Prospect: Patient Information

Scandonest 30 mg/ml injectable solution

Mepivacaine hydrochloride

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

• Keep this prospect, as you may need to read it again.
• • If you have any questions, consult your doctor, dentist, or pharmacist.
  • This medicine has been prescribed only to 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 prospect. See section 4.

1. What is Scandonest and how is it used

2. What you need to know before starting to use Scandonest

3. How to use Scandonest

4. Possible adverse effects

5. Storage of Scandonest

6. Contents of the package and additional information

Scandonest is 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..

Do not use Scandonest:

• 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:
• • serious heart rhythm disorders due to an abnormality of the electrical impulse that triggers the heartbeat;
  • uncontrolled epilepsy;
• children under 4 years of age (approximately 20 kg body weight).

Warnings and precautions

Consult your dentist before starting to use Scandonest if you have any of the following conditions:

• heart disease;
• severe anemia;
• severe or untreated high blood pressure (hypertension);
• low blood pressure (hypotension);
• epilepsy;
• liver disease;
• kidney disease;
• diseases that affect the nervous system and cause neurological disorders (porphyria);
• high blood acidity (acidosis);
• blood circulation;
• poor overall health;
• inflammation or infection at the injection site.

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

Other medications and Scandonest

Inform your dentist if you are taking, have taken recently, 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 high blood pressure (propranolol).

Use of Scandonest 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.

It is recommended, as a precaution, to avoid using this product during pregnancy, unless strictly necessary.

Nursing mothers 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. You may experience dizziness (including a sensation of "spinning", fatigue, and visual disturbances) and loss of consciousness after administration of this medication (see section 4). You should not leave the dental clinic until you are sure the effects have worn off (usually within 30 minutes) after the dental procedure.

Scandonest contains sodium

This medication contains 24.67 mg of sodium per 10 ml (maximum recommended dose).This is equivalent to 1.23% of the maximum recommended daily sodium intake for an adult.

Use in athletes

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

Scandonest should only be used by or under the supervision of dentists, stomatologists, or other qualified physicians, 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 you are administered more Scandonest than you should

The following symptoms may be signs of toxicity due to excessive doses of local anesthetics:agitation, numbness sensation in 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 low or irregular heart rate. If you experience any of these effects,stop administration and seek medical assistance immediately..

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 Scandonest, 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 reactions or similar to allergies);
• Pain due to nerve damage (neuropathic pain);
• Burning sensation, pins and needles, and tingling in the skin without apparent physical cause around the mouth (paresthesia);
• Abnormal sensation inside and around the mouth (hypoaesthesia);
• Metalllic taste, distorted taste, loss of taste (dysgeusia);
• Dizziness (mild dizziness);
• Tremors;
• 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 spinning (vertigo);
• Inadequate heart contraction (cardiac arrest), rapid and irregular heartbeats (ventricular fibrillation), intense and oppressive chest pain (angina pectoris);
• Heart rhythm disorders (conduction disorders, atrioventricular block), abnormal slow heart rhythm (bradycardia), abnormal rapid heart rhythm (tachycardia), palpitations;
• Low blood pressure;
• Increased blood flow (hyperemia);
• Difficulty breathing, abnormal breathing rate or very rapid breathing;
• Yawning;
• Sensation of dizziness, vomiting, mouth ulcers 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;

Not known(frequency cannot be estimated from available data):

• Euphoria, anxiety/nervousness;
• Involuntary eye movements, eye problems such as pupil constriction, eyelid drooping (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 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 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);
• 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 of side effects

If you experience any type of side effect, consult your doctor or dentist, 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: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.

This medication does not require special conditions for storage.

Do not freeze.

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

Medicationsshould not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This way, you will help protect the environment.

Composition of Scandonest

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

Each cartridge of 1.7 ml of injectable solution contains 51 mg of mepivacaine hydrochloride.

Each cartridge of 2.2 ml of injectable solution contains 66 mg of mepivacaine hydrochloride.

• The other ingredients are sodium chloride, sodium hydroxide, and water for injection.

Appearance of Scandonest and contents of the package

This medicine is a transparent and colorless solution. It is packaged in a glass cartridge with a rubber seal that is kept in place with an aluminum cap.

The commercial presentation is a box with 50 cartridges of 1.7 ml or 2.2 ml.

Holder of the marketing authorization and responsible for manufacturing:

SEPTODONT

58, rue du Pont de Créteil

94100 Saint-Maur-Des-Fossés

France

This medicine has been authorized in the Member States of the EEA with the following names:

Austria: Scandonest 3% without Vasokonstriktor – Injektionslösung

Bélgica: Scandonest 3% sans Vasoconstricteur, solution injectable

Bulgaria:Scandonest 30 mg/ml, solution for injection

Croacia: Scandonest 30 mg/ml otopina za injekciju

Dinamarca: Scandonest, 30 mg/ml, injektionsvæske, opløsning

Estonia:Scandonest, 30 mg/ml süstelahus

Finlandia: Scandonest 30 mg/ml, injektioneste, liuos

Francia: Scandonest 30 mg/ml, solution injectable à usage dentaire

Alemania: Scandonest 3% ohne Vasokonstriktor, Injektionslösung

Grecia: Scandonest 3 %,εν?σιμοδι?λυμα

Hungría: Scandonest 30 mg/ml oldatos injekció

Irlanda: Scandonest 3% w/v, Solution for Injection

Italia: SCANDONEST 3% senza vasocostrittore soluzione iniettabile

Letonia: Scandonest 30 mg/ml škidums injekcijam

Lituania:Scandonest 30 mg/ml injekcinis tirpalas

Luxemburgo: Scandonest 3% sans Vasoconstricteur, solution injectable

Malta: Scandonest 30 mg/ml, solution for injection

Holanda: Scandonest 3% zonder vasoconstrictor, oplossing voor injectie

Noruega:Scandonest Plain 30 mg/ml injeksjonsvæske, oppløsning

Polonia: Scandonest 30 mg/ml, roztwór do wstrzykiwan

Portugal: Scandonest 30 mg/ml, solução injectável

Rumanía: Scandonest 3% Plain, solutie injectabila

Eslovaquia: Scandonest 3%, injekcný roztok

Eslovenia: Scandicaine 30 mg/ml raztopina za injiciranje

Suecia:Scandonest 30 mg/ml, injektionsvätska, lösning

Reino Unido:Scandonest 3% Plain, solution for injection

Date of the last review of this prospectus:March 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/