Prospect: Information for the user.

Levobupivacaína Altan 5 mg/ml injectable solution and for perfusion EFG

Levobupivacaína

1. What is Levobupivacaína Altan 5 mg/ml and for what it is used
2. What you need to know before starting to use Levobupivacaína Altan 5mg/ml
3. How to useLevobupivacaína Altan 5 mg/ml

4. Possible adverse effects

5. Storage of Levobupivacaína Altan 5mg/ml

6. Contents of the package and additional information

Levobupivacaína Altan 5 mg/ml belongs to a group of medicines called local anesthetics. This type of medicine is used to anesthetize parts of the body or to relieve pain.

Adults:

Levobupivacaína Altan 5 mg/ml is used as a local anesthetic to anesthetize parts of the body before major surgery (for example, epidural in cases of cesarean section) and minor surgery (such as in the eye or mouth).

It is also used for pain relief

• after major surgery
• during childbirth

Children:

Levobupivacaína Altan 5 mg/ml can also be used in children to anesthetize parts of the body before an operation and for pain reliefafter minor surgery, such as an inguinal hernia.

Levobupivacaína Altan 5 mg/ml has not been tested in children under 6 months

Do not use Levobupivacaína Altan 5 mg/ml

• If you are allergic (hypersensitive) to levobupivacaine, to any local anesthetic similar or to any of the other components of this medication (see section 6)

• If you have very low blood pressure

• To relieve pain by administering it via injection in the area around the cervix during the early stage of labor (paracervical block).

• To anesthetize a part of the body by injecting Levobupivacaína Altan 5 mg/ml intravenously.

Warnings and precautions

Inform your doctor before they administer Levobupivacaína Altan 5 mg/ml if you have any of the conditions or diseases listed below. You may need closer monitoring or a lower dose.

• If you suffer from heart disease

• If you suffer from a nervous system disease

• If you are weak or ill

• If you are elderly

• If you have liver disease.

Use of Levobupivacaína Altan 5 mg/ml with other medications:Inform your doctor or nurse if you are using, have used recently, or may need to use any other medication. Inform them especially if you are taking medications for:

• Arrhythmias (such as mexiletine)

• Fungal infections (such as ketoconazole) as they may affect the metabolism of Levobupivacaína Altan 5 mg/ml

• Asthma (such as theophylline) as it may affect how long Levobupivacaína Altan 5 mg/ml stays in your body.

Pregnancy, breastfeeding and fertilityand fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or nurse before using this medication.Levobupivacaína Altan 5 mg/ml should not be administered to relieve pain by injecting it in the area around the cervix or cervix during labor (paracervical block).

No effects of Levobupivacaína Altan 5 mg/ml on the fetus have been known during the early stages of pregnancy. Therefore, Levobupivacaína Altan 5 mg/ml should not be used during the first three months of pregnancy, unless your doctor considers it necessary.

No information is available on whether levobupivacaine passes through breast milk. However, based on the experience with similar medications, it is expected that only small amounts of levobupivacaine will pass through breast milk.

Therefore, breastfeeding is possible after using a local anesthetic.

Driving and operating machinery

The use of Levobupivacaína Altan 5 mg/ml may have a significant effect on your ability to drive and operate machinery. Do not drive or operate machinery until all the effects of Levobupivacaína Altan 5 mg/ml and surgery have passed. Make sure you are advised on this by your doctor or nurse before leaving the hospital.

Important information about some of the components of Levobupivacaína Altan:

Patients with low-sodium diets should note that this medication contains 3.5 mg/ml of sodium in the solution of the vial or ampoule.

Your doctor will administer Levobupivacaína Altan 5 mg/ml through an injection via a needle or through a small tube inserted into your back (epidural). Levobupivacaína Altan 5 mg/ml can also be injected into other parts of the body to anesthetize the area being treated, such as the eye, arm, or leg.

Your doctor and nurse will closely monitor you while you are receiving Levobupivacaína Altan 5 mg/ml.

Levobupivacaína Altan 5 mg/ml.

Dose

The amount of Levobupivacaína Altan 5 mg/ml you will receive and how often it will be administered will depend on what it is being used for and your physical condition, age, and weight. You will be given the minimum dose necessary to achieve anesthesia in the required area. The dose will be carefully chosen by your doctor.

When using Levobupivacaína Altan 2.5 mg/ml to relieve childbirth pain or for a cesarean delivery (epidural), the dose used will be carefully controlled.

If you are given more Levobupivacaína Altan 5 mg/ml than you should

If you are given more Levobupivacaína Altan 5 mg/ml than you should, you may experience tongue numbness, dizziness, blurry vision, muscle contraction, severe breathing difficulties (including respiratory arrest), and even seizures. If you notice any of these symptoms, inform your doctor immediately.

Too much Levobupivacaína Altan 5 mg/ml can also cause hypotension, bradycardia, tachycardia, and changes in your heart rhythm. Your doctor may need to give you other medications to help stop these symptoms.

