ISOGAINE 30 mg/ml INJECTABLE SOLUTION

Introduction

Patient Information Leaflet

Isogaine 30 mg/ml injectable solution

, Mepivacaine Hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, dentist or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Isogaine is and what it is used for
2. What you need to know before you use Isogaine
3. How to use Isogaine
4. Possible side effects
5. Storage of Isogaine
6. Contents of the pack and other information

1. What Isogaine is and what it is used for

Isogaine is a local anesthetic 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 (with a body weight of approximately 20 kg). It contains the active ingredient mepivacaine hydrochloride and belongs to the group of anesthetics of the nervous system.

2. What you need to know before you use Isogaine

Do not use Isogaine

• if you are allergic to mepivacaine or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other local anesthetics of the same group (e.g., bupivacaine or lidocaine);
• if you have:

• heart disorders due to an electrical impulse anomaly that triggers the heartbeat (severe conduction disorders);
• uncontrolled epilepsy;

• children under 4 years of age (with a body weight of approximately 20 kg).

Warnings and precautions

Consult your dentist before using Isogaine if you:

• have heart disorders;
• have severe anemia;
• have high blood pressure (severe or uncontrolled hypertension);
• have low blood pressure (hypotension);
• have epilepsy;
• have liver disease;
• have kidney disease;
• have a disease that affects the nervous system and produces neurological disorders (porphyria);
• have high blood acidity (acidosis);
• have poor blood circulation;
• your general health is deteriorated;
• the injection site is inflamed or infected.

If any of these situations apply to you, talk to your dentist. He or she may decide to reduce the dose.

Other medicines and Isogaine

Tell your dentist if you are taking, have recently taken, or might take any other medicines, in particular:

• other local anesthetics;
• medicines used to treat stomach and intestine ulcers (such as cimetidine);
• sedatives and tranquilizers;
• medicines used to stabilize the heartbeat (antiarrhythmics);
• cytochrome P450 1A2 inhibitors;
• medicines used to treat high blood pressure (propranolol).

Using Isogaine with food

Avoid eating, even chewing gum, until you have regained normal sensitivity 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 have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

Mothers who are breastfeeding are advised not to breastfeed for 10 hours after anesthesia with this product.

Driving and using machines

This medicine may have a minor influence on the ability to drive and use machines. Dizziness (including a sensation of "spinning", fatigue, and vision disorders) and loss of consciousness may occur after administration of this medicine (see section 4). You should not leave the dental office until you have regained your skills (usually within 30 minutes) after the dental procedure.

Isogaine contains excipients

This medicine contains 2.36 mg of sodium (a major component of table salt/cooking salt) per milliliter. This is equivalent to 0.118% of the maximum recommended daily sodium intake for an adult.

Use in athletes

This medicine contains mepivacaine, which may produce a positive result in doping tests.

3. How to use Isogaine

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

They will determine the correct dose and adjust it according to the procedure, your age, weight, and general health.

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

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

If you are given too much Isogaine

The following symptoms may be signs of toxicity due to excessive doses of local anesthetics: agitation, numbness of lips and tongue, tingling and numbness around the mouth, dizziness, vision and hearing disturbances, and ringing in the ears, muscle stiffness or muscle spasms, low blood pressure, and slow or irregular heartbeat. If you experience any of these effects, the injection should be stopped immediately and urgent medical assistance should be sought.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

After administration of Isogaine, one or more of the following side effects may occur:

Common side effects(may affect up to 1 in 100 people):

Headache

Uncommon side 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 reactions or similar to allergies);
• pain due to nerve injury (neuropathic pain);
• burning sensation, tingling, and numbness in 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 (dysgeusia);
• dizziness (mild dizziness);
• tremor;
• loss of consciousness, seizure (convulsion), coma;
• fainting;
• confusion, disorientation;
• speech disorders, excessive talkativeness;
• restlessness, agitation;
• balance disorders (disequilibrium);
• somnolence;
• blurred vision, difficulty focusing clearly on an object, visual disturbances;
• sensation of spinning (vertigo);
• ineffective heart contraction (cardiac arrest), rapid and erratic heartbeats (ventricular fibrillation), severe and oppressive chest pain (angina pectoris);
• heart rhythm coordination problems (conduction disorders, atrioventricular block), slow and abnormal heart rhythm (bradycardia), rapid and abnormal heart rhythm (tachycardia), palpitations;
• low blood pressure;
• increased blood flow (hyperemia);
• breathing difficulties, abnormally slow or rapid breathing;
• yawning;
• nausea, vomiting, ulcers in the mouth or gums, swelling of the tongue, lips, or gums;
• excessive sweating;
• muscle spasms;
• chills;
• swelling at the injection site.

Rare side effects(may affect up to 1 in 10,000 people)

• high blood pressure;

Unknown frequency side effects(frequency cannot be estimated from the 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 enoftalmía), double vision or loss of vision;
• ear disorders, such as ringing in the ears, increased hearing sensitivity;
• inability of the heart to contract effectively (myocardial depression);
• vasodilation;
• changes in skin color with confusion, cough, rapid breathing and heart rate, sweating: these may be symptoms of tissue hypoxia;
• rapid or difficult breathing, somnolence, headache, inability to think and somnolence, which may be signs of high carbon dioxide levels in the blood (hypercapnia);
• voice alteration (hoarseness);
• swelling of the mouth, lips, tongue, and gums, excessive saliva production;
• fatigue, feeling of weakness, feeling of heat, pain at the injection site;
• nerve injury.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Isogaine

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 which is stated on the carton and blister after EXP.

The expiry date is the last day of the month stated.

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

The cartridges are for single use. The administration of the medicine should take place immediately after opening the cartridge. The 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. This will help protect the environment.

6. Contents of the pack and other information

Composition of Isogaine

• The active substance is mepivacaine hydrochloride 30mg/ml.

Each 1.8 ml cartridge contains 54 milligrams of mepivacaine hydrochloride.

Each milliliter of solution contains 30 milligrams of mepivacaine hydrochloride.

• The other ingredients are Sodium chloride, Water for injections.

Appearance of Isogaine and pack contents

This medicine is a clear and translucent solution.

Cartridges of 1.8 ml in PVC blister packs.

The commercial presentation is a box with 50 cartridges of 1.8 ml or 1 cartridge of 1.8 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Clarben, S.A.

Av. Valdelaparra 27

Alcobendas 28108 - Spain.

Manufacturer

CLARBEN, S.A.

Eduardo Marconi, 2. Polígono Industrial Codein.

Fuenlabrada (Madrid)

28946 - Spain

Date of last revision of this leaflet: February 2020

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