Scandinibsa 30 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

SCANDINIBSA 30 mg/ml solution for injection

Mepivacaine hydrochloride

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.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

  • 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.

Contents of the leaflet

1. What SCANDINIBSA 30 mg/ml is and what it is used for

2. What you need to know before using SCANDINIBSA 30 mg/ml

3. How to use SCANDINIBSA 30 mg/ml

4. Possible side effects

   1. How to store SCANDINIBSA 30 mg/ml

5. Contents of the pack and other information

1. What SCANDINIBSA 30 mg/ml is and what it is used for

SCANDINIBSA 30 mg/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 approximately 20 kg). It contains the active substance mepivacaine hydrochloride and belongs to the group of nervous system anesthetics.

2. What you need to know before using SCANDINIBSA 30 mg/ml

Do not use SCANDINIBSA 30 mg/ml

• if you are allergic to mepivacaine or to any of the other ingredients 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 abnormality in the electrical impulse triggering the heartbeat (severe conduction disturbances);

• uncontrolled epilepsy;

• children under 4 years of age (body weight approximately 20 kg).

Warnings and precautions

Talk to your dentist before using SCANDINIBSA 30 mg/ml if you:

• have heart disorders;
• have severe anaemia;
• have high blood pressure (severe or untreated hypertension);
• have low blood pressure (hypotension);
• have epilepsy;
• have liver disease;
• have kidney disease;
• have a disease affecting the nervous system causing neurological disorders (porphyria);
• have high acidity in the blood (acidosis);
• have poor blood circulation;
• have a generally weakened health condition;
• have inflammation or infection at the injection site.

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

Other medicines and SCANDINIBSA 30 mg/ml

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

• other local anaesthetics;
• medicines used to treat stomach and intestinal burning or ulcers (such as cimetidine);
• sedatives and tranquilizers;
• medicines used to stabilize heart rhythm (antiarrhythmics);
• cytochrome P450 1A2 inhibitors;
• medicines used to treat hypertension (propranolol).

Use of SCANDINIBSA 30 mg/ml with food

Avoid eating, including chewing gum, until normal sensation returns, 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 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 mothers are advised not to breastfeed for 10 hours following anaesthesia with this product.

Driving and using machines

This medicine may have a minor influence on the ability to drive and use machines. Dizziness (including sensations 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 office until your abilities have returned (usually within 30 minutes) after the dental procedure.

Mepivacaine contains sodium

This medicine contains 1.18 mg of sodium (main component of table/cooking salt) per ml. This corresponds to 0.059% of the maximum daily recommended sodium intake for an adult.

Use in athletes

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

3. How to use SCANDINIBSA 30 mg/ml

SCANDINIBSA 30 mg/ml should 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 effective dose required to achieve adequate anesthesia should be used.

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

If you are given more SCANDINIBSA 30 mg/ml than you should

The following symptoms may be signs of toxicity due to excessive doses of local anesthetics: agitation, numbness of the lips and tongue, prickling and tingling sensations around the mouth, dizziness, visual and auditory disturbances, tinnitus, muscle stiffness or muscle spasms, low blood pressure, and slow or irregular heartbeat. 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 at telephone number: 91 562 04 20, indicating the medication 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 30 mg/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, 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 taste (dysgeusia);
• dizziness (mild lightheadedness);
• tremor;
• loss of consciousness, seizure (convulsion), coma;
• fainting;
• confusion, disorientation;
• speech disorders, excessive talkativeness;
• restlessness, agitation;
• disturbance of balance sensation (imbalance);
• somnolence;
• blurred vision, difficulty focusing clearly on an object, visual disturbances;
• sensation of spinning (vertigo);
• inability of the heart to contract effectively (cardiac arrest), rapid and irregular heartbeats (ventricular fibrillation), severe and constricting chest pain (angina pectoris);
• impaired coordination of heartbeat (conduction disorders, atrioventricular block), abnormally slow heart rate (bradycardia), abnormally rapid heart rate (tachycardia), palpitations;
• low blood pressure;
• increased blood flow (hyperemia);
• difficulty breathing, abnormally slow or very rapid breathing;
• yawning;
• dizziness, vomiting, mouth or gum ulcers, swelling of the tongue, lips, or gums;
• excessive sweating;
• muscle spasms;
• chills;
• swelling at the injection site.

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 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 elevated carbon dioxide levels 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.

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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of SCANDINIBSA 30 mg/ml

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of SCANDINIBSA 30 mg/ml

• The active substance is mepivacaine hydrochloride 30 mg/ml.

Each 1.8 ml cartridge of injectable solution contains 54 mg of mepivacaine hydrochloride.

• The other ingredients are sodium chloride, sodium hydroxide (for pH adjustment), and water for injections.

Appearance of SCANDINIBSA 30 mg/ml and contents of the container

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

The marketing presentation is a box containing 1 or 100 cartridges of 1.8 ml.

Marketing Authorization Holder and Manufacturer

Laboratorios Inibsa, S.A.

Ctra. Sabadell a Granollers, km 14.5

08185 Lliçà de Vall (Barcelona), Spain

Telephone +34 938 609 500

Fax +34 938 439 695

e-mail: [email protected]

Date of the most recent review of this leaflet: February 2020

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 healthcare professionals only

Method of administration

Local injection into the oral mucosa.

FOR DENTAL ANAESTHESIA USE ONLY

Before administering a local anaesthetic, a complete resuscitation equipment set 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 administered slowly and preceded by aspiration to avoid accidental intravascular injection, which could lead to toxic effects.

Specialists must be adequately trained in these procedures and be familiar with the diagnosis and management of adverse effects, systemic toxicity, and other complications.

In addition, considering the anaesthetic technique and the patient's condition, 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"; "Warnings and special precautions for use"). Therefore, reference to the full text is necessary to ensure correct use of the product.

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

AUTO-ASPIRATION

Auto-aspiration requires a self-aspirating syringe. To perform auto-aspiration, apply gentle pressure on the plunger and immediately release it. The elastic spring of the cartridge membrane, initially pressed against the base shaft of the syringe, creates negative pressure within the cartridge, ensuring aspiration.

MANUAL ASPIRATION

Manual aspiration requires a syringe equipped with a hook or harpoon. Manual aspiration is achieved when the harpoon engages the anaesthetic cartridge and the plunger is pulled backward.

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.