SEPTANEST WITH ADRENALINE 40 mg/mL + 5 micrograms/mL INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Septanest with Adrenaline40mg/ml + 5micrograms/ml injectable solution

Septanest with Adrenaline40mg/ml + 10micrograms/ml injectable solution

Articaine hydrochloride/epinephrine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

Contents of the package leaflet

1. What Septanest with Adrenaline is and what it is used for
2. What you need to know before you are given Septanest with Adrenaline
3. How to use Septanest with Adrenaline
4. Possible side effects
5. Storage of Septanest with Adrenaline
6. Contents of the pack and other information

1. What Septanest with Adrenaline is and what it is used for

Septanest with Adrenaline is used to numb (anesthetize) the oral cavity during dental procedures.

This medicine contains two active substances:

• 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 with Adrenaline is indicated in 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 medicines:

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

2. What you need to know before you are given Septanest with Adrenaline

Do not useSeptanest withAdrenaline if you have any of the following conditions:

• Allergy to articaine or adrenaline or any of the other components of this medicine (listed in section 6).
• Allergy to other local anesthetics.
• Uncontrolled epilepsy.

Warnings and precautions

Talk to your dentist before starting to use Septanest with Adrenaline if you have any of the following conditions:

• Severe heart rhythm disorders (e.g., second and third degree AV block).
• Acute heart failure (acute cardiac weakness, e.g., unexpected chest pain at rest or after a heart attack).
• Low blood pressure.
• Abnormally fast heartbeats.
• Heart attack in the last 3-6 months.
• Coronary revascularization graft in the last 3 months.
• You are taking certain blood pressure medications called beta-blockers, such as propranolol. There is a risk of hypertensive crisis (very high blood pressure) or severe slowing of the pulse (see section "Using Septanest with Adrenaline with other medicines").
• Very high blood pressure.
• You are taking certain medications for depression and Parkinson's disease (tricyclic antidepressants). These medications can enhance the effects of adrenaline.
• Epilepsy.
• Lack of a natural chemical called cholinesterase in the blood (plasma cholinesterase deficiency).
• Kidney problems.
• Severe liver problems.
• A disease called Myasthenia Gravis that causes muscle weakness.
• Porphyria that causes both neurological complications and skin problems.
• If you are using other local anesthetics that cause reversible loss of sensation (including volatile anesthetics, such as halothane).
• If you are taking certain medications called antiplatelet or anticoagulant agents to prevent the narrowing or hardening of blood vessels in the arms and legs.
• If you are over 70 years old.
• You have or have had any heart problems.
• You have uncontrolled diabetes.
• A severe case of overactive thyroid (thyrotoxicosis).
• A tumor called pheochromocytoma.
• A disease called glaucoma that affects the eyes.
• Inflammation or infection of the area where you will receive the injection.
• Reduced oxygen levels in the body's tissues (hypoxia), high potassium levels in the blood (hyperkalemia), and metabolic disorders such as acidosis.

Using Septanest with Adrenaline with other medicines

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

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

• 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.
• Medicines for the heart and blood pressure (such as guanadrel, guanethidine, propranolol, nadolol).
• Tricyclic antidepressants for treating depression (such as amitriptyline, desipramine, imipramine, nortriptyline, maprotiline, and protriptiline).
• COMT inhibitors for treating Parkinson's disease (such as entacapone or tolcapone).
• MAO inhibitors for treating depressive or anxiety disorders (such as moclobemide, phenelzine, tranylcypromine, linezolid).
• Medicines for irregular heartbeats (such as digitalis, quinidine).
• Medicines for migraine attacks (such as methysergide or ergotamine).
• Sympathomimetic vasopressors (such as cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline), used to raise blood pressure: if taken in the 24 hours prior to the planned dental treatment, this should be postponed.
• Neuroleptic drugs (such as phenothiazines).

Using Septanest with Adrenaline with food

Avoid eating, even chewing gum, until you have regained normal sensation. Otherwise, there is a risk that you may bite 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 medicine.

