Septanest with adrenaline 40 mg/ml + 10 micrograms/ml solution for injection

Patient Information Leaflet

Introduction

Patient Information Leaflet

Septanest with adrenaline 40 mg/ml + 5 micrograms/ml injectable solution

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

articaine hydrochloride/epinephrine

Read this entire 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, ask your dentist, doctor, or pharmacist.
• If you experience any side effects, consult your dentist, doctor, or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Septanest with adrenaline is and what it is used for
2. What you need to know before being administered Septanest with adrenaline
3. How to use Septanest with adrenaline
4. Possible side effects
5. How to store 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, thereby prolonging the effect of articaine. It also reduces bleeding during surgery.

Your dentist will administer either 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 of age (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 potential for significant bleeding.

2. What you need to know before Septanest with adrenaline is administered to you

Do not use Septanest with adrenaline if you have any of the following conditions:

• Allergy to articaine or adrenaline, or to any of the other components of this medicine (listed in section 6).
• Allergy to other local anaesthetics.
• Epilepsy not properly controlled with medication.

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- or third-degree AV block).
• Acute heart failure (acute cardiac weakness, e.g., unexpected chest pain at rest or after a myocardial infarction [i.e., heart attack]).
• Low blood pressure (hypotension).
• Abnormally rapid heartbeats.
• Myocardial infarction within the last 3–6 months.
• Coronary artery bypass graft within the last 3 months.
• You are taking blood pressure medications called beta-blockers, such as propranolol. There is a risk of hypertensive crisis (very high blood pressure) or severe slowing of the heartbeat (see section "Use of Septanest with adrenaline with other medicines").
• Very high blood pressure.
• You are simultaneously taking medications for depression and Parkinson's disease (tricyclic antidepressants). These medicines may intensify the effects of adrenaline.
• Epilepsy.
• Deficiency of a natural chemical substance called cholinesterase in the blood (plasma cholinesterase deficiency).
• Kidney problems.
• Severe liver problems.
• A condition called Myasthenia Gravis that causes muscle weakness.
• Porphyria, which causes both neurological complications and skin problems.
• You are using other local anaesthetics that cause reversible loss of sensation (including volatile anaesthetics such as halothane).
• You are taking antiplatelet or anticoagulant medicines to prevent narrowing or hardening of blood vessels in the arms and legs.
• You are over 70 years of age.
• You have or have had any heart problems.
• You have uncontrolled diabetes.
• Severe overactivity of the thyroid gland (thyrotoxicosis).
• A tumour called phaeochromocytoma.
• A condition called closed-angle glaucoma affecting the eyes.
• Inflammation or infection at the site where the injection will be given.
• Reduced oxygen levels in body tissues (hypoxia), high potassium levels in the blood (hyperkalemia), and metabolic disorders resulting from excess acid in the blood (metabolic acidosis).

Use of Septanest with adrenaline with other medicines

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

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

• Other local anaesthetics causing reversible loss of sensation (including volatile anaesthetics such as halothane).
• Sedatives (such as benzodiazepines, opioids), for example, to reduce anxiety before the dental procedure.
• Medicines for heart conditions and blood pressure (such as guanadrel, guanethidine, propranolol, nadolol).
• Tricyclic antidepressants for treating depression (such as amitriptyline, desipramine, imipramine, nortriptyline, maprotiline, and protriptyline).
• COMT inhibitors for treating Parkinson's disease (such as entacapone or tolcapone).
• MAO inhibitors for treating depressive or anxiety disorders (such as moclobemide, phenelzine, tranilcypramine, linezolid).
• Medicines for irregular heartbeats (e.g., 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 within the previous 24 hours before the planned dental treatment, the procedure should be postponed.
• Neuroleptic drugs (e.g., phenothiazines).

Use of Septanest with adrenaline with food

Avoid eating, including chewing gum, until normal sensation has returned. 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 are planning to become pregnant, consult your dentist or doctor before using this medicine.

Your dentist or doctor will decide whether you can take Septanest with adrenaline during pregnancy.

Breastfeeding may be resumed 5 hours after anaesthesia.

Adverse effects on fertility are not expected with the doses used in a dental procedure.

Driving and use of machines

If you experience adverse effects, including dizziness, blurred vision, or fatigue, you should not drive or operate machinery until you have recovered your faculties (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, and is therefore considered essentially "sodium-free".
• Sodium metabisulfite: in rare cases, this may cause severe allergic reactions and breathing difficulties (bronchospasm).

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

3. How to use Septanest with adrenaline

Only doctors and dentists are trained to administer 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 will determine the appropriate dose based on your age, weight, general health status, and the dental procedure being performed.

