Leaflet: information for the user

Levobupivacaína Normon 1.25 mg/ml solution for infusion EFG

Only for epidural route

Levobupivacaína

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Levobupivacaína Normon 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 Normoninfusion solutionisonly for use in adults.

Levobupivacaína Normon is used for the treatment of pain:

• after major surgery.
• during childbirth.

No use Levobupivacaína Normon:

• If you are allergic (hypersensitive) to levobupivacaine, to any local anesthetic similar or to any of the other components of this medication (listed in 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 Normon intravenously.

Warnings and precautions

Consult your doctor or nurse before starting to use Levobupivacaína Normon. You may need closer monitoring or a lower dose.

• Si usted sufre una enfermedad del Sistema Nervioso.
• Si está débil o enfermo.
• Si es anciano.
• Si padece una enfermedad hepática.

Use of Levobupivacaína Normon with other medications

Inform your doctor or pharmacist 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 Normon.
• Asthma (such as theophylline) as it may affect how long Levobupivacaína Normon remains in your body

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor before using this medication.

Levobupivacaína Normon should not be administered to relieve pain via injection in the area around the cervix or cervix during labor (paracervical block).

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

The passage of levobupivacaine through breast milk is unknown; 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 Normon 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 Normon and the immediate effects of surgery have passed. Ensure you are advised on this by your doctor or nurse before leaving the hospital.

Important information about some of the components of Levobupivacaína Normon

This medication contains 353.85 mg of sodium (main component of table salt/for cooking) in each 100 ml bag and 707.7 mg in each 200 ml bag. This corresponds to 17.7% of the maximum daily sodium intake recommended for an adult in the 100 ml bag and 35.4% in the 200 ml bag.

Your doctor will administer Levobupivacaína Normon through a small tube inserted into your back (epidural). Your doctor and nurse will closely monitor you while Levobupivacaína Normon is being administered.

Dose

Adults:

The amount of Levobupivacaína Normon that will be administered and the frequency at which it will be done will depend on the purpose for which it is used 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 Levobupivacaína Normon is used to relieve childbirth pain, the dose used will be carefully controlled.

Children:

Not recommended.

If you are administered more Levobupivacaína Normon than you should:

If you are administered more Levobupivacaína Normon than you should, you may experience tongue numbness, dizziness, blurred vision, muscle contraction, severe difficulty breathing (including respiratory arrest) and even seizures. If you notice any of these symptoms, inform your doctor immediately.

Too much Levobupivacaína Normon 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, this medicine may cause side effects, although not everyone will experience them.

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

Very common: may affect more than 1 in 10 people

• feeling of fatigue or weakness, difficulty breathing, paleness (these are all signs of anemia)

Common: may affect 1 in 10 people

• fetal distress

Unknown: cannot be estimated from available data

• serious allergic reactions (hypersensitivity) that cause severe difficulty breathing, difficulty swallowing, urticaria, very low blood pressure, and swelling of the tongue or throat
• apnea
• cardiac arrest or heart block
• loss of consciousness
• paralysis
• seizures

Other side effects that may occur:

Very common: may affect more than 1 in 10 people

• low blood pressure
• nausea

Common: may affect 1 in 10 people

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

Unknown: cannot be estimated from available data

• recognizable allergic reactions (hypersensitivity) characterized by red and irritated skin, sneezing, excessive sweating, increased heart rate, fainting, or swelling of the face, lips, and mouth
• drowsiness
• blurred vision
• localized tingling
• numb tongue
• muscle weakness or tremors
• loss of bladder and bowel control
• 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 become permanent.

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keepthis medicationout of the sight and reach of children.

• Do not usethis medicationafter 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 this medication if you observe particles within the solution.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Levobupivacaína Normon

The active ingredient is levobupivacaína (as hydrochloride).

Levobupivacaína Normon 1.25 mg/ml solution for infusion: one milliliter contains 1.25 mg of levobupivacaína (as hydrochloride). Each bag contains 125 mg of levobupivacaína (as hydrochloride) in 100 ml and 250 mg of levobupivacaína (as hydrochloride) in 200 ml.

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

Appearance of the product and contents of the package

Levobupivacaína Normon is a colorless, transparent solution. It is presented in bags of 100 ml and 200 ml of ready-to-use infusion solution. It is supplied in containers that contain 24 bags of 100 ml of solution and 12 bags of 200 ml of solution.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos- Madrid (SPAIN)

OTHER PRESENTATIONS

LevobupivacaínaNormon0.625 mg/ml solution for infusion EFG

LevobupivacaínaNormon2.5 mg/ml solution for injection and infusion EFG

LevobupivacaínaNormon5 mg/ml solution for injection and infusion EFG

LevobupivacaínaNormon7.5 mg/ml solution for injection and infusion EFG

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain: Levobupivacaína Normon 1.25 mg/ml solution for infusion EFG

Portugal:Levobupivacaína Normon1.25 mg/ml solution for infusion

Date of the last review of this leaflet: July 2021.

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

This information is intended solely for healthcare professionals:

Levobupivacaína Normon 1.25 mg/ml solution for infusion EFG

Instructions for use and handling

Levobupivacaína Normon 1.25 mg/ml solution for infusion EFG isonlyfor single use and by epidural route and must not be administered intravenously. Do not use unless the solution is clear and the container 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.

Expiry date after dilution with a 0.9% sodium chloride solution:

The chemical and physical stability in use has been demonstrated for the levobupivacaína dose of 1.25 mg/ml with 8.3-8.4 micrograms/ml of clonidine, 50 micrograms/ml of morphine, and 2 micrograms/ml of 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 levobupivacaína dose of 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 7 days at 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 °C, unless the mixture has been prepared in controlled and validated aseptic conditions.

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

Levobupivacaína Normon 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

Levobupivacaína administration must be performedonlyby a doctor who has the necessary training and experience or under their supervision.

For information on dosage, consult the Product Technical Data Sheet.

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