Label: information for the user

ARTICAÍNA / EPINEFRINA DERMOGEN 40 mg/ml + 5 micrograms/ml injectable solution EFG

hydrochloride of/ Epinephrine (adrenaline)

Read this label carefully before starting to use this medicine, because it contains important information for you.

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

Contents of the label

1. What isARTICAÍNA / EPINEFRINA DERMOGENand for what it is used

2. What you need to know before ARTICAÍNA / EPINEFRINA DERMOGEN is administered

3. How to useARTICAÍNA / EPINEFRINA DERMOGEN

4. Possible adverse effects

5. Storage ofARTICAÍNA / EPINEFRINA DERMOGEN

6. Contents of the package and additional information

Articaína / Epinefrina Dermogenis used to numb (anesthetize) the oral cavity during dental procedures.

This medication contains two active principles:

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

Your dentist will administerArticaína / Epinefrina Dermogen 40 mg/ml + 5 micrograms/ml or Articaína / Epinefrina Dermogen 40 mg/ml + 10 micrograms/ml.

Articaína / Epinefrina Dermogenis indicated for children over 4 years old (approximately 20 kg body weight), adolescents, and adults.

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

• Articaína / Epinefrina Dermogen 40 mg/ml + 5 micrograms/mlis usually used for simple and short dental procedures.
• Articaína / Epinefrina Dermogen 40 mg/ml + 10 micrograms/mlis more suitable for longer procedures or those with significant bleeding.

No use ARTICAÍNA / EPINEFRINA DERMOGENif you suffer from any of the following conditions:

• allergy to articaína 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.

Advertencias and precautions

Consult your dentist before starting to useArticaína / Epinefrina Dermogenif you suffer from any of the following conditions:

• severe heart rhythm disorders (e.g., AV block of second and third degree).
• acute heart failure (e.g., unexpected chest pain at rest or after a myocardial infarction [i.e., heart attack]).
• low blood pressure.
• abnormally fast heartbeats.
• myocardial infarction in the last 3-6 months.
• coronary revascularization graft in the last 3 months.
• 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 ofArticaína / Epinefrina Dermogenwith other medications").
• very high blood pressure.
• you are taking antidepressants and Parkinson's disease medications (tricyclic antidepressants) simultaneously. These medications may intensify the effects of adrenaline.
• epilepsy.
• deficiency of a natural chemical substance called plasma cholinesterase in the blood.
• renal problems.
• severe liver problems.
• a disease calledMyasthenia Gravisthat 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 70 years old.
• you have or have had any heart problems.
• you have uncontrolled diabetes.
• severe hyperthyroidism (thyrotoxicosis).
• pheochromocytoma.
• glaucoma of the closed angle 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 due to excessive acid in the blood (metabolic acidosis).

Use ofARTICAÍNA / EPINEFRINA DERMOGENwithother medications

Inform your dentist if you are taking, have taken recently, 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 amitriptilina, desipramina, imipramina, nortriptilina, maprotilina, and protriptilina).
• 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).
• Sympathomimetic vasopressors (such as cocaína, anfetaminas, fenilefrina, pseudoefedrina, oximetazolina), used to elevate blood pressure: if taken in the 24 hours prior to the planned dental treatment, this should be postponed.
• Neuroleptics (e.g., phenothiazines).

Use ofArticaína / Epinefrina Dermogenwith foods

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, breastfeeding, and fertility:

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

Your dentist or doctor will decide if you can takeArticaína / Epinefrina Dermogenduring pregnancy.

Breastfeeding can be resumed 5 hours after anesthesia.

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

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 30 minutes after the dental procedure).

ARTICAÍNA / EPINEFRINA DERMOGEN contains sodium and metabisulfito

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

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

Only doctors and dentists are trained to use Articaína / Epinefrina Dermogen.

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

You should use the lowest dose that provides effective anesthesia.

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

If you use more ARTICAÍNA / EPINEFRINA DERMOGEN than 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, pallor of the skin, headache, agitation or restlessness, disorientation, loss of balance, tremors or involuntary muscle contractions, dilated pupil, 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).

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 ofArticaína / Epinefrina Dermogen.

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 of eyelid drooping and pupil constriction (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 appear.

