Leaflet: information for the user

SCANDINIBSA 20 mg/ml +10 micrograms/mlInjectable solution

mepivacaine hydrochloride / epinephrine (adrenaline)

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

• Keep this leaflet, as you may need to read it again.

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

1. What is SCANDINIBSA 20 mg/ml +10 micrograms/mland what it is used for

2.What you need to know before you are given SCANDINIBSA 20 mg/ml + 10 micrograms/ml

3.How to administer SCANDINIBSA 20 mg/ml + 10 micrograms/ml

4. Possible side effects

5. Storage of SCANDINIBSA 20 mg/ml +10 micrograms/ml

6.Contents of the pack and additional information

SCANDINIBSA 20 mg/ml + 10 micrograms/mlis a local anesthetic that numbs a specific area to prevent or minimize pain. This medication is used for local dental procedures in adults, adolescents, and children over 4 years of age (body weight of 20kg or more).It contains the active ingredients mepivacaine hydrochloride and epinephrine (adrenaline) and belongs to the group of nervous system anesthetics.

You should not use SCANDINIBSA 20 mg/ml + 10 micrograms/ml

• if you are allergic to mepivacaine or adrenaline or any of the other components of this medicine (listed in section 6);
• if you are allergic to other local anesthetics in the same group (for example, bupivacaine or lidocaine);
• if you have:

• serious heart rhythm disorders due to an abnormality of the electrical impulse that triggers the heartbeat (severe alterations of the atrioventricular conduction);
• uncontrolled epilepsy;
• any of the following heart diseases: unstable angina, recent myocardial infarction, coronary artery bypass surgery, refractory or difficult-to-control arrhythmias, tachycardia, uncontrolled or untreated severe hypertension, and uncontrolled or untreated congestive heart failure;

• in children under 4 years of age (body weight less than 20 kg).

Warnings and precautions

Consult your dentist before they administer SCANDINIBSA 20 mg/ml + 10 micrograms/ml if you:

• have heart problems (arrhythmias, conduction disorders, insufficiency, coronary artery disease, history of myocardial infarction);
• have cerebrovascular problems;
• have high blood pressure (severe or untreated hypertension);
• have low blood pressure (hypotension);
• have epilepsy;
• have liver disease;
• have kidney disease;
• have a neurological disorder that causes neurological symptoms (porphyria);
• have high blood acidity (acidosis);
• have poor blood circulation;
• are an elderly patient;
• have an inflamed or infected injection site;
• have uncontrolled diabetes;
• have excessive thyroid hormones in the blood (thyrotoxicosis);
• have phaeochromocytoma (a rare, usually benign tumor that develops in an adrenal gland);
• have susceptibility to acute angle-closure glaucoma (a sudden increase in eye pressure that is characterized by severe pain and acute vision loss).

If any of these situations apply to you, talk to your dentist. They will be able to decide whether to reduce your dose.

Other medicines and SCANDINIBSA 20 mg/ml + 10 micrograms/ml

Inform your dentist if you are taking, have taken recently, or may need to take any other medicine, particularly:

• other local anesthetics;
• medicines used to treat heartburn and stomach and intestinal ulcers (such as cimetidine);
• sedatives and tranquilizers;
• medicines used to stabilize the heartbeat (antiarrhythmics);
• inhibitors of cytochrome P450 1A2;
• heart and blood pressure medicines (such as guanadrel, guanetidine, 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, tranylcypromine, linezolid).
• Migraine medicines (such as metisergide or ergotamine).
• vasopressor sympathomimetics (such as cocaine, amphetamines, phenylephrine, pseudoephedrine, oxymetazoline), used to raise blood pressure: if taken in the 24 hours before planned dental treatment, this should be postponed.
• Neuroleptics (for example, phenothiazines).
• Antiarrhythmic medicines for treating heart rhythm problems or arrhythmias (such as digitalis and quinidine).

Use of SCANDINIBSA 20 mg/ml + 10 micrograms/ml with food

Avoid eating, even chewing gum, until you regain normal sensitivity to prevent the risk of biting your lips, inner 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 pharmacist before using this medicine.

