Mepivastesin

Leaflet attached to the packaging: patient information

MEPIVASTESIN, 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, so you can read it again if you need to.
• If you have any doubts, consult a doctor, dentist, or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects not listed in this leaflet, they should tell their doctor, dentist, or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Mepivastesin and what is it used for

Mepivastesin is a local anesthetic that numbs a specific area to prevent or minimize pain. The medicine 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 Mepivastesin

When not to use Mepivastesin

• 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 abnormal electrical impulses triggering heart contractions (severe conduction disorders);
• untreated epilepsy;
• in children under 4 years old (approximately 20 kg body weight).

Warnings and precautions

Before starting to use Mepivastesin, 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;
• infection or inflammation at the injection site.

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

Mepivastesin 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 hypnotics;
• medicines used to treat heart rhythm disorders (antiarrhythmic medicines);
• cytochrome P450 1A2 inhibitors;
• medicines used to treat high blood pressure (propranolol).

Mepivastesin 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 administration of the anesthetic.

Driving and using machines

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

Mepivastesin contains sodium

The medicine contains 1.87 mg of sodium in 1.7 ml of solution, which is less than 1 mmol of sodium (23 mg) in 1.7 ml of solution, meaning the medicine is considered "sodium-free".

3. How to use Mepivastesin

Mepivastesin 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.

Using a higher dose of Mepivastesin than recommended

After administering excessive doses of the local anesthetic, 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 you have any further questions about using this medicine, consult your doctor or dentist.

4. Possible side effects

Like all medicines, Mepivastesin can cause side effects, although not everybody gets them. After administering Mepivastesin, one or more of the following side effects 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 difficulty breathing, wheezing/asthma, hives (redness): these may be symptoms of hypersensitivity (allergic reactions or reactions similar to allergy);
• nerve damage pain (neuropathic pain);
• burning, tingling, numbness around the mouth, without visible changes (paresthesia);
• disturbances of sensation in and around the mouth (hypoesthesia);
• metallic taste, altered taste, loss of taste (taste disturbances);
• dizziness (feeling of emptiness in the head);
• trembling;
• loss of consciousness, seizures (convulsions), coma;
• weakness;
• confusion, disorientation;
• speech disturbances, logorrhea;
• nervousness, agitation;
• balance disturbances (loss of balance);
• drowsiness;
• blurred vision, difficulty focusing on an object, vision disturbances;
• feeling of spinning (peripheral vertigo);
• heart failure to contract properly (cardiac arrest), rapid and irregular heartbeat (ventricular flutter), severe and crushing chest pain (angina pectoris);
• heart rhythm coordination problems (conduction disorders, atrioventricular block), abnormal slow heartbeat (bradycardia), abnormal fast heartbeat (tachycardia), palpitations;
• low blood pressure;
• increased blood flow (hyperemia);
• breathing difficulties, such as shortness of breath, extremely slow or fast breathing;
• yawning;
• nausea, vomiting, oral ulcers or gum swelling, tongue, lip, or gum swelling;
• 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

Frequency not known(frequency cannot be estimated from the available data):

• euphoria, anxiety/nervousness;
• smell disturbances
• involuntary eye movements, eye problems, such as pupil constriction, eyelid drooping

(as in Horner's syndrome), dilated pupils, enophthalmos (the eye sinking into the orbit), double vision, or loss of vision;

• hearing disturbances, such as ringing in the ears, hypersensitivity to sounds;
• heart failure to contract properly (heart failure);
• vessel dilation (vasodilation);
• 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);
• voice changes (hoarseness);
• swelling of the mouth, lips, tongue, and gums, excessive saliva production;
• difficulty swallowing
• fatigue, weakness, feeling of heat, pain at the injection site;
• nerve damage.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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 authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mepivastesin

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the label and carton (metal can) after EXP. The expiry date refers to the last day of the month. Store in a temperature below 25°C, protected from light. Do not use this medicine if you notice that the solution is not clear and colorless. The ampoules are for single use only. After opening the ampoule, the medicine should be administered immediately. Unused solution should be discarded. Medicines should not be disposed of via wastewater or household waste. Ask your dentist, doctor, or pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Mepivastesin contains

• The active substance is mepivacaine hydrochloride.
• 1 ml of solution for injection contains 30 mg of mepivacaine hydrochloride.
• Each ampoule with 1.7 ml of solution for injection contains 51 mg of mepivacaine hydrochloride.
• The other ingredients are sodium chloride, water for injections, and sodium hydroxide solution 9% (for pH adjustment).

What Mepivastesin looks like and contents of the pack

Mepivastesin is a clear, colorless solution. It is packed in single-dose ampoules made of neutral glass type I, closed at one end with an aluminum cap with a bromobutyl rubber disk, and at the other end with a bromobutyl rubber stopper. The metal can contains 50 ampoules of 1.7 ml.

Marketing authorization holder

Pierrel S.p.A., Strada Statale Appia 7bis, 46/48 81043 Capua (CE), Italy, tel: +39 0823 626 111, fax: +39 0823 626 228

Manufacturer

Solventum Germany GmbH, ESPE Platz, 82229 Seefeld, Germany

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:
The medicinal product is administered only by dentists, so the full text of the Summary of Product Characteristics will be attached to the end of the patient leaflet as a detachable section.