Scandonest 30 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Scandonest 30 mg/ml solution for injection

Mepivacaine hydrochloride

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
  • If you have any questions, consult your doctor, dentist or pharmacist.
  • This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
  • If you experience any adverse effects, consult your doctor, dentist or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Scandonest is and what it is used for
2. What you need to know before using Scandonest
3. How to use Scandonest
4. Possible adverse 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 anaesthetic that numbs a specific area to prevent or minimize pain. This medicine is used for local dental procedures in adults, adolescents, and children over 4 years of age (body weight approximately 20 kg). It contains the active substance mepivacaine hydrochloride and belongs to the group of nervous system anaesthetics.

2. What you need to know before using Scandonest

Do not use Scandonest:

• if you are allergic to mepivacaine or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other local anaesthetics of the same group (e.g. bupivacaine or lidocaine);
• if you have:
  • heart disorders due to an abnormality in the electrical impulse triggering the heartbeat (severe conduction disturbances);
  • uncontrolled epilepsy not managed by treatment;
• children under 4 years of age (body weight approximately 20 kg).

Warnings and precautions

Talk to your dentist before using Scandonest if you have any of the following conditions:

• 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 disorders (porphyria);
• high acidity in the blood (acidosis);
• blood circulation problems;
• poor general health;
• inflammation or infection at the injection site.

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

Other medicines and Scandonest

Tell your dentist if you are taking, have recently taken, or might need to take any other medicines, especially:

• other local anaesthetics;
• medicines used to treat stomach and intestinal burning or ulcers (such as cimetidine);
• sedatives and tranquilizers;
• medicines used to stabilize heart rhythm (antiarrhythmics);
• cytochrome P450 1A2 inhibitors;
• medicines used to treat hypertension (propranolol).

Scandonest and food

Avoid eating, including chewing gum, until normal sensation returns, 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 become pregnant, consult your dentist or pharmacist before using this medicine.

As a precautionary measure, it is preferable to avoid using this product during pregnancy unless strictly necessary.

Breastfeeding mothers are advised not to breastfeed for 10 hours following anaesthesia with this product.

Driving and using machines

This medicine may have a minor influence on the ability to drive and operate machinery. Dizziness (including sensations of spinning), fatigue, visual disturbances, and loss of consciousness may occur after administration of this medicine (see section 4). You should not leave the dental office until you are certain that these effects have worn off (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 cause a positive result in doping control tests.

3. How to use Scandonest

Scandonest should only be used by, or under the supervision of, dentists, stomatologists, or other trained physicians, via slow local injection.

The appropriate dose will be determined by them and adjusted according to the procedure, your age, weight, and general health condition.

The lowest dose necessary to achieve effective anesthesia should be used.

This medicine is administered as an injection into the oral cavity.

If you are given more Scandonest than you should

The following symptoms may be signs of toxicity due to excessive doses of local anesthetics: agitation, numbness of the lips and tongue, prickling and tingling sensations around the mouth, dizziness, visual and auditory disturbances, tinnitus, muscle stiffness or muscle spasms, low blood pressure, and slow or irregular heart rate. If you experience any of these effects, stop administration immediately and seek medical assistance without delay.

If you have any further questions about the use of this medicine, ask your doctor or dentist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

After administration of Scandonest, one or more of the following adverse effects may occur:

Frequent adverse effects (may affect up to 1 in 10 people):

• Headache

Rare adverse 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 allergy-like reactions);
• Pain due to nerve injury (neuropathic pain);
• Burning sensation, prickling, and tingling of 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 sensation (dysgeusia);
• Dizziness (mild lightheadedness);
• Tremor;
• Loss of consciousness, seizure (convulsion), coma;
• Fainting;
• Confusion, disorientation;
• Speech disorders, excessive talkativeness;
• Restlessness, agitation;
• Disturbance in sense of balance (imbalance);
• Drowsiness;
• Blurred vision, difficulty focusing clearly on an object, visual disturbances;
• Sensation of spinning (vertigo);
• Inability of the heart to contract effectively (cardiac arrest), rapid and irregular heartbeats (ventricular fibrillation), severe, crushing chest pain (angina pectoris);
• Problems coordinating heartbeats (conduction disorders, atrioventricular block), abnormally slow and irregular heart rate (bradycardia), abnormally fast heart rate (tachycardia), palpitations;
• Low blood pressure;
• Increased blood flow (hyperemia);
• Difficulty breathing, abnormally slow or very rapid breathing;
• Yawning;
• Dizziness, vomiting, mouth or gum ulcers, swelling of the tongue, lips, or gums;
• Excessive sweating;
• Muscle spasms;
• Chills;
• Swelling at the injection site.

Very rare adverse 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, 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 enophthalmos), double vision or loss of vision;
• Ear disorders, such as tinnitus, auditory hypersensitivity;
• Inability of the heart to contract effectively (myocardial depression);
• Widening of blood vessels (vasodilation);
• Changes in skin color accompanied by confusion, cough, rapid breathing, and rapid heart rate, sweating: these may be symptoms of tissue oxygen deficiency (hypoxia);
• Rapid or difficult breathing, drowsiness, headache, inability to think clearly, and drowsiness, which may be signs of high carbon dioxide concentration in the blood (hypercapnia);
• Voice alteration (hoarseness);
• Swelling of the mouth, lips, tongue, and gums, excessive salivation;
• Fatigue, feeling of weakness, sensation of warmth, pain at the injection site;
• Nerve injury.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or dentist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es

By reporting adverse 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 stated on the cartridge label and on the outer carton after EXP.

The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice that the solution is not clear and colourless.

Cartridges are for single use only. The medicine should be administered immediately after opening the cartridge. Any unused solution must be discarded.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging once they are no longer needed. 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 injectable solution contains 51 mg of mepivacaine hydrochloride.

Each 2.2 ml cartridge 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 pack

This medicine is a clear, colourless solution. It is packaged in a glass cartridge sealed with a rubber stopper held in place by an aluminium cap.

The marketing presentation is a box containing 50 cartridges 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 medicine has been authorised in the EEA Member States 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 šķidums 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 wstrzykiwan
Portugal: Scandonest 30 mg/ml, solução injectável
Romania: Scandonest 3% Plain, solutie injectabila
Slovakia: Scandonest 3%, injekčný 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 the most recent review of this leaflet: March 2020.

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