Patient Information Leaflet

Articaína/Epinefrina Normon40mg/ml + 10micrograms/mlInjectable Solution EFG

articaína hidrocloruro/epinefrina (adrenalina)

Read 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, consult your dentist, doctor or pharmacist.
• If you experience any side effects, consult your dentist, doctor or pharmacist, even if they are not listed in this leaflet. See section4.

Articaína/Epinefrina Normon is a local anesthetic (a medication used to numb a specific area) for use in dentistry. It contains the local anesthetic articaína, as well as epinefrina (adrenaline). Epinefrina narrows the blood vessels at the injection site and causes local ischemia in the area, as well as prolonging the effect of the local anesthetic.

Articaína/Epinefrina Normon is used for infiltration anesthesia and nerve block anesthesia before dental treatments. This includes:

• Surgical interventions in the mucous membrane and bone tissue that require stronger ischemia.
• Surgical interventions in the pulp (amputation and excision).
• Extraction of fractured or desmodontic teeth (osteotomy).
• Prolonged surgical procedures.
• Percutaneous osteosynthesis.
• Cystectomy.
• Mucogingival procedures.
• Apical root resection.

Do not use Articaína/Epinefrina Normon

• If you are allergic to articaína or to other local anesthetics of the acid-amide type.
• If you are allergic to epinephrine or to any of the other components of this medication (including those listed in section6).
• If you have severe cardiac arrhythmias (e.g., second- and third-degree AV block).
• If you have a very low pulse.
• If you have congestive heart failure (acute heart weakness, e.g., unexpected chest pain at rest or after a myocardial injury [e.g., heart attack]).
• If you have very low blood pressure.
• If you have bronchial asthma and are hypersensitive to sulfite (asthma attacks caused by sulfite).
• If you have uncontrolled epilepsy that is not adequately treated with medication.

Due to the effects of the active principle epinephrine, articaína/epinephina should not be used:

• If you have elevated intraocular pressure (glaucoma).
• If you have hyperthyroidism.
• If you have paroxysmal tachycardia.
• If you have a specific type of cardiac arrhythmia (absolute arrhythmia with rapid and irregular heartbeat).
• If you have had a heart attack in the last 3 or 6months.
• If you have had a coronary bypass in the last 3months.
• If you are taking certain beta-blockers (e.g., propanolol), there is a risk of experiencing a severe hypertension crisis or a severe bradycardia.
• If you have pheochromocytoma (a tumor that produces adrenaline, normally found in the adrenal medulla).
• If you have very high blood pressure.
• If you are being treated simultaneously with certain antidepressants and antiparkinsonian medications (tricyclic antidepressants or MAO inhibitors), as these active principles can increase the cardiovascular effects of epinephrine; this may apply up to 14 days after completing treatment with MAO inhibitors.

Articaína/epinephina cannot be administered intravenously (into a vein).

Due to the epinephrine content, Articaína/Epinefrina Normon is not indicated for distal phalangeal anesthesia (e.g., fingers of the hand and foot) because there is a risk of local blood flow blockage.

Warnings and precautions

Consult your dentist or pharmacist before starting to use Articaína/Epinefrina Normon:

• If you have a specific enzyme deficiency (colinesterase deficiency), as you can expect a prolonged and sometimes increased effect of articaína/epinephina.

• If you have inflammation or infection of the injection site. In this case, you can expect an increased absorption of articaína/epinephina, which reduces its effectiveness.
• If you are over 70years old.
• If you have reduced tissue oxygen levels (hypoxia), elevated potassium levels in the blood (hyperkalemia), and metabolic alterations due to excessive acid in the blood (metabolic acidosis).

