Articaine / epinephrine Dermogen 40 mg/ml + 10 micrograms/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

ARTICAINE / EPINEPHRINE DERMOGEN 40 mg/ml + 10 micrograms/ml solution for injection EFG

articaine hydrochloride / epinephrine (adrenaline)

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your dentist, doctor, or pharmacist.
• If you experience any adverse effects, consult your dentist, doctor, or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What ARTICAINE / EPINEPHRINE DERMOGEN is and what it is used for.
2. What you need to know before being administered ARTICAINE / EPINEPHRINE DERMOGEN.
3. How to use ARTICAINE / EPINEPHRINE DERMOGEN.
4. Possible adverse effects.
5. How to store ARTICAINE / EPINEPHRINE DERMOGEN.
6. Contents of the pack and other information.

1. What ARTICAÏNE / EPINEPHRINE DERMOGEN is and what it is used for

Articaïne / Epinephrine Dermogen is used to numb (anesthetize) the oral cavity during dental procedures.

This medicine contains two active substances:

• Articaïne, a local anesthetic that prevents pain.
• Epinephrine, a vasoconstrictor that narrows the blood vessels at the injection site, thereby prolonging the effect of articaïne. It also reduces bleeding during surgery.

Your dentist will administer either Articaïne / Epinephrine Dermogen 40 mg/ml + 5 micrograms/ml or Articaïne / Epinephrine Dermogen 40 mg/ml + 10 micrograms/ml.

Articaïne / Epinephrine Dermogen is indicated in children over 4 years of age (approximately 20 kg body weight), adolescents, and adults.

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

• Articaïne / Epinephrine Dermogen 40 mg/ml + 5 micrograms/ml is usually used for simple and short dental procedures.
• Articaïne / Epinephrine Dermogen 40 mg/ml + 10 micrograms/ml is more suitable for longer procedures or those with potentially significant bleeding.

2. What you need to know before ARTICAINE / EPINEPHRINE DERMOGEN is administered to you

Do not use ARTICAINE / EPINEPHRINE DERMOGEN if you have any of the following conditions:

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

Warnings and precautions

Consult your dentist before starting to use Articaine / Epinephrine Dermogen if you have any of the following conditions:

• Severe cardiac rhythm disorders (e.g., second- or third-degree AV block).
• Acute heart failure (acute cardiac weakness, e.g., unexpected chest pain at rest or following 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 Articaine / Epinephrine Dermogen 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 epinephrine.
• 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.
• If you are using other local anesthetics that cause reversible loss of sensation (including volatile anesthetics such as halothane).
• If you are taking medications called antiplatelets or anticoagulants to prevent narrowing or hardening of blood vessels in arms and legs.
• If you are over 70 years old.
• You have or have had any heart problems.
• You have uncontrolled diabetes.
• Severe hyperthyroidism (thyrotoxicosis).
• A tumor called pheochromocytoma.
• A condition called closed-angle glaucoma affecting the eyes.
• Inflammation or infection at the site where the injection will be administered.
• Low 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 ARTICAINE / EPINEPHRINE DERMOGEN with other medicines

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

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

• Other local anesthetics causing reversible loss of sensation (including volatile anesthetics such as halothane).
• Sedatives (such as benzodiazepines, opioids), for example, to reduce anxiety before the dental procedure.
• Medicines for 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,
  fenelzine, tranilcypramine, linezolid).
• Medicines for irregular heartbeats (e.g., 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 within the previous 24 hours before the planned dental treatment, the procedure should be postponed.
• Neuroleptic drugs (e.g., phenothiazines).

Use of Articaine / Epinephrine Dermogen 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, breastfeeding, and fertility:

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

Your dentist or doctor will decide whether you can use Articaine / Epinephrine Dermogen during pregnancy.

Breastfeeding may be resumed 5 hours after anesthesia.

Adverse effects on fertility are not 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).

ARTICAINE / EPINEPHRINE DERMOGEN contains sodium and sodium metabisulfite

• Sodium: this medicine contains less than 23 mg (1 mmol) of sodium per cartridge and is therefore considered essentially "sodium-free".
• Sodium metabisulfite: in rare cases, may cause severe allergic reactions and breathing difficulties (bronchospasm).

If there is any risk of an allergic reaction, your dentist will choose another anesthetic medication.

3. How to use ARTICAINE / EPINEPHRINE DERMOGEN

Only physicians and dentists are trained to use Articaine / Epinephrine Dermogen.

Your dentist will choose between Articaine / Epinephrine Dermogen 40 mg/ml + 5 micrograms/ml or Articaine / Epinephrine Dermogen 40 mg/ml + 10 micrograms/ml and will determine the appropriate dose based on your age, weight, general health status, and the dental procedure being performed.

The lowest dose providing effective anesthesia should be used.

