LEVOBUPIVACAINE ALTAN 0.625 mg/mL SOLUTION FOR INFUSION

Introduction

Prospective: Informationfortheuser

LevobupivacaineAltan 0.625 mg/ml solution for infusionEFG

Levobupivacaine

Contents of the prospectus:

1. What is Levobupivacaine Altan 0.625 mg/ml and what is it used for
2. What you need to know before starting to use Levobupivacaine Altan 0.625 mg/ml
3. How to use Levobupivacaine Altan 0.625 mg/ml
4. Possible side effects
5. Storage of Levobupivacaine Altan 0.625 mg/ml
6. Package contents and additional information

1. What is Levobupivacaine Altan 0.625 mg/ml and what is it used for

Levobupivacaine Altan 0.625 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 0.625 mg/ml solution for infusion is only for use in adults.

Levobupivacaine Altan 0.625 mg/ml is used to treat pain :

• after major surgery,

• during childbirth.

2. What you need to know before starting to use Levobupivacaine Altan 0.625 mg/ml

Do not use Levobupivacaine Altan 0.625 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 childbirth (paracervical block).
• To anesthetize a part of the body by injecting Levobupivacaine Altan 0.625 mg/ml intravenously.

Warnings and precautions

Tell your doctor or nurse before they administer Levobupivacaine Altan 0.625 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 0.625 mg/ml with other medicines:

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

• Atrial arrhythmias (such as mexiletine)
• Fungal infections (such as ketoconazole) as they may affect the metabolism of Levobupivacaine Altan 0.625 mg/ml
• Asthma (such as theophylline) as they may affect how long Levobupivacaine Altan 0.625 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 0.625 mg/ml should not be administered to relieve pain by injecting it into the area around the uterine cervix during childbirth (paracervical block).

The effects of Levobupivacaine Altan 0.625 mg/ml on the fetus during the first phases of pregnancy are not known. Therefore, Levobupivacaine Altan 0.625 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 the ability to drive and use machines. You should not drive or use machinery until all the effects of Levobupivacaine 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 Levobupivacaine Altan 0.625 mg/ml:This medicine contains 15 mmol (3.5 mg/ml) of sodium per 100 ml bag, which should be taken into account in patients with low-sodium diets.

3. How to use Levobupivacaine Altan 0.625 mg/ml

Your doctor will administer Levobupivacaine Altan 0.625 mg/ml by injection through a needle or through a small tube inserted into your back (epidural). Your doctor and nurse will carefully monitor you while you are being administered Levobupivacaine Altan 0.625 mg/ml.

DoseAdults:

The amount of Levobupivacaine Altan 0.625 mg/ml that will be administered to you and the frequency of administration will depend on what it is used for 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 Levobupivacaine Altan 0.625 mg/ml is used to relieve childbirth pain, the dose used will be carefully controlled.

Children:

It is not recommended for use in children.

If you are administered more Levobupivacaine Altan 0.625 mg/ml than you should:

If you are administered more Levobupivacaine Altan 0.625 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 0.625 mg/ml can also cause hypotension, 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, this medicine can have side effects, although not everyone gets them. Some of the side effects of Levobupivacaine Altan 0.625 mg/ml solution for infusion 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(frequency cannot be estimated from the available data):• severe allergic reactions (hypersensitivity) that cause severe difficulty breathing, difficulty swallowing, urticaria, and very low blood pressure.

• allergic reactions (hypersensitivity) recognizable by having 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 block or cardiac arrest • localized tingling • numb tongue • muscle weakness or tremors • loss of control of urine and feces • paralysis • convulsions • tingling, numbness, or other strange sensation • prolonged erection of the penis, which may be painful • nervous disorders that may include closure of the eyes, small pupils (black center of the eye), sunken eye socket, sweating, and/or redness of one side of the face.

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

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

If you think you are experiencing any of the side effects that are getting worse or if you notice any side effect not mentioned in this prospectus, inform your doctor or nurse.

Reporting 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 prospectus. 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 contribute to providing more information on the safety of this medicine.

5. Storage of Levobupivacaine Altan 0.625 mg/ml

This medicine does not require special storage conditions.

Keep out of the reach and sight of children

Do not use Levobupivacaine Altan 0.625 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 keep this medicine for you

The solution must be used immediately after opening

Do not use Levobupivacaine Altan 0.625 mg/ml if you observe particles inside 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. Package contents and additional information

Composition of Levobupivacaine Altan 0.625 mg/ml solution for infusion

The active ingredient is levobupivacaine (as hydrochloride)

Levobupivacaine Altan 0.625 mg/ml: one ml contains 0.625 mg of levobupivacaine (as hydrochloride).

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

Appearance of the product and package contents

Levobupivacaine Altan 0.625 mg/ml is a clear, transparent solution. Each polypropylene or polyolefin bag without PVC contains 100 ml of solution. It is supplied in packs of 5 bags and 24 bags of 100 ml solution.

Marketing authorization holder and manufacturer

Holder:Altan Pharmaceuticals, S.A.

C/ Cólquide 6, Portal 2, 1ª Planta, Oficina F, Edificio Prisma, Las Rozas,

28230 Madrid (Spain).

Manufacturer:

Altan Pharmaceuticals, S.A.

P.I. Bernedo S/N.

01118 Bernedo, Álava-Spain

This prospectus 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

-----------------------------------------------------------------------------------------------------------------------

This information is intended only for doctors or healthcare professionals:

Instructions for use/manipulation

Levobupivacaine Altan 0.625 solution for infusion is for single use only and for epidural use and should not be administered 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 treatment with levobupivacaine for more than 24 hours is limited.

Expiration after dilution with a 0.9% sodium chloride solution:

The 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 °C or 20-22 °C. The 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 °C or 20-22 °C.

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

Levobupivacaine Altan 0.625 mg/ml solution for infusion 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 who has the necessary training and experience or under their supervision.

For information on posology, consult the Product Technical Sheet.

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