Isogaine 30 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Isogaine 30 mg/ml solution for injection

, Mepivacaine hydrochloride

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, dentist or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Isogaine is and what it is used for

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

2. What you need to know before using Isogaine

Do not use Isogaine

• 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 of the same group (for example, bupivacaine or lidocaine);

• if you have:

• heart disorders due to an abnormality in the electrical impulse that triggers the heartbeat (severe conduction disturbances);

• uncontrolled epilepsy due to treatment;

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

Warnings and precautions

Talk to your dentist before using Isogaine if you:

• have heart disorders;
• have severe anaemia;
• have high blood pressure (severe or untreated hypertension);
• have low blood pressure (hypotension);
• have epilepsy;
• have liver disease;
• have kidney disease;
• have a disease affecting the nervous system causing neurological disorders (porphyria);
• have high acidity in the blood (acidosis);
• have poor blood circulation;
• have a generally weakened health condition;
• have inflammation or infection at the injection site.

If any of these conditions apply to you, speak with your dentist. He or she may decide to reduce your dose.

Other medicines and Isogaine

Tell your dentist if you are taking, have recently taken, or might need to take any other medicines, particularly:

• other local anaesthetics;
• medicines used to treat stomach and intestinal burns and ulcers (such as cimetidine);
• tranquilizers and sedatives;
• medicines used to stabilize heart rhythm (antiarrhythmics);
• cytochrome P450 1A2 inhibitors;
• medicines used to treat hypertension (propranolol).

Use of Isogaine with food

Avoid eating, including chewing gum, until normal sensation returns, 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 become pregnant, consult your dentist or pharmacist before using this medicine.

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

Breastfeeding mothers are advised not to breastfeed for 10 hours following anaesthesia with this product.

Driving and use of machines

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

Isogaine contains ingredient(s) requiring declaration

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

Use in athletes

This medicine contains mepivacaine, which may result in a positive test in doping controls.

3. How to use Isogaine

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

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

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

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

If you are given more Isogaine than you should

The following symptoms may be signs of toxicity due to excessive doses of local anesthetics: agitation, numbness of the lips and tongue, prickling and tingling sensations around the mouth, dizziness, visual and auditory disturbances, tinnitus, muscle stiffness or muscle spasms, low blood pressure, and slow or irregular heart rate. If you experience any of these effects, the injection must be stopped immediately and emergency medical assistance should be sought.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, stating the medication and the amount ingested.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

• Headache

Rare adverse effects (may affect up to 1 in 1,000 people):

• Skin rash, itching, swelling of the face, lips, gums, tongue and/or throat, breathing difficulty, wheezing/asthma, hives (urticaria): these may be symptoms of hypersensitivity reactions (allergic or allergy-like reactions);
• Pain due to nerve injury (neuropathic pain);
• Burning sensation, prickling, and tingling of the skin without apparent physical cause around the mouth (paresthesia);
• Abnormal sensation inside and around the mouth (hypoesthesia);
• Metallic taste, distorted taste, loss of taste sensation (dysgeusia);
• Dizziness (mild lightheadedness);
• Tremor;
• Loss of consciousness, seizure (convulsion), coma;
• Fainting;
• Confusion, disorientation;
• Speech disorders, excessive talkativeness;
• Restlessness, agitation;
• Disturbance of balance sensation (imbalance);
• Drowsiness;
• Blurred vision, difficulty focusing clearly on an object, visual disturbances;
• Sensation of spinning (vertigo);
• Inability of the heart to contract effectively (cardiac arrest), rapid and irregular heartbeats (ventricular fibrillation), severe and constricting chest pain (angina pectoris);
• Impaired coordination of heartbeats (conduction disorders, atrioventricular block), abnormally slow heart rate (bradycardia), abnormally fast heart rate (tachycardia), palpitations;
• Low blood pressure;
• Increased blood flow (hyperemia);
• Breathing difficulty, abnormally slow or very rapid breathing;
• Yawning;
• Dizziness, vomiting, mouth or gum ulcers, swelling of the tongue, lips or gums;
• Excessive sweating;
• Muscle spasms;
• Chills;
• Swelling at the injection site.

Very rare adverse 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, 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 enophthalmos), double vision or loss of vision;
• Ear disorders such as tinnitus, auditory hypersensitivity;
• Inability of the heart to contract effectively (myocardial depression);
• Widening of blood vessels (vasodilation);
• Changes in skin color accompanied by confusion, coughing, rapid breathing and rapid heartbeat, sweating: these may be symptoms of tissue oxygen deficiency (hypoxia);
• Rapid or difficult breathing, drowsiness, headache, inability to think clearly, and drowsiness, which may be signs of high carbon dioxide concentration in the blood (hypercapnia);
• Voice alteration (hoarseness);
• Swelling of the mouth, lips, tongue and gums, excessive salivation;
• Fatigue, feeling of weakness, sensation of warmth, pain at the injection site;
• Nerve injury.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the cartridge label and the outer carton after EXP.

The expiry date refers to the last day of the month indicated.

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

Cartridges are for single use only. The medicine should be administered immediately after opening the cartridge. Any unused solution must be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Isogaine

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

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

Each ml of solution contains 30 milligrams of mepivacaine hydrochloride.

• The other ingredients are sodium chloride, water for injections.

Appearance of Isogaine and contents of the pack

This medicine is a colorless and translucent solution.

Packs containing 1.8 ml cartridges in PVC blister holders.

The marketing presentation is a box containing either 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 the most recent review of this leaflet: February 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/