Levobupivacaine Altan 5 mg/ml solution for injection and infusion EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Levobupivacaine Altan 5 mg/ml solution for injection and infusion EFG

Levobupivacaine

Package leaflet contents:

1. What Levobupivacaína Altan 5 mg/ml is and what it is used for
2. What you need to know before using Levobupivacaína Altan 5 mg/ml
3. How to use Levobupivacaína Altan 5 mg/ml
4. Possible side effects
5. Storage of Levobupivacaína Altan 5 mg/ml
6. Contents of the pack and other information

1. What Levobupivacaína Altan 5 mg/ml is and what it is used for

Levobupivacaína Altan 5 mg/ml belongs to a group of medicines called local anaesthetics. These medicines are used to numb parts of the body or to relieve pain.

Adults:

Levobupivacaína Altan 5 mg/ml is used as a local anaesthetic to numb parts of the body before major surgery (e.g. epidural anaesthesia in cases of caesarean section) and minor surgery (such as in the eye or mouth).

It is also used for pain relief

• after major surgery
• during childbirth

Children:

Levobupivacaína Altan 5 mg/ml 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.

Levobupivacaína Altan 5 mg/ml has not been studied in children under 6 months of age.

2. What you need to know before using Levobupivacaine Altan 5 mg/ml

Do not use Levobupivacaine Altan 5 mg/ml

• If you are allergic (hypersensitive) to levobupivacaine, to any similar local anaesthetic, or to any of the other ingredients of this medicine (see section 6)
• If you have very low blood pressure
• For pain relief by administration via injection around the cervix during early labour (paracervical block)
• To anaesthetize a part of the body by injecting Levobupivacaine Altan 5 mg/ml intravenously.

Warnings and precautions

Inform your doctor before receiving Levobupivacaine Altan 5 mg/ml if you have any of the conditions or diseases listed below. You may require closer monitoring or a lower dose.

• If you have heart problems
• If you have a nervous system disorder
• If you are weak or unwell
• If you are elderly
• If you have liver disease

Use of Levobupivacaine Altan 5 mg/ml with other medicines: Inform your doctor or nurse 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 they may affect the metabolism of Levobupivacaine Altan 5 mg/ml
• Asthma (such as theophylline), as it may affect how long Levobupivacaine Altan 5 mg/ml 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 or nurse before using this medicine. Levobupivacaine Altan 5 mg/ml must not be administered for pain relief by injection around the cervix during labour (known as paracervical block).

The effects of Levobupivacaine Altan 5 mg/ml on the fetus during early pregnancy are unknown. Therefore, Levobupivacaine Altan 5 mg/ml should not be used during the first trimester 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 pass into breast milk.

Breastfeeding is therefore possible after the use of a local anaesthetic.

Driving and using machines

The use of Levobupivacaine Altan 5 mg/ml may have a considerable effect on the ability to drive and operate machinery. You must not drive or use machinery until all effects of Levobupivacaine Altan 5 mg/ml and of the 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 components of Levobupivacaine Altan:

Patients on low-sodium diets should take into account that this medicine contains 3.5 mg/ml of sodium in the solution in the bag or ampoule.

3. How to use Levobupivacaína Altan 5 mg/ml

Your doctor will administer Levobupivacaína Altan 5 mg/ml by injection either through a needle or via a small tube inserted into your back (epidural). Levobupivacaína Altan 5 mg/ml may 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 Levobupivacaína Altan 5 mg/ml is being administered.

Dosage

The amount of Levobupivacaína Altan 5 mg/ml that you will receive and how often it is given depends on the intended use and on your physical condition, age, and weight. You will be given the lowest dose that achieves anesthesia in the required area. Your doctor will carefully select the dose.

When Levobupivacaína Altan 2.5 mg/ml is used to relieve labor pain or for cesarean delivery (via epidural), the dose administered will be carefully controlled.

If you are given more Levobupivacaína Altan 5 mg/ml than you should

If you are given more Levobupivacaína Altan 5 mg/ml than recommended, you may experience numbness of the tongue, dizziness, blurred vision, muscle twitching, severe breathing difficulties (including respiratory arrest), and even seizures. If you notice any of these symptoms, inform your doctor immediately.

Sometimes, excessive Levobupivacaína Altan 5 mg/ml 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 one may cause adverse effects, although not everyone experiences them. Some of the adverse effects of Levobupivacaine Altan 5 mg/ml may be serious.

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

Very common adverse effects (may affect more than 1 in 10 patients):

• feeling tired or weak, difficulty breathing, paleness (all of these are signs of anaemia)
• low blood pressure
• nausea

Common adverse effects (may affect up to 1 in 10 patients):

• dizziness
• headache
• vomiting
• fetal distress
• back pain
• fever
• postoperative pain

Frequency not known (cannot be estimated from the available data):

• serious allergic reactions (hypersensitivity) causing severe breathing difficulty, difficulty swallowing, hives, and very low blood pressure
• allergic reactions (hypersensitivity) characterized by red, irritated skin, sneezing, excessive sweating, increased heart rate, fainting, or swelling of the face, lips, mouth, tongue, or throat
• seizures
• loss of consciousness
• somnolence
• blurred vision
• respiratory arrest
• cardiac block or cardiac arrest
• localized tingling
• numb tongue
• muscle weakness or tremors
• loss of control of urine and faeces
• paralysis
• tingling, numbness, or other unusual sensations
• prolonged penile erection, which may be painful
• nervous system disorders that may include eye closure, small pupils (central black part 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 may persist for a long period or become permanent. If you feel that any of the adverse effects you experience worsen, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or nurse.

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 via the Spanish Pharmacovigilance System for Human Medicinal Products website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levobupivacaine Altan 5 mg/ml

No special storage conditions are required.

Keep out of the sight and reach of children.

Do not use Levobupivacaine Altan 5 mg/ml 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 Levobupivacaine Altan 5 mg/ml 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 and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Levobupivacaine Altan 5 mg/ml

The active substance is levobupivacaine (as hydrochloride).

One millilitre of solution contains 5 mg of levobupivacaine (as hydrochloride). Each 10 ml vial contains 50 mg.

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

Appearance of the product and contents of the container

It is a clear, transparent solution presented in type I glass vials.

Each vial contains 50 mg of levobupivacaine in a 10 ml vial. It is supplied in packs of 5 and 10 vials.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Altan Pharmaceuticals, S.A.

C/ Cólