MEPIVACAINE PHYSAN 10 mg/ml INJECTABLE SOLUTION

Introduction

Leaflet: information for the user

Mepivacaine Physan10 mg/ml Injectable Solution

mepivacaine hydrochloride

Read the entire leaflet carefully before starting to use the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Mepivacaine Physan is and what it is used for
2. What you need to know before starting to use Mepivacaine Physan
3. How to use Mepivacaine Physan
4. Possible side effects
5. Storage of Mepivacaine Physan
6. Package contents and additional information

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

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

Mepivacaine Physan has been prescribed to you to provide an anesthetic effect.

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

Do not useMepivacaine Physan

• if you are allergic to mepivacaine hydrochloride or to any of the other components of this medicine (listed in section 6).
• if you are allergic to any other local anesthetic of the same group (e.g., bupivacaine, lidocaine).
• if you have heart rhythm disorders. Ask your doctor for advice, as Mepivacaine Physan may not be suitable 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 Mepivacaine Physan:

• if you have any heart problems.
• if you have 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 tests.

Other medicines and Mepivacaine Physan

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

Mepivacaine Physan should be used with caution if you are receiving treatment with medicines with a similar structure to local anesthetics, such as those used for heart rhythm disorders (so-called class Ib antiarrhythmics, such as lidocaine), as this increases the risk of side effects.

Prolonged treatment with antiarrhythmics (medicines to control heart rhythm), psychotropic drugs (medicines that act on mental activity), or anticonvulsants (medicines against convulsions) may reduce sensitivity to anesthetics.

You should be careful if you are taking central nervous system depressant medicines at the same time, as they may increase depressive effects.

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

Blood coagulation inhibitors (medicines to prevent blood clots) and anti-inflammatory medicines may increase the risk of bleeding.

Use ofMepivacaine Physanwith alcohol

Excessive alcohol consumption may reduce sensitivity to anesthetics.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Your doctor will prescribe Mepivacaine Physan, taking into account the benefit to you and the risk to your baby.

Mepivacaine Physan is excreted in breast milk, but the risk of the child suffering adverse reactions does not seem likely if the recommended doses are respected.

Driving and using machines

The use of Mepivacaine Physan may have a mild effect on mental functions and may alter movement and coordination for a time.

Mepivacaine Physancontains sodium

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

3. How to use Mepivacaine Physan

Follow your doctor's instructions for administering Mepivacaine Physan exactly. If in doubt, consult your doctor or pharmacist again.

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

The dose, speed of administration, and duration of treatment will vary depending on the anesthetic procedure to be performed, the area to be anesthetized, and the patient's weight, clinical situation, and response.

If you use moreMepivacaine Physanthan you should

In case of overdose, adverse reactions may occur at the heart and blood vessel level: low blood pressure and altered heart rhythm. Adverse effects may also occur at the central nervous system level: agitation, sensation of numbness of lips, tongue, and around the mouth, dizziness, vision and hearing disturbances, and ringing in the ears. Difficulty speaking, muscle stiffness, or spasms are more severe symptoms that precede generalized convulsions.

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

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

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

4. Possible side effects

Like all medicines, Mepivacaine Physan can cause side effects, although not everyone will experience them.

Rare side effects (observed in 1 to 10 out of 10,000 patients/people)

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

Heart disorders and infarction (in cases of overdose).

Unconsciousness and convulsions (in cases of overdose).

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

Reporting ofside effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Mepivacaine Physan

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

No special storage conditions are required.

Do not use Mepivacaine Physan after the expiration date stated on the ampoule and carton of the product. The expiration date is the last day of the month indicated.

The unused solution should be disposed of in accordance with local regulations.

Medicines should not be thrown away via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofMepivacaine Physan

• The active ingredient is Mepivacaine Hydrochloride 20.0 mg/ml.
• The other components are: Sodium Chloride, Sodium Hydroxide (for pH adjustment), and water for injectable preparations.

Appearance of the product and package contents

Mepivacaine Physan 20 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.

Marketing authorization holder

LAPHYSAN S.A.U.

Anabel Segura, 11 Edificio A, Planta 4, Puerta D,

28108 Alcobendas (Madrid)

Spain

Manufacturer:

LABORATORIOS BASI – INDUSTRIA FARMACÉUTICA, S.A.

Parque Industrial Manuel Lourenço Ferreira,

Nº 8, Nº 15 y Nº 16

3450-232 Mortágua – Portugal

Date of the last revision of this leaflet: July 2008

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

This information is intended only for healthcare professionals

Local and regional anesthetic procedures, except for those of a more trivial nature, should always be performed by properly trained professionals and in areas with immediate access to resuscitation equipment and medicines. Specialists should receive appropriate training for these procedures and be familiar with the diagnosis and treatment of side effects, toxicity, or other complications.

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

Taking this into account, 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 according to the guidelines described and the recommendations included in the different sections of the Technical Data Sheet ("Posology and method of administration"; "Special warnings and precautions for use"), so it is necessary to refer to the text of the same to ensure the correct use of the product.

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