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

• Gingival inflammation
• Neuropathic pain: pain due to nerve damage
• Numbness or decreased sensation within and around the mouth
• Metals taste, taste alterations 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 100 people:

• 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 1,000 people:

• Nervousness, anxiety
• Facial nerve disorder (facial paralysis)
• Drowsiness
• Involuntary eye movement
• Diplopia, temporary blindness
• Eye lid drooping and pupil constriction (Horner's syndrome)
• Enophthalmia (sinking of the eyeball into the orbit)
• Tinnitus, increased sensitivity of the ear
• Palpitations
• Flushes
• Wheezing (bronchospasm, wheezing, whistling in bronchi), asthma
• 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 10,000 people:

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

Frequency not known: cannot be estimated from available data

• Extreme good mood (euphoria)
• Problems with heart rhythm coordination (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
• Throat burning syndrome
• Redness of the skin (erythema)
• Abnormal increase in sweating
• Worsening of neuromuscular symptoms of Kearns-Sayre syndrome
• Sensation of heat or cold
• Masseter muscle block

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.esBy reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C. Store the blister in the outer packaging to protect it from light.

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 thrown down the drain or in the trash.Your dentist will know how to dispose of the medications you no longer use.By doing so, you will help protect the environment.

Composition of ARTICAÍNA / EPINEFRINA DERMOGEN

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

• Each cartridge of 1.8 ml of injectable solution ofArticaína / Epinefrina Dermogen 40 mg/ml + 5 micrograms/mlcontains 72 mg of hydrochloride of articaína and 8 micrograms of adrenaline (as tartrate of adrenaline).
• Each milliliter ofArticaína / Epinefrina Dermogen 40 mg/ml + 5 micrograms/mlcontains 40 mg of hydrochloride of articaína and 5 micrograms of adrenaline (as tartrate of adrenaline).

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

Aspect of the product and content of the package

ARTICAINA / EPINEFRINA DERMOGEN is a transparent and colorless solution.

Package containing a cartridge of 1.8 ml and a leaflet.

Package containing 50 cartridges of 1.8 ml (clinical package) in 5 PVC blister supports with 10 cartridges each and a leaflet.

Package containing 100 cartridges of 1.8 ml (clinical package) in 10 PVC blister supports with 10 cartridges each and a leaflet.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for the manufacture

Name and address of the holder of the marketing authorization.

FARMALIDER, S.A.

c\ La Granja, nº1

28108– Alcobendas, Madrid

Spain

Name and address of the manufacturer of the specialty.

PIERREL, S.P.A.

Via Nazzionale Appia (Capua, Caserta)

I-81043 Italy

Date of the last review of this leaflet:February 2020

Other sources of information

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices.

………………………………………………………………………………………………..

This information is intended solely for healthcare professionals

Dosage

For all populations, the lowest effective dose should be used. The required dose should be determined on an individual basis.

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

For most routine dental procedures, it is preferable to useArticaína / Epinefrina Dermogen40 mg/ml + 5 micrograms/ml.

For more complex procedures, such as pronounced hemostasis, it is preferable to useArticaína / Epinefrina Dermogen40 mg/ml + 10 micrograms/ml.

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 articaína is 7 mg/kg, with a maximum absolute dose of articaína of 500 mg. The maximum dose of articaína 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 ofArticaína / Epinefrina Dermogenhas not been established in children under 4 years of age. No data are available.

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 articaína is only 7 mg/kg, with a maximum absolute dose of 385 mg of articaína for a healthy child of 55 kg of body weight.

Special populations

Older patients and patients with renal disorders:

Due to the absence 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 closely 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 articaína is first inactivated by non-specific esterases of 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 medication

This medication 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 the induction of regional anesthesia with local anesthetics, it should be ensured that a resuscitation team and appropriate medication are available to apply immediate treatment for any respiratory or cardiovascular emergency. The patient's level of consciousness should be monitored after each injection of local anesthesia.

When usingArticaína / Epinefrina Dermogenfor 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 reports of 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 articaína 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 articaína and the presence of adrenaline, as it may reduce perineural blood flow and prevent local elimination of articaína.

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 respiratory or cardiovascular emergency.

According to the severity of the symptoms of overdose, 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 local anesthetic should be stopped immediately. If necessary, the patient should be placed in a supine position.

The symptoms of CNS depression (convulsions, CNS depression) should be treated immediately with appropriate 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 doses appropriate to their age and weight.

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

Special precautions for elimination and other manipulations

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 only. 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.