Package leaflet: Information for the patient

SCANDIVIN, 30 mg/mL, solution for injection in cartridge
Mepivacaini hydrochloridum
Please read carefully the entire leaflet before use, 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 you experience any adverse effects, including any not listed in this leaflet, tell your doctor, dentist or pharmacist. See section 4.

Table of contents

What Scandivin 30 mg/mL is and what it is used for
Important information before using Scandivin 30 mg/mL
How to use Scandivin 30 mg/mL
Possible side effects
How to store Scandivin 30 mg/mL
Contents of the pack and other information

1. What Scandivin 30 mg/mL is and what it is used for
Scandivin 30 mg/mL is a local anaesthetic 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 of age (approximately 20 kg body weight). It contains the active substance mepivacaine hydrochloride and belongs to a group of medicines called local nervous system anaesthetics.

2. Important information before using Scandivin 30 mg/mL

When not to use Scandivin 30 mg/mL

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

Warnings and precautions
Before starting treatment with Scandivin 30 mg/mL, discuss with your dentist if you have:

heart diseases;
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);
increased blood acidity (acidosis);
circulatory disorders;
general poor health;
inflammation or infection at the injection site.

Please inform your dentist about any of the above conditions. Your dentist may decide to administer a lower dose of the medicine.
Scandivin 30 mg/mL and other medicines
Tell your dentist about all medicines you are currently using or have recently used, as well as any medicines you plan 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 heart rhythm disorders (antiarrhythmics);
cytochrome P450 1A2 inhibitors;
medicines used to treat hypertension (propranolol).

Scandivin 30 mg/mL and food
Avoid eating and chewing gum until normal sensation returns, especially in children, due to the risk of biting the lips, inner cheek or tongue.
Children and adolescents
The maximum recommended dose may be easily exceeded in children and adolescents when higher concentrations of mepivacaine (3%) are used.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should consult your 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 and fatigue may occur, as well as loss of consciousness (see section 4). You should not leave the dental office until full recovery of function (usually within 30 minutes) after the dental procedure.
Scandivin 30 mg/mL contains sodium
The medicine contains 1.18 mg of sodium (main component of table salt) in each ml. This corresponds to 0.059% of the maximum recommended daily dietary sodium intake for adults.
Use in athletes
The medicine contains mepivacaine, which may result in a positive doping test.

3. How to use Scandivin 30 mg/mL

Scandivin 30 mg/mL should only be administered by or under the supervision of dentists or
other trained physicians through slow local injection.
The physician will adjust the appropriate dose according to the chosen procedure, age, body weight, and the patient's general health condition.
The lowest effective dose required to achieve adequate anesthesia should be used.
This medicine is administered via intraoral injection.
Administration of a dose higher than recommended of Scandivin 30 mg/mL
Following overdose of local anesthetic agents, the following signs of toxicity may occur: excitation, numbness of lips and tongue, prickling and tingling 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.
In case of overdose or accidental ingestion, consult a physician or pharmacist immediately or go to a hospital emergency department.
If you have any further questions regarding the use of this medicine, consult your doctor or dentist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
After administration of Scandivin 30 mg/mL, one or more of the following adverse reactions may occur.

Common side effects (may occur in up to 1 in 10 patients):

headache

Rare side effects (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 reactions or allergy-like reactions);
pain due to nerve damage (neuropathic pain);
burning, pricking, tingling sensation around the mouth without visible physical cause (paraesthesia);
disturbances of sensation in and around the mouth (hypoesthesia);
metallic taste, altered taste, loss of taste (taste disturbances);
dizziness (feeling of faintness);
tremor;
loss of consciousness, seizures, coma;
faintness;
confusion, disorientation;
speech disorder, dysarthria;
nervousness, restlessness;
loss of balance (imbalance);
somnolence;
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 (hyperaemia);
breathing difficulties, such as shortness of breath, very slow or very fast breathing;
yawning;
nausea, vomiting, ulceration of the mouth or gums, swelling of the tongue, lips or gums;
excessive sweating;
muscle spasms;
chills;
swelling at the injection site.

Very rare side effects (may occur in up to 1 in 10,000 patients):

high blood pressure.

