Levobupivacaine Normon 0,625 mg/ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levobupivacaine Normon 0.625 mg/ml solution for infusion EFG

For epidural use only

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 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 adverse effects.
5. How to store Levobupivacaine Normon.

Pack contents and other 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.

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

Levobupivacaine Normon is used for pain treatment:

• after major surgery,
• during childbirth.

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.
• For pain relief by injection around the cervix during early labour (paracervical block).
• To anaesthetize a part of the body by injecting Levobupivacaína Normon intravenously.

Warnings and precautions

Talk to your doctor or nurse before using Levobupivacaína Normon. You may need 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 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 this may affect how long Levobupivacaína Normon remains in your body.

Pregnancy, breastfeeding and fertility

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

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

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 your doctor considers it necessary.

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 the use of a local anaesthetic.

Driving and using machines

Levobupivacaína Normon may have a considerable effect on the ability to drive and use machines. 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 353.85 mg of sodium (a main component of table/cooking salt) in each 100 ml bag. This corresponds to 17.7% of the maximum daily recommended intake of sodium for an adult.

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 you will receive and how often it is given will depend on what it is being used for, and on 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 labour pain, the dose administered will be carefully controlled.

Children:

Not recommended.

If you are given more Levobupivacaine Normon than you should be

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 respiratory arrest), and even seizures. If you notice any of these symptoms, inform your doctor immediately.

Sometimes, too much Levobupivacaine 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 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 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
• 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, irritated skin, sneezing, excessive sweating, increased heart rate, fainting, or swelling of the face, lips, and mouth
• somnolence
• 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 disorders that may include eyelid closure, small pupils (the black centre 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 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 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 sight and reach of children.

• Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is 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 pack and other information

Composition of Levobupivacaína Normon

The active substance is levobupivacaine (as hydrochloride).

Levobupivacaína Normon 0.625 mg/ml solution for infusion: one millilitre contains 0.625 mg of levobupivacaine (as hydrochloride). Each bag contains 62.5 mg of levobupivacaine (as hydrochloride) in 100 ml.

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

Nature of the product and pack contents

Levobupivacaína Normon is a colourless, clear solution. It is supplied in 100 ml bags of ready-to-use solution for infusion. It is provided in packages containing 24 bags.

Marketing Authorisation Holder and Manufacturer

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

OTHER PRESENTATIONS

Levobupivacaína Normon 1.25 mg/ml solution for infusion EFG
Levobupivacaína Normon 2.5 mg/ml solution for injection and for infusion EFG
Levobupivacaína Normon 5 mg/ml solution for injection and for infusion EFG
Levobupivacaína Normon 7.5 mg/ml solution for injection and for infusion EFG

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

Spain: Levobupivacaína Normon 0.625 mg/ml solution for infusion EFG
Portugal: Levobupivacaína Normon 0.625 mg/ml solução para perfusão

Date of the most recent review of this summary: July 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:

Levobupivacaína Normon 0.625 mg/ml solution for infusion EFG

Instructions for use and handling

Levobupivacaína Normon 0.625 mg/ml solution for infusion 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 undamaged. Discard any unused solution.

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

Stability after dilution with 0.9% sodium chloride solution:

Chemical and physical in-use stability has been demonstrated for levobupivacaine 0.625 mg/ml with added clonidine at 8.3–8.4 micrograms/ml, morphine at 50 micrograms/ml, and fentanyl at 2 micrograms/ml, stored for 30 days at 2–8 °C or 20–22 °C. Chemical and physical in-use stability has also been demonstrated for levobupivacaine 0.625 mg/ml with sufentanil added 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 period 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.

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

Method of administration

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

For dosage information, refer to the Product Information (Technical Data Sheet).

Careful aspiration is recommended before infusion to prevent intravascular injection. If signs of toxicity occur, administration must be stopped immediately.