The lowest dose that provides effective anaesthesia should be used.

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

If you are given 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, inform your dentist immediately. Symptoms of overdose include severe weakness, pallor, headache, agitation or restlessness, disorientation, loss of balance, tremors or involuntary shivering, pupil dilation, blurred vision, difficulty focusing objects clearly, speech disturbances, dizziness, seizures, stupor, loss of consciousness, coma, yawning, abnormally slow or rapid breathing which may lead to temporary respiratory arrest, and inability of the heart to contract (cardiac failure).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420, indicating the medication and the amount ingested.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

While you are at the dentist's office, your dentist will closely monitor the effects of Septanest with adrenaline.

Inform your dentist, doctor or pharmacist immediately if you experience any of the following serious adverse effects:

• Swelling of the face, tongue or pharynx, difficulty swallowing, urticarial 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 of drooping eyelid and pupil constriction (Horner’s syndrome)

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

Other adverse effects not listed above may also occur in some patients.

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

• Inflammation of the gums
• Neuropathic pain: pain due to nerve injury
• Numbness or reduced sense of touch inside and around the mouth
• Metallic taste, taste disturbances or loss of taste function
• Increased, unpleasant or abnormal sense of touch
• Increased sensitivity to heat
• Headache
• Abnormally rapid heartbeat
• Abnormally slow heartbeat
• Low blood pressure
• Swelling of the tongue, lips and gums

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

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

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

• Restlessness, anxiety
• Facial nerve disorder (facial paralysis)
• Drowsiness
• Involuntary eye movements
• Double vision, temporary blindness
• Drooping eyelid and pupil constriction (Horner’s syndrome)
• Sunken eyeball within the orbit (enophthalmos)
• Ringing in the ears, increased ear sensitivity
• Palpitations
• Flushing
• Wheezing (bronchospasm, whistling sounds in the bronchi), asthma
• Difficulty breathing
• Exfoliation and ulceration of the gums
• Exfoliation at the injection site
• Urticarial hives
• Involuntary muscle contractions
• Fatigue, weakness
• Chills

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

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

Frequency not known: cannot be estimated from available data

• Extreme feelings of well-being (euphoria)
• Heart rhythm coordination problems (conduction disorders, atrioventricular block)
• Increased blood volume in a part of the body leading to congestion of blood vessels
• Widening or narrowing of blood vessels
• Hoarseness
• Difficulty swallowing
• Swelling of the cheeks and local swelling
• Burning mouth syndrome
• Skin redness (erythema)
• Abnormal increase in sweating
• Worsening of neuromuscular symptoms in Kearns-Sayre syndrome
• Sensation of heat or cold
• Jaw locking

Reporting of adverse effects

If you experience any adverse effect, consult your dentist, doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse 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 expiry date stated on the label and the carton after EXP. The expiry date refers to 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 colour.

Cartridges are for single use only. Use immediately after opening the cartridge. Any unused solution must be discarded.

Medicines should not be disposed of via wastewater or household waste. Your dentist will know how to dispose of medicines that are no longer needed. This helps protect the environment.

6. Contents of the pack and other information

Composition of Septanest with adrenaline

• The active substances are articaine hydrochloride and epinephrine (adrenaline tartrate).

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

• Each millilitre 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, water for injections.

Appearance of the product and contents of the pack

Septanest with adrenaline is a clear, colourless 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 in place by an aluminium cap.

Pack containing 50 glass cartridges of 1.7 ml.

Pack containing 50 auto-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 certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Septodont

58, rue du Pont de Créteil

94100 Saint-Maur-des-Fossés

France

This medicinal product is authorised 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, ενέσιμο διάλυμα
Septanest Forte, 40 mg/ml + 10 micrograms/ml, ενέσιμο διάλυμα

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, ενέσιμο διάλυμα
Septanest 4% + 1:100.000, ενέσιμο διάλυμα

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 šķidums injekcijām
Septanest Forte 40 mg/ml + 10 mikrogrami/ml šķidums injekcijām

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 wstrzykiwania
SEPTANEST Z ADRENALINA 1: 100 000 (40 mg+0,01mg)/ml, roztwór do wstrzykiwania

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

Date of most recent 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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

---

This information is intended for healthcare professionals only:

Dosage

For all populations, the lowest effective dose should be used. The required dose must be determined individually.