Possible side effects (frequency cannot be estimated from the available data):

feeling of euphoria, anxiety/nervousness;
involuntary eye movements, eye problems such as constricted pupils, drooping of the upper eyelid (as in Horner’s syndrome), dilated pupils, recession of the eyeball into the orbit due to changes in orbital volume (called enophthalmos), double vision or loss of vision;
hearing disturbances such as ringing in the ears (tinnitus), sensitivity to sound;
inability of the heart to contract properly (myocardial failure);
widening of blood vessels (vasodilation);
skin colour changes with disorientation, cough, rapid heartbeat, rapid breathing, sweating: these may be symptoms of inadequate oxygen supply to tissues (hypoxia);
rapid or difficult breathing, drowsiness, headache, inability to think or sleep, which may be symptoms of high carbon dioxide levels in the blood (hypercapnia);
change in voice (hoarseness);
swelling of lips, tongue and gums, excessive salivation;
fatigue, feeling of weakness, feeling of warmth, pain at injection site;
nerve damage.

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, please inform your doctor or dentist. Side effects 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
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Scandivin 30 mg/mL

Keep this medicine out of the sight and reach of children.
There are no special requirements for storage of this medicine.
Do not use this medicine after the expiry date stated on the label of the inner
and outer packaging following EXP. The expiry date refers to the last day of the stated month.
Do not use this medicine if the solution appears cloudy or discoloured.
The ampoules are for single use only. After opening the ampoule, the medicine should be administered
immediately. Any 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. These measures will help protect
the environment.

6. Contents of the pack and other information

What Scandivin 30 mg/mL contains

The active substance is mepivacaine hydrochloride 30 mg/mL. Each 1.8 mL cartridge of solution for injection contains 54 mg of mepivacaine hydrochloride.
The other ingredients are: sodium chloride, hydrochloric acid (E507), sodium hydroxide (E524), and water for injections.

What Scandivin 30 mg/mL looks like and contents of the pack
This medicine is a clear, colourless solution.
It is supplied in glass cartridges.
Outer packaging: PVC/paper foil blister, PET-PE/PET foil blister, or PET-PE/PVC foil blister, in a cardboard box.
Pack size: 50 cartridges of 1.8 mL.

Marketing Authorisation Holder and Manufacturer
Laboratorios Inibsa, S.A.
Ctra. Sabadell a Granollers, km 14,5
08185 Lliçà de Vall (Barcelona), Spain
Telephone: +34 938 609 500
Fax: +34 938 439 695
e-mail: [email protected]

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium MEPICART 30 mg/ml solution for injection
Bulgaria МЕПИДЕНТАЛ 30 mg/ml Инжекционен разтвор
Cyprus MEPIDENTAL 30 mg/ml solution for injection
Denmark MEPIDENTAL
Estonia SCANDIVIN
Finland MEPIDENTAL 30 mg/ml injection solution, solution
Latvia SCANDIVIN 30 mg/ml solution for injection in cartridge
Lithuania SCANDIVIN 30 mg/ml injekcinis tirpalas užtaise
Luxembourg MEPICART 30 mg/ml solution injectable
Netherlands MEPICART 30 mg/ml solution for injection
Poland SCANDIVIN

Information intended exclusively for healthcare professionals

Route of administration
Local injection into the oral mucosa.
FOR DENTAL ANAESTHESIA USE ONLY
Before administering local anaesthesia, full resuscitation equipment must be available, including
oxygen delivery and assisted ventilation systems, as well as medications necessary for the treatment of
potential toxic reactions.
Injections must be administered slowly and preceded by aspiration to prevent rapid and accidental
intravascular injection, which may lead to toxic effects.
Specialists must have appropriate training in such procedures and must be familiar with the diagnosis and management of adverse effects, systemic toxicity, and other complications.
In view of this, as well as anaesthetic techniques and patient conditions, administration must follow the recommendations and procedures described in various sections of the Summary of Product Characteristics (e.g., "Dosage and administration"; "Special warnings and precautions for use"). The full text of these sections should therefore be consulted to ensure correct use of this product.
Solutions should be used immediately after opening. Any unused solution should be discarded.
SELF-ASPIRATING CARTRIDGES
An automatic aspirating syringe is required for self-aspiration. Self-aspiration is achieved by gently depressing and then immediately releasing the plunger. The flexible membrane within the cartridge, pre-compressed against the axis of the syringe base, creates negative pressure inside the cartridge, enabling aspiration.
MANUAL ASPIRATION
A syringe equipped with a harpoon or hook is required for manual aspiration. Manual aspiration is achieved when the harpoon is attached to the anaesthetic cartridge and the plunger is withdrawn.
Pharmaceutical incompatibilities
There is a risk of precipitation at pH above 6.5. This should be taken into account when adding alkaline solutions, such as carbonates.