As a precaution, it is recommended to avoid using this product during pregnancy, unless strictly necessary.

Mothers breastfeeding are advised not to breastfeed for 10 hours after anesthesia with this product.

Driving and operating machines

This medicine may have a small effect on your ability to drive and use machines. Dizziness (including a sensation of "spinning", fatigue, and visual disturbances) and loss of consciousness may occur after administration of this medicine (see section 4). You should not leave the dental clinic until you have regained your abilities (usually within 30 minutes) after the dental procedure.

SCANDINIBSA 20 mg/ml + 0.01 mg/ml contains methyl parahydroxybenzoate, sodium metabisulfite, and sodium

This medicine may cause severe allergic reactions and bronchospasm (sudden sensation of choking) because it contains sodium metabisulfite.

It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden sensation of choking) because it contains methyl parahydroxybenzoate.

This medicine contains less than 23 mg of sodium (1 mmol) per ml; it is essentially "sodium-free".

Use in athletes

This medicine contains mepivacaine, which may produce a positive result in doping control tests.

SCANDINIBSA 20 mg/ml + 0.01 micrograms/ml should only be used under the supervision of dentists, stomatologists, or other qualified doctors, via slow local injection.

They will determine the correct dose and adjust it according to the procedure, age, weight, and overall health status.

The lowest effective dose should be used.

This medication is administered as an injection into the oral cavity.

If more SCANDINIBSA 20 mg/ml + 10 micrograms/ml is administered than prescribed

The following symptoms may be signs of toxicity due to excessive doses:

- of local anesthetics (mepivacaine): agitation, numbness sensation of lips and tongue, pinching and tingling around the mouth, dizziness, eye and ear discomfort, and buzzing in the ears, muscle stiffness or muscle spasms, low blood pressure, and irregular or low heart rate, loss of consciousness, and generalized seizures. Seizures can last from a few seconds to several minutes and quickly lead to hypoxia (lack of oxygen in the blood and cells) and hypercapnia (excess carbon dioxide in the blood). In severe cases, it may cause respiratory arrest.

- of adrenaline: restlessness, agitation, presyncope, syncope (transient and complete loss of consciousness), pallor, apnea (respiratory arrest), bradypnea (respiratory frequency below certain values), tachypnea (respiratory frequency above certain values), respiratory depression, cardiac arrest, myocardial depression.

If you experience any of these effects, the injection administration should be stopped immediately and seek urgent medical assistance.

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

If you have any other questions about the use of this medication, ask your doctor or dentist.

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

After the administration of SCANDINIBSA 20 mg/ml + 10 micrograms/ml, one or more of the following side effects may appear:

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

Headache

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

• Skin rash, itching, swelling of the face, lips, gums, tongue, and/or throat, and difficulty breathing, wheezing/asthma, hives (urticaria): these may be symptoms of hypersensitivity reactions (allergic reactions or similar to allergies);
• Pain due to nerve damage (neuropathic pain);
• Burning, prickling, and tingling sensations in the skin without an apparent physical cause around the mouth (paresthesia);
• Abnormal sensation inside and around the mouth (hypoaesthesia);
• Metals taste, distorted taste, loss of tactile sense (dysgeusia);
• Dizziness (mild drowsiness);
• Trembling;
• Loss of consciousness, seizure, coma;
• Fainting;
• Confusion, disorientation;
• Speech disorders, excessive chatter;
• Restlessness, agitation;
• Balance disorder (dizziness);
• Somnolence;
• Blurred vision, problems focusing clearly on an object, visual disturbances;
• Sensation of rotation (vertigo);
• Sudden stop of heartbeats (cardiac arrest), irregular heartbeats (arrhythmias such as ventricular fibrillation), intense and oppressive chest pain caused by reduced blood flow to the heart (angina pectoris);
• Abnormal heart rhythm coordination problems (conduction disorders, atrioventricular block), abnormal slow and abnormal heart rhythm (bradycardia), abnormal fast heart rhythm (tachycardia), palpitations;
• Low blood pressure;
• Difficulty breathing, abnormally slow or rapid breathing, breathing with insufficient force (respiratory depression), apnea (pause in breathing of at least 10 seconds);
• Yawns;
• Nausea, vomiting, ulcers in the mouth or gums, swelling of the tongue, lips, or gums;
• Excessive sweating;
• Muscle spasms;
• Chills;
• Swelling at the injection site.
• Swollen and edematous thyroid gland