For routine procedures, the normal dose for adult patients is 1 cartridge, although less than one cartridge may be sufficient to achieve effective anaesthesia. More cartridges may be required for more extensive procedures, according to the dentist's judgement, 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 those requiring pronounced haemostasis, Septanest with adrenaline 40 mg/ml + 10 micrograms/ml injectable solution is preferred.

Concomitant use of sedatives to reduce patient anxiety:

The maximum safe dose of local anaesthetic may be reduced in sedated patients due to an additive effect on central nervous system depression.

Adults and adolescents (aged 12 to 18 years)

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 articaine dose of 500 mg corresponds to a healthy adult weighing more than 70 kg.

Children (aged 4 to 11 years)

The safety of Septanest with adrenaline has not been established in children aged 4 years and younger. No data are available.

The amount to be injected should be determined based on the child's age, body weight, and the extent of the procedure. The effective mean dose is 2 mg/kg and 4 mg/kg for simple and complex procedures, respectively. The lowest dose providing effective dental anaesthesia should be used. In children aged 4 years (or from 20 kg (44 lbs) body weight) and older, the maximum dose of articaine is 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 absence of clinical data, special precautions should be taken by administering the lowest dose that provides effective anaesthesia in elderly patients and in patients with renal disorders.

Elevated plasma levels of the drug may occur in these patients, especially after repeated use. If re-injection is required, the patient should be closely monitored for any signs of relative overdose.

Patients with hepatic impairment

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

Patients with plasma cholinesterase deficiency

Elevated plasma levels of the drug may occur in patients with cholinesterase deficiency or those receiving treatment with acetylcholinesterase inhibitors, since the product is inactivated by 90% via plasma esterases. Therefore, the lowest effective dose should be used.

Method of administration

Infiltration and perineural route in the oral cavity.

If inflammation and/or infection is present at the injection site, local anaesthesia should be administered with caution. The injection speed should be very slow (1 ml/min).

Precautions to be taken before handling or administering the medicine

This medicine should only be used by a physician or dentist with adequate training and familiar with the diagnosis and treatment of systemic toxicity, or under their supervision. Before initiating regional anaesthesia with local anaesthetics, appropriate resuscitation equipment and medication must be available to allow immediate treatment of any respiratory or cardiovascular emergency. The patient's level of consciousness should be monitored after each local anaesthetic injection.

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

Special warnings

Adrenaline reduces blood flow in the gums, potentially causing local tissue necrosis.

Very rare cases of prolonged or irreversible nerve injury and taste loss have been reported following mandibular nerve block anaesthesia.

Precautions for use

Risk associated with accidental intravascular injection:

Accidental intravascular injection may result in high systemic levels of adrenaline and articaine. This may lead to serious adverse reactions such as seizures, followed by central nervous and cardiorespiratory depression and coma, progressing to respiratory and circulatory arrest.

Therefore, prior to injecting the local anaesthetic, aspiration must be performed to ensure the needle has not entered a blood vessel. However, the absence of blood in the syringe does not guarantee that intravascular injection has not occurred.

Risk associated with intraneural injection:

Accidental intraneural injection may cause the drug to travel retrogradely along the nerve.

To avoid intraneural injection and prevent nerve injury during nerve blocks, the needle should be slightly withdrawn whenever the patient experiences an electric shock sensation during injection or if the injection is particularly painful. If nerve injury occurs from the needle, the neurotoxic effect may be exacerbated by the potential chemical neurotoxicity of articaine and the presence of adrenaline, which may reduce perineural blood flow and impair local elimination of articaine.

Treatment of overdose

Before administering regional anaesthesia with local anaesthetics, appropriate resuscitation equipment and medication must be available to allow immediate treatment of any respiratory or cardiovascular emergency.

Depending on the severity of overdose symptoms, the physician or dentist should implement protocols to ensure airway protection and provide assisted ventilation if necessary.

The patient's level of consciousness should be monitored after each local anaesthetic injection.

If signs of acute systemic toxicity occur, injection of the local anaesthetic must be stopped immediately. If necessary, place the patient in a supine position.

Symptoms of CNS toxicity (seizures, CNS depression) should be treated immediately with appropriate airway/respiratory support and administration of anticonvulsant drugs.

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

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

In case of cardiac arrest, immediate cardiopulmonary resuscitation must be performed.

Special precautions for disposal and other handling

This medicine should not be used if the solution is cloudy or discoloured.

To avoid the risk of infection (e.g., transmission of hepatitis), the syringe and needles used to prepare the solution must always be new and sterile.

Cartridges are for single use only. If only part of the cartridge is used, the remainder must be discarded.

Disposal of unused medicine and all materials that have come into contact with it must be carried out in accordance with local regulations.