Your dentist or doctor will decide if you can take Septanest with Adrenaline during pregnancy.

Breastfeeding can be resumed 5 hours after anesthesia.

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

Driving and using machines

If you experience side effects, including dizziness, blurred vision, or fatigue, do not drive or operate machinery until you have recovered (usually within 30 minutes after the dental procedure).

Septanest with Adrenaline contains sodium and sodium metabisulfite.

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

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

3. How to use Septanest with Adrenaline

Only doctors and dentists are trained to use Septanest with Adrenaline.

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 determine the appropriate dose based on your age, weight, general health, and dental procedure.

The lowest dose that provides effective anesthesia should be used.

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

If you use more Septanest with Adrenaline 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, pale skin, headache, agitation or restlessness, disorientation, loss of balance, tremors or involuntary shaking, dilated pupils, blurred vision, speech difficulties, dizziness, convulsions, stupor, loss of consciousness, coma, yawning, abnormally slow or rapid breathing that can lead to temporary respiratory arrest, and heart failure.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

When you are in the dentist's office, the dentist will closely monitor the effects of Septanest with Adrenaline.

Tell your dentist, doctor, or pharmacist immediately if you experience any of the following serious 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 can be symptoms of an allergic reaction (hypersensitivity).
• A combination of drooping eyelid and constricted pupil (Horner's syndrome).

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

Other side effects may also occur in some patients that are not listed above.

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

• Gingivitis
• Neuropathic pain: pain due to nerve injury
• Numbness or decreased sensation inside and around the mouth
• Metallic taste, taste disturbances, or loss of taste function
• Increased, unpleasant, or abnormal sensation
• Increased sensitivity to heat
• Headache
• Abnormally fast heartbeats
• Abnormally slow heartbeats
• Low blood pressure
• Swelling of the tongue, lips, and gums

Uncommon side effects: may affect up to 1 in 100 people:

• Burning sensation
• High blood pressure
• Inflammation of the tongue and mouth
• Nausea, vomiting, diarrhea
• Rash, itching
• Pain in the neck or at the injection site

Rare side effects: may affect up to 1 in 1,000 people:

• Nervousness, anxiety
• Facial nerve disorder (facial paralysis)
• Somnolence
• Involuntary eye movement
• Double vision, temporary blindness
• Drooping eyelid and constricted pupil (Horner's syndrome)
• Sinking of the eyeball into the orbit (enoftalmia)
• Ringing in the ears, increased ear sensitivity
• Palpitations
• Hot flashes
• Wheezing (bronchospasm, wheezing), asthma
• Difficulty breathing
• Exfoliation and ulceration of the gums
• Exfoliation at 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 the available data

• Extreme euphoria
• Heart conduction problems (conduction disorders, atrioventricular block)
• Increased blood flow to a part of the body leading to congestion of blood vessels
• Widening or narrowing of blood vessels
• Hoarseness
• Difficulty swallowing
• Swelling of the cheeks and local swelling
• Burning mouth syndrome
• Redness of the skin (erythema)
• Abnormal sweating
• Worsening of neuromuscular symptoms of Kearns-Sayre syndrome
• Feeling of heat or cold
• Jaw locking

Reporting side effects

If you experience any side effects, talk to your dentist, doctor, or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Septanest with Adrenaline

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

Do not use this medicine after the expiration date that appears on the label and carton after EXP. The expiration date is the last day of the month indicated.

Store below 30°C.

Do not freeze.

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

Do not use this medicine if you notice 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.

Medicines should not be disposed of via wastewater or household waste. Your dentist will know how to dispose of unused medicines, helping to protect the environment.

6. Container Content and Additional Information

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 injectable solution 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).

• Each 1.7 ml cartridge of Septanest with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution contains 68 mg of articaine hydrochloride and 17 micrograms of epinephrine (as adrenaline tartrate).
• Each milliliter of Septanest with adrenaline 40 mg/ml + 10 micrograms/ml contains 40 mg of articaine hydrochloride and 10 micrograms of epinephrine (as adrenaline tartrate).

