LEVOBUPIVACAINE NORMON 1.25 mg/mL SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Levobupivacaine Normon 1.25 mg/ml Solution for Infusion EFG

For 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, you may need to read it again.
• If you have any further 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 the Package Leaflet

1. What is Levobupivacaine Normon and what is it used for.
2. What you need to know before you start using Levobupivacaine Normon.
3. How to use Levobupivacaine Normon.
4. Possible side effects.
5. Storage of Levobupivacaine Normon.
6. Contents of the pack and further information.

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

Levobupivacaine Normon belongs to a group of medicines called local anesthetics. This type of medicine is used to anesthetize parts of the body or to relieve pain.

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

Levobupivacaine Normon is used to treat pain:

• after major surgery.
• during childbirth.

2. What you need to know before you start using Levobupivacaine Normon

Do not use Levobupivacaine Normon:

• If you are allergic (hypersensitive) to levobupivacaine, to any other local anesthetic or to any of the other ingredients of this medicine (listed in section 6).
• If you have very low blood pressure.
• To relieve pain by injecting it into the area around the cervix during the early stages of childbirth (paracervical block).
• To anesthetize a part of the body by injecting Levobupivacaine Normon intravenously.

Warnings and Precautions

Talk to your doctor or nurse before you start using Levobupivacaine Normon. You may need closer monitoring or a lower dose.

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

Using Levobupivacaine Normon with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Tell them especially if you are taking medicines for:

• Arrhythmias (such as mexiletine).
• Fungal infections (such as ketoconazole) as they may affect the metabolism of Levobupivacaine Normon.
• Asthma (such as theophylline) as it may affect how long Levobupivacaine Normon stays in your body.

Pregnancy, Breastfeeding, and Fertility

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

Levobupivacaine Normon should not be administered to relieve pain by injecting it into the area around the cervix during childbirth (paracervical block).

The effects of Levobupivacaine Normon on the fetus during the first stages of pregnancy are not known. Therefore, Levobupivacaine Normon should not be used during the first three months of pregnancy unless your doctor considers it necessary.

It is not known if levobupivacaine passes into breast milk; however, based on experience with similar drugs, it is expected that only small amounts of levobupivacaine will pass into breast milk. Breastfeeding is therefore possible after using a local anesthetic.

Driving and Using Machines

Using Levobupivacaine Normon may have a considerable effect on your ability to drive and use machines. Do not drive or use machinery until the effects of Levobupivacaine Normon and the immediate effects of surgery have worn off. Make sure you are advised about this by your doctor or nurse before you leave the hospital.

Important Information about Some of the Ingredients of Levobupivacaine Normon

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

3. How to Use Levobupivacaine Normon

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

Dose

Adults:

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

When Levobupivacaine Normon is used to relieve pain during childbirth, the dose used 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 contraction, severe difficulty breathing (including respiratory arrest), and even convulsions. If you notice any of these symptoms, tell your doctor immediately.

Sometimes too much Levobupivacaine Normon can also cause low blood pressure, bradycardia, or tachycardia, and changes in your heart rhythm. Your doctor may need to give you other medicines to help stop these symptoms. If you have any other questions about the use of this medicine, ask your doctor or nurse.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Very Common: may affect more than 1 in 10 people

• feeling tired or weak, difficulty breathing, pale skin (these are all signs of anemia).

Common: may affect up to 1 in 10 people

• fetal distress.

Unknown: cannot be estimated from the available data

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

Other side effects that may occur:

Very Common: may affect more than 1 in 10 people

• low blood pressure.
• nausea.

Common: may affect up to 1 in 10 people

• dizziness.
• headache.
• vomiting.
• back pain.
• fever.
• postoperative pain.

Unknown: cannot be estimated from the available data

• allergic reactions (hypersensitivity) recognizable by having 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 sensation.
• prolonged erection of the penis, which can be painful.
• neurological disorders that may include drooping eyelids, small pupils (black center of the eye), sunken eye socket, sweating, and/or flushing of one side of the face.

Bradycardia, tachycardia, irregular heartbeats, and changes in heart rhythm that can be seen on an ECG (electrocardiogram) have also been reported as side effects.

In very rare cases, some side effects can become permanent.

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Vigilance System for Human Use: https://www.notificaram.es. By reporting side 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 which is stated on the packaging after EXP. The expiry date is the last day of the month stated.
• 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Levobupivacaine Normon

The active substance is levobupivacaine (as hydrochloride).

Levobupivacaine Normon 1.25 mg/ml solution for infusion: one milliliter 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 ingredients are sodium chloride, sodium hydroxide, hydrochloric acid, and water for injections.

Appearance and Packaging of the Product

Levobupivacaine Normon is a clear, colorless solution. It is available in 100 ml and 200 ml bags of solution for infusion ready for use. It is supplied in packs containing 24 bags of 100 ml solution and 12 bags of 200 ml solution.

Marketing Authorization Holder and Manufacturer

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 medicine is authorized 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 solução para perfusão

Date of Last Revision of this Leaflet: July 2021.

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

This information is intended only for healthcare professionals:

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 for epidural use only and should not be administered intravenously. Do not use unless the solution is clear and the packaging is intact. Discard any unused solution.

As with all parenteral medicines, the solution/dilution should be inspected visually prior to use. Only clear solutions without visible particles should be used.

Stability after dilution with a 0.9% sodium chloride solution:

The chemical and physical stability in use has been demonstrated for the levobupivacaine dose of 1.25 mg/ml with 8.3-8.4 micrograms/ml of clonidine, 50 micrograms/ml of morphine, and 2 micrograms/ml of fentanyl, stored for 30 days at 2-8°C or 20-22°C. The chemical and physical stability in use has been demonstrated for the levobupivacaine dose of 1.25 mg/ml with sufentanil added at a concentration of 0.4 micrograms/ml and stored for 30 days at 2-8°C or 7 days at 20-22°C.

From a microbiological point of view, the product should be used immediately. If not, the storage time and conditions of the product before use are the responsibility of the user and normally should not be more than 24 hours at 2-8°C, unless the mixture has been prepared in controlled and validated aseptic conditions.

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

Levobupivacaine Normon should not be mixed with other medicines except those listed above. Dissolution with alkaline solutions such as sodium bicarbonate may cause precipitation.

Method of Administration

Administration of levobupivacaine should only be performed by a doctor who has the necessary training and experience or under their supervision.

For information on dosage, consult the Product Characteristics.

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