Prospect: information for the user

Septanest with adrenaline40mg/ml + 5micrograms/ml injectable solution

Septanest with adrenaline40mg/ml + 10micrograms/ml injectable solution

articaína hydrochloride/epinephrine

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your dentist, doctor, or pharmacist.
• If you experience adverse effects, consult your dentist, doctor, or pharmacist, even if they are not listed in this prospect.See section4.

1.What isSeptanest withadrenalineand for what it is used

2.What you need to know before being administeredSeptanest withadrenaline

3.How to useSeptanest withadrenaline

4.Possible adverse effects

5.Storage ofSeptanest withadrenaline

6.Contents of the package and additional information

Septanest withadrenalineis used to numb (anesthetize) the oral cavity during dental procedures.

This medication contains two active principles:

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

Your dentist will administer Septanest with adrenaline 40 mg/ml + 5 micrograms/ml or Septanest with adrenaline 40 mg/ml + 10 micrograms/ml.

Septanest withadrenaline is indicated for children over 4years (approximately 20kg of body weight), adolescents, and adults.

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

• Septanest with adrenaline 40 mg/ml + 5 micrograms/ml is usually used for simple and brief dental procedures.
• Septanest with adrenaline 40 mg/ml + 10 micrograms/ml is more suitable for longer procedures or those with significant bleeding risks.

No useSeptanest with adrenaline if you have any of the following medical conditions:

• allergy to articaine or adrenaline or to any of the other components of this medication (listed in section6).
• allergy to other local anesthetics.
• uncontrolled epilepsy.

Warnings and precautions

Consult your dentist before starting to useSeptanest withadrenalineif you have any of the following medical conditions:

• severe heart rhythm disorders (e.g., AV block of second and third degree).
• acute heart failure (sudden chest pain at rest or after a myocardial infarction [i.e., heart attack]).
• low blood pressure.
• abnormally rapid heartbeats.
• myocardial infarction in the last 3-6months.
• coronary revascularization graft in the last 3months.
• you are taking beta-blockers, such as propranolol. There is a risk of hypertensive crisis (very high blood pressure) or severe bradycardia (see section «Use ofSeptanest withadrenalinewith other medications»).
• very high blood pressure.
• you are taking antidepressants and medications for Parkinson's disease (tricyclic antidepressants) simultaneously. These medications may intensify the effects of adrenaline.
• epilepsy.
• deficiency of a natural chemical substance called plasma cholinesterase.
• renal problems.
• severe liver problems.
• a disease called Myasthenia Gravis that causes muscle weakness.
• porphyria that causes both neurological complications and skin problems.
• you are using other local anesthetics that cause reversible loss of sensation (including volatile anesthetics, such as halothane).
• you are taking antiplatelet or anticoagulant medications to prevent the narrowing or hardening of blood vessels in arms and legs.
• you are over 70years old.
• you have or have had any heart problems.
• you have uncontrolled diabetes.
• you have a severe case of hyperthyroidism (thyrotoxicosis).
• you have a tumor called pheochromocytoma.
• you have a disease called angle-closure glaucoma that affects the eyes.
• you have inflammation or infection in the area where you will receive the injection.
• you have reduced oxygen levels in your body tissues (hypoxia), high potassium levels in your blood (hyperkalemia), and metabolic disorders due to excessive acid in your blood (metabolic acidosis).

Use ofSeptanest withadrenalinewith other 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 sensation (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 amitriptiline, desipramine, imipramine, nortriptiline, maprotiline, and protriptiline).
• 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).
• vasopressors (such as cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline), used to raise blood pressure: if taken in the 24hours before the planned dental treatment, it should be postponed.
• neuroleptics (e.g., phenothiazines).

Use ofSeptanest withadrenalinewith food

Avoid eating, even chewing gum, until you have recovered normal sensation. 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 plan to become pregnant, consult your dentist or doctor before using this medication.

Your dentist or doctor will decide if you can takeSeptanest withadrenalineduring pregnancy.

Breastfeeding can be resumed 5hours 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 30minutes after the dental procedure).

Septanest withadrenalinecontains sodium and sodium metabisulfite.

• Sodium: this medication contains less than 23mg (1mmol) of sodium per cartridge, so it is considered essentially «sodium-free».
• Sodium metabisulfite: 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 useSeptanest withadrenaline.

