Levobupivacaine Normon 7.5 mg/ml solution for injection and infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Levobupivacaine Normon 7.5 mg/ml solution for injection and infusion EFG

Levobupivacaine

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

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

Leaflet contents

1. What Levobupivacaine Normon is and what it is used for.
2. What you need to know before using Levobupivacaine Normon.
3. How to use Levobupivacaine Normon.
4. Possible side effects.
5. How to store Levobupivacaine Normon.

Pack contents and other information.

1. What Levobupivacaína Normon is and what it is used for

Levobupivacaína Normon belongs to a group of medicines called local anaesthetics. This type of medicine is used to numb parts of the body or to relieve pain.

Adults:

Levobupivacaína Normon is used as a local anaesthetic to numb parts of the body before major surgery (except in cases of caesarean 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 may also be used in children to numb parts of the body before surgery and for relief of pain after minor surgery, such as inguinal hernia repair.

Levobupivacaína Normon has not been studied in children under 6 months of age.

2. What you need to know before using Levobupivacaína Normon

Do not use Levobupivacaína Normon:

• If you are allergic (hypersensitive) to levobupivacaine, to any similar local anaesthetic, or to any of the other ingredients of this medicine (listed in section 6).
• If you have very low blood pressure.
• To anaesthetize a part of the body by injecting Levobupivacaína Normon intravenously.
• For pain relief during childbirth.

Warnings and precautions

Consult your doctor or nurse before using Levobupivacaína Normon. You may require closer monitoring or a lower dose.

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

Using Levobupivacaína Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform them if you are taking medicines for:

• Arrhythmias (such as mexiletine).
• Fungal infections (such as ketoconazole), as these may affect the metabolism of Levobupivacaína Normon.
• Asthma (such as theophylline), as it may affect how long Levobupivacaína Normon remains in your body.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Levobupivacaína Normon 7.5 mg/ml must not be administered for pain relief during childbirth or as a local anaesthetic during caesarean section.

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

It is not known whether levobupivacaine passes into breast milk; however, based on experience with similar drugs, it is expected that only small amounts of levobupivacaine pass into breast milk. Breast-feeding is therefore possible after using a local anaesthetic.

Driving and using machines

The use of Levobupivacaína Normon may have a considerable effect on the ability to drive and operate machinery. You should not drive or operate machinery until all effects of Levobupivacaína Normon and the immediate effects of surgery have worn off. Make sure you have received advice on this from your doctor or nurse before leaving the hospital.

Important information about some of the ingredients of Levobupivacaína Normon:

This medicine contains 28 mg of sodium (a main component of cooking/table salt) per ampoule. This corresponds to 1.4% of the maximum daily recommended sodium intake for an adult.

3. How to use Levobupivacaine Normon

Levobupivacaine Normon can be injected into areas of the body where anesthesia is required, such as the eye, arm, or leg.

Your doctor and nurse will carefully monitor you while Levobupivacaine Normon is being administered.

Dosage

The amount of Levobupivacaine Normon you will receive and how often it is given will depend on the intended use and on your physical condition, age, and weight. The lowest effective dose required to achieve anesthesia in the targeted area will be administered. Your doctor will carefully select the dose.

If you are given more Levobupivacaine Normon than you should

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

Sometimes, excessive Levobupivacaine Normon may also cause hypotension, bradycardia or tachycardia, and changes in heart rhythm. Your doctor may need to give you other medications to help manage these symptoms. If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

If you think you are experiencing any of the adverse effects listed below, inform your doctor or nurse immediately.

• Very common: may affect more than 1 in 10 people
  feeling tired or weak, difficulty breathing, paleness (these are all signs of anaemia)

Unknown frequency: cannot be estimated from available data

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

Other adverse 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 frequency: cannot be estimated from available data

• allergic reactions (hypersensitivity) recognizable by red, 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 control of urine and faeces
• tingling, numbness, or other unusual sensations
• prolonged penile erection, which may be painful
• nervous system disorders that may include eye closure, small pupils (black centre of the eye), sunken eye socket, sweating and/or redness on one side of the face

Bradycardia, tachycardia, irregular heartbeat, and changes in heart rhythm that may have been observed on an ECG (electrocardiogram) have also been reported as adverse effects.

In very rare cases, some adverse effects may persist for a long period or become permanent.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levobupivacaine Normon

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

• Your doctor will store this medicine for you.

• The solution should be used immediately after opening.

• Do not use this medicine if you notice particles in the solution.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the container and other information

Composition of Levobupivacaine Normon

The active substance is levobupivacaine (as hydrochloride).

Levobupivacaine Normon 7.5 mg/ml solution for injection and infusion: one millilitre contains 7.5 mg of levobupivacaine (as hydrochloride). Each ampoule contains 75 mg in 10 ml.

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

Appearance of the product and contents of the container

Levobupivacaine Normon 7.5 mg/ml is supplied in 10 ml type I glass ampoules. It is packaged in packs of 10 ampoules.

Marketing Authorisation Holder and Manufacturer

LABORATORIOS NORMON S.A.
Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

OTHER PRESENTATIONS

Levobupivacaine Normon 2.5 mg/ml solution for injection and infusion EFG
Levobupivacaine Normon 5 mg/ml solution for injection and infusion EFG
Levobupivacaine Normon 1.25 mg/ml solution for infusion EFG
Levobupivacaine Normon 0.625 mg/ml solution for infusion EFG

This medicinal product is authorised in the European Economic Area member states under the following names:

Spain: Levobupivacaine Normon 7.5 mg/ml solution for injection and infusion EFG
Portugal: Levobupivacaine Normon 7.5 mg/ml injectable solution or for infusion

Date of the most recent revision of this leaflet: May 2021.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Levobupivacaine Normon 7.5 mg/ml solution for injection and infusion EFG

Instructions for use and handling

Levobupivacaine Normon 7.5 mg/ml solution for injection and infusion is for single use only. Any unused solution must be discarded.

From a microbiological standpoint, the product should be used immediately. If not, the storage duration and conditions prior to use are the user's responsibility.

Experience regarding the safety of treatment with levobupivacaine for more than 24 hours is limited.

Shelf-life after first opening: The product must be used immediately.

Shelf-life after dilution with 0.9% sodium chloride solution: Chemical and physical in-use stability has been demonstrated for solutions diluted with 0.9% sodium chloride for 7 days at 20–22 °C.

As with all parenteral medicinal products, the solution/dilution should be inspected visually before use. Only clear solutions without visible particles should be used.

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

Standard solutions of levobupivacaine should be diluted with 9 mg/ml (0.9%) sodium chloride injection solution, 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 levobupivacaine in 9 mg/ml (0.9%) sodium chloride injection solution. Chemical and physical in-use stability has been demonstrated with clonidine, morphine or fentanyl for 40 hours at 20–22 °C.

Levobupivacaine Normon must not be mixed with other medicinal products except those listed above. Dilution with alkaline solutions such as sodium bicarbonate may result in precipitation.

Method of administration

Levobupivacaine must be administered by a physician with appropriate training and experience, or under the supervision of such a physician.

For information on dosage, refer to the Product Information Leaflet.

Careful aspiration is recommended 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 in incremental doses at a rate of 7.5–30 mg/min, while monitoring the patient's vital signs and maintaining verbal contact.

If toxic symptoms occur, discontinue the injection immediately.