Scandivin

Package Leaflet: Information for the Patient

SCANDIVIN, 30 mg/mL, Solution for Injection in a Cartridge

Mepivacaine Hydrochloride

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• In Case of Any Doubts, Consult a Doctor, Dentist, or Pharmacist.
• This Medication has been Prescribed Specifically for You. Do not Pass it on to Others. The Medication may Harm them, even if their Symptoms are the Same as Yours.
• If the Patient Experiences any Undesirable Effects, including those not Mentioned in this Package Leaflet, they Should Inform their Doctor, Dentist, or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What Scandivin 30 mg/mL is and what it is Used for
• 2. Important Information Before Using Scandivin 30 mg/mL
• 3. How to Use Scandivin 30 mg/mL
• 4. Possible Undesirable Effects
• 5. How to Store Scandivin 30 mg/mL
• 6. Package Contents and other Information

1. What Scandivin 30 mg/mL is and what it is Used for

Scandivin 30 mg/mL is a Local Anesthetic that Numbs a Specific Area to Prevent or Minimize Pain. The Medication is Used Locally in Dental Procedures for 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 Scandivin 30 mg/mL

When not to Use Scandivin 30 mg/mL

• If the Patient is Allergic to Mepivacaine or any of the other Ingredients of this Medication (listed in Section 6);
• If the Patient is Allergic to other Local Anesthetics Belonging to the same Group of Medications (e.g., Lidocaine, Bupivacaine);
• If the Patient has:
• Heart Conduction Disorders Caused by Abnormal Electrical Impulses Triggering Heart Contraction (severe Conduction Disorders);
• Seizures Resistant to Treatment;
• Children Under 4 Years Old (approximately 20 kg Body Weight).

Warnings and Precautions

Before Starting to Use Scandivin 30 mg/mL, the Patient Should Discuss it with their Dentist if they have:

• Heart Disease;
• Severe Anemia;
• High Blood Pressure (severe or Untreated Hypertension);
• Low Blood Pressure (Hypotension);
• Seizures;
• Liver Disease;
• Kidney Disease;
• A Disease Affecting the Nervous System and Causing Neurological Disorders (Porphyria);
• Increased Blood Acidity (Acidosis);
• Blood Circulation Disorders;
• General Weakness;
• Inflammation or Infection at the Injection Site.

The Patient Should Inform their Dentist about any of the Above Conditions. The Dentist may Decide to Administer a Lower Dose of the Medication.

Scandivin 30 mg/mL and other Medications

The Patient Should Tell their Dentist about all Medications they are Currently Taking or have Recently Taken, as well as any Medications they Plan to Take, especially if they are:

• other Local Anesthetics;
• Medications Used to Treat Heartburn, Stomach Ulcers, and Intestinal Ulcers (such as Cimetidine);
• Sedatives and Sleep Aids;
• Medications Used to Treat Heart Rhythm Disorders (Antiarrhythmic Medications);
• Cytochrome P450 1A2 Inhibitors;
• Medications Used to Treat High Blood Pressure (Propranolol).

Scandivin 30 mg/mL with Food

The Patient Should Avoid Eating and Chewing Gum until Normal Sensation Returns, especially in Children, due to the Risk of Biting their Lips, the Inside of their Cheeks, or their Tongue.

Children and Adolescents

The Maximum Recommended Dose may be Easily Exceeded in Children and Adolescents when Using High Concentrations of Mepivacaine (3%).

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 Medication. As a Precaution, it is Recommended to Avoid Using the Medication during Pregnancy, unless it is Necessary. Breastfeeding Women Should not Breastfeed for 10 Hours after Administration of the Anesthetic.

Driving and Operating Machinery

This Medication may have a Minor Impact on the Ability to Drive and Operate Machinery. After Administration of the Medication, Dizziness (including a Feeling of Spinning, Visual Disturbances, and Fatigue), Loss of Consciousness (see Section 4) may Occur. The Patient Should not Leave the Dental Office until they have Regained Full Fitness (usually within 30 Minutes) after the Dental Procedure.

Scandivin 30 mg/mL Contains Sodium

The Medication Contains 1.18 mg of Sodium (a Major Component of Table Salt) per mL. This Corresponds to 0.059% of the Maximum Recommended Daily Intake of Sodium in the Diet for Adults.

Use in Athletes

The Medication Contains Mepivacaine, which may Result in a Positive Test Result in Doping Control Tests.

