LEVOBUPIVACAINE NORMON 5 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Levobupivacaine Normon 5 mg/ml Solution for Injection and Perfusion 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 further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

Adults:

Levobupivacaine Normon is used as a local anesthetic to anesthetize parts of the body before major surgery (e.g. as an epidural in cases of cesarean section) 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 can also be used in children to anesthetize parts of the body before an operation and for pain relief after minor surgery, such as an inguinal hernia.

Levobupivacaine Normon has not been tested in children under 6 months.

2. What you need to know before you use 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 uterine cervix during the early stages of labor (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 heart problems.
• 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 uterine cervix or cervix during labor (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 or use machines. Do not drive or use machinery until all the effects of Levobupivacaine Normon and the immediate effects of surgery have passed. Make sure you are advised about this by 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 (main component of table/cooking salt) in each ampoule. This is equivalent to 1.4% of the maximum recommended daily intake of sodium for an adult..

3. How to use Levobupivacaine Normon

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

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

Dose

The amount of Levobupivacaine Normon that will be administered to you and how often it will be administered will depend on what it is used for and your physical condition, age and weight. You will be administered 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 or for a cesarean section (epidurally), the dose used will be carefully controlled.

If you are given too much Levobupivacaine Normon

If you are administered too much Levobupivacaine Normon, 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, inform 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 mentioned below, tell 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 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
• heart block or cardiac arrest
• 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 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 strange sensation
• prolonged erection of the penis, which can be painful
• nervous disorders that can include closure of the eyes, small pupils (black center of the eye), sunken eye socket, sweating and/or redness of one side of the face.

It has also been reported as side effects, bradycardia, tachycardia, irregular heartbeats and changes in heart rhythm that may be seen on an ECG (electrocardiogram).

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is possible side effects 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 carton after EXP. The expiry date is the last day of the month shown.
• Your doctor will keep 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 other information

Composition of Levobupivacaine Normon

The active substance is levobupivacaine (as hydrochloride).

Levobupivacaine Normon 5 mg/ml solution for injection and perfusion: 1 ml contains 5 mg of levobupivacaine (as hydrochloride). Each ampoule contains 50 mg in 10 ml.

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

Appearance and pack contents

Levobupivacaine Normon 5 mg/ml is presented in 10 ml glass ampoules type I. It is supplied 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 perfusion EFG

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

Levobupivacaine Normon 1.25 mg/ml solution for perfusion EFG

Levobupivacaine Normon 0.625 mg/ml solution for perfusion EFG

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Levobupivacaine Normon 5 mg/ml solution for injection and perfusion EFG

Portugal: Levobupivacaine Normon 5 mg/ml solução injetável ou para perfusão

Date of last revision of this leaflet: May 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 5 mg/ml solution for injection and perfusion EFG

Instructions for use and handling

Levobupivacaine Normon 5 mg/ml solution for injection and perfusion is for single use only. Discard any unused solution.

From a microbiological point of view, the product should be used immediately after opening. If not, the storage time and conditions of the product before use are the responsibility of the user.

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

Expiry after first opening: The product should be used immediately.

Expiry after dilution with a 0.9% sodium chloride solution: The chemical and physical stability in use has been demonstrated in 0.9% sodium chloride solutions for 7 days at 20-22°C.

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

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

Dilutions of standard levobupivacaine solutions should be performed with 9 mg/ml (0.9%) sodium chloride injection solution and using aseptic techniques.

It has been shown 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. The chemical and physical stability in use has been demonstrated with clonidine, morphine or fentanyl for 40 hours at 20-22°C.

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

Method of administration

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

For information on posology, consult the Summary of Product Characteristics.

Careful aspiration is recommended before and during injection to prevent intravascular injection.

Aspiration should be repeated before and during the administration of a bolus dose, which should be injected slowly and in dose increments at a rate of 7.5 - 30 mg/min, while monitoring the patient's vital functions and maintaining verbal contact with them.

If toxic symptoms appear, the injection should be stopped immediately.