Scandinibsa 20 mg/ml + 10 micrograms/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

SCANDINIBSA 20 mg/ml + 10 micrograms/ml Solution for injection

mepivacaine hydrochloride / epinephrine (adrenaline)

Read the 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, consult your doctor, dentist or pharmacist.

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

Leaflet contents:

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 administered SCANDINIBSA 20 mg/ml + 10 micrograms/ml
3. How SCANDINIBSA 20 mg/ml + 10 micrograms/ml is administered
4. Possible adverse effects
5. How to store SCANDINIBSA 20 mg/ml + 10 micrograms/ml
6. Contents of the pack and other 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 anaesthetic 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 20 kg or greater). It contains the active substances mepivacaine hydrochloride and epinephrine (adrenaline) and belongs to the group of nervous system anaesthetics.

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

Do not use SCANDINIBSA 20 mg/ml + 10 micrograms/ml

• if you are allergic to mepivacaine or adrenaline, or to any of the other components of this medicine (listed in section 6);

• if you are allergic to other local anaesthetics of the same group (e.g., bupivacaine or lidocaine);

• if you have:

• heart disorders due to an electrical impulse abnormality that triggers the heartbeat (severe atrioventricular conduction disturbances);

• uncontrolled epilepsy;

• any of the following heart conditions: unstable angina, recent myocardial infarction, coronary artery bypass surgery, refractory or difficult-to-control arrhythmias, tachycardia, untreated or uncontrolled severe hypertension, or untreated or uncontrolled congestive heart failure;

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

Warnings and precautions

Talk to your dentist before SCANDINIBSA 20 mg/ml + 10 micrograms/ml is administered if you:

• have heart disorders (arrhythmias, conduction disturbances, heart failure, 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 disorder affecting the nervous system causing neurological symptoms (porphyria);
• have high acidity in the blood (acidosis);
• have poor blood circulation;
• are an elderly patient;
• have an inflamed or infected injection site;
• have uncontrolled diabetes;
• have excess thyroid hormones in the blood (thyrotoxicosis);
• have a phaeochromocytoma (a rare, usually non-cancerous (benign) tumour that develops in an adrenal gland);
• are susceptible to acute angle-closure glaucoma (increased pressure inside the eye characterized by severe pain and acute vision loss).

If any of these conditions apply to you, discuss them with your dentist. They may decide to reduce your dose.

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

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

• other local anaesthetics;
• medicines used to treat stomach or intestinal burning and ulcers (such as cimetidine);
• tranquilizers and sedatives;
• medicines used to stabilize heart rhythm (antiarrhythmics);
• cytochrome P450 1A2 inhibitors;
• medicines for heart 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, 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 within the previous 24 hours before planned dental treatment, the procedure should be postponed;
• neuroleptic drugs (e.g., phenothiazines);
• antiarrhythmic medicines for treating heart rhythm problems or arrhythmias (such as digitalis glycosides and quinidine).

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

Avoid eating, including chewing gum, until normal sensation returns, 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 become pregnant, consult your dentist or pharmacist before using this medicine.

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

Breastfeeding women are advised not to breastfeed for 10 hours following anaesthesia with this product.

Driving and use of machines

This medicine may have a minor influence on the ability to drive and operate machinery. Dizziness (including sensations of spinning), fatigue, and visual disturbances, as well as loss of consciousness, may occur after administration of this medicine (see section 4). You should not leave the dental office until your abilities have returned (usually within 30 minutes) after the dental procedure.

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

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

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

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

Use in athletes

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

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

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

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

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

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, numbness of lips and tongue, prickling and tingling around the mouth, dizziness, visual and auditory disturbances, tinnitus, muscle stiffness or muscle spasms, low blood pressure, and low or irregular heart rate, loss of consciousness, and onset of generalized seizures. Seizures may last from a few seconds to several minutes and may rapidly lead to hypoxia (lack of oxygen in the blood and body cells) 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 (reduction in respiratory rate below certain values), tachypnea (increase in respiratory rate above certain values), respiratory depression, cardiac arrest, myocardial depression.

