Leaflet: information for the user

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

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.

Contents of the pack and additional information.

LevobupivacaínaNormonbelongs 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:

LevobupivacaínaNormonis used asa local anestheticto anesthetize parts of the body before major surgery(except in cases of cesarean section)and minor surgery (such as in the eye or mouth).

It is also used for

• relief of pain after major surgery.

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 LevobupivacaínaNormon:

• 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 anesthetize a part of the body by injecting LevobupivacaínaNormonintravenously.
• For the treatment of pain during childbirth.

Warnings and precautions

Consult your doctoror nursebefore starting to useLevobupivacaína Normon. You may need closer monitoring oruse a lower dose.

• If you suffer from heart disease.
• 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 LevobupivacaínaNormonwith other medications

Inform your doctor or pharmacistif you are using, have used recentlyor 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 Normonremains in your body.

Pregnancy, lactationandfertility

If you are pregnant or breastfeeding, consult your doctor before using this medication.

Levobupivacaína Normon7.5 mg/ml should not be administeredto alleviate pain during childbirth or as a local anestheticduring a cesarean section.

The effects of Levobupivacaína Normonon the fetus during the early stages of pregnancy are unknown. Therefore, Levobupivacaína Normonshould 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 the experience with similar drugs, 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 ofLevobupivacaína Normonmay 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. Make sure 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 ampule. This is equivalent to 1.4% of the maximum daily sodium intake recommended for an adult..

Levobupivacaína Normon can be injected into the parts of the body whose area you want to anesthetize, such as the eye, arm or leg.

Your doctor and nurse will closely monitor you while you are receiving Levobupivacaína Normon.

Dose

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

Ifyou are givenmore LevobupivacaínaNormonthan 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 or 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 medications,this medicationcan 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 peoplefeeling tired or weak, difficulty breathing, paleness (these are all signs of anemia)

Unknown: cannot be estimated from available data

• serious allergic reactions (hypersensitivity) that cause severe difficulty breathing, difficulty swallowing, hives, and 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 peopledizziness
• headache
• vomiting
• back pain
• fever
• postoperative pain

Unknown: cannot be estimatedfrom 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 tingling
• numb tongue
• muscle weakness or tremors
• loss of bladder and bowel control
• tingling, numbness, or other unusual sensation
• 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 redness 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 time or become permanent.

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 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 medication.

• 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 usethis 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. By doing so, you will help protect the environment.

Composition of Levobupivacaína Normon

The active principle is levobupivacaína (as hydrochloride).

Levobupivacaína Normon 7.5 mg/ml injectable solution and for perfusion: one milliliter contains 7.5 mg of levobupivacaína (as hydrochloride). Each ampoule contains 75 mg in 10 ml.

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

Aspect of the product and content of the package

Levobupivacaína Normon 7.5 mg/ml is presented in 10 ml glass type I ampoules. It is supplied in packages 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 2.5 mg/ml injectable solution and for perfusion EFG

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

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

Instructions for use and handling

Levobupivacaína Normon 7.5 mg/ml injectable solution and for perfusion is only for single use. Discard any unused solution.

From a microbiological point of view, the product must be used immediately. 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 solution dilutions of levobupivacaína should be prepared with injectable sodium chloride 9 mg/ml (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 injectable sodium chloride 9 mg/ml (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 who has the necessary training and experience or under their supervision.

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

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, stop the injection immediately.