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

If you use more ARTICAINE / EPINEPHRINE DERMOGEN than you should

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

While you are at your dentist's office, your dentist will closely monitor the effects of Articaine / Epinephrine Dermogen.

Immediately inform your dentist, doctor, or pharmacist if you experience any of the following serious adverse effects:

• Swelling of the face, tongue, or pharynx, difficulty swallowing, hives, or breathing difficulties (angioedema)
• Rash, itching, throat swelling, and breathing difficulties: 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 adverse effects not listed above may also occur in some patients.

Frequent 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
• Inflammation of the tongue and mouth
• Nausea, vomiting, diarrhea
• Rash, itching
• Pain in the neck or at the injection site

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 sounds in the bronchi), asthma
• Difficulty breathing
• Exfoliation and ulceration of the gums
• Exfoliation at the injection site
• Hives
• 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 congestion of blood vessels
• 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 or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ARTICAINA / EPINEFRINA DERMOGEN

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 the month indicated.

Do not store above 30°C. Keep the blister in the outer packaging to protect it from light.

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 no longer in use. This helps protect the environment.

6. Package contents and other information

Composition of ARTICAINE / EPINEPHRINE DERMOGEN

• The active substances are articaine hydrochloride and adrenaline tartrate.

  • Each 1.8 ml cartridge of injectable solution of Articaine / Epinephrine Dermogen 40 mg/ml + 10 micrograms/ml contains 72 mg of articaine hydrochloride and 18 micrograms of adrenaline (as adrenaline tartrate).
  • Each milliliter of Articaine / Epinephrine Dermogen 40 mg/ml + 10 micrograms/ml contains 40 mg of articaine hydrochloride and 10 micrograms of adrenaline (as adrenaline tartrate).

• The other components are sodium chloride, disodium edetate, sodium metabisulphite (E-223), sodium hydroxide, water for injections.

Appearance of the product and contents of the container

ARTICAINE / EPINEPHRINE DERMOGEN is a clear, colourless solution.

Pack containing one 1.8 ml cartridge and a leaflet.

Pack containing 50 cartridges of 1.8 ml (clinical pack) in 5 PVC blisters with 10 cartridges each and a leaflet.

Pack containing 100 cartridges of 1.8 ml (clinical pack) in 10 PVC blisters with 10 cartridges each and a leaflet.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

FARMALIDER, S.A.

c\ La Granja 1

28108– Alcobendas (Madrid)

Spain

Manufacturer

PIERREL, S.P.A.

Via Nazionale Appia (Capua, Caserta)

I-81043 Italy

Date of the most recent revision of this leaflet: February 2020

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios).

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This information is intended for healthcare professionals only.

Dosage

For all populations, the lowest effective dose required to achieve adequate anesthesia should be used. The necessary dose must be determined individually.

For routine procedures, the normal dose for adult patients is one cartridge, although less than a full cartridge may be sufficient for effective anesthesia. 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, Articaine / Epinephrine Dermogen 40 mg/ml + 5 micrograms/ml is preferred.

For more complex procedures, such as those requiring pronounced hemostasis, Articaine / Epinephrine Dermogen 40 mg/ml + 10 micrograms/ml is preferred.

Concomitant use of sedatives to reduce patient anxiety:

The safe maximum dose of local anesthetic 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 500 mg of articaine. The maximum dose of 500 mg of articaine corresponds to a healthy adult weighing more than 70 kg.

Children (aged 4 to 11 years)

The safety of Articaine / Epinephrine Dermogen has not been established in children under 4 years of age. 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 effective dose providing adequate dental anesthesia 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 anesthesia 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 must 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 anesthesia, particularly after repeated use, although 90% of articaine is initially inactivated by nonspecific tissue and plasma esterases.

Patients with plasma cholinesterase deficiency

Elevated plasma levels of the drug may occur in patients with cholinesterase deficiency or those receiving treatment with acetylcholinesterase inhibitors, as the drug is inactivated by 90% via plasma esterases. Therefore, the lowest effective dose providing adequate anesthesia 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 anesthesia 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. Prior to the induction of regional anesthesia with local anesthetics, 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 anesthetic injection.

When using Articaine / Epinephrine Dermogen for infiltration or regional nerve block anesthesia, 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 loss have been reported following mandibular nerve block anesthesia.

Precautions for use

Risk associated with accidental intravascular injection:

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

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

Risk associated with accidental intraneural injection:

Accidental intraneural injection may cause the drug to travel retrograde along the nerve.

To avoid intraneural injection and prevent nerve injury during nerve blocks, the needle should be slightly withdrawn whenever the patient experiences an electric shock 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.

Treatment of overdose

Prior to administering regional anesthesia with local anesthetics, 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 that include the need to protect airways and provide assisted ventilation.

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

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

Symptoms of CNS toxicity (seizures, CNS depression) should be treated immediately with appropriate airway/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 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 should 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.