MEPIVACAINE PHYSAN 20 mg/ml INJECTABLE SOLUTION
Ask a doctor about a prescription for MEPIVACAINE PHYSAN 20 mg/ml INJECTABLE SOLUTION
How to use MEPIVACAINE PHYSAN 20 mg/ml INJECTABLE SOLUTION
Introduction
Package Leaflet: Information for the User
Mepivacaine Physan20 mg/ml injectable solution
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 or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
- If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack:
- What Mepivacaine Physan is and what it is used for
- What you need to know before you use Mepivacaine Physan
- How to use Mepivacaine Physan
- Possible side effects
- Storage of Mepivacaine Physan
- Contents of the pack and further 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 for you to provide an anesthetic effect.
2. What you need to know before you use Mepivacaine Physan
Do not useMepivacaine 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 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 advisable 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 might use any other medicines.
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 the depressant effects.
Local irritation, swelling, or edema may occur when used at the same time as certain disinfectants.
Blood coagulation inhibitors (medicines to prevent blood clots) and anti-inflammatory medicines may increase the risk of bleeding.
UsingMepivacaine 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 from 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
Ampoules of 2 ml:
This medicine contains less than 23 mg of sodium (1 mmol) per ampoule; it is essentially "sodium-free".
Ampoules of 10 ml:
This medicine contains 28 mg of sodium (main component of table/cooking salt) in each ampoule. This is equivalent to 1.4% of the maximum recommended daily sodium intake for an adult.
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3. How to use Mepivacaine Physan
Follow exactly the administration instructions of Mepivacaine Physan indicated by your doctor. In case of 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 level of the heart and blood vessels: lowering of blood pressure and alteration of heart rhythm. Adverse effects may also occur at the level of the central nervous system: 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 serious 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 questions 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 everybody gets them.
Rare side effects (observed in between 1 and 10 of every 10,000 patients)
Allergic reactions, including serious reactions (so-called 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 of side effects
If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
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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 expiry date stated on the ampoule and carton. The expiry 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 disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. FURTHER INFORMATION
Composition ofMepivacaine Physan
- The active substance is Mepivacaine Hydrochloride 20.0 mg/ml.
- The other ingredients are: Sodium Chloride, Sodium Hydroxide (for pH adjustment), and water for injectable preparations.
Appearance and packaging
Mepivacaine Physan 20 mg/ml injectable solution is packaged in glass ampoules.
The commercial presentation is a pack with 1 ampoule or clinical packs 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 on this medicine is available on the website of the Spanish Medicines and Health Products Agency (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 professionals who are properly trained 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, systemic 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 are going to 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 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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- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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