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

Like all medicines, it may cause side effects, although not everyone will experience them. Some of the side effects ofLevobupivacaína Altan 5 mg/ml may be severe.

If you consider that you are experiencing any of the side effects listed below, inform your doctor or nurse immediately.

Very common side effects (may affect more than 1 in 10 patients):

• feeling of fatigue or weakness, difficulty breathing, paleness (all are signs of anemia)
• low blood pressure
• nausea

Common side effects (may affect up to 1 in 10 patients):

• dizziness
• headache
• vomiting
• fetal distress
• back pain
• fever
• postoperative pain

Unknown frequency (cannot be estimated from available data):

• serious allergic reactions (hypersensitivity) that cause severe difficulty breathing, severe difficulty swallowing, urticaria, and very low blood pressure.
• allergic reactions (hypersensitivity) recognizable by red and irritated skin, sneezing, excessive sweating, increased heart rate, fainting, or swelling of the face, lips, mouth, tongue, or throat
• seizures
• loss of consciousness
• drowsiness
• blurred vision
• respiratory arrest
• cardiac arrest or heart block
• localized numbness
• numb tongue
• muscle weakness or tremors
• loss of bladder and bowel control
• paralysis
• tingling, numbness, or other unusual sensations
• prolonged erection of the penis, which may be painful
• nervous system disorders that may include eye closure, small pupils (black center of the eye), sunken eye socket, sweating, and/or flushing of one side of the face.

Bradycardia, tachycardia, irregular heartbeats, and changes in heart rhythm that may be seen on an ECG (electrocardiogram) have also been reported as side effects.

In very rare cases, some side effects may persist for a long time or become permanent.

If you consider that any of the side effects you are experiencing are worsening or if you notice any side effects not mentioned in this leaflet, inform your doctor or nurse.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use Website:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

No special conservation conditions are required.

Keep out of sight and reach and out of sight of children.

Do not use Levobupivacaína Altan 5 mg/ml after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Your doctor will store this medication for you.

The solution must be used immediately after opening.

Do not use Levobupivacaína Altan 5 mg/ml if you observe particles within the solution.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you do not need. This will help protect the environment.

Composition of Levobupivacaína Altan 5 mg/ml

The active principle is levobupivacaína (as hydrochloride)

One milliliter of solution contains 5 mg of levobupivacaína (as hydrochloride). Each ampoule of 10 ml contains 50 mg.

The other components are water for injection, sodium chloride, sodium hydroxide, and hydrochloric acid.

Appearance of the product and contents of the package

It is a clear, transparent solution packaged in type I glass ampoules.

Each ampoule contains 50 mg levobupivacaine in a 10 ml ampoule. It is supplied in packs of5 and 10 ampoules.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Altan Pharmaceuticals, S.A.

C/ Cólquide, Nº 6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma,

28230 Las Rozas (Madrid) – Spain

Responsible for manufacturing:

Altan Pharmaceuticals, S.A.

Avda. de la Constitución, 198-199, Polígono Industrial Monte Boyal,

Casarrubios del Monte, 45950 Toledo – Spain

Altan Pharmaceuticals, S.A..

Polígono Industrial de Bernedo s/n 01118 Bernedo Álava-Spain

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Date of the last review of this leaflet:07/2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es
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This information is intended solely for doctors or healthcare professionals:

Instructions for use/manipulation

Levobupivacaína Altan 5 mg/ml is only for single use. Discard any unused solution.

From a microbiological point of view, the product must be used immediately after opening. If not, the storage time and product conditions in use before use are the responsibility of the user.

The experience on the safety of treatment with levobupivacaína for more than 24 hours is limited.

Expiration date after the first opening: The product must be used immediately

Expiration date after dilution with a 0.9% sodium chloride solution: The chemical and physical stability in use has been demonstrated in 0.9% sodium chloride solutions for 7 days at 20-22 °C.
As with all parenteral medications, the solution/dilution must be visually inspected prior to use. Only clear solutions without visible particles should be used.

Dilutions of standard levobupivacaína solutions should be made with 0.9% sodium chloride solution for injection and using aseptic techniques.

It has been demonstrated that 8.4 micrograms/ml of clonidine, 0.05 mg/ml of morphine, and 4 micrograms/ml of fentanyl are compatible with levobupivacaína in 0.9% sodium chloride solution for injection. The chemical and physical stability in use has been demonstrated with clonidine, morphine, or fentanyl for 40 hours at 20-22 °C.

Levobupivacaína Altan 5 mg/ml should not be mixed with other medications except those listed above. Dissolution with alkaline solutions such as sodium bicarbonate may lead to precipitation.

Administration form
Levobupivacaína administration should be performed by a doctor with the necessary training and experience or under their supervision.

For information on dosage, consult the Product Technical File.

It is recommended to perform careful aspiration before and during injection to prevent intravascular injection.

Aspiration should be repeated before and during administration of a bolus dose, which should be injected slowly and in increments of dose at a rate of 7.5 - 30 mg/min, while monitoring the patient's vital functions and maintaining verbal contact with them.

If toxic symptoms appear, stop the injection immediately.