Articaína/Epinefrina Normon should only be used after a thorough medical examination:

• If you have coagulation disorders.
• If you have renal function disorders (e.g., nephritis).
• If you have liver function disorders (e.g., cirrhosis).
• If you are receiving other local anesthetics simultaneously, i.e., medications that cause reversible loss of sensitivity, including inhalation anesthetics, such as halothane (see “Other medications and Articaína/Epinefrina Normon”).
• If you have epilepsy (see section 4).
• If, simultaneously, you are taking medications called platelet aggregation inhibitors or coagulation inhibitors to prevent vasospasm and/or vasoconstriction of the arms and legs.
• If you have low blood pressure.
• If you have myasthenia gravis, which causes muscle weakness.
• If you have porphyria, which causes neurological complications or skin problems.
• In case of reduced tissue oxygen levels (hypoxia), elevated potassium levels in the blood (hyperkalemia), and metabolic alterations due to excessive acid in the blood (metabolic acidosis).

If you have the following diseases, then Articaína/Epinefrina Normon 40 mg/ml + 10 micrograms/ml should only be used after a thorough examination by a healthcare professional, and your dentist should consider administering Articaína/Epinefrina Normon 40 mg/ml + 5 micrograms/ml instead of Articaína/Epinefrina Normon 40 mg/ml + 10 micrograms/ml due to the lower epinephrine content:

• Cardiovascular disorders, such as:
• • Heart failure (myocardial weakness).
  • Coronary disease (constriction of coronary arteries).
  • Angina pectoris (alteration of heart blood flow with chest pain and pressure).
  • After a heart attack.
  • Cardiac arrhythmias (irregular heartbeat).
  • High blood pressure.
  • Arteriosclerosis (narrowing of arteries due to sedimentation, e.g., of blood lipids).
  • Cerebral circulation disorder.
  • After a stroke.

• Bronchitis, chronic bronchitis, or emphysema.
• Diabetes mellitus.
• Severe anxiety disorder.

Your dentist will review your medical history:

• And the medication you are taking concomitantly to prevent adverse effects.
• Will perform a test injection if there is a risk of an allergic reaction to the medication.
• Will select the minimum possible dose.
• And will carefully check before the injection that no blood vessel has been hit.

The use of this medication may lead to prolonged numbness of the mouth area after dental treatment. In young children, caution should be exercised to prevent them from biting, as this may cause soft tissue injuries.

After using articaína/epinephina, do not consume food until the local anesthetic has worn off.

Other medications and Articaína/Epinefrina Normon

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

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

• Sedatives (with central sedative effect, e.g., benzodiazepines, opioids), for example, to reduce your anxiety due to the dentist appointment.
• Tricyclic antidepressants for treating depression (e.g., amitriptyline, desipramine, imipramine, nortriptyline, maprotiline, and protriptyline).
• MAO inhibitors for treating depressive or anxiety disorders (e.g., moclobemide, phenelzine, tranylcypromine, linezolid).
• Medications for treating cardiac arrhythmias (e.g., digitalis, quinidine).
• Medications for migraines (e.g., metisergide or ergotamine).
• Medications for the heart and blood pressure (e.g., guanadrel, guanethidine, propranolol, nadolol).
• Vasoconstrictors (e.g., cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline) to increase blood pressure: If used in the last 24hours, then the scheduled dental treatment should be postponed.
• Neuroleptics (e.g., phenothiazine).

If you are receiving other local anesthetics simultaneously, their effects on the cardiovascular and nervous systems may increase.

Articaína/Epinefrina Normon contains the active principle epinephrine. This active substance constricts blood vessels and increases blood pressure. The hypertensive effect of epinephrine may be intensified by other medications for treating depression and Parkinson's disease. Tricyclic antidepressants and MAO inhibitors should not be taken simultaneously (see section 2 “What you need to know before starting to use Articaína/Epinefrina Normon”).

If you are taking certain beta-blockers (e.g., propranolol), then articaína/epinephina should not be administered (see “Do not use Articaína/Epinefrina Normon”).

Epinephrine may inhibit the release of insulin from the pancreas, reducing the effectiveness of oral antidiabetic medications (medications for treating diabetes mellitus).

If articaína/epinephina is used simultaneously with certain inhalation anesthetics (e.g., halothane), this may trigger cardiac arrhythmias.

Please note: in patients treated with coagulation inhibitors (“anticoagulants” such as heparin or acetylsalicylic acid), accidental puncture of a blood vessel when administering local anesthetics may cause severe bleeding; these patients also have a high tendency to bleed in general.

