Product Information for the Patient

Articaína/Epinefrina Normon40mg/ml + 5micrograms/mlInjectable Solution EFG

articaína hydrochloride/epinephrine (adrenaline)

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, as you may need to refer to 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 not listed in this product information. 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 epinephrine (adrenaline). Epinephrine constricts 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. These include routine procedures such as uncomplicated extraction of one or more teeth, removal of caries, or preparation of crowns.

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 heart 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 chronic bronchitis and are sensitive to sulfites (asthma attacks caused by sulfites).
• If you have uncontrolled epilepsy that is not adequately treated with medication.

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

• If you have high intraocular pressure (glaucoma).
• If you have hyperthyroidism.
• If you have paroxysmal tachycardia.
• If you have a specific type of heart 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, usually found in the adrenal gland).
• 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 ingredients can increase the cardiovascular effects of epinephrine; this may apply up to 14 days after completing treatment with MAO inhibitors.

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

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

Warnings and precautions

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

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

• If you have inflammation or infection of the injection site. In this case, you can expect an increased absorption of articaína/epinephrine, which reduces its effectiveness.
• If you are over 70years old.
• If you have reduced oxygen levels in the body tissue (hypoxia), high 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 bleeding disorders.
• If you have kidney 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 antiplatelet aggregation inhibitors or coagulation inhibitors to prevent constriction and/or hardening of blood vessels in 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 oxygen levels in the body tissue (hypoxia), high potassium levels in the blood (hyperkalemia), and metabolic alterations due to excessive acid in the blood (metabolic acidosis).

Similarly, if you have the following diseases, Articaína/Epinefrina Normon can only be used after a thorough medical examination:

• 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.
  • Heart arrhythmias (irregular heartbeat).
  • High blood pressure.
  • Arteriosclerosis (narrowing of arteries due to sedimentation, e.g., of blood lipids).
  • Alteration of blood flow in the brain.
  • After a stroke.

• Chronic bronchitis, emphysema (abnormal distension of the lungs).
• 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 allergy 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/epinephrine, do not consume food until the local anesthesia has worn off.

Other medications and Articaína/Epinefrina Normon

Inform your dentist or pharmacist if you are taking/using, have taken/used recently, 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 (e.g., benzodiazepines, opioids), for example, to reduce your anxiety due to the dentist appointment.
• Tricyclic antidepressants to treat depression (e.g., amitriptyline, desipramine, imipramine, nortriptyline, maprotiline, and protriptyline).
• MAO inhibitors to treat depressive or anxiety disorders (e.g., moclobemide, phenelzine, tranylcypromine, linezolid).
• Medications to treat heart arrhythmias (e.g., digitals, quinidine).
• Medications to treat migraine attacks (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 taking other local anesthetics simultaneously, their effects on the cardiovascular system and the nervous system may increase.

Articaína/Epinefrina Normon contains the active ingredient epinephrine. This active substance constricts blood vessels and increases blood pressure. The hypertensive effect of epinephrine may be intensified by other medications for the treatment of depression and Parkinson's disease. Do not take tricyclic antidepressants and MAO inhibitors at the same time (please 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/epinephrine 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 the treatment of diabetes mellitus).

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

Please note: in patients treated with anticoagulants (e.g., heparin or acetylsalicylic acid), accidental puncture of a blood vessel when administering local anesthetics may cause severe bleeding; in addition, these patients 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 regain normal sensitivity; otherwise, there is a risk of biting your lips, cheeks, or tongue. This applies especially to 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/epinephrine only after a thorough risk-benefit assessment.

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

The active ingredients of Articaína/Epinefrina Normon break down quickly in the body. Consequently, no harmful amounts of the active ingredients are transferred to the baby through breast milk. Therefore, during short-term use of articaína/epinephrine, 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 road 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 contains sodium metabisulfite (E233)

Rarely, it may cause severe allergic 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 40mg/ml + 5micrograms/ml and Articaína/Epinefrina Normon 40mg/ml + 10micrograms/ml, and will determine the appropriate dose taking into account your age, weight, general health status, and dental procedure.

The lowest dose 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 1.7ml 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, no painful injection in the gums is 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 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 lower jaw anesthesia (mandibular anesthesia) which is common in these cases.

For the removal of caries, for the preparation of a filling, and for the shaping of crowns, 0.5-1.7 ml of articaína/epinephrine per tooth is sufficient, depending on the scope and duration of the treatment. However, this does not apply to lower molars.

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 liver 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 possible amount of anesthesia.

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 be performed in two levels?, i.e., rotating the cannula 90°, or even better 180°?. When using cylindrical ampoules, Uniject®K or Uniject®K vario are especially suitable for this purpose. The injection pressure should be adjusted to the sensitivity of the tissue.

Adverse reactions

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 may 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 pharmacistimmediatelyif you notice one of the following severe side effects:

• 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's 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).
• Metalllic taste, taste distortions or loss of taste.
• Reduced sensitivity in the mouth or facial area (hypesthesia).
• Headache.
• Increased tactile perception, unpleasant or unusual.
• Increased sensitivity to heat.
• Abnormally fast heart rate.
• Abnormally slow heart rate.
• Low blood pressure.
• Swelling of the tongue, lips and gums.

Infrequent(may affect up to 1 in 100 people)

• Dizziness.
• Burning sensation.
• High blood pressure.
• Swelling of the tongue and mouth.
• 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.
  • Swelling of the face (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's syndrome).
• Enophthalmos (sinking of the eyeball into the orbit due to a change in the volume of the orbit).
• Tinnitus, hypersensitivity to sound.
• Palpitations.
• Hot flashes.
• Wheezing (bronchospasms), 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).
• Heart conduction or formation disorders (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.

• Nerve damage (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 nerve 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.
• Hoarseness.
• 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 bronchospasms. 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 bites and, therefore, of 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 Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse reactions, 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 5 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 8.5 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 manufacturer

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 1/200 000, solution injectable

RomaniaNormocain40 mg/0.005 mg/ml injectable solution

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/).