges must not be used for other patients. Waste must be discarded.

The Summary of Product Characteristics includes guidelines and recommendations to ensure correct use of the product (see Dosage and method of administration; Warnings and special precautions for use).