Use of Articaína/Epinefrina Normon with food

After the procedure, avoid eating and chewing gum until you recover normal sensitivity; otherwise, there is a risk of biting your lips, cheeks, or tongue. This applies especially to young children.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your dentist or doctor before using this medication.

If you are pregnant, your dentist should use articaína/epinephina only after a thorough risk-benefit assessment.

Regarding the use of articaína, there is no documented experience during pregnancy, except at birth. Experimental studies in animals have shown that high doses of epinephrine have had adverse effects on the creatures. After accidental injection of articaína/epinephina into a maternal blood vessel, epinephrine may cause reduced uterine blood flow.

If you are pregnant, then Articaína/Epinefrina Normon 40 mg/ml + 5 micrograms/ml should be preferred over Articaína/Epinefrina Normon 40 mg/ml + 10 micrograms/ml, as the former contains less epinephrine.

The active substances in Articaína/Epinefrina Normon break down quickly in the body. Consequently, no harmful amounts of the active substances are transferred to the baby in breast milk. Therefore, during short-term use of articaína/epinephina, breastfeeding can be resumed 5hours after anesthesia.

In the doses used for dental treatment, no adverse effects on reproductive capacity are expected.

Driving and operating machines

After the procedure, your dentist will decide when you can participate actively in car travel or operate machines. In corresponding studies, local anesthesia with articaína did not cause any detectable deterioration of normal driving ability.

If you experience side effects such as dizziness, vision problems, or fatigue, you cannot drive vehicles or operate machines until you feel better again (usually within 30 minutes after dental treatment).

Use in athletes

This medication contains epinephrine, which may produce a positive result in doping control tests.

Articaína/Epinefrina Normoncontains sodium

This medication contains less than 1mmol of sodium (23mg) per cartridge; this is essentially “sodium-free”.

Articaína/Epinefrina Normon containsmetabisulfito de sodio (E233)

Rarely, it may cause severe hypersensitivity reactions and bronchospasm.

If there is a risk of allergic reaction, your dentist will choose another anesthetic.

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

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

The lowest dose that is sufficient for effective anesthesia (numbing) should be used.

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

Your dentist will decide on the dosage and method of application of Articaína/Epinefrina Normon. They will generally follow the following recommendations:

Dose

For the extraction of upper teeth without complications in a non-inflammatory stage, a 1.7 ml injection per tooth is usually sufficient. In some cases, a posterior injection of 1 to 1.7 ml may be necessary to achieve complete local anesthesia. In most cases, painful injections in the gums are not required.

If a cut or puncture in the gum is necessary, a 0.1 ml injection per puncture is sufficient.

For the extraction of an adjacent row of teeth, the full dose of articaína/epinephrine is usually not necessary. The number of injections can usually be reduced.

For extractions with a straight forceps of lower premolars in a non-inflammatory stage, a 1.7 ml injection per tooth is usually sufficient. If complete effectiveness is not achieved after this, your dentist may perform a posterior injection of 1 to 1.7 ml. Only if complete anesthesia is still not achieved, your dentist may perform the anesthesia of the entire lower jaw nerve (mandibular anesthesia), which is common in these cases.

For oral surgery, your dentist will individually adjust the dose of articaína/epinephrine according to the severity and duration of the intervention.

During a treatment, adults can be administered up to 7 mg of articaína per kilogram of body weight. Normally, quantities of up to 500 mg (corresponding to 12.5 ml of injectable solution) are well tolerated.

Patients of advanced age and patients with severe liver and kidney function disorders

In patients of advanced age and in patients with severe liver and kidney function disorders (e.g., nephritis or cirrhosis), high levels of articaína in plasma may occur. If you are among these patients, your dentist should take special care to use the smallest amount of anesthesia necessary.

Use in children and adolescents

If Articaína/Epinefrina Normon is used in children, the minimum volume necessary for sufficient anesthesia should be used. The injection dose should be determined individually taking into account the child's age and weight. A maximum dose of 7 mg of articaína per kilogram of body weight (0.175 ml/kg) should not be exceeded.

The use of this medication in children under 1 year has not been studied.

