Prospect: Informationfortheuser

LevobupivacaínaAltan 0,625 mg/ml solution for infusionEFG

Levobupivacaína

1.What is LevobupivacaínaAltan 0,625 mg/ml and for what it is used

2.What you need to know before starting touseLevobupivacaínaAltan 0,625 mg/ml

3.How to useLevobupivacaínaAltan 0,625 mg/ml

4.Possible adverse effects

5.Storage ofLevobupivacaínaAltan 0,625 mg/ml

6.Contents of the package and additional information

LevobupivacaínaAltan 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.

LevobupivacaínaAltan 0.625 mg/ml solution for infusion isonly for use in adults.

LevobupivacaínaAltan 0.625 mg/ml is used for the treatment of pain:

•after major surgery,

•during childbirth.

No use Levobupivacaína Altan 0.625 mg/ml

• If you are allergic (hypersensitive) to levobupivacaína, to any similar local anesthetic 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 uterine cervix during the early stage of labor (paracervical block)
• To anesthetize a part of the body by injecting Levobupivacaína Altan 0.625 mg/mlintravenously

Warnings and precautions

Inform your doctor or nurse before they administer Levobupivacaína Altan 0.625 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 0.625 mg/ml with other medications:

Inform your doctor or nurse if you are using or have recently used any other medication. Inform them especially if you are taking medications for:

• Arrhythmias (such as mexiletina)
• Fungal infections (such as ketoconazol) as they may affect the metabolism of Levobupivacaína Altan 0.625 mg/ml
• Asthma (such as theophylline) as they may affect how long Levobupivacaína Altan 0.625 mg/ml stays in your body

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or nurse before using this medication.Levobupivacaína Altan 0.625 mg/ml should not be administered to relieve pain via injection in the area around the uterine cervix or cervix during labor (paracervical block).

The effects of Levobupivacaína Altan 0.625 mg/ml on the fetus during the early stages of pregnancy are unknown. Therefore, Levobupivacaína Altan 0.625 mg/ml should not be used during the first three months of pregnancy, unless your doctor considers it necessary.

The passage of levobupivacaína through breast milk is unknown. However, based on experience with similar medications, it is expected that only small amounts of levobupivacaína 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.

Important information about some of the components of Levobupivacaina Altan 0.625 mg/ml:This medication contains 15 mmol (3.5 mg/ml) of sodium per 100 ml bottle, which should be taken into account in patients with low-sodium diets.

Your doctor will administer Levobupivacaína Altan 0.625 mg/ml through an injection via a needle or through a small tube inserted into your back (epidural). Your doctor and nurse will closely monitor you while Levobupivacaína Altan 0.625 mg/ml is being administered.

Dose
Adults:

The amount of Levobupivacaína Altan 0.625 mg/ml to be administered and the frequency 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 desired area. The dose will be carefully chosen by your doctor.

When Levobupivacaína Altan 0.625 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 0.625 mg/ml than you should:

If you are administered more Levobupivacaína Altan 0.625 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.

Too much Levobupivacaína Altan 0.625 mg/ml may 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, this medicine may have side effects, although not everyone will experience them. Some of the side effects of Levobupivacaine Altan 0.625 mg/ml infusion solution may be serious.

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

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

• 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 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, urticaria, and very low blood pressure.

• Allergic reactions (hypersensitivity) recognizable by red, 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
• Numbness, numbness, or other unusual sensations
• Prolonged and painful erection of the penis
• Neurological 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.

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

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

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

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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano Website:www.notificaRAM.es.By reporting side effects, you can contribute toproviding more information on the safety of this medicine.

This medication does not require special conditions for conservation.

Keep out of the reach and sight of children

Do not use Levobupivacaína 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 store this medication for you

The solution must be used immediately after opening

Do not use Levobupivacaína Altan 0.625 mg/ml if you observe particles within the solution

Medications 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. This will help protect the environment.

Composition of Levobupivacaína Altan 0.625 mg/mL solution for infusion

The active ingredient is levobupivacaína (as hydrochloride)

Levobupivacaína Altan 0.625 mg/mL: 1 mL contains 0.625 mg of levobupivacaína (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 0.625 mg/mL is a clear, transparent solution. Each polypropylene or polyolefin bag free of PVC contains 100 mL of solution. It is supplied in packages of 5 bags and 24 bags of 100 mL solution.

Holder of the marketing authorization and responsible for manufacturing

Holder:Altan Pharmaceuticals, S.A.

C/ Cólquide 6, Portal 2, 1st Floor, Office F, Edificio Prisma, Las Rozas,

28230 Madrid (Spain).

Responsible for manufacturing:

Altan Pharmaceuticals, S.A.

P.I. Bernedo S/N.

01118 Bernedo, Álava-Spain

This leaflet has been reviewed in07/2023

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 / handling

Levobupivacaína Altan 0.625 solution for infusion 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 0.9% sodium chloride 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 at 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 0.625 mg/mL solution for infusion 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.

It is recommended to perform a careful aspiration before injection to prevent intravascular injection. If toxic symptoms appear, stop the injection immediately.