3. How to Use Scandivin 30 mg/mL

Scandivin 30 mg/mL Should be Used Exclusively 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 Necessary to Achieve Effective Anesthesia Should be Used. This Medication is Administered by Injection into the Mouth.

Using a Higher Dose of Scandivin 30 mg/mL than Recommended

After Administration of Excessive Doses of Local Anesthetics, the Following Symptoms of Poisoning may Occur: Excitement, Feeling of Numbness in the Lips and Tongue, Prickling and Tingling around the Mouth, Dizziness, Visual and Hearing Disturbances, Ringing in the Ears, Stiffness and Shaking of the Muscles, Low Blood Pressure, Weak or Irregular Heartbeat. If any of these Symptoms Occur, the Administration of the Medication Should be Stopped Immediately and Medical Help Should be Sought. In Case of Overdose or Accidental Ingestion, Medical Help Should be Sought Immediately. If the Patient has any Further Questions about the Use of this Medication, they Should Consult their Doctor or Dentist.

4. Possible Undesirable Effects

Like all Medications, this Medication can Cause Undesirable Effects, although not Everybody gets them. After Administration of Scandivin 30 mg/mL, one or more of the Following Undesirable Effects may Occur.
Common Undesirable Effects(may Occur in up to 1 in 10 Patients)

• Headache

Rare Undesirable Effects(may Occur in up to 1 in 1,000 Patients):

• Rash, Itching, Swelling of the Face, Lips, Gums, Tongue, and/or Throat, and Difficulty Breathing, Wheezing/ Asthma, Hives (Redness): these may be Symptoms of an Allergic Reaction (Allergic Reactions or Reactions Similar to Allergies);
• Pain due to Nerve Damage (Neuropathic Pain);
• Feeling of Burning, Prickling, Tingling around the Mouth, without any Visible Physical Cause (Paresthesia);
• Disorders of Sensation in the Mouth and around the Mouth (Hypoaesthesia);
• Metallic Taste, Altered Taste, Loss of Taste (Taste Disorders);
• Dizziness (Feeling of Dizziness);
• Trembling;
• Loss of Consciousness, Seizures (Convulsions), Coma;
• Weakness;
• State of Confusion, Disorientation;
• Speech Disorders, Logorrhea;
• Nervousness, Agitation;
• Balance Disorders (Lack of Balance);
• Drowsiness;
• Blurred Vision, Difficulty Focusing on an Object, Visual Disturbances;
• Feeling of Spinning (Dizziness);
• Heart Failure to Contract Properly (Cardiac Arrest), Rapid and Irregular Heartbeat (Atrial Fibrillation), Severe and Crushing Chest Pain (Angina Pectoris);
• Heart Conduction Problems (Conduction Disorders, Atrioventricular Block), Abnormal Slow Heartbeat (Bradycardia), Abnormal Rapid Heartbeat (Tachycardia), Heart 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 Ulcers, Swelling of the Tongue, Lips, or Gums;
• Excessive Sweating;
• Muscle Cramps;
• Chills;
• Swelling at the Injection Site.

Very Rare Undesirable Effects(may Occur in up to 1 in 10,000 Patients):

• High Blood Pressure.

Undesirable Effects of Unknown Frequency(Frequency cannot be Estimated from Available Data):

• State of Euphoria, Anxiety/Nervousness;
• Involuntary Eye Movements, Eye Problems, such as Constricted Pupils, Drooping Eyelids (as in Horner's Syndrome), Dilated Pupils, Sunken Eyeball in the Orbit (called Enophthalmos), Double Vision or Loss of Vision;
• Hearing Disorders, such as Ringing in the Ears, Sensitivity to Sounds;
• Heart Failure to Contract Properly (Cardiac Failure);
• Vasodilation (Vasodilation);
• Changes in Skin Color 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);
• Altered Voice (Hoarseness);
• Swelling of the Lips, Tongue, and Gums, Excessive Salivation;
• Fatigue, Feeling of Weakness, Feeling of Heat, Pain at the Injection Site;
• Nerve Damage.

Reporting Undesirable Effects

If any Undesirable Effects Occur, including those not Mentioned in this Package Leaflet, the Patient Should Inform their Doctor or Dentist. Undesirable Effects can be Reported Directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Urzad Rejestracji Produktow Leczniczych, Wyrobów Medycznych i Produktow Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Undesirable Effects can also be Reported to the Marketing Authorization Holder. By Reporting Undesirable Effects, more Information can be Collected on the Safety of the Medication.

