Prospecto:InformationfortheUser

Levobupivacaína Altan 1,25 mg/ml solution for infusion EFG

Levobupivacaína

1. What is Levobupivacaína Altan 1,25 mg/ml and what is it used for

2. What you need to know before starting to use Levobupivacaína Altan 1,25 mg/ml

3. How to use Levobupivacaína Altan 1,25 mg/ml

4. Possible adverse effects

5. Storage of Levobupivacaína Altan 1,25 mg/ml

6. Contents of the package and additional information

Levobupivacaína 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.

Levobupivacaína Altan 1,25 mg/ml isonly for use in adults.

Levobupivacaína Altan 1,25 mg/ml is used for the treatment of pain:

• after major surgery

• during childbirth

No use Levobupivacaína Altan 1,25 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 1,25 mg/ml intravenously.

Warnings and precautions

Inform your doctor before they administer Levobupivacaína Altan 1,25 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 a nervous system disease

• If you are weak or ill

• If you are elderly

• If you have liver disease.

Use of Levobupivacaína Altan 1,25 mg/ml with other medications:

Inform your doctor or nurse if you are using, have used recently, or may need to use other medications. 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 1,25 mg/ml

•?Asthma (such as theophylline) as they may affect how long Levobupivacaína Altan 1,25 mg/ml remains in your body.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, consult your doctor or nurse before using this medication Levobupivacaína Altan 1,25 mg/ml should not be administered to relieve pain via injection in the area around the cervix or cervix during labor (paracervical block).

There is no known effect of Levobupivacaína Altan 1,25 mg/ml on the fetus during the early stages of pregnancy. Therefore, Levobupivacaína 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 through breast milk. However, based on experience with similar medications, 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 operating machinery

The use of Levobupivacaína Altan 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 and surgery have passed. Make sure your doctor or nurse advises you on this before leaving the hospital.

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Important information about some of the components of Levobupivacaina Altan 1,25 mg/ml:This medication contains 15 mmol (3.5 mg/ml) of sodium per 100 ml vial and 30 mmol (3.5 mg/ml) of sodium per 200 ml vial, which should be taken into account in patients with low-sodium diets.

Your doctor will administer Levobupivacaína 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 Levobupivacaína Altan 1,25 mg/ml is being administered.

Dose
Adults:
The amount of Levobupivacaína Altan 1,25 mg/ml that will be administered and the frequency of administration will depend on the intended use and your physical condition, age, and weight. You will be administered the minimum dose required to achieve anesthesia in the affected area. The dose will be carefully chosen by your doctor.

When Levobupivacaína Altan 1,25 mg/ml is used to relieve childbirth pain, the dose used will be carefully controlled.

Children:

Its use is not recommended in children.

If you are administered more Levobupivacaína Altan 1,25 mg/ml than you should

If you are administered more Levobupivacaína Altan 1,25 mg/ml than you should, you may experience tongue numbness, dizziness, blurred vision, muscle contraction, severe breathing difficulties (including respiratory arrest) and even seizures. If you notice any of these symptoms, inform your doctor immediately. Sometimes, too much Levobupivacaína Altan 1,25 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.

Like all medicines, it may cause side effects, although not everyone will experience them. Some of the side effects of Levobupivacaína Altan 1.25 mg/ml can be serious.

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 people):

• feeling of fatigue 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):

• severe allergic reactions (hypersensitivity) that cause severe difficulty breathing, severe difficulty swallowing, hives, and very low blood pressure.

• recognizable allergic reactions (hypersensitivity) characterized 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 heart block
• localized numbness
• numb tongue
• muscle weakness or tremors
• loss of bladder and bowel control
• paralysis
• seizures
• tingling, numbness, or other unusual sensations
• prolonged and painful erection of the penis

• 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 become permanent.

Reporting of side effects

If you experience any type of side effect, consult yourdoctor, pharmacist, or nurse, even if it is apossible side effect that does not appear 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 toproviding more information on the safety of this medicine.

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This medication does not require special conditions for conservation.

Keep out of the reach and sight of children

Do not use Levobupivacaína Altan 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 1,25 mg/ml if you observe particles within the solution

Medicines should not be thrown into the drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you do not need. In this way, you will help to protect the environment.

Composition of Levobupivacaína Altan 1.25 mg/mL solution for infusion

The active ingredient is levobupivacaine (as hydrochloride)
Levobupivacaína Altan 1.25 mg/mL: 1 mL contains 1.25 mg of levobupivacaine (as hydrochloride).

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

Appearance of the product and contents of the package

Levobupivacaína Altan 1.25 mg/mL is a clear, transparent solution.

Each polypropylene or polyolefin PVC-free bag contains 100 mL or 200 mL of solution. It is supplied in packages of 5 bags and 24 bags of 100 mL solution or in packages of 12 bags of 200 mL solution.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Altan Pharmaceuticals, S.A.

C/ Cólquide 6, portal 2, 1st floor, office F, Edificio Prisma

28230 Madrid - Spain

Manufacturer responsible:

Altan Pharmaceuticals, S.A.

P.I. Bernedo S/N.

01118 Bernedo, Álava.-Spain

This leaflet has been revised in07/2023

The detailed and updated information on 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 / handling

Levobupivacaína Altan 1.25 mg/mL isonlyfor single use and by epidural route and must not be administered intravenously. Do not use unless the solution is clear and the package is intact. Discard any unused solution.

As for all parenteral medications, the solution/dilution must be visually inspected prior to use. Only clear solutions without visible particles should be used.

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

Expiry after dilution with a sodium chloride 0.9% solution:
The chemical and physical stability in use has been demonstrated for the two levobupivacaine doses of 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 levobupivacaine doses of 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 must be used immediately. If not, the storage time and the product in use conditions before using it are the responsibility of the user and normally should not be more than 24 hours at 2-8 °, unless the mixture has been prepared in controlled and validated aseptic conditions.

Levobupivacaína Altan 1.25 mg/mL must not be mixed with other medications except those listed above. Dissolution with alkaline solutions such as sodium bicarbonate may lead to precipitation.

Administration form

The administration of Levobupivacaína must be performed only by a doctor who has the necessary training and experience or under the supervision of the same.

For information on dosage, consult the Technical Data Sheet of the product.

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