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

Appearance of the Product and Container Content

Septanest withadrenalineis a clear and colorless solution.

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

Box containing 50 glass cartridges of 1.7 ml.

Box containing 50 self-aspirating glass cartridges of 1.7 ml.

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder and 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 under 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

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

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

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

????????? ? ????????? 1/100 000, 40 mg/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 with adrenaline 40 mg/ml + 5 micrograms/ml injectable solution

Septanest with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution

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

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

Date of Last Revision of this Leaflet:

05/2022

Other Sources of Information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

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This information is intended only for healthcare professionals:

Dosage

For all populations, the lowest dose that will produce effective anesthesia should be used. The necessary dose must be determined individually.

For a routine procedure, the normal dose for adult patients is 1 cartridge, but the content 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.

In the case of most routine dental procedures, it is preferable to use Septanest with adrenaline 40 mg/ml + 5 micrograms/ml.

For more complex procedures, such as pronounced hemostasis, it is preferable to use Septanest with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution.

Concomitant use of sedatives to reduce patient anxiety:

The maximum safe dose of the 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 articaine is 7 mg/kg, with an absolute maximum dose of articaine of 500 mg. The maximum dose of articaine of 500 mg corresponds to a healthy adult weighing over 70 kg.

Children (between 4 and 11 years of age)

The safety of Septanest with adrenaline has not been established in children under 4 years of age. No data are available.

The amount to be injected must 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 from 4 years (or from 20 kg (44 lbs) body weight) and older, the maximum dose of articaine is only 7 mg/kg, with an absolute maximum dose of 385 mg of articaine for a healthy child weighing 55 kg.

Special Populations

Elderly patients and patients with renal disorders:

Due to the lack of clinical data, special precautions should be taken to administer the lowest dose that provides effective anesthesia in elderly patients and in patients with renal disorders.

High plasma levels of the drug may occur in these patients, especially after repeated use. In case of re-injection, the patient should be closely monitored to identify any signs of relative overdose.

Patient with hepatic impairment

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

Patient with plasma cholinesterase deficiency

High plasma levels of the drug may occur in patients with plasma cholinesterase deficiency or under treatment with acetylcholinesterase inhibitors, as the product is inactivated by 90% by plasma esterases. Therefore, the lowest dose that provides effective anesthesia should be used.

Method of Administration

Infiltration and perineural route 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 medicinal product

This medicinal product should only be used by a doctor or a 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, the availability of a resuscitation equipment and adequate medication should be ensured to provide immediate treatment for 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 can cause local tissue necrosis.

Very rare cases of prolonged or irreversible nerve damage and taste loss have been reported after mandibular block anesthesia.

Precautions for Use

Risk associated with accidental intravascular injection:

An accidental intravascular injection can cause high levels of adrenaline and articaine in the systemic circulation. This can be associated with serious adverse reactions, such as convulsions, followed by central nervous system depression and cardiorespiratory 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 intravascular injection has not occurred.

Risk associated with intraneural injection:

An accidental intraneural injection can 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 sensation of 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 articaine and the presence of adrenaline, as it can reduce perineural blood flow and prevent local elimination of articaine.

Treatment of Overdose

Before the administration of regional anesthesia with local anesthetics, the availability of a resuscitation equipment and adequate medication should be ensured to provide immediate treatment for any respiratory or cardiovascular emergency.

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

The symptoms of the CNS (convulsions, CNS depression) should be treated immediately with adequate respiratory support and the administration of anticonvulsant drugs.

Optimal oxygenation and ventilation, along with circulatory support and treatment of acidosis, can prevent cardiac arrest.

If cardiovascular depression (hypotension, bradycardia) occurs, appropriate treatment with intravenous fluids, vasopressors, or inotropic agents should be considered. Children should be administered doses according to their age and weight.

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

Special Precautions for Disposal and Other Handling

This medicinal product 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. If only part of the cartridge is used, the remainder should be discarded.

The disposal of unused medicinal products and all materials that have come into contact with them will be carried out in accordance with local regulations.