Package Insert: Information for the User

Mepivacaína Physan10 mg/ml Injectable Solution

mepivacaína hidrocloruro

Read this package insert carefully before starting to use the medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Mepivacaína Physan and how is it used

2. What you need to know before starting to use Mepivacaína Physan

3. How to use Mepivacaína Physan

4. Possible adverse effects

5. Storage of Mepivacaína Physan

6. Contents of the package 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 to provide anesthetic effect.

Do not 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. Consult your doctor, as Mepivacaína Physan may 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 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 Physan should be used with caution if you are receiving treatment with medications similar in structure to local anesthetics, such as antiarrhythmic medications of class Ib (such as lidocaína), as this increases the risk of side effects.

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

You should be careful if you are taking central nervous system depressants 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 and anti-inflammatory medications may increase the risk of bleeding.

Use of Mepivacaína Physan with alcohol

Excessive alcohol consumption may reduce sensitivity to anesthetics.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Your doctor will prescribe Mepivacaína Physan taking into account the benefit it may have over the risk to your baby.

Mepivacaína Physan is 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 machinery

The use of Mepivacaína Physan may exert a slight effect on mental functions and may alter movement and coordination for a time.

Mepivacaína Physan contains sodium

This medication contains 31.5 mg of sodium (main component of table salt/for cooking) per ampoule. This corresponds to 1.6% of the maximum daily sodium intake recommended for an adult..

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: decreased 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 possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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 contents 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 medicine is available on the website of the Spanish Agency of 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 properly 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 receiving 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

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

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