MEPIVACAINE DERMOGEN 30 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

Mepivacaine Dermogen 30 mg/ml Solution for Injection EFG

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, dentist or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What Mepivacaine Dermogen is and what it is used for

Mepivacaine Dermogen is a local anaesthetic 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 substance mepivacaine hydrochloride and belongs to the group of nervous system anaesthetics.

2. What you need to know before you use Mepivacaine Dermogen

Do not use Mepivacaine Dermogen

• 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 anaesthetics 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 by treatment;

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

Warnings and precautionsConsult your dentist before using Mepivacaine Dermogen if you:

• have heart disorders;
• have severe anaemia;
• 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 causes 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 Mepivacaine Dermogen

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

• other local anaesthetics;
• medicines used to treat stomach and intestine ulcers and heartburn (such as cimetidine);
• tranquillizing and sedating medicines;
• medicines used to stabilize the heartbeat (antiarrhythmics);
• cytochrome P450 1A2 inhibitors;

medicines used to treat high blood pressure (propranolol).

Using Mepivacaine Dermogen 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, breast-feeding and fertility:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your 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 breast-feeding are advised not to breast-feed for 10 hours after anaesthesia 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 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 regained your skills (usually within 30 minutes) after the dental procedure.

Mepivacaine Dermogen contains sodium:

This medicine contains less than 23 mg of sodium (1 mmol) per ml; it is essentially "sodium-free".

Use in athletes

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

3. How to use Mepivacaine Dermogen

Mepivacaine Dermogen should only be used by or under the supervision of dentists, stomatologists or other trained doctors, 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 dose necessary to achieve effective anaesthesia should be used.

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

If you are given too much Mepivacaine Dermogen

The following symptoms may be signs of toxicity due to excessive doses of local anaesthetics: 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 low or irregular heart rate. 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 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 Dermogen, one or more of the following side effects may occur:

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, tingling and numbness in the skin without apparent physical cause around the mouth (paraesthesia);
• 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 enophthalmia), 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 colour with confusion, cough, rapid breathing and 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, high 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 via 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 Dermogen

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton and on the label 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 colourless.

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

Medicines should not be disposed of via wastewater or household waste. Return the cartridges and any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of cartridges and medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mepivacaine Dermogen

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

Each 1.8 ml cartridge of solution for injection contains 54 mg of mepivacaine hydrochloride.

• The other ingredients are sodium chloride, sodium hydroxide and water for injection.

Appearance of Mepivacaine Dermogen and contents of the pack

Mepivacaine Dermogen 30 mg/ml is a colourless and translucent solution for injection.

It is packed in PVC blister packs.

The commercial presentation is a box with 1, 50 or 100 cartridges of 1.8 ml.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

FARMALIDER, S.A.

C\ La Granja, nº1

28108– Alcobendas (Madrid)

Spain

Manufacturer

PIERREL, S.P.A.

Via Nazzionale Appia (Capua, Caserta)

I-81043 Italy

Date of last revision of this leaflet: February 2020

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