MEPIVACAINE NORMOGEN 30 mg/mL INJECTABLE SOLUTION

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

Mepivacaine Normogen 30 mg/ml 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 (body weight of approximately 20 kg). It contains the active ingredient mepivacaine hydrochloride and belongs to the group of nervous system anesthetics.

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

Do not use Mepivacaine Normogen 30 mg/ml:

• 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., lidocaine, bupivacaine);
• if you have:
• • heart disorders due to an electrical impulse anomaly that triggers the heartbeat (severe conduction disorders);
  • uncontrolled epilepsy by treatment;
• Children under 4 years of age (body weight of approximately 20 kg)

Warnings and precautions

Consult your dentist before starting to use Mepivacaine Normogen 30 mg/ml:

• If you have severe heart disorders;
• If you have severe anemia;
• If you have high blood pressure (severe or uncontrolled 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 that affects the nervous system and produces neurological disorders (porphyria);
• If you have high blood acidity (acidosis);
• If you have poor blood circulation;
• If your general state of health is deteriorated;
• If 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.

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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 and heartburn (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).

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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.

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If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, dentist, 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.

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This medicine may have a minor influence on the ability to drive and use machines. Dizziness (including a feeling 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 recovered your skills (usually within 30 minutes) after the dental procedure.

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This medicine contains less than 23 mg (1 mmol) of sodium per cartridge, i.e., it is essentially "sodium-free".

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Athletes are informed that this medicine contains a component that may produce a positive doping control result

3. How to use Mepivacaine Normogen 30 mg/ml

Mepivacaine Normogen 30 mg/ml 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 state of 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 more Mepivacaine Normogen 30 mg/ml than you should

The following symptoms may be signs of toxicity due to excessive doses of local anesthetics: agitation, numbness of lips and tongue, pins and needles 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 administration should be interrupted immediately and urgent medical assistance should be sought.

In case of overdose or accidental ingestion, consult the Toxicology Information Service (Tel. 91 562 04 20), indicating the product and the amount received.

If you have any further questions on 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 Mepivacaine Normogen 30 mg/ml, one or more of the following side effects may appear.

Common side effects(may affect up to 1 in 10 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, pins and needles, and tingling in the skin without apparent physical cause around the mouth (paresthesia);
• Abnormal sensation inside and around the mouth (hypoesthesia);
• Metallic taste, distortion of taste, 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;
• Feeling 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);
• Difficulty breathing, abnormally slow or rapid breathing;
• Feeling of dizziness, 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 enophthalmia), double vision or loss of vision;
• Ear disorders, such as ringing in the ears, increased hearing sensitivity;
• Ineffective heart contraction (myocardial depression);
• Vasodilation;
• Changes in skin color with confusion, cough, rapid breathing, and rapid heart rate, sweating: these may be symptoms of tissue oxygen deficiency (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.

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If you experience any side effects, talk to your doctor or dentist, even if it is 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: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mepivacaine Normogen 30 mg/ml

Keep this medicine out of the sight and reach of children. This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the cartridge label and on the carton after EXP. The expiry date is the last day of the month shown.

Do not use this medicine if you notice visible signs of deterioration.

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 dentist, doctor, or pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mepivacaine Normogen 30 mg/ml

The active substance is mepivacaine hydrochloride.

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

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

The other ingredients are: sodium chloride, sodium hydroxide (for pH adjustment), and water for injection.

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This medicine is a clear and colorless solution.

Mepivacaine Normogen 30 mg/ml is presented in glass cartridges.

Pack containing 1 cartridge of 1.7 ml.

Pack containing 50 cartridges of 1.7 ml.

Pack containing 100 cartridges of 1.7 ml.

Not all pack sizes may be marketed.

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LABORATORIOS NORMON, S.A.

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

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