SCANDINIBSA 30 mg/ml INJECTABLE SOLUTION

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

Do not use SCANDINIBSA 30 mg/ml

• if you are allergic to mepivacaine or any of the other ingredients 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 conduction disorders);
• uncontrolled epilepsy;

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

Warnings and precautions

Consult your dentist before starting to use SCANDINIBSA 30 mg/ml if you:

• have heart disorders;
• have severe anemia;
• have high blood pressure (severe or uncontrolled 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;
• your general state of health is deteriorated;
• the injection site is inflamed or infected.

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

Other medicines and SCANDINIBSA 30 mg/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);
• sedatives and tranquilizers;
• medicines used to stabilize the heartbeat (antiarrhythmics);
• cytochrome P450 1A2 inhibitors;
• medicines used to treat high blood pressure (propranolol).

Using SCANDINIBSA 30 mg/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 doctor or pharmacist for advice before using this medicine.

As a precautionary measure, 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 disorders) 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.

Mepivacaine contains sodium

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

Use in athletes

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

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, by slow local injection.

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

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 too much SCANDINIBSA 30 mg/ml

The following symptoms may be signs of toxicity due to excessive doses of local anesthetics: agitation, numbness of lips and tongue, pins and needles around the mouth, dizziness, vision and hearing disturbances, and ringing in the ears, muscle stiffness or spasms, low blood pressure, and slow or irregular heartbeat. If you experience any of these effects, the injection should be stopped immediately and emergency medical assistance should be sought.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological 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 30 mg/ml, one or more of the following side effects may occur:

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 numbness in 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 taste (dysgeusia);
• 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;
• sensation of spinning (vertigo);
• ineffective heart contraction (cardiac arrest), rapid and erratic heartbeats (ventricular fibrillation), severe and oppressive chest pain (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;
• increased blood flow (hyperemia);
• breathing difficulties, abnormally slow or rapid breathing;
• yawning;
• sensation of dizziness, nausea, ulcers in the mouth or gums, swelling of the tongue, lips, or gums;
• excessive sweating;
• muscle spasms;
• chills;
• swelling at the injection site.

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 enophthalmia), double vision or loss of vision;
• ear disorders, such as ringing in the ears, increased hearing sensitivity;
• inability of the heart to contract effectively (myocardial depression);
• widening of blood vessels (vasodilation);
• changes in skin color with confusion, cough, rapid breathing and heart rate, sweating: these may be symptoms of oxygen deficiency in tissues (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, excessive saliva production;
• fatigue, feeling of weakness, feeling of heat, pain at the injection site;
• nerve injury.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 carton and the label after EXP.

The expiry date is the last day of the month stated.

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

The cartridges are for single use. The administration of the medicine 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. Contents of the pack and further information

Composition of SCANDINIBSA 30 mg/ml

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

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

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

Appearance of SCANDINIBSA 30 mg/ml and pack contents

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

The commercial presentation is a box with 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

Phone +34 938 609 500

Fax +34 938 439 695

e-mail: [email protected]

Date of last revision 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

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This information is intended only for healthcare professionals

Method of administration

Local injection into the oral mucosa.

FOR USE ONLY IN DENTAL ANESTHESIA

Before administering a local anesthetic, a complete resuscitation equipment, provided with an oxygenation and ventilation 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 proper 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 carried out 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.

AUTOASPIRATION

To perform autoaspiration, an automatic aspiration syringe is required. Autoaspiration is performed by applying gentle pressure on the piston and immediately releasing it. The elastic spring of the cartridge membrane, which is initially pressed against the base axis of the syringe, creates a negative pressure inside the cartridge that guarantees aspiration.

MANUAL ASPIRATION

To perform manual aspiration, a syringe with a hook or harpoon is required. Manual aspiration is achieved when the harpoon is fixed to the anesthesia cartridge and the plunger is pulled back.

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.