Package leaflet: Information for the patient

Scandonest 30 mg/ml, solution for injection
Mepivacaine hydrochloride
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor, dentist, or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor, dentist, or pharmacist. See section 4.

Leaflet contents

What Scandonest is and what it is used for
Important information before using Scandonest
How to use Scandonest
Possible adverse reactions
How to store Scandonest
Contents of the pack and other information

1. What Scandonest is and what it is used for

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

2. 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 anaesthetics belonging to the same group of medicines (e.g. lidocaine, bupivacaine);
if the patient has:
heart problems caused by abnormal electrical impulses triggering heart contractions (severe conduction disorders);
treatment-resistant epileptic seizures;
in children under 4 years of age (approximately 20 kg body weight).

Warnings and precautions
Before starting treatment with Scandonest, discuss with your dentist if the patient has:

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

Inform the doctor about any of the above conditions. The doctor may decide to administer a lower dose of the medicine.

Scandonest and other medicines
Inform the doctor about all medicines currently used or recently used, as well as any medicines the patient plans to use, especially:

other local anaesthetics;
medicines used to treat heartburn, stomach and intestinal ulcers (such as cimetidine);
sedatives and hypnotics;
medicines used to treat cardiac arrhythmias (antiarrhythmics);
cytochrome P450 1A2 inhibitors;
medicines used to treat hypertension (propranolol).

Scandonest and food
Avoid eating and chewing gum until normal sensation returns, particularly in children, due to the risk of biting the lips, inner cheek, or tongue.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor, dentist, or pharmacist before using this medicine.
As a precaution, it is recommended to avoid using this medicine during pregnancy unless necessary.
Breastfeeding women should not breastfeed for 10 hours after administration of the anaesthetic.

Driving and operating machinery
This medicine may have a minor influence on the ability to drive and operate machinery. After administration, dizziness (including vertigo), visual disturbances, fatigue, and loss of consciousness may occur (see section 4). The patient should not leave the dental office until certain that these disturbances have resolved (usually within 30 minutes) following the dental procedure.

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

3. How to use Scandonest

Scandonest should be administered only by or under the supervision of dentists or other
trained physicians, via slow local injection.
The physician will adjust the appropriate dose according to the procedure selected, age, body weight, and general health condition of the patient.
The lowest effective dose required to achieve adequate anaesthesia should be used.
This medicine is administered by injection in the oral cavity.
Use of a higher than recommended dose of Scandonest
Following overdose of local anaesthetic agents, the following signs of toxicity may occur:
central nervous system stimulation, numbness of lips and tongue, tingling and prickling sensations around the mouth, dizziness, visual and auditory disturbances, tinnitus, muscle stiffness and tremors, low blood pressure, weak or irregular heartbeat.
If any of these symptoms occur, administration of the drug must be stopped immediately and medical assistance should be sought.
If you have any further questions about the use of this medicine, consult your dentist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
One or more of the following adverse reactions may occur after administration of Scandonest.

Common adverse reactions (may occur in up to 1 in 10 patients):

headache

Rare adverse reactions (may occur in up to 1 in 1,000 patients):

rash, itching, swelling of the face, lips, gums, tongue and (or) throat, and breathing difficulties, wheezing/asthma, urticaria (hives): these may be symptoms of hypersensitivity reactions (allergic or allergy-like reactions);
pain due to nerve damage (neuropathic pain);
burning sensation, pricking, tingling around the mouth, without any 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 faintness);
tremor;
loss of consciousness, seizures, coma;
fainting;
confusion, disorientation;
speech disturbance, dysarthria;
nervousness, restlessness;
loss of balance (imbalance);
drowsiness;
blurred vision, difficulty focusing on an object, visual disturbances;
sensation of spinning (vertigo);
inability of the heart to contract properly (cardiac arrest), rapid and irregular heartbeat (ventricular fibrillation), severe and crushing chest pain (angina pectoris);
problems with coordination of heartbeat (conduction disturbances, atrioventricular block), abnormally slow heartbeat (bradycardia), abnormally fast heartbeat (tachycardia), palpitations;
low blood pressure;
increased blood flow (hyperemia);
breathing difficulties, such as shortness of breath, exceptionally slow or rapid breathing;
yawning;
nausea, vomiting, oral or gingival ulceration, swelling of the tongue, lips or gums;
excessive sweating;
muscle spasms;
chills;
swelling at the injection site.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):

high blood pressure

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

state of euphoria, anxiety/nervousness;
involuntary eye movements, eye problems such as pupil constriction, drooping of the upper eyelid (as in Horner's syndrome), dilated pupils, enophthalmos (recession of the eyeball into the orbit due to changes in orbital volume), double vision or loss of vision;
hearing disturbances, such as tinnitus, hyperacusis;
inability of the heart to contract properly (myocardial failure);
dilation of blood vessels (vasodilation);
skin discoloration accompanied by confusion, cough, rapid heartbeat, rapid breathing, sweating: these may be symptoms of tissue hypoxia (hypoxia);
rapid or difficult breathing, drowsiness, headache, inability to think or fall asleep, which may indicate high levels of carbon dioxide in the blood (hypercapnia);
altered voice (hoarseness);
swelling of the lips, tongue and gums, excessive salivation;
fatigue, feeling of weakness, sensation of warmth, pain at the injection site;
nerve damage.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration 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

Keep this medicine out of the sight and reach of children.
No special storage instructions apply.
Do not freeze.
Do not use this medicine after the expiry date stated on the carton and vial label after:
EXP.
The expiry date refers to the last day of the stated month.
The abbreviation “Lot” indicates the batch number.
Do not use this medicine if the solution appears non-clear or not colourless.
The vials are for single use only. After opening the vial, the medicine should be administered immediately.
Any unused solution must be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your
doctor or pharmacist how to dispose of medicines no longer required. Such measures 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 1.7 ml ampoule of solution for injection contains 51 mg of mepivacaine hydrochloride.

Each 2.2 ml ampoule of 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, colourless solution. It is supplied in glass ampoules sealed with a rubber stopper and an aluminium cap to hold the stopper in place.
The carton contains 50 ampoules of 1.7 ml or 2.2 ml.
Marketing Authorisation Holder and Manufacturer
SEPTODONT
58, rue du Pont de Créteil
94100 Saint-Maur-Des-Fossés
France
This medicinal product is authorised in the European Economic Area countries 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