Levobupivacaine Normon 1.25 mg/ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levobupivacaine Normon 1.25 mg/ml solution for infusion EFG

Epidural use only

Levobupivacaine

Read all of 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, 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.

Contents of this leaflet

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.
6. Contents of the pack 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.

Levobupivacaína Normon solution for infusion is for use in adults only.

Levobupivacaína Normon is used for pain treatment:

• after major surgery.
• during childbirth.

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 injecting around the cervix during early labour (paracervical block).
• To anaesthetize a part of the body by intravenous injection of Levobupivacaine Normon.

Warnings and precautions

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

• 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, tell 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 it may affect how long Levobupivacaine Normon remains in your body.

Pregnancy, breast-feeding and fertility

If you are pregnant, breast-feeding, think you may be pregnant, or plan 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 drugs, it is expected that only small amounts of levobupivacaine would pass into breast milk. Breastfeeding is therefore possible after administration of a local anaesthetic.

Driving and using machines

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 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 Levobupivacaine Normon

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

3. How to use Levobupivacaine Normon

Your doctor will administer Levobupivacaine Normon to you through a small tube inserted into your back (epidural). Your doctor and nurse will carefully monitor you while you are receiving Levobupivacaine Normon.

Dosage

Adults:

The amount of Levobupivacaine Normon that will be administered and how often it is given will depend on what it is being used for, as well as your physical condition, age, and weight. You will be given the lowest dose that achieves anesthesia in the required area. The dose will be carefully selected by your doctor.

When Levobupivacaine Normon is used to relieve labor pain, the dose administered will be carefully controlled.

Children:

Not recommended.

If you are given more Levobupivacaine Normon than you should

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

Sometimes, too much Levobupivacaine 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 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 anaemia)

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
• 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) characterized 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 (the black centre 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 observed on an ECG (electrocardiogram) have also been reported as adverse effects.

In very rare cases, some adverse effects 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 can also report them directly through 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 unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levobupivacaine Normon

The active substance is levobupivacaine (as hydrochloride).

Levobupivacaine Normon 1.25 mg/ml solution for infusion: one millilitre contains 1.25 mg of levobupivacaine (as hydrochloride). Each bag contains 125 mg of levobupivacaine (as hydrochloride) in 100 ml and 250 mg of levobupivacaine (as hydrochloride) in 200 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 is a colourless, clear solution. It is supplied in 100 ml and 200 ml bags of ready-to-use solution for infusion. It is provided in packaging containing 24 bags of 100 ml solution and 12 bags of 200 ml solution.

Marketing Authorisation Holder and Manufacturer Responsible

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

OTHER PRESENTATIONS

Levobupivacaine Normon 0.625 mg/ml solution for infusion EFG
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 7.5 mg/ml solution for injection and infusion EFG

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Spain: Levobupivacaine Normon 1.25 mg/ml solution for infusion EFG
Portugal: Levobupivacaine Normon 1.25 mg/ml solution for infusion

Date of the most recent review of this leaflet: July 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 1.25 mg/ml solution for infusion EFG

Instructions for use and handling

Levobupivacaine Normon 1.25 mg/ml solution for infusion EFG is for single use only and is intended for epidural administration; it must not be administered intravenously. Do not use unless the solution is clear and the container is intact. Any unused solution should be discarded.

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

Shelf-life after dilution with 0.9% sodium chloride solution:

Chemical and physical in-use stability has been demonstrated for levobupivacaine 1.25 mg/ml solution containing 8.3–8.4 micrograms/ml clonidine, 50 micrograms/ml morphine and 2 micrograms/ml fentanyl, stored for 30 days at 2–8 °C or 20–22 °C. Chemical and physical in-use stability has also been demonstrated for levobupivacaine 1.25 mg/ml solution containing sufentanil at a concentration of 0.4 micrograms/ml, stored for 30 days at 2–8 °C or 7 days at 20–22 °C.

From a microbiological standpoint, the product should be used immediately. If not, the storage duration and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8 °C, unless the solution has been prepared under controlled and validated aseptic conditions.

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

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

Method of administration

Levobupivacaine must be administered only by a physician with appropriate training and experience, or under their supervision.

For information on dosage, refer to the Summary of Product Characteristics.

Careful aspiration is recommended before infusion to prevent intravascular injection. If toxic symptoms occur, the injection must be stopped immediately.