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

• High blood pressure;

Possible side effects(frequency cannot be estimated from available data):

• Euphoria, anxiety/nervousness;
• Involuntary eye movements, eye problems such as pupil constriction, eyelid drooping (as in Horner's syndrome), dilated pupil, posterior displacement of the eyeball within the orbit due to changes in orbital volume (called enophthalmia), double vision or loss of vision;
• Ear problems, such as tinnitus, hyperacusis;
• Heart failure to contract effectively (myocardial depression);
• Widening of blood vessels (vasodilation);
• Changes in skin color with confusion, cough, rapid breathing, and rapid heart rate, sweating: these may be symptoms of tissue hypoxia;
• Rapid or difficult breathing, somnolence, headache, inability to think, and somnolence, which may be signs of high carbon dioxide levels in the blood (hypercapnia);
• Voice changes (hoarseness);
• Swelling of the mouth, lips, tongue, and gums, high saliva production;
• Fatigue, feeling of weakness, feeling of heat, pain at the injection site;
• Nerve damage;
• Increased blood flow (hyperemia);
• Chest pain

Reporting side effects

If you experience any type of side effect, consult your 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 the Spanish System for Pharmacovigilance of Medicines for Human Use:https://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.

Store below 25°C.

Store the cartridge in the outer packaging to protect it from light.

Do not use this medication after the expiration date that appears on the cartridge label and on the box after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you notice that the solution is not transparent and colorless.

The cartridges are for single use only. The administration of the medication should take place immediately after opening the cartridge. Unused solution should be discarded.

Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of SCANDINIBSA 20 mg/ml + 10 micrograms/ml

• The active principles aremepivacainehydrochloride and epinephrine (adrenaline).

Each cartridge of 1.8 ml of injectable solution contains 36 mg of mepivacaine hydrochloride and 18 micrograms of adrenaline (as adrenaline tartrate).

• The other ingredients are sodium chloride, sodium metabisulfite (E-223), methylparaben (E-218), hydrochloric acid (for pH adjustment) and water for injectable preparations.

Appearance ofSCANDINIBSA 20 mg/ml + 10 micrograms/mland contents of the package

This medicine is a transparent and colorless solution.It is packaged in glass cartridges.

The commercial presentations are: package containing 100 cartridges of 1.8 ml and package containing 1 cartridge of 1.8 ml.

It is possible that not all package sizes are marketed.

Holder of the marketing authorization and responsible for manufacturing

Inibsa Laboratories, S.A.

Ctra. Sabadell a Granollers, km 14.5

08185 Lliçà de Vall (Barcelona) Spain

Tel.: +34 938 609 500

Fax: +34 938 439 695

[email protected]

Date of the last review of this leaflet: 11/2021.

The detailed information of this medicine 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 doctors or healthcare professionals

Before administering a local anesthetic, a complete resuscitation team should be available, equipped with an oxygenation and assisted ventilation system, and with the appropriate medications for the treatment of possible toxic reactions.

Injections should always be administered slowly and with prior aspiration, to avoid accidental rapid intravascular injection, which could cause toxic effects.

Specialists should receive appropriate training for these procedures, and be familiar with the diagnosis and treatment of side effects, systemic toxicity, or other complications.

Having this in mind, in addition to the anesthetic technique and the situation of the patients who are to receive the treatment, the administration of the specialty should be carried out in accordance with the guidelines described and the recommendations included in the different sections of the Technical Data Sheet (“Posology and administration form”;“Advertencias and special precautions for use”),so it is necessary to refer to the text of the same to ensure correct use of the product.

The solutions should be used immediately after opening. Any remaining portion of the used solution should be discarded.

Incompatibilities

From a pH>6.5 there is a risk of precipitation. This characteristic should be taken into account when adding alkaline solutions, such as carbonates.