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

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

Levobupivacaine

Read the entire 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 adverse effects, consult your doctor or nurse, even if they are adverse effects 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 additional information.

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

Levobupivacaine 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:

Levobupivacaine Normon is used as a local anaesthetic to numb parts of the body before major surgery (for example, as an epidural in caesarean sections) and minor surgery (such as in the eye or mouth).

It is also used for pain relief

• after major surgery.
• during childbirth.

Children:

Levobupivacaine Normon may also be used in children to numb parts of the body before surgery and for pain relief after minor surgery, such as inguinal hernia repair.

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

2. What you need to know before using Levobupivacaine Normon

Do not use Levobupivacaine Normon:

• If you are allergic (hypersensitive) to levobupivacaine, to any other similar local anaesthetic, or to any of the other ingredients of this medicine (listed in section 6).
• If you have very low blood pressure.
• For pain relief by administering injection into the area around the cervix during early labour (paracervical block).
• To anaesthetize a part of the body by injecting Levobupivacaine Normon intravenously.

Warnings and precautions

Consult your doctor or nurse before starting to use Levobupivacaine Normon.

You may require closer monitoring or a lower dose if:

• You have heart problems.
• You have a nervous system disorder.
• You are weak or unwell.
• You are elderly.
• You have liver disease.

Using Levobupivacaine Normon with other medicines

Inform 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 Levobupivacaine Normon.
• Asthma (such as theophylline), as this may affect how long Levobupivacaine Normon remains in your body.

Pregnancy, breastfeeding and fertility

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

Levobupivacaine Normon must not be administered for pain relief by injection around the cervix during labour (known as paracervical block).

The effects of Levobupivacaine Normon on the fetus during early pregnancy are unknown. Therefore, Levobupivacaine 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 medicines, it is expected that only small amounts of levobupivacaine pass into breast milk. Breastfeeding is therefore possible after the use of a local anaesthetic.

Driving and using machines

The use of Levobupivacaine Normon may have a considerable effect on the ability to drive or operate machinery. You must not drive or use machines until all effects of Levobupivacaine Normon and the immediate effects of surgery have passed. 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 Levobupivacaine Normon:

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

3. How to use Levobupivacaína Normon

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

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

Dosage

The amount of Levobupivacaína Normon you will receive and how often it is given will depend on the intended use and your physical condition, age and weight. You will be given the lowest dose that achieves anaesthesia in the required area. The dose will be carefully selected by your doctor.

When Levobupivacaína Normon is used to relieve labour pain or for caesarean section (via epidural), the dose administered will be carefully controlled.

If you are given more Levobupivacaína Normon than you should

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

Sometimes, excessive Levobupivacaína Normon may 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 further questions about the use of this medicine, ask your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine can 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 of tiredness or weakness, difficulty breathing, paleness (these are all signs of anemia)

Common: may affect 1 in 10 people

• fetal distress

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
• cardiac 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) 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 control of urine and feces
• tingling, numbness, or other unusual sensations
• prolonged penile erection, which may be painful
• neurological disturbances that may include eyelid closure, small pupils (black center of the eye), sunken eye socket, sweating and/or redness on one side of the face

Bradycardia, tachycardia, irregular heartbeats, and changes in heart rhythm 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 through the Spanish Pharmacovigilance System for Human Medicines: 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 container 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 drains or household waste. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Pack contents and other information

Composition of Levobupivacaine Normon

The active substance is levobupivacaine (as hydrochloride).

Levobupivacaine Normon 2.5 mg/ml solution for injection and infusion: one millilitre contains 2.5 mg of levobupivacaine (as hydrochloride). Each ampoule contains 25 mg in 10 ml.

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

Appearance of the product and contents of the pack

Levobupivacaine Normon 2.5 mg/ml is supplied in 10 ml Type I glass ampoules. It is available 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 5 mg/ml solution for injection and infusion EFG

Levobupivacaine Normon 7.5 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 Member States of the European Economic Area under the following names:

Spain: Levobupivacaine Normon 2.5 mg/ml solution for injection and infusion EFG

Portugal: Levobupivacaine Normon 2.5 mg/ml solução injetável ou para perfusão

Date of the most recent review of this summary: May 2021.

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

This information is intended for healthcare professionals only:

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

Instructions for use and handling

Levobupivacaine Normon 2.5 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 after opening. If not, the storage time and conditions of the product in use prior to administration are the responsibility of the user.

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 in 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 dosage information, refer to the Summary of Product Characteristics.

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.