Method of use

Articaína/Epinefrina Normon is intended for use in the oral cavity.

To prevent infections (e.g., transmission of hepatitis), new and sterile syringes and cannulas should always be used for each injection.

To avoid intravascular injection, a aspiration test should generally be performed at two levels?, i.e., rotating the cannula 90°, or even better 180°?. When using cylindrical ampoules, Uniject®K or Uniject®K vario are particularly suitable for this purpose. The injection pressure should be adjusted to the sensitivity of the tissue.

Adverse effects

The proper functioning and optimal protection against breakage of the crystal are guaranteed by the use of suitable injection supports (anesthesia by infiltration: Uniject®K or Uniject®K vario; intraligamentary anesthesia: Ultraject®). Damaged cylindrical ampoules cannot be used for injection.

For single use only. Unused solution should be discarded.

The solution should be transparent and colorless. If it presents coloration or turbidity, the medication should not be used.

If you use more Articaína/Epinefrina Normon than you should

It is unlikely that you will be administered too much of this injection, but if you start to feel unwell, inform your dentist. Symptoms of overdose include intense weakness, pale skin, headache, feeling of agitation or restlessness, feeling of disorientation, loss of balance, involuntary tremors or shakiness, dilated pupils, blurred vision, difficulty focusing clearly on an object, speech disturbances, dizziness, convulsions, stupor, loss of consciousness, coma, yawning, abnormally slow or rapid breathing that could cause temporary cessation of breathing, heart failure to contract effectively (called cardiac arrest).

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

If you have any further questions about the use of this medication, contact your dentist, doctor, or pharmacist.

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

While you are in your dentist's consultation, your dentist will closely observe the effects of Articaína/Epinefrina Normon.

Inform your dentist, doctor or pharmacist immediately if you notice one of the following severe side effects:immediately

• Swollen face, tongue or throat, difficulty swallowing, hives or difficulty breathing (angioedema).
• Rash, itching, swelling of the neck and difficulty breathing: These may be symptoms of an allergic reaction (hypersensitivity).
• A combination of eyelid drooping and pupil constriction (Horner syndrome).

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

However, in some patients, other secondary effects may occur that have not been mentioned previously.

Frequent(may affect up to 1 in 10 people)

• Gingival inflammation.
• Nausea.
• Vomiting.
• Uncomfortable sensations (paresthesias).
• Neuropathic pain (pain due to nerve damage).
• Metals taste, taste distortions or loss of taste.
• Reduced sensitivity in the mouth or facial area (hypesthesia).
• Headache.
• Increased unpleasant or unusual tactile perception.
• Increased sensitivity to heat.
• Abnormally fast heart rate.
• Abnormally slow heart rate.
• Low blood pressure.
• Swollen tongue, lips and gums.

Infrequent(may affect up to 1 in 100 people)

• Dizziness.
• Burning sensation.
• High blood pressure.
• Gingival and oral inflammation.
• Diarrhea.
• Rash, itching.
• Neck pain or pain at the injection site.

Rare(may affect up to 1 in 1,000 people)

• They may cause hypersensitivity reactions (allergic or allergic-type reactions). They may manifest as swelling and/or inflammation at the injection site. Hypersensitivity reactions that do not limit themselves to the injection site manifest as:
• • Redness.
  • Itching.
  • Red, watery eyes.
  • Runny nose.
  • Facial swelling (angioedema) with swelling of the upper and/or lower lip and/or cheeks.
  • Swelling in the throat area with constriction and difficulty swallowing.
  • Hives.
  • Difficulty breathing, even up to anaphylactic shock.

• Anxiety, nervousness.
• Facial nerve disorder (facial paralysis).
• Drowsiness.
• Uncontrolled eye movement.
• During or shortly after the injection of local anesthetics in the head area, vision problems (blurred vision, double vision, dilated pupils, blindness) may occur. These are usually transient.
• Eye lid drooping and pupil constriction (Horner syndrome).
• Enophthalmos (sinking of the eyeball into the orbit due to a change in the volume of the orbit).
• Tinnitus, hyperacusis.
• Palpitations.
• Hot flashes.
• Wheezing (bronchospasm), asthma.
• Difficulty breathing.
• Sloughing and ulceration of the gums.
• Sloughing at the injection site.
• Hives (urticaria).
• Muscle spasms, involuntary muscle contractions.
• Fatigue, weakness.
• Chills.

