Prospecto: Information for the patient

SCANDINIBSA 30mg/ml injectable solution

Mepivacaine hydrochloride

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, dentist or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

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

1.What isSCANDINIBSA 30 mg/mland for what it is used

2.What you need to know before starting to useSCANDINIBSA 30 mg/ml

3.How to useSCANDINIBSA 30 mg/ml

4.Possible adverse effects

1. Storage ofSCANDINIBSA 30 mg/ml

6.Contents of the package and additional information

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

No use SCANDINIBSA 30 mg/ml

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

• cardiac disorders due to an abnormality of the electrical impulse that triggers the heartbeat (severe conduction disturbances);
• uncontrolled epilepsy;

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

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 untreated hypertension);
• have low blood pressure (hypotension);
• have epilepsy;
• have liver disease;
• have kidney disease;
• have a disease affecting the nervous system and causing neurological disorders (porphyria);
• have high blood acidity (acidosis);
• have poor blood circulation;
• have a deteriorated general state of health;
• have inflamed or infected the injection site area.

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

Other medications and SCANDINIBSA 30 mg/ml

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

• other local anesthetics;
• medications used to treat heartburn and stomach and intestinal ulcers (such as cimetidine);
• sedatives and tranquilizers;
• medications used to stabilize the heartbeat (antiarrhythmics);
• inhibitors of cytochrome P450 1A2;
• medications used to treat hypertension (propranolol).

Use of SCANDINIBSA 30 mg/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 medication.

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 machinery

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

Mepivacaine contains sodium

This medication contains 1.18 mg of sodium (main component of table salt/for cooking) in each ml. This is equivalent to 0.059% of the recommended daily maximum sodium intake for an adult.

Use in athletes

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

SCANDINIBSA 30 mg/ml should only be used under the supervision of dentists, stomatologists, or other qualified medical professionals, 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 30 mg/ml is administered than prescribed

The following symptoms may be signs of toxicity due to excessive doses of local anesthetics: agitation, numbness sensation in the lips and tongue, pinching and tingling around the mouth, dizziness, discomfort in vision and hearing, and buzzing in the ears, muscle stiffness or muscle spasms, low blood pressure, and irregular or slow heart rate. 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 administration of SCANDINIBSA 30 mg/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 or similar reactions);
• Pain due to nerve damage (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 (hypoaesthesia);
• Metals taste, distorted taste, loss of taste (dysgeusia);
• Dizziness (mild drowsiness);
• Tremor;
• Loss of consciousness, seizure, coma;
• Fainting;
• Confusion, disorientation;
• Speech disorders, excessive chatter;
• Restlessness, agitation;
• Balance disorder (dizziness);
• Drowsiness;
• Blurred vision, difficulty focusing on an object, visual disturbances;
• Sensation of rotation (vertigo);
• Inadequate heart contraction (cardiac arrest), rapid and irregular heartbeats (ventricular fibrillation), intense and oppressive chest pain (angina pectoris);
• Cardiac conduction disorders, atrioventricular block, abnormal slow heart rate (bradycardia), abnormal rapid heart rate (tachycardia), palpitations;
• Low blood pressure;
• Increased blood flow (hyperemia);
• Difficulty breathing, abnormal breathing rate or very rapid breathing;
• Yawns;
• Sensation of dizziness, vomiting, mouth or gum ulcers, tongue swelling, lip or gum swelling;
• 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;

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

• Euphoria, anxiety/nervousness;
• Involuntary eye movements, eye problems such as pupil constriction, eyelid drooping (Horner's syndrome), dilated pupil, posterior displacement of the eyeball within the orbit due to changes in orbital volume (ophthalmia), 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, drowsiness, headache, inability to think, and drowsiness, 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.

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.

No special conditions for conservation are required.

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. The administration of the medication should take place immediately after opening the cartridge. Unused solution should be discarded.

Medications should not be thrown into the drains or trash. Ask your pharmacist how to dispose of the containers and medications that you do not need. By doing so, you will help protect the environment.

Composition of SCANDINIBSA 30 mg/ml

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

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

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

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

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

The commercial presentation is a box with 1 or 100 cartridges of 1.8ml.

Holder of the marketing authorization and responsible for manufacturing

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]

Last review date of this leaflet: February 2020

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

Administration method

Local injection in the oral mucosa.

ONLY FOR USE IN DENTAL ANESTHESIA

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

Considering this, as well as the anesthetic technique and the situation of the patients receiving 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 method”;“Advertencias and precautions for special 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.

SELF-ASPIRATION

To perform self-aspiration, an automatic aspiration syringe is required. Self-aspiration is performed by applying gentle pressure on the piston and immediately releasing it. The elastic spring of the cartridge membrane, which initially presses against the axis of the base of the syringe, creates a negative pressure inside the cartridge that ensures 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 anesthetic 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.