Your dentist will choose between Septanest with adrenaline 40 mg/ml + 5 micrograms/ml or Septanest with adrenaline 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 provides effective anesthesia should be used.

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

If you use moreSeptanest withadrenaline than you should

It is unlikely that you will be administered too much of this injection, but if you start to feel unwell, tell your dentist. Symptoms of overdose include acute weakness, pale skin, headache, agitation or restlessness, disorientation, loss of balance, involuntary tremors or shakiness, dilated pupils, 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).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

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 ofSeptanest withadrenaline.

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: these may be symptoms of an allergic reaction (hypersensitivity).
• A combination ofdrooping eyelidandpupil constriction(Horner syndrome).

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

In other patients, other side effects not listed above may also appear.

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

• Swelling of the gums
• Neuropathic pain: pain due to nerve damage
• Numbness or decreased sensation inside and around the mouth
• Metals taste, alterations in taste or loss of gustatory function
• Increased, unpleasant or abnormal sensation of touch
• Abnormal increase in sensitivity to heat
• Headache
• Abnormally rapid heartbeats
• Abnormally slow heartbeats
• Low blood pressure
• Swelling of the tongue, lips and gums

Less frequent side effects: they may affect up to 1 in 100people:

• 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: they may affect up to 1 in 1,000people:

• Nervousness, anxiety
• Facial nerve disorder (facial paralysis)
• Drowsiness
• Involuntary eye movement
• Diplopia, temporary blindness
• Drooping eyelid andpupil constrictionof thepupil(Horner syndrome)
• Enophthalmos (hollowing of the eye within the orbit)
• Tinnitus, increased sensitivity of the ear
• Palpitations
• Flushes
• Bronchospasm, asthma (sibilant sounds in the bronchi)
• Difficulty breathing
• Exfoliation and ulceration of the gums
• Exfoliation of the injection site
• Hives.
• Involuntary muscle contraction
• Fatigue, weakness
• Chills

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

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

Frequency not known: cannot be estimated from available data

• Extreme good mood (euphoria)
• Cardiac conduction disorders, atrioventricular block
• Increased blood volume in a part of the body leading to congestion of the blood vessels
• Widening or narrowing of the blood vessels
• Snoring
• Difficulty swallowing
• Swelling of the cheeks and local swelling
• Thirst
• Enlargement of theskin(erythema)
• Abnormal increase in sweating
• Worsening of neuromuscular symptoms of Kearns-Sayre syndrome
• Sensation of heat or cold
• Trigeminal nerve block

Reporting of side effects

If you experience any type of side effect, consult your dentist, 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.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 30°C.

Do not freeze.

Store the cartridges in the outer packaging to protect them 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 should be discarded.

Medications should not be thrown down the drain or in the trash. Your dentist will know how to dispose of the medications that you no longer use. In this way, you will help protect the environment.

Composition ofSeptanest withadrenaline

• The active ingredients are articaine hydrochloride and epinephrine (adrenaline tartrate).
• • Each 1.7 ml cartridge of Septanest with adrenaline 40 mg/ml + 5 micrograms/ml contains 68 mg of articaine hydrochloride and 8.5 micrograms of epinephrine (as adrenaline tartrate).
  • Each milliliter of Septanest with adrenaline 40 mg/ml + 5 micrograms/ml contains 40 mg of articaine hydrochloride and 5 micrograms of epinephrine (as adrenaline tartrate).

• The other components are sodium chloride, sodium metabisulfite (E-223), sodium hydroxide, and water for injection.

Appearance of the product and contents of the package

Septanest with adrenaline is a transparent and colorless solution.

It is packaged in single-use glass cartridges, sealed at the base with a movable rubber plunger and at the top with a rubber seal held by an aluminum cap.

Box containing 50 glass cartridges of 1.7 ml.

Box containing 50 auto-aspirable glass cartridges of 1.7 ml.

Package containing 4 boxes of 50 glass cartridges of 1.7 ml.

Package containing 8 boxes of 50 glass cartridges of 1.7 ml.