Very rare(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 available data)

• Redness of the skin (erythema).
• Extreme good mood (euphoria).
• Disorders of the heart's conduction system (conduction disorders, AV block).
• Cardiac arrhythmias, heart failure and shock (sometimes potentially fatal).
• Depending on the dose (especially in too high doses or in the case of an accidental injection into a blood vessel), central nervous system disorders, e.g.:
• • Anxiety, nervousness.
  • Drowsiness, drowsiness even up to loss of consciousness, coma.
  • Respiratory disorders up to respiratory arrest.
  • Muscle tremors, muscle spasms up to convulsions.

• Damage to the nerves (e.g. facial nerve) may occur during any dental procedure and cannot be ruled out. It is caused by the path of the nerves through the injection area or by an incorrect injection technique. It may cause facial paralysis. A reduction in taste sensation is also possible.

• An accidental injection into a blood vessel in the injection area may lead to inadequate oxygen supply to the tissue and even tissue necrosis.

• Increased blood flow to a part of the body, leading to obstruction of blood vessels.
• Dilation or constriction of blood vessels.
• Snoring.
• Difficulty swallowing.
• Swelling of the cheeks and local swelling.
• Burning sensation in the tongue (burning mouth syndrome).
• Unusual sweating.
• Worsening of neuromuscular symptoms of Kearns-Sayre syndrome.
• Sensation of heat or cold.
• Trismus.

Sodium metabisulfite (E233) may trigger severe hypersensitivity reactions and bronchospasm. Hypersensitivity reactions may manifest as vomiting, diarrhea, wheezing, acute asthma attacks, altered consciousness or shock.

Additional side effects in children

In young children, compared to adults, there is a higher risk of biting injuries and, therefore, soft tissue injuries due to prolonged numbness of the mouth area after dental treatment.

Special warnings

If an undesirable effect occurs suddenly or intensifies rapidly, report it to a doctor immediately. This is especially important, as some of these side effects (e.g. low blood pressure or difficulty breathing) can be life-threatening.

Reporting of adverse reactions

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect. This includes any side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By 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 label and the box after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Do not freeze.

Store the cartridges in the outer packaging to protect them from light.

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

The cartridges are for single use. Use immediately after opening the cartridge. Dispose of any remaining solution.

Medications should not be disposed of through drains or in the trash. Deposit containers and unused medications at the SIGRE collection point at the pharmacy. Your dentist will know how to dispose of unused medications. By doing so, you will help protect the environment.

Composition of Articaína/Epinefrina Normon

• The active substances are articaína hydrochloride and epinephrine. One milliliter of injectable solution contains 40 mg of hydrochloride of articaína and 10 micrograms of adrenaline (epinephrine).

Each cartridge of 1.7 ml of injectable solution of Articaína/Epinefrina Normon contains 68 mg of hydrochloride of articaína and 17 micrograms of adrenaline (epinephrine).

• The other ingredients are: sodium chloride, sodium metabisulphite (E233), hydrochloric acid, and water for injectable preparations.

Appearance of the product and contents of the packaging

Articaína/Epinefrina Normon is a transparent and colorless solution, practically free of visible particles.

Colorless type I glass cartridge.

Grey bromobutyl rubber plunger.

Aluminum cap with an inner grey bromobutyl rubber disc.

Cartridge support (PVC/Aluminum blister).

Package containing 1 cartridge of 1.7 ml.

Package containing 50 cartridges of 1.7 ml.

Package containing 100 cartridges of 1.7 ml.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

This medicine is authorized in the member states of the European Economic Area with the following names

PortugalNormocain

BulgariaNormocain

FranceCHLORHYDRATE D’ARTICAINE NORMON 40mg/ml ADRENALINE 1/100 000, solution injectable

RomaniaNormocain 40 mg/ 0.010 mg/ml solutie injectabila

Last review date of this leaflet:May 2023

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