Patient Information Leaflet

MMepivacaineNormogen30mg/ml Injectable SolutionEFG

Mepivacaine Hydrochloride

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 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, dentist, or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Mepivacaine Normogen 30 mg/ml and what it is used for

2. What you need to know before using Mepivacaine Normogen 30 mg/ml

3. How to use Mepivacaine Normogen 30 mg/ml

4. Possible side effects

5. Storage of Mepivacaine Normogen 30 mg/ml

6. Contents of the pack and additional information

Mepivacaína Normogen 30 mg/ml 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 mepivacaína hydrochloride and belongs to the group of nervous system anesthetics.

No use Mepivacaína Normogen 30 mg/ml:

• 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, lidocaine, bupivacaine);
• 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 Mepivacaína Normogen 30 mg/ml:

• if you have severe heart disorders;
• if you have severe anemia;
• if you have high blood pressure (severe or untreated hypertension);
• if you have low blood pressure (hypotension);
• if you have epilepsy;
• if you have liver disease;
• if you have kidney disease;
• if you have a disease affecting the nervous system and causing neurological disorders (porphyria);
• if you have high blood acidity (acidosis);
• if you have poor blood circulation;
• if your overall health is deteriorated;
• if the area of the injection site is inflamed or infected.

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 Mepivacaína Normogen 30 mg/ml

Inform your dentist if you are taking, have taken recently, 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 Mepivacaína Normogen 30 mg/ml 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, Lactation, and Fertility

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

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

It is recommended that breastfeeding mothers do not breastfeed for 10 hours after anesthesia with this product.

Driving and Operating Machines

This medication may have a small influence on the ability to drive and operate machines. 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.

Mepivacaína Normogen 30 mg/ml contains sodium

This medication contains less than 23 mg (1 mmol) of sodium per cartridge, which is essentially "sodium-free".

Use in Athletes

Inform athletes that this medication contains a component that may produce a positive analytical result in doping control.

Mepivacaína Normogen 30 mg/ml should only be used by or under the supervision of dentists, stomatologists, or other qualified physicians, 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 You Are Given More Mepivacaína Normogen 30 mg/ml Than You Should

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 low or irregular 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 the Toxicological Information Service (Tel. 91 562 04 20), indicating the product and the amount received.

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 Mepivacaína Normogen 30 mg/ml, one or more of the following side effects may appear.

Frequent side effects(may affect up to 1 in 10 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;
• nerve damage pain;
• burning, prickling, and tingling sensation in the skin without apparent physical cause around the mouth (paresthesia);
• abnormal sensation inside and around the mouth (hypoaesthesia);
• metallic taste, distorted taste, loss of taste (dysgeusia);
• dizziness (mild drowsiness);
• shaking;
• 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 rotation (vertigo);

• ineffective heart contraction (cardiac arrest), rapid and irregular heartbeats (ventricular fibrillation), intense and oppressive chest pain (angina pectoris);
• cardiac conduction disorders (trastornos de la conducción,

auriculoventricular 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;
• yawns;
• sensation of dizziness, vomiting, mouth or gum ulcers, tongue, lip, or gum swelling;
• 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;

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 (calledenophthalmia), double vision or loss of vision;
• ear problems, such as tinnitus, hyperacusis;
• ineffective heart contraction (myocardial depression);
• vasodilation;
• skin color changes 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);
• swelling of the mouth, lips, tongue, and gums, high saliva production;
• fatigue, feeling of weakness, feeling of heat, pain at the injection site;
• nerve damage.

Communication of side effects

If you experience any type of side effect, consult your doctor or dentist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: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 sight and reach of children. This medication does not require special conditions for conservation.

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 visible signs of deterioration.

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

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

Composition of Mepivacaine Normogen 30 mg/ml

The active principle is mepivacaine hydrochloride

1 ml of injectable solution contains 30.00 mg of mepivacaine hydrochloride.

Each cartridge of 1.7 ml of injectable solution contains 51 mg of mepivacaine hydrochloride.

The other ingredients are: sodium chloride, sodium hydroxide (to adjust the pH) and injection water

A specto of the product and contents of the packaging

This medicine is a transparent and colorless solution.

Mepivacaine Normogen 30 mg/ml is presented in glass cartridges

Packaging containing 1 cartridge of 1.7 ml.

Packaging containing 50 cartridges of 1.7 ml

Packaging containing 100 cartridges of 1.7 ml

It is possible that not all packaging sizes will be marketed.

T itle of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

F echa of the last review of this leaflet: July 2020

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