Leaflet: information for the user

Mepivacaína Physan20 mg/ml injectable solution

mepivacaína hydrochloride

Read this leaflet carefully before you start using the medicine, because 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 and should not be given to others, even if they have the same symptoms, 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 isMepivacaína Physanand what it is used for

2. What you need to know before starting to useMepivacaína

3. How to useMepivacaína Physan

4. Possible side effects

5. Storage ofMepivacaína Physan

6. Contents of the pack and additional information

Mepivacaína Physan is a local anesthetic (an agent that reduces or eliminates sensations, affecting a particular region) that belongs to the subgroup of amides.

Mepivacaína Physanhas been prescribed for you to provide anesthetic effect.

No useMepivacaína Physan

• If you are allergic to mepivacaína hydrochloride or any of the other components of this medication (listed in section 6).
• If you are allergic to any other local anesthetics in the same group (for example, bupivacaína, lidocaína).
• If you have heart rhythm disorders. Ask your doctor, asMepivacaína Physanmay not be recommended for you.
• If you have uncontrolled epilepsy.
• If you have acute intermittent porphyria (a hereditary metabolic disorder that affects the nervous system and can cause mental disorders).

Warnings and precautions

Consult with your doctor or pharmacist before starting to use Mepivacaína Physan

• If you have any heart problems.
• If you have any severe liver disease.
• If you have any kidney problems.
• If you are a weakened or elderly patient.
• For athletes, there is a possibility of positive results in anti-doping controls.

Other medications and Mepivacaína Physan

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Mepivacaína Physanshould be used with caution if you are receiving treatment with medications similar in structure to local anesthetics, such as those used for heart rhythm disorders (class Ib antiarrhythmics such as lidocaína), as this increases the risk of side effects.

A prolonged treatment with antiarrhythmics (medications to control heart rhythm), psychopharmaceuticals (medications that act on mental activity) or anticonvulsants (medications against seizures) may reduce sensitivity to anesthetics.

You should be careful if you are taking medications that depress the Central Nervous System at the same time, as they may increase the depressive effects.

Irritation, swelling, or edema may occur when used at the same time with certain disinfectants.

Blood thinners (medications to prevent blood clots) and anti-inflammatory medications may increase the risk of bleeding.

Use ofMepivacaína Physanwith alcohol

Excessive alcohol consumption may reduce sensitivity to anesthetics.

Pregnancy and lactation

Consult with your doctor or pharmacist before using any medication.

Your doctor will prescribeMepivacaína Physanconsidering the benefit it may have over the risk to your baby.

Mepivacaína Physanis excreted in breast milk, but the risk of the baby experiencing adverse reactions does not seem probable if the recommended doses are respected.

Driving and operating machines

The use ofMepivacaína Physanmay have a slight effect on mental functions and may alter movement and coordination for a time.

Mepivacaína Physancontains sodium

Bottles of 2 ml:

This medication contains less than 23 mg of sodium (1mmol) per ; this is essentially “sodium-free”.

Bottles of 10 ml:

This medication contains 28 mg of sodium (main component of table salt/for cooking) in each . This is equivalent to 1.4% of the maximum daily sodium intake recommended for an adult.

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Follow exactly the administration instructions for Mepivacaína Physan as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again..

Mepivacaína Physan will be administered by your doctor in the form of an injection.

The dose, rate of administration, and duration of treatment will be variable depending on the anesthetic procedure being performed, the area to be anesthetized, and the patient's weight, clinical condition, and response.

If you use more Mepivacaína Physan than you should

In case of overdose, adverse reactions may occur at the level of the heart and blood vessels: low blood pressure and alteration of heart rhythm. Adverse effects may also occur at the level of the central nervous system: agitation, numbness of the lips, tongue, and around the mouth, dizziness, discomfort in vision and hearing, and buzzing in the ears. More severe symptoms such as difficulty speaking, muscle rigidity, or spasms precede generalized convulsions.

If these signs of toxicity appear, the injection of the anesthetic should be stopped immediately.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

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

Like all medications, Mepivacaína Physan may produce adverse effects, although not all people will experience them.

Adverse effects that are rare (observed in between 1 and 10 of every 10,000 patients/people)

Allergic reactions, including severe reactions (the so-called anaphylactic shock), which include skin rash, difficulty breathing, and swelling of the tongue and throat.

Heart problems and myocardial infarction (in cases of overdose).

Loss of consciousness and seizures (in cases of overdose).

Neurological reactions associated with the anesthetic techniques used, regardless of the anesthetic used.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do 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 adverse effects, you can contribute to providing more information about the safety of this medication.

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

No special storage conditions are required.

Do not useMepivacaína Physanafter the expiration date that appears on the ampoule and the product packaging. The expiration date is the last day of the month indicated.

Unused solution must be disposed of in accordance with local regulations.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition ofMepivacaína Physan

• The active principle is Mepivacaína Hydrochloride 20.0 mg/ml.
• The other components are: Sodium Chloride, Sodium Hydroxide (for pH adjustment) and Water for Injection.

Aspect of the product and content of the package

Mepivacaína Physan20 mg/ml injectable solution is packaged in glass ampoules.

The commercial presentation is a package with 1 ampoule, or clinical packages with 50 or 100 glass ampoules of 2 ml or 10 ml.

Holder of the marketing authorization

LAPHYSAN S.A.U.

Anabel Segura, 11
Edificio A, 4th Floor, Door D,

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing:

LABORATORIOS BASI – PHARMACEUTICAL INDUSTRY, S.A.

Parque Industrial Manuel Lourenço Ferreira,

Nº 8, Nº 15 and Nº 16

3450-232 Mortágua – Portugal

Last revision date of this leaflet: July 2008

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

This information is intended solely for doctors or healthcare professionals

Local-regional anesthetic procedures, except for the most trivial, should always be performed by adequately trained professionals in areas with immediate access to resuscitation equipment and medications. Specialists should receive appropriate training for these procedures and be familiar with the diagnosis and treatment of side effects, systemic toxicity, or other complications.

When performing major blocks, a catheter should be inserted before injecting the anesthetic.

Considering this, as well as the anesthetic technique and the situation of the patients who will receive the treatment, the administration of the specialty should be carried out in accordance with the guidelines described and the recommendations included in the different sections of the Technical Data Sheet (“Posology and administration form”; “Warnings and special precautions for use”), so it is necessary to refer to the text of the same to ensure correct use of the product.

The solutions should be used immediately after opening. Any remaining portion of the used solution should be discarded.

Incompatibilities

From a pH>6.5 there is a risk of precipitation. This characteristic should be taken into account when adding alkaline solutions, such as carbonates.

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