Only certain package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Austria:Septanest mit Epinephrin 1:200.000 - 40 mg/ml + 5 Mikrogramm/ml, Injektionslösung

Septanest mit Epinephrin 1:100.000 - 40 mg/ml + 10 Mikrogramm/ml, Injektionslösung

Bulgaria:???????????????????1/200 000,40mg/ml+5??????????/ml??????????????????

???????????????????1/100 000,40mg/ml+10??????????/ml??????????????????

Croatia:Septanest 40 mg/ml + 0.005 mg/ml otopina za injekciju

Septanest Forte 40 mg/ml + 0.01 mg/ml otopina za injekciju

Cyprus:Septanest, 40 mg/ml + 5 micrograms/ml, εν?σιμο δι?λυμα

Septanest Forte, 40 mg/ml + 10 micrograms/ml, εν?σιμο δι?λυμα

Czech Republic:Septanest s adrenalinem 1:200 000, 40 mg/ml + 5 mikrogramu/ml, injekcní roztok

Septanest s adrenalinem 1:100 000, 40 mg/ml + 10 mikrogramu/ml, injekcní roztok

Denmark:Septanest, 40 mg/ml + 5 mikrogram/ml, injektionsvæske, opløsning

Septocaine, 40 mg/ml + 10 mikrogram/ml, injektionsvæske, opløsning

Estonia:Septanest, 40 mg/ml + 5 mikrogrammi/ml, süstelahus

Septanest Forte, 40 mg/ml + 10 mikrogrammi/ml, süstelahus

Finland:Septocaine, 40 mg/ml + 5 mikrogrammaa/ml, injektioneste, liuos

Septocaine Forte, 40 mg/ml + 10 mikrogrammaa/ml, injektioneste, liuos

France:Septanest 40 mg/mL Adrénalinée au 1/200 000, solution injectable à usage dentaire

Septanest 40 mg/mL Adrénalinée au 1/100 000, solution injectable à usage dentaire

Germany:Septanest mit Epinephrin 1:200.000 - 40 mg/ml + 0.005 mg/ml Injektionslösung

Septanest mit Epinephrin 1:100.000 - 40 mg/ml + 0.01 mg/ml Injektionslösung

Greece:Septanest 4% + 1:200.000, εν?σιμο δι?λυμα

Septanest 4% + 1:100.000, εν?σιμο δι?λυμα

Hungary:Septanest 40 mg/ml + 10 mikrogramm/ml, injekciós oldat

Italy:Septanest 40 mg/ml + 5 microgrammi/ml soluzione iniettabile con adrenalina

Septanest 40 mg/ml + 10 microgrammi/ml soluzione iniettabile con adrenalina

Latvia:Septanest 40 mg/ml + 5 mikrogrami/ml škidums injekcijam

Septanest Forte 40 mg/ml + 10 mikrogrami/ml škidums injekcijam

Lithuania:Septanest 40 mg/ml + 5 mikrogramai/ml, injekcinis tirpalas

Septanest Forte 40 mg/ml + 10 mikrogramai/ml, injekcinis tirpalas

Luxembourg:Septanest Normal, 40 mg/ml+ 5 microgrammes/ml, solution injectable

Septanest Spécial, 40 mg/ml+ 10 microgrammes/ml, solution injectable

Malta:Septanest with adrenaline 1/200,000, 40 mg/ml + 5 micrograms/ml solution for injection

Septanest with adrenaline 1/100,000, 40 mg/ml + 10 micrograms/ml, solution for injection

Netherlands:Septanest N 40 mg/ml + 5 microgram/ml, oplossing voor injectie

Septanest SP 40 mg/ml + 10 microgram/ml, oplossing voor injectie

Norway:Septocaine 40 mg/ml+5 mikrogram/ml, injeksjonsvæske, oppløsning

Septocaine Forte 40 mg/ml+10 mikrogram/ml, injeksjonsvæske, oppløsning

Poland:SEPTANEST Z ADRENALINA 1: 200 000 (40 mg+0.005mg)/ml, roztwór do wstrzykiwan

