Package Insert: Information for the User

Levobupivacaína Normon 2.5 mg/ml Injectable Solution and for Infusion EFG

Levobupivacaína

Read this package insert carefully before starting to use this medication, because it contains important information for you.

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

Contents of the package and additional information.

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.

Adults:

Levobupivacaína Normon is used as a local anesthetic to anesthetize parts of the body before major surgery (for example, as an epidural in cases of cesarean section) and minor surgery (such as in the eye or mouth).

It is also used for the relief of pain

• after major surgery.
• during childbirth.

Children:

Levobupivacaína Normon can also be used in children to anesthetize parts of the body before an operation and for the relief of pain after minor surgery, such as an inguinal hernia.

Levobupivacaína Normon has not been tested in children under 6 months.

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.

• If you suffer from heart disease.
• If you suffer from a nervous system disorder.
• If you are weak or ill.
• If you are elderly.
• If you have liver disease.

Use of Levobupivacaína Normon with other medications

Inform your doctor or pharmacist if you are using, have used recently or may have 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 stays in your body.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be 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 28 mg of sodium (main component of table salt/for cooking) in each ampoule. This is equivalent to 1.4% of the maximum daily sodium intake recommended for an adult.

Your doctor will administer Levobupivacaína Normon through an injection via a needle or through a small tube inserted into your back (epidural). Levobupivacaína Normon can also be injected into other parts of the body to anesthetize the area being treated, such as the eye, arm, or leg.

Your doctor and nurse will closely monitor you while Levobupivacaína Normon is being administered.

Dose

The amount of Levobupivacaína Normon you will receive and how often it will be administered will depend on what it is being used for and your physical condition, age, and weight. You will be given the minimum dose necessary to achieve anesthesia in the required area. The dose will be carefully chosen by your doctor.

When Levobupivacaína Normon is used to relieve childbirth pain or for a cesarean delivery (epidural), the dose used will be carefully controlled.

If you are givenmore Levobupivacaína Normon than you should

If you are given 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

• tiredness 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

• allergic reactions (hypersensitivity) recognizable by red and irritated skin, sneezing, excessive sweating, increased heart rate, fainting, or swelling of the face, lips, and mouth.
• drowsiness
• blurred vision
• localized numbness
• 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 persist for a long period or 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 medicationif 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 packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Levobupivacaína Normon

The active principle is levobupivacaína (as hydrochloride).

Levobupivacaína Normon 2.5 mg/ml injectable solution and for perfusion: one milliliter contains 2.5 mg of levobupivacaína (as hydrochloride). Each ampoule contains 25 mg in 10 ml.

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

Aspect of the product and content of the packaging

Levobupivacaína Normon 2.5 mg/ml is presented in 10 ml glass type I ampoules. It is supplied in packs of 10 ampoules.

Holder of the marketing authorization and responsible for the manufacture

Laboratorios Normon S.A.

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

OTHER PRESENTATIONS

Levobupivacaína Normon 5 mg/ml injectable solution and for perfusion EFG

Levobupivacaína Normon 7.5 mg/ml injectable solution and for perfusion EFG

Levobupivacaína Normon 1.25 mg/ml solution for perfusion EFG

Levobupivacaína Normon 0.625 mg/ml solution for perfusion EFG

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

Spain: Levobupivacaína Normon 2.5 mg/ml injectable solution and for perfusion EFG

Portugal: Levobupivacaína Normon 2.5 mg/ml solution injectable or for perfusion

Date of the last review of this leaflet:May 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 2.5 mg/ml injectable solution and for perfusion EFG

Instructions foruse and handling

Levobupivacaína Normon 2.5 mg/ml injectable solutionand for perfusion is only for single use. Discard any unused solution.

From a microbiological point of view, the product must be used immediately after opening. If not, the storage time and the product's conditions in use before using it are the responsibility of the user.

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

Expiration date after the first opening: The product must be used immediately.

Expiration date after dilution with a sodium chloride 0.9% solution: The chemical and physical stability in use has been demonstrated in sodium chloride 0.9% solutions for 7 days at 20-22 °C.

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

A sterile blister pack should be chosen when a sterile ampoule surface is required. The ampoule surface is not sterile if the sterile blister pack is damaged.

Standard solutions of levobupivacaína dilutions should be prepared with 9 mg/ml sodium chloride injectable solution (0.9%) and using aseptic techniques.

It has been demonstrated that 8.4 micrograms/ml of clonidine, 0.05 mg/ml of morphine, and 4 micrograms/ml of fentanyl are compatible with levobupivacaína in 9 mg/ml sodium chloride injectable solution (0.9%). The chemical and physical stability in use has been demonstrated with clonidine, morphine, or fentanyl for 40 hours at 20-22 °C.

Levobupivacaína Normon should not be mixed with other medications except for those listed above. Dilution with alkaline solutions such as sodium bicarbonate may lead to precipitation.

Administration form

Levobupivacaína administration should be performed by a doctor with the necessary training and experience or under their supervision.

For information on dosage, consult the Product Technical File.

Careful aspiration should be performed before and during injection to prevent intravascular injection.

Aspiration should be repeated before and during administration of a bolus dose, which should be injected slowly and in increments of dose at a rate of 7.5 - 30 mg/min, while monitoring the patient's vital functions and maintaining verbal contact with the patient.

If toxic symptoms appear, interrupt the injection immediately.