Scandonest 30 mg/ml

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the patient

Scandonest 30 mg/ml, solution for injection

Mepivacaine hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, dentist, or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, dentist, or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What Scandonest is and what it is used for
• 2. Important information before using Scandonest
• 3. How to use Scandonest
• 4. Possible side effects
• 5. How to store Scandonest
• 6. Contents of the pack and other information

1. What Scandonest is and what it is used for

Scandonest is a local anesthetic that numbs a specific area to prevent or minimize pain. The medicine is used locally in dental procedures in adults, adolescents, and children over 4 years old (approximately 20 kg body weight). It contains the active substance mepivacaine hydrochloride and belongs to the group of nervous system anesthetics.

2. Important information before using Scandonest

When not to use Scandonest

• if the patient is allergic to mepivacaine or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other local anesthetics belonging to the same group of medicines (e.g., lidocaine, bupivacaine);
• if the patient has:
• heart rhythm disorders caused by an abnormal electrical impulse triggering a heart contraction (severe conduction disorders);
• untreated epilepsy;
• children under 4 years old (approximately 20 kg body weight).

Warnings and precautions

Before starting to use Scandonest, the patient should discuss it with their dentist if they have:

• heart problems;
• severe anemia;
• high blood pressure (severe or uncontrolled hypertension);
• low blood pressure (hypotension);
• epilepsy;
• liver disease;
• kidney disease;
• a disease affecting the nervous system and causing neurological disorders (porphyria);
• increased blood acidity (acidosis);
• circulatory disorders;
• general weakness;
• inflammation or infection at the injection site.

The patient should tell their doctor about any of the above conditions. The doctor may decide to administer a lower dose of the medicine.

Scandonest and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, especially if they are:

• other local anesthetics;
• medicines used to treat heartburn, stomach ulcers, and intestinal ulcers (such as cimetidine);
• sedatives and sleeping pills;
• medicines used to treat heart rhythm disorders (antiarrhythmic medicines);
• cytochrome P450 1A2 inhibitors;
• medicines used to treat high blood pressure (propranolol).

Scandonest with food

The patient should avoid eating and chewing gum before regaining normal sensation, especially in children, due to the risk of biting their lips, the inside of their cheeks, or their tongue.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor, dentist, or pharmacist before using this medicine. As a precaution, it is recommended to avoid using the medicine during pregnancy, unless necessary. Breastfeeding women should not breastfeed for 10 hours after anesthesia administration.

Driving and using machines

This medicine may have a minor effect on the ability to drive and use machines. After administration of the medicine, dizziness (including a feeling of spinning, vision disturbances, and fatigue) and loss of consciousness (see section 4) may occur. The patient should not leave the dental office until they are sure that the disturbances have passed (usually within 30 minutes) after the dental procedure.

Scandonest contains sodium

The medicine contains 24.67 mg of sodium in 10 ml (the maximum recommended dose). This corresponds to 1.23% of the maximum recommended daily sodium intake in the diet for adults.

3. How to use Scandonest

Scandonest should only be used by or under the supervision of dentists or other trained doctors through slow local injection. The doctor will adjust the appropriate dose according to the selected procedure, age, body weight, and overall health of the patient. The smallest dose should be used to achieve effective anesthesia. This medicine is administered by injection into the mouth.

Overdose of Scandonest

After administration of excessive doses of local anesthetics, the following symptoms of poisoning may occur: excitement, numbness of the lips and tongue, tingling and numbness around the mouth, dizziness, vision and hearing disturbances, ringing in the ears, stiffness and trembling of the muscles, low blood pressure, weak or irregular heartbeat. If any of these symptoms occur, the administration of the medicine should be stopped immediately, and medical help should be sought. If the patient has any further questions about the use of this medicine, they should ask their dentist.