5. How to Store Scandivin 30 mg/mL

The Medication Should be Stored out of Sight and Reach of Children. There are no Special Requirements for Storing the Medication. Do not Use this Medication after the Expiration Date Stated on the Cartridge Label and Outer Packaging after EXP. The Expiration Date Refers to the Last Day of the Specified Month. Do not Use this Medication if the Solution is not Clear and Colorless. The Cartridges are for Single Use. After Opening the Cartridge, the Medication Should be Administered Immediately. Any Unused Solution Should be Discarded. Medications Should not be Disposed of via Wastewater or Household Waste. The Patient Should Ask their Pharmacist how to Dispose of Medications they no Longer Use. This will Help Protect the Environment.

6. Package Contents and other Information

What Scandivin 30 mg/mL Contains

• The Active Substance is Mepivacaine Hydrochloride 30 mg/mL. Each Cartridge with 1.8 mL 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 what the Package Contains

This Medication is a Clear and Colorless Solution. It is Packaged in Glass Cartridges. The Outer Packaging: a Blister Pack of PVC/Paper or PET-PE/PET or PET-PE/PVC, in a Cardboard Box. Package Size: 50 Cartridges of 1.8 mL.

Marketing Authorization Holder and Manufacturer

Laboratorios Inibsa, S.A., Ctra. Sabadell a Granollers, km 14.5, 08185 Lliçà de Vall (Barcelona), Spain, Phone: +34 938 609 500, Fax: +34 938 439 695, e-mail: [email protected]

This Medication is Authorized for Marketing in the Member States of the European Economic Area under the Following Names:

Belgium: MEPICART 30 mg/ml solution injectable
Bulgaria: МЕПИДЕНТАЛ 30 mg/ml Инжекционен разтвор
Cyprus: MEPIDENTAL 30 mg/ml solution for injection
Denmark: MEPIDENTAL
Estonia: SCANDIVIN
Finland: MEPIDENTAL 30 mg/ml injektioneste, liuos
Latvia: SCANDIVIN 30 mg/ml šķīdums injekcijām kārtridžā
Lithuania: SCANDIVIN 30 mg/ml injekcinis tirpalas užtaise
Luxembourg: MEPICART 30 mg/ml solution injectable
Netherlands: MEPICART 30 mg/ml oplossing voor injectie
Poland: SCANDIVIN

Date of Last Update of the Package Leaflet:

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Information Intended for Healthcare Professionals Only

Method of Administration
Local Injection into the Mucous Membrane of the Mouth.
FOR USE ONLY IN DENTAL ANESTHESIA
Before Administering the Local Anesthetic, Full Resuscitation Equipment, including an Oxygenation and Ventilation System, and Medications Necessary for the Treatment of Potential Toxic Reactions, must be Available.
Injections Should be Performed Slowly and with Prior Aspiration to Prevent Rapid and Accidental Intravascular Injections, which can Lead to Toxic Effects.
Specialists must Undergo Appropriate Training in these Procedures and must be Familiar with the Diagnosis and Treatment of Side Effects, Systemic Toxicity, and other Complications.
In Light of this, as well as the Anesthesia Technique and the Situation of the Patients to be Treated, Administration must be Carried out in Accordance with the Recommendations and Scheme Described in the Different Points of the Summary of Product Characteristics ("Dosage and Method of Administration"; "Special Warnings and Precautions for Use"), so it is Necessary to Consult the Text to Ensure the Correct Use of this Product.
Solutions Should be Used Immediately after Opening. Any Unused Solutions Should be Discarded.
AUTOMATIC ASPIRATION
Automatic Aspiration Requires an Automatic Aspirating Syringe. Automatic Aspiration is Performed by Gently Pressing the Plunger and then Immediately Releasing it. The Elastic Membrane in the Cartridge Membrane, which is Pre-pressed against the Axis of the Syringe Base, Creates a Vacuum Inside the Cartridge, which Ensures Aspiration.
MANUAL ASPIRATION
Manual Aspiration Requires a Syringe with a Hook or Harpoon. Manual Aspiration is Achieved when the Harpoon is Attached to the Anesthetic Cartridge and the Plunger is Pulled Back.
Pharmaceutical Incompatibilities
There is a Risk of Precipitation at a pH above 6.5. This Should be Taken into Account when Adding Alkaline Solutions, such as Carbonates.