SEPTANEST Z ADRENALINA 1: 100 000 (40 mg+0.01mg)/ml, roztwór do wstrzykiwan

Portugal:Septanest 1/200,000, 40 mg/ml + 5 microgramas/ml, solução injetável

Septanest 1/100,000, 40 mg/ml + 10 microgramas/ml, solução injetável

Romania:SEPTANEST CU ADRENALINA 1/200000 40 mg/0.005 mg/ml solutie injectabila

SEPTANEST CU ADRENALINA 1/100000 40 mg/0.01 mg/ml solutie injectabila

Slovakia:Septanest 40 mg/ml + 5 mikrogramov/ml injekcný roztok

Septanest Forte 40 mg/ml + 10 mikrogramov/ml injekcný roztok

Slovenia:Septanestepi 40 mg/0.005 mg v 1 ml raztopina za injiciranje

Septanestepi 40 mg/0.01 mg v 1 ml raztopina za injiciranje

Spain:Septanest con adrenalina 40 mg/ml + 5 microgramos/ml solución inyectable

Septanest con adrenalina 40 mg/ml + 10 microgramos/ml solución inyectable

Sweden:Septocaine 40 mg/ml + 5 mikrogram/ml, injektionsvätska, lösning

Septocaine Forte 40 mg/ml + 10 mikrogram/ml, injektionsvätska, lösning

Last review date of this leaflet:

05/2022

Other sources of information

The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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This information is intended solely for healthcare professionals:

Posology

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

For routine procedures, the normal dose for adult patients is 1 cartridge, but the contents of less than one cartridge may be sufficient for effective 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, Septanest with adrenaline 40 mg/ml + 5 micrograms/ml is preferred.

For more complex procedures, such as pronounced hemostasis, Septanest with adrenaline 40 mg/ml + 10 micrograms/ml solution is preferred.

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 (12 to 18 years old)

In adults and adolescents, the maximum dose of articaine is 7 mg/kg, with a maximum absolute dose of articaine of 500 mg. The maximum dose of articaine of 500 mg corresponds to a healthy adult of more than 70 kg body weight.

Children (4 to 11 years old)

No safety data are available for children 4 years and younger. 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 average effective dose is 2 mg/kg and 4 mg/kg for simple and complex procedures, respectively. The lowest dose that provides effective dental anesthesia should be used.

In children 4 years (or 20 kg (44 lbs) body weight) and older, the maximum dose of articaine is only 7 mg/kg, with a maximum absolute dose of 385 mg of articaine for a healthy child of 55 kg body weight.

Special populations

Older adults and patients with renal impairment:

Due to the lack of clinical data, special precautions should be taken to administer the lowest effective dose in older adults and patients with renal impairment.

Prolonged high 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 hepatic impairment

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

Patients with plasma cholinesterase deficiency

Prolonged high 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 dose that provides effective anesthesia should be used.

Administration

Infiltration and perineural injection in the oral cavity.

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

Precautions to be taken before handling or administering the drug

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

When using Septanest with adrenaline for infiltration or regional anesthetic block, the injection should always be administered slowly and with prior aspiration.

Special warnings

Adrenaline reduces blood flow to the gums, which may cause local tissue necrosis.

Rare cases of prolonged or irreversible nerve damage and taste loss have been reported after mandibular block analgesia.

Precautions for use

Risk associated with accidental intravascular injection:

An accidental intravascular injection may cause high levels of adrenaline and articaine 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 may progress to respiratory and circulatory arrest.

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 an intravascular injection has not occurred.

Risk associated with accidental intraneural injection:

An accidental intraneural injection may cause the drug to move retrogradely along 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 sensation of discharge during injection or if the injection is particularly painful. If nerve damage occurs due to the needle, the chemical neurotoxicity of articaine and the presence of adrenaline may exacerbate the effect, as adrenaline may reduce perineural blood flow and prevent local elimination of articaine.

Treatment of overdose

Before administering regional anesthesia with local anesthetics, it should be ensured that a resuscitation team and appropriate medication are available for immediate treatment of 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 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 occur, the injection of local anesthetic should be stopped immediately. If necessary, place the patient in a supine position.

CNS symptoms (convulsions, CNS depression) should be treated immediately with appropriate respiratory support and administration of anticonvulsants.

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, immediate cardiopulmonary resuscitation should be performed.

Special precautions for disposal and other handling

This drug 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 part of the cartridge is used, the rest should be discarded.

The disposal of unused medication and all materials that have come into contact with it should be carried out in accordance with local regulations.