4. Possible side effects

Like all medicines, Scandonest 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

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

• rash, itching, swelling of the face, lips, gums, tongue, and/or throat, and difficulty breathing, wheezing/asthma, hives (redness): these may be symptoms of hypersensitivity (allergic reactions or reactions similar to allergy);
• pain due to nerve damage (neuropathic pain);
• burning, tingling, numbness around the mouth without visible physical cause (paresthesia);
• disturbances of sensation in the mouth and around the mouth (hypoesthesia);
• metallic taste, altered taste, loss of taste (taste disturbances);
• dizziness (feeling of dizziness);
• trembling;
• loss of consciousness, seizures (convulsions), coma;
• weakness;
• confusion, disorientation;
• speech disturbances, logorrhea;
• nervousness, excitement;
• balance disturbances (loss of balance);
• drowsiness;
• blurred vision, difficulty focusing on an object, vision disturbances;
• feeling of spinning (dizziness);
• heart failure to contract properly (cardiac arrest), rapid and irregular heartbeat (ventricular fibrillation), severe and crushing chest pain (angina pectoris);
• heart rhythm coordination problems (conduction disorders, atrioventricular block), slow and irregular heartbeat (bradycardia), rapid heartbeat (tachycardia), palpitations;
• low blood pressure;
• increased blood flow (hyperemia);
• breathing difficulties, such as shortness of breath, extremely slow or rapid breathing;
• yawning;
• nausea, vomiting, mouth ulcers or gum inflammation, swelling of the tongue, lips, or gums;
• excessive sweating;
• muscle cramps;
• chills;
• swelling at the injection site.

Very rare side effects(may affect up to 1 in 10,000 people):

• high blood pressure

Side effects of unknown frequency(frequency cannot be estimated from the available data):

• euphoria, anxiety/nervousness;
• involuntary eye movements, eye problems, such as constriction of the pupil, drooping of the eyelid (as in Horner's syndrome), dilated pupils, enophthalmos (sunken eye), double vision, or loss of vision;
• hearing disturbances, such as ringing in the ears, hypersensitivity to sound;
• heart failure to contract properly (cardiac failure);
• vasodilation (dilation of blood vessels);
• skin color changes with disorientation, cough, rapid heartbeat, rapid breathing, sweating: these may be symptoms of tissue hypoxia (hypoxia);
• rapid or difficult breathing, drowsiness, headache, inability to think and fall asleep, which may be symptoms of high carbon dioxide levels in the blood (hypercapnia);
• changed voice (hoarseness);
• swelling of the mouth, lips, tongue, and gums, excessive salivation;
• fatigue, feeling of weakness, feeling of heat, pain at the injection site;
• nerve damage.

Reporting side effects

If side effects occur, including any not listed in the leaflet, the patient should tell their doctor. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl

5. How to store Scandonest

The medicine should be stored out of sight and reach of children. There are no special precautions for storage. Do not freeze. Do not use this medicine after the expiry date stated on the label and carton after: EXP. The expiry date refers to the last day of the month. The abbreviation "Lot" means batch number. Do not use this medicine if the solution is not clear and colorless. The cartridges are for single use. After opening the cartridge, the medicine should be administered immediately. Unused solution should be discarded. Medicines should not be disposed of via wastewater or household waste. The patient should ask their doctor or pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Scandonest contains

• The active substance is mepivacaine hydrochloride 30 mg/ml; Each cartridge with 1.7 ml solution for injection contains 51 mg of mepivacaine hydrochloride.

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

• The other ingredients are: sodium chloride, sodium hydroxide, water for injections.

What Scandonest looks like and contents of the pack

This medicine is a clear and colorless solution. It is packed in glass cartridges with a rubber stopper and an aluminum cap holding the stopper in place. The carton contains 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 medicinal product is authorized in the Member States of the European Economic Area under 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 %, ενέσιμο διάλυμα
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 šķīdums injekcijām
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 wstrzykiwań
Portugal: Scandonest 30 mg/ml, solução injectável
Romania: Scandonest 3% Plain, soluţie injectabilă
Slovakia: Scandonest 3%, injekčný roztok
Slovenia: Scandicaine 30 mg/ml raztopina za injiciranje
Spain: Scandonest 30 mg/ml, solución inyectable
Sweden: Scandonest 30 mg/ml, injektionsvätska, lösning
United Kingdom: Scandonest 3% Plain, solution for injection
Date of last revision of the leaflet:03/2020