Patient Information Leaflet

Isogaine 30 mg/ml Injectable Solution

Hidrocloruro de Mepivacaina

Read this leaflet carefully before you start using this medicine, as 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 must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Is Isogaine and for what it is used

2. What you need to know before starting to use Isogaine

3. How to use Isogaine

4. Possible side effects

5. Storage of Isogaine

6. Contents of the pack and additional information

Isogaine is a local anesthetic that numbs a specific area to prevent or minimize pain. This medication is used for local dental procedures in adults, adolescents, and children over 4 years of age (approximately 20 kg body weight).It contains the active ingredient hydrochloride of mepivacaine and belongs to the group of nervous system anesthetics.

Do not use Isogaine

• if you are allergic to mepivacaine or any of the other components of this medication (listed in section 6);
• if you are allergic to other local anesthetics in the same group (for example, bupivacaine or lidocaine);
• if you have:

• cardiac disorders due to an abnormality of the electrical impulse that triggers the heartbeat (severe conduction disturbances);
• uncontrolled epilepsy by treatment;

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

Warnings and precautions

Consult your dentist before starting to use Isogaine if you:

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

If any of these situations apply to you, speak with your dentist. They will be able to decide to reduce your dose.

Other medications and Isogaine

Inform your dentist if you are taking, have recently taken, or may need to take any other medication, particularly:

• other local anesthetics;
• medications used to treat heartburn and stomach and intestinal ulcers (such as cimetidine);
• sedatives and tranquilizers;
• medications used to stabilize the heartbeat (antiarrhythmics);
• inhibitors of cytochrome P450 1A2;
• medications used to treat hypertension (propranolol).

Use of Isogaine with food

Avoid eating, even chewing gum, until you regain normal sensitivity to prevent the risk of biting your lips, inner cheeks, or tongue, especially in children.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your dentist or pharmacist before using this medication.

It is recommended, as a precaution, to avoid using this product during pregnancy, unless it is strictly necessary.

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

Driving and operating machinery

This medication may have a small influence on your ability to drive and operate machinery. Dizziness (including a sensation of "spinning," fatigue, and visual disturbances) and loss of consciousness may occur after administration of this medication (see section 4). You should not leave the dental clinic until you have regained your abilities (usually within 30 minutes) after the dental procedure.

Isogaine contains excipients of mandatory declaration

This medication contains 2.36 mg of sodium (main component of table salt/for cooking) in each milliliter. This is equivalent to 0.118% of the recommended daily maximum sodium intake for an adult.

Use in athletes

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

Isogaine should only be used by or under the supervision of dentists, stomatologists, or other qualified medical professionals, via slow local injection.

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

The lowest effective dose should be used.

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

If more Isogaine than prescribed is administered

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

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

Headache

Rare 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 or similar reactions);
• Pain due to nerve damage (neuropathic pain);
• Burning sensation, pins and needles, and tingling in the skin without apparent physical cause around the mouth (paresthesia);
• Abnormal sensation inside and around the mouth (hypoaesthesia);
• Metals taste, distorted taste, loss of taste (dysgeusia);
• Dizziness (mild drowsiness);
• Trembling;
• Loss of consciousness, seizure, coma;
• Fainting;
• Confusion, disorientation;
• Speech disorders, excessive chatter;
• Restlessness, agitation;
• Balance disorder (dizziness);
• Drowsiness;
• Blurred vision, difficulty focusing on an object, visual disturbances;
• Sensation of spinning (vertigo);
• Inadequate heart contraction (cardiac arrest), rapid and irregular heartbeats (ventricular fibrillation), intense and oppressive chest pain (angina pectoris);
• Heartbeat coordination disorders (conduction disorders, atrioventricular block), abnormal slow heart rate (bradycardia), abnormal rapid heart rate (tachycardia), palpitations;
• Low blood pressure;
• Increased blood flow (hyperemia);
• Difficulty breathing, abnormally slow or rapid breathing;
• Yawning;
• Sensation of dizziness, vomiting, mouth or gum ulcers, tongue, lip, or gum swelling;
• Excessive sweating;
• Muscle spasms;
• Chills;
• Swelling at the injection site.

Very rare side effects(may affect up to 1 in 10,000 people):

• High blood pressure;

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

• Euphoria, anxiety/nervousness;
• Involuntary eye movements, eye problems such as pupil constriction, eyelid drooping (as in Horner's syndrome), dilated pupil, posterior displacement of the eyeball within the orbit due to changes in orbital volume (called enophthalmia), double vision or loss of vision;
• Ear problems, such as tinnitus, hyperacusis;
• Heart inability to contract effectively (myocardial depression);
• Widening of blood vessels (vasodilation);
• Changes in skin color with confusion, cough, rapid breathing, and rapid heart rate, sweating: these may be symptoms of tissue hypoxia;
• Rapid or difficult breathing, drowsiness, headache, inability to think, and drowsiness, which may be signs of high carbon dioxide levels in the blood (hypercapnia);
• Voice changes (hoarseness);
• Mouth, lip, tongue, and gum swelling, excessive saliva production;
• Fatigue, feeling of weakness, feeling of heat, pain at the injection site;
• Nerve damage.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the reach and sight of children.

This medication does not require special storage conditions.

Do not freeze.

Do not use this medication after the expiration date that appears on the cartridge label and on the box after CAD.

The expiration date is the last day of the month indicated.

Do not use this medication if you notice that the solution is not transparent and colorless.

The cartridges are for single use. The medication administration should take place immediately after opening the cartridge. Unused solution should be discarded.

Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Isogaine

- The active principle is hydrochloride of mepivacaine 30mg/ml.

Each cartridge of 1.8 ml of solution contains 54 milligrams of hydrochloride of mepivacaine.

Each ml of solution contains 30 milligrams of hydrochloride of mepivacaine.

• The other ingredients are Sodium chloride, Water for injectable preparations.

Appearance of Isogaine and contents of the packaging

This medicine is a colorless and transparent solution.

Cartons with cartridges of 1.8 ml in PVC blister packaging.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Clarben, S.A.

C/ Asura 111 local 1 and 4

Madrid 28043 - Spain.

Responsible for manufacturing

CLARBEN, S.A.

Eduardo Marconi, 2. Industrial Codein.

Fuenlabrada (Madrid)

28946 - Spain

Date of the last review of this prospectus: February 2020

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/