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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

4. Possible adverse effects

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

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

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

Headache

Rare adverse 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 or allergy-like reactions);
• pain due to nerve injury (neuropathic pain);
• burning sensation, prickling, and tingling of the skin without apparent physical cause around the mouth (paresthesia);
• abnormal sensation inside and around the mouth (hypoesthesia);
• metallic taste, taste distortion, loss of sense of touch (dysesthesia);
• dizziness (mild lightheadedness);
• tremor;
• loss of consciousness, seizure, coma;
• fainting;
• confusion, disorientation;
• speech disorders, excessive talkativeness;
• restlessness, agitation;
• disturbance of balance sensation (imbalance);
• drowsiness;
• blurred vision, difficulty focusing clearly on an object, visual disturbances;
• sensation of spinning (vertigo);
• sudden stop in heartbeat (cardiac arrest), irregular heartbeats (arrhythmias such as ventricular fibrillation), severe, constricting chest pain caused by reduced blood flow to the heart (angina pectoris);
• impaired coordination of heartbeat (conduction disorders, atrioventricular block), abnormally slow heart rate (bradycardia), abnormally fast heart rate (tachycardia), palpitations;
• low blood pressure;
• difficulty breathing, abnormally slow or very rapid breathing, breathing with insufficient force (respiratory depression), apnea (pause in breathing lasting at least 10 seconds);
• yawning;
• nausea, vomiting, mouth or gum ulcers, swelling of the tongue, lips, or gums;
• excessive sweating;
• muscle spasms;
• chills;
• swelling at the injection site;
• edematous swelling of the thyroid gland

Very rare adverse 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, 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 vision loss;
• ear disorders such as ringing in the ears (tinnitus), auditory hypersensitivity;
• inability of the heart to contract effectively (myocardial depression);
• widening of blood vessels (vasodilation);
• changes in skin color accompanied by confusion, cough, rapid breathing, and rapid heart rate, sweating: these may be symptoms of tissue oxygen deficiency (hypoxia);
• rapid or difficult breathing, drowsiness, headache, inability to think clearly, and somnolence, which may be signs of high carbon dioxide concentration in the blood (hypercapnia);
• voice changes (hoarseness);
• swelling of the mouth, lips, tongue, and gums, excessive salivation;
• fatigue, feeling of weakness, sensation of warmth, pain at the injection site;
• nerve injury;
• increased blood flow (hyperemia);
• chest pain

Reporting of adverse effects

If you experience any type of adverse effect, consult your 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 Medicines: https://www.notificaram.es. By reporting adverse 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 label of the cartridge and on the box after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice that the solution is not clear and colourless.

Cartridges are for single use only. The medicine should be administered immediately after opening the cartridge. Any unused solution must be discarded.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

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

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

Each 1.8 ml cartridge 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), methyl parahydroxybenzoate (E-218), hydrochloric acid (for pH adjustment) and water for injections.

Appearance of SCANDINIBSA 20 mg/ml + 10 microgram/ml and contents of the pack

This medicine is a clear, colourless solution. It is packaged in glass cartridges.

Pack sizes: packages containing 100 cartridges of 1.8 ml and packages 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 the most recent revision of this package 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

This information is intended for doctors or healthcare professionals only

Before administering a local anesthetic, a complete resuscitation equipment must be available, including an oxygen supply and assisted ventilation system, as well as appropriate medications for the treatment of potential toxic reactions.

Injections must always be performed slowly and with prior aspiration to avoid accidental intravascular injection, which could result in rapid systemic absorption and toxic effects.

Specialists must have received appropriate training in these procedures and be familiar with the diagnosis and management of adverse reactions, systemic toxicity, and other complications.

In addition, considering the anesthetic technique and the patient's condition, the administration of this medicinal product must follow the guidelines and recommendations described in the different sections of the Summary of Product Characteristics (“Dosage and method of administration”; “Special warnings and precautions for use”). Therefore, it is essential to refer to the full text of the Summary of Product Characteristics to ensure correct use of the product.

Solutions should be used immediately after opening. Any unused portion of the solution must be discarded.

Incompatibilities

There is a risk of precipitation at pH > 6.5. This characteristic must be taken into account when adding alkaline solutions, such as carbonates.