Mepivacaine Physan 10 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mepivacaine Physan 10 mg/ml Solution for injection

mepivacaine hydrochloride

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Mepivacaína Physan is a local anaesthetic (an agent that reduces or blocks sensations by affecting a particular region) belonging to the amide subgroup.

Mepivacaína Physan has been prescribed to provide you with anaesthetic effect.

2. What you need to know before using Mepivacaine Physan

Do not use Mepivacaine Physan

• if you are allergic to mepivacaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to any other local anaesthetic of the same group (e.g. bupivacaine, lidocaine).
• if you have heart rhythm disorders. Consult your doctor, as Mepivacaine Physan may not be advisable for you.
• if you have uncontrolled epilepsy.
• if you suffer from acute intermittent porphyria (a hereditary metabolic disorder affecting the nervous system that may cause mental disturbances).

Warnings and precautions

Talk to your doctor or pharmacist before using Mepivacaine Physan:

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

Other medicines and Mepivacaine Physan

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Prolonged treatment with antiarrhythmics (medicines to control heart rhythm), psychotropic drugs (medicines acting on mental function), or anticonvulsants (medicines for seizures) may reduce sensitivity to anaesthetics.

Caution is required if you are taking central nervous system depressants at the same time, as they may enhance the depressant effects.

Local irritation, swelling, or oedema may occur when used concomitantly with certain disinfectants.

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

Alcohol consumption and Mepivacaine Physan

Excessive alcohol consumption may reduce sensitivity to anaesthetics.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Your doctor will prescribe Mepivacaine Physan after considering the benefit to you against any potential risk to your baby.

Mepivacaine Physan is excreted in breast milk, but the risk of adverse reactions in the infant appears unlikely if recommended doses are respected.

Driving and use of machines

The use of Mepivacaine Physan may have a slight effect on mental function and may temporarily affect movement and coordination.

Mepivacaine Physan contains sodium

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

3. How to use Mepivacaína Physan

Follow exactly the instructions for the administration of Mepivacaína Physan provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Mepivacaína Physan will be administered by your doctor as an injection.

The dose, rate of administration, and duration of treatment will vary depending on the type of 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: drop in blood pressure and disturbances in heart rhythm. Adverse effects may also occur at the central nervous system level: agitation, numbness of the lips, tongue, and around the mouth, dizziness, visual and auditory disturbances, and tinnitus. Difficulty speaking, muscle stiffness, or spasms are more severe symptoms that precede generalized seizures.

If these signs of toxicity appear, administration of the anesthetic must be immediately discontinued.

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

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

4. Possible adverse effects

Like all medicines, Mepivacaína Physan may cause adverse effects, although not everyone will experience them.

Rare adverse effects (observed in between 1 and 10 out of every 10,000 patients/individuals)

Allergic reactions, including severe reactions (so-called anaphylactic shock), such as skin rash, breathing difficulties, and swelling of the tongue and throat.

Heart disorders and heart attack (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 employed.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mepivacaína Physan

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

No special storage conditions are required.

Do not use Mepivacaína Physan after the expiry date stated on the ampoule and the carton. The expiry date refers to the last day of the month indicated.

Any unused solution must be disposed of in accordance with local regulations.

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

6. Contents of the container and other information

Composition of Mepivacaína Physan

• The active substance is Mepivacaine Hydrochloride 20.0 mg/ml.
• The other components are: Sodium chloride, Sodium hydroxide (for pH adjustment), and Water for injections.

Appearance of the product and contents of the pack

Mepivacaína Physan 20 mg/ml solution for injection is supplied in glass ampoules.

The commercial presentation is a pack containing 1 ampoule, or clinical packs containing 50 or 100 glass ampoules of 2 ml or 10 ml.

Marketing Authorisation Holder

LAPHYSAN S.A.U.

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

28108 Alcobendas (Madrid)

Spain

Manufacturer:

LABORATORIOS BASI – INDUSTRIA FARMACÉUTICA, S.A.

Manuel Lourenço Ferreira Industrial Park,

Nos. 8, 15 and 16

3450-232 Mortágua – Portugal

Date of the most recent revision of this leaflet: July 2008

Detailed information on 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 for healthcare professionals only

Loco-regional anaesthetic procedures, except for the most trivial ones, should always be performed by appropriately trained professionals and in areas with immediate access to resuscitation equipment and medications. Specialists must receive appropriate training in these procedures and be familiar with the diagnosis and management of adverse effects, systemic toxicity, and other complications.

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

In addition to this, and depending on the anaesthetic technique and the patient's condition, administration of the product must follow the guidelines and recommendations described in the different sections of the Summary of Product Characteristics (“Dosage and method of administration”; “Special warnings and precautions for use”). Therefore, reference to the full text is necessary to ensure correct use of the product.

Solutions should be used immediately after opening. Any unused portion of the solution must be discarded.

Incompatibilities

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