SCANDONEST 30 mg/ml INJECTABLE SOLUTION

2. What you need to know before you use Scandonest

Do not use Scandonest:

• 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 electrical impulse anomaly that triggers the heartbeat (severe conduction disorders);
  • uncontrolled epilepsy by treatment;
• children under 4 years of age (body weight of approximately 20 kg).

Warnings and precautions

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

• heart disorders;
• severe anemia;
• high blood pressure (severe or uncontrolled hypertension);
• low blood pressure (hypotension);
• epilepsy;
• liver disease;
• kidney disease;
• disease that affects the nervous system and produces neurological disorders (porphyria);
• high acidity in the blood (acidosis);
• blood circulation;
• poor general health;
• inflammation or infection at the injection site.

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

Other medicines and Scandonest

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 heartburn and stomach and intestine ulcers (such as cimetidine);
• sedative and tranquilizer medicines;
• medicines used to stabilize the heartbeat (antiarrhythmics);
• cytochrome P450 1A2 inhibitors;
• medicines used to treat high blood pressure (propranolol).

Using Scandonest 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 dentist or pharmacist for advice before using this medicine.

As a precautionary measure, it is preferable to avoid the use of 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 are sure that the effects have disappeared (usually within 30 minutes) after the dental procedure.

Scandonest contains sodium

This medicine contains 24.67 mg of sodium per 10 ml (maximum recommended dose). This is equivalent to 1.23% 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 Scandonest

Scandonest 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 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 Scandonest

The following symptoms may be signs of toxicity due to excessive doses of local anesthetics: agitation, numbness of lips and tongue, tingling and numbness around the mouth, dizziness, vision and hearing disturbances, and ringing in the ears, muscle stiffness or muscle spasms, low blood pressure, and slow or irregular heartbeat. If you experience any of these effects, stop administration and seek medical attention immediately.

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 Scandonest, one or more of the following side effects may occur:

Common side effects(may affect up to 1 in 10 people):

Headache

Uncommon side effects(may affect up to 1 in 100 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, tingling, and numbness in 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 dizziness);
• tremor;
• loss of consciousness, seizure (convulsion), coma;
• fainting;
• confusion, disorientation;
• speech disorders, excessive talkativeness;
• restlessness, agitation;
• balance disorders (disequilibrium);
• somnolence;
• 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 disorders (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, vomiting, ulcers in the mouth or gums, swelling of the tongue, lips, or gums;
• excessive sweating;
• muscle spasms;
• chills;
• swelling at the injection site.

Rare side effects(may affect up to 1 in 1,000 people)

• high blood pressure;

Unknown frequency(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);
• vasodilation;
• changes in skin color with confusion, cough, rapid breathing, and rapid heart rate, sweating: these may be symptoms of oxygen deficiency in tissues (hypoxia);
• rapid or difficult breathing, somnolence, headache, inability to think, and somnolence, 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, dentist, or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.aemps.gob.es/

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Scandonest

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

This medicine does not require any special storage conditions.

Do not freeze.

Do not use this medicine after the expiry date which is stated on the carton and on 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 clear and colorless.

The cartridges are for single use. Administration of the medicine should take place immediately after opening the cartridge. 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 other information

Composition of Scandonest

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

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

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

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

Appearance and pack of Scandonest

This medicine is a clear and colorless solution. It is packaged in a glass cartridge with a rubber stopper held in place by an aluminum cap.

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

Marketing authorization holder and manufacturer:

SEPTODONT

58, rue du Pont de Créteil

94100 Saint-Maur-Des-Fossés

France

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

Austria: Scandonest 3% ohne Vasokonstriktor – Injektionslösung

Belgium: Scandonest 3% sans Vasoconstricteur, solution injectable

Bulgaria: Scandonest 30 mg/ml, solution for injection

Croatia: Scandonest 30 mg/ml otopina za injekciju

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

Estonia: Scandonest, 30 mg/ml süstelahus

Finland: Scandonest 30 mg/ml, injektioneste, liuos

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

Germany: Scandonest 3% ohne Vasokonstriktor, Injektionslösung

Greece: Scandonest 3 %, εν?σιμο δι?λυμα

Hungary: Scandonest 30 mg/ml oldatos injekció

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

Italy: SCANDONEST 3% senza vasocostrittore soluzione iniettabile

Latvia: Scandonest 30 mg/ml škidums injekcijam

Lithuania: Scandonest 30 mg/ml injekcinis tirpalas

Luxembourg: Scandonest 3% sans Vasoconstricteur, solution injectable

Malta: Scandonest 30 mg/ml, solution for injection

Netherlands: Scandonest 3% zonder vasoconstrictor, oplossing voor injectie

Norway: Scandonest Plain 30 mg/ml injeksjonsvæske, oppløsning

Poland: Scandonest 30 mg/ml, roztwór do wstrzykiwan

Portugal: Scandonest 30 mg/ml, solução injectável

Romania: Scandonest 3% Plain, solutie injectabila

Slovakia: Scandonest 3%, injekcný roztok

Slovenia: Scandicaine 30 mg/ml raztopina za injiciranje

Sweden: Scandonest 30 mg/ml, injektionsvätska, lösning

United Kingdom: Scandonest 3% Plain, solution for injection

Date of last revision of this leaflet:March 2020.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS): http://www.aemps.gob.es/