LEVOBUPIVACAINE ALTAN 1.25 mg/mL SOLUTION FOR INFUSION

Introduction

Leaflet:InformationfortheuserLevobupivacaine Altan 1.25 mg/ml solution for infusion EFG

Levobupivacaine

Contents of the leaflet:

1. What is Levobupivacaine Altan 1.25 mg/ml and what is it used for
2. What you need to know before starting to use Levobupivacaine Altan 1.25 mg/ml
3. How to use Levobupivacaine Altan 1.25 mg/ml
4. Possible side effects
5. Storage of Levobupivacaine Altan 1.25 mg/ml
6. Package contents and additional information

1. What is Levobupivacaine Altan 1.25 mg/ml and what is it used for

Levobupivacaine Altan 1.25 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. Levobupivacaine Altan 1.25 mg/ml is only for use in adults.

Levobupivacaine Altan 1.25 mg/ml is used to treat pain:

• after major surgery
• during childbirth

2. What you need to know before starting to use Levobupivacaine Altan 1.25 mg/ml

Do not use Levobupivacaine Altan 1.25 mg/ml

• If you are allergic (hypersensitive) to levobupivacaine, to any similar local anesthetic, or to any of the other components of this medicine (see section 6)
• If you have very low blood pressure

• To relieve pain by injecting it into the area around the uterine cervix during the early stages of labor (paracervical block).
• To anesthetize a part of the body by injecting Levobupivacaine Altan 1.25 mg/ml intravenously.

Warnings and precautions

Tell your doctor before administering Levobupivacaine Altan 1.25 mg/ml if you have any of the following conditions or diseases. You may need closer monitoring or a lower dose.

• If you have a nervous system disease
• If you are weak or ill
• If you are elderly
• If you have liver disease.

Using Levobupivacaine Altan 1.25 mg/ml with other medicines:

Tell your doctor or nurse if you are using, have recently used, or may need to use other medicines. Inform them, especially if you are taking medicines for:

• Arrhythmias (such as mexiletine)
• Fungal infections (such as ketoconazole) as they may affect the metabolism of Levobupivacaine Altan 1.25 mg/ml

Asthma (such as theophylline) as it may affect how long Levobupivacaine Altan 1.25 mg/ml stays in your body.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or nurse before using this medicine. Levobupivacaine Altan 1.25 mg/ml should not be administered to relieve pain by injecting it into the area around the uterine cervix during labor (paracervical block).

The effects of Levobupivacaine Altan 1.25 mg/ml on the fetus during the first phases of pregnancy are not known. Therefore, Levobupivacaine Altan 1.25 mg/ml should not be used during the first three months of pregnancy, unless your doctor considers it necessary.

It is not known if levobupivacaine passes into breast milk. However, based on experience with similar drugs, it is expected that only small amounts of levobupivacaine will pass into breast milk. Breastfeeding is therefore possible after using a local anesthetic.

Driving and using machines

The use of Levobupivacaine Altan may have a significant effect on your ability to drive and use machines. You should not drive or use machinery until all the effects of Levobupivacaine Altan and surgery have passed. Make sure you are advised about this by your doctor or nurse before leaving the hospital.

Important information about some of the components of Levobupivacaine Altan 1.25 mg/ml:This medicine contains 15 mmol (3.5 mg/ml) of sodium per 100 ml bag and 30 mmol (3.5 mg/ml) of sodium per 200 ml bag, which should be taken into account in patients with low-sodium diets.

3. How to use Levobupivacaine Altan 1.25 mg/ml

Your doctor will administer Levobupivacaine Altan 1.25 mg/ml by injection through a needle or through a small tube inserted into your back (epidural). Your doctor and nurse will closely monitor you while administering Levobupivacaine Altan 1.25 mg/ml.

DoseAdults:The amount of Levobupivacaine Altan 1.25 mg/ml administered to you and the frequency of administration will depend on the purpose of use and your physical condition, age, and weight. You will be administered the minimum dose that achieves anesthesia in the required area. The dose will be carefully chosen by your doctor.

When using Levobupivacaine Altan 1.25 mg/ml to relieve labor pain, the dose used will be carefully controlled.

Children:

It is not recommended for use in children.

If you are administered more Levobupivacaine Altan 1.25 mg/ml than you should

If you are administered more Levobupivacaine Altan 1.25 mg/ml than you should, you may experience numbness of the tongue, dizziness, blurred vision, muscle contraction, severe breathing difficulties (including respiratory arrest), and even convulsions. If you notice any of these symptoms, inform your doctor immediately. Sometimes, too much Levobupivacaine Altan 1.25 mg/ml can also cause low blood pressure, bradycardia, or tachycardia, and changes in your heart rhythm. Your doctor may need to give you other medicines to help stop these symptoms.

4. Possible side effects

Like all medicines, Levobupivacaine Altan 1.25 mg/ml can cause side effects, although not everyone gets them. Some of the side effects of Levobupivacaine Altan 1.25 mg/ml can be serious.

If you think you are experiencing any of the side effects mentioned below, inform your doctor or nurse immediately.

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

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

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

• 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 breathing difficulties, swallowing difficulties, 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.
• loss of consciousness
• drowsiness
• blurred vision
• respiratory arrest
• cardiac arrest or block
• localized tingling
• numb tongue
• muscle weakness or tremors
• loss of bladder and bowel control
• paralysis
• convulsions
• tingling, numbness, or other unusual sensations
• prolonged erection of the penis, which can be painful

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

In very rare cases, some side effects can become permanent.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use Website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levobupivacaine Altan 1.25 mg/ml

.

This medicine does not require special storage conditions.

Keep out of the reach and sight of children

Do not use Levobupivacaine Altan after the expiration date stated on the packaging after Exp. The expiration date is the last day of the month indicated.

Your doctor will store this medicine for you

The solution should be used immediately after opening

Do not use Levobupivacaine Altan 1.25 mg/ml if you notice particles in the solution

Medicines should not be disposed of through 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. Composition of Levobupivacaine Altan 1.25 mg/ml solution for infusion

Composition of Levobupivacaine Altan 1.25 mg/ml solution for infusion

The active ingredient is levobupivacaine (as hydrochloride). Levobupivacaine Altan 1.25 mg/ml: one ml contains 1.25 mg of levobupivacaine (as hydrochloride).

The other ingredients are water for injection, sodium chloride, sodium hydroxide, and a small amount of hydrochloric acid.

Appearance of the product and package contents

Levobupivacaine Altan 1.25 mg/ml is a clear, transparent solution.

Each polypropylene or polyolefin bag, free of PVC, contains 100 ml or 200 ml of solution. It is supplied in packs of 5 bags and 24 bags of 100 ml solution or in packs of 12 bags of 200 ml solution.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Holder:

Altan Pharmaceuticals, S.A.

C/ Cólquide 6, portal 2, 1ª planta, oficina F, Edificio Prisma

28230 Madrid - Spain

Manufacturer:

Altan Pharmaceuticals, S.A.

P.I. Bernedo S/N.

01118 Bernedo, Álava.-Spain

This leaflet was revised in 07/2023

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

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This information is intended only for doctors or healthcare professionals:

Instructions for use/manipulation

Levobupivacaine Altan 1.25 mg/ml is for single use only and should be administered epidurally and not intravenously. Do not use unless the solution is clear and the packaging is intact. Discard any unused solution.

As with all parenteral medicines, the solution/dilution should be visually inspected before use. Only clear solutions without visible particles should be used.

Experience with the safety of levobupivacaine treatment for more than 24 hours is limited.

Expiry after dilution with a 0.9% sodium chloride solution: Chemical and physical stability in use has been demonstrated for the two doses of levobupivacaine 0.625 mg/ml and 1.25 mg/ml with 8.3-8.4 micrograms/ml clonidine, 50 micrograms/ml morphine, and 2 micrograms/ml fentanyl, stored for 30 days at 2-8 ºC or 20-22 ºC. Chemical and physical stability in use has been demonstrated for the two doses of levobupivacaine 0.625 mg/ml and 1.25 mg/ml with sufentanil added in a concentration of 0.4 micrograms/ml and stored for 30 days at 2-8 ºC or 20-22 ºC.

From a microbiological point of view, the product should be used immediately. If not, the storage time and conditions of the product before use are the responsibility of the user and should not normally exceed 24 hours at 2-8 ºC, unless the mixture has been prepared in controlled and validated aseptic conditions.

Levobupivacaine Altan 1.25 mg/ml should not be mixed with other medicines except those listed above. Dissolution with alkaline solutions such as sodium bicarbonate may cause precipitation.

Method of administration

Administration of Levobupivacaine should only be performed by a doctor with the necessary training and experience or under their supervision.

For information on posology, consult the Product Characteristics Sheet.

Careful aspiration is recommended before injection to prevent intravascular injection. If toxic symptoms appear, interrupt the injection immediately.