SCANDINIBSA 20 mg/mL + 10 micrograms/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

SCANDINIBSA 20 mg/ml + 10 micrograms/mlInjectable Solution

mepivacaine hydrochloride / epinephrine (adrenaline)

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

Contents of the package leaflet:

1. What SCANDINIBSA 20 mg/ml + 10 micrograms/ml is and what it is used for
2. What you need to know before you are given SCANDINIBSA 20 mg/ml + 10 micrograms/ml
3. How SCANDINIBSA 20 mg/ml + 10 micrograms/ml is administered
4. Possible side effects
5. Storage of SCANDINIBSA 20 mg/ml + 10 micrograms/ml
6. Package contents and further information

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

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

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

SCANDINIBSA 20 mg/ml + 10 micrograms/ml must not be used

• 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 of the same group (e.g., bupivacaine or lidocaine);
• if you have:

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

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

Warnings and precautions

Consult your dentist before you are given SCANDINIBSA 20 mg/ml + 10 micrograms/ml if you:

• have heart disorders (arrhythmias, conduction disorders, heart failure, coronary artery disease, history of myocardial infarction);
• 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 disease that affects the nervous system and produces neurological disorders (porphyria);
• have high blood acidity (acidosis);
• have poor blood circulation;
• are an elderly patient;
• have inflammation or infection at the injection site.
• have uncontrolled diabetes
• have an excess of thyroid hormones in the blood (thyrotoxicosis)
• have pheochromocytoma (a rare, usually non-cancerous tumor that develops in an adrenal gland).
• have susceptibility to acute closed-angle glaucoma (increased pressure inside the eye characterized by severe pain and sudden vision loss).

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

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

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

• other local anesthetics;
• medicines used to treat stomach and intestinal ulcers (such as cimetidine);
• tranquilizing and sedating medicines;
• medicines used to stabilize heart rhythm (antiarrhythmics);
• cytochrome P450 1A2 inhibitors;
• Heart and blood pressure medicines (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 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 planned dental treatment, this should be postponed.
• Neuroleptic drugs (e.g., phenothiazines).
• Antiarrhythmic medicines for treating heart rhythm problems or arrhythmias (such as digitalis and quinidine medicines).

Using SCANDINIBSA 20 mg/ml + 10 micrograms/ml with food

Avoid eating, even chewing gum, until you have regained normal sensitivity to prevent the risk of biting your lips, the inside of your cheeks, or your tongue, especially in children.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your dentist or pharmacist for advice before using this medicine.

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

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

Driving and using machines

This medicine may have a minor influence on the ability to drive and use machines. Dizziness (including a feeling of spinning, fatigue, and vision disturbances) and loss of consciousness may occur after administration of this medicine (see section 4). You should not leave the dental office until you have recovered your skills (usually within 30 minutes) after the dental procedure.

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

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

It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden feeling of suffocation) because it contains methylparaben.

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

Use in athletes

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

3. How SCANDINIBSA 20 mg/ml + 10 micrograms/ml is administered

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

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

The lowest necessary dose should be used to achieve effective anesthesia.

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

If you are given more SCANDINIBSA 20 mg/ml + 10 micrograms/ml than you should

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

• of local anesthetics (mepivacaine): agitation, feeling of numbness of lips and tongue, pins and needles around the mouth, dizziness, vision and hearing disturbances, and ringing in the ears, muscle stiffness or muscle spasms, low blood pressure, and low or irregular heart rate, loss of consciousness, and the onset of generalized convulsions. Convulsions may last from a few seconds to several minutes and rapidly lead to hypoxia (lack of oxygen in the blood and tissues) and hypercapnia (excess carbon dioxide in the blood). In severe cases, respiratory arrest may occur.
• of adrenaline: restlessness, agitation, presyncope, syncope (complete and transient loss of consciousness), pallor, apnea (respiratory arrest), bradypnea (decreased respiratory rate), tachypnea (increased respiratory rate), respiratory depression, cardiac arrest, myocardial depression.

If you experience any of these effects, the injection administration should be interrupted immediately, and emergency medical assistance should be sought.

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

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

4. Possible side effects

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

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

Common 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 injury (neuropathic pain);
• burning sensation, pins and needles, and tingling on the skin without apparent physical cause around the mouth (paresthesia);
• abnormal sensation inside and around the mouth (hypoesthesia);
• metallic taste, distortion of taste, loss of sense of touch (dysesthesia);
• dizziness (mild dizziness);
• tremor;
• loss of consciousness, seizure (convulsion), coma;
• fainting;
• confusion, disorientation;
• speech disorders, excessive talkativeness;
• restlessness, agitation;
• balance disorders (disequilibrium);
• drowsiness;
• blurred vision, problems focusing clearly on an object, visual disturbances;
• feeling of spinning (vertigo);
• sudden stop of heartbeats (cardiac arrest), erratic heartbeats (arrhythmias such as ventricular fibrillation), severe and oppressive chest pain caused by reduced blood flow to the heart (angina pectoris);
• heart rhythm coordination problems (conduction disorders, atrioventricular block), slow and abnormal heart rhythm (bradycardia), rapid and abnormal heart rhythm (tachycardia), palpitations;
• low blood pressure;
• breathing difficulties, abnormally slow or rapid breathing, breathing with insufficient force (respiratory depression), apnea (pause in breathing for at least 10 seconds);
• yawning;
• 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.
• thyroid edema

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

• high blood pressure;

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

• euphoria, anxiety/nervousness;
• involuntary eye movements, eye problems such as pupil constriction, drooping of the upper eyelid (as in Horner's syndrome), dilated pupil, posterior displacement of the eyeball within the orbit due to changes in orbital volume (called enophthalmos), double vision or loss of vision;
• ear disorders, such as ringing in the ears, increased hearing sensitivity;
• heart failure to contract effectively (myocardial depression);
• vasodilation;
• skin color changes with confusion, cough, rapid breathing and heart rate, sweating: these may be symptoms of tissue oxygen deficiency (hypoxia);
• rapid or difficult breathing, drowsiness, headache, inability to think, and drowsiness, which may be signs of high carbon dioxide levels in the blood (hypercapnia);
• voice alteration (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 injury.
• increased blood flow (hyperemia);
• chest pain

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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

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

Store below 25°C.

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

Do not use this medicine after the expiry date stated on the cartridge label and carton after EXP. The expiry date is the last day of the month indicated.

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

The cartridges are for single use. The medicine administration should take place immediately after opening the cartridge. The unused solution should be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and further information

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

• The active ingredients are mepivacaine hydrochloride and epinephrine (adrenaline).

Each 1.8 ml cartridge of injectable solution contains 36 mg of mepivacaine hydrochloride and 18 micrograms of epinephrine (as epinephrine 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 of SCANDINIBSA 20 mg/ml + 10 micrograms/ml and package contents

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorios Inibsa, 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 last revision of this leaflet: 11/2021.

Detailed information on this medicine 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

Before administering a local anesthetic, a complete resuscitation equipment, provided with an oxygenation and ventilation assistance system, and the appropriate medicines for the treatment of possible toxic reactions, should be available.

Injections should always be performed 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.

Taking this into account, as well as the anesthetic technique and the situation of the patients to be treated, the administration of the specialty should be performed according to the guidelines described and the recommendations included in the different sections of the Technical Data Sheet ("Posology and method of administration"; "Special warnings and precautions for use"), so it is necessary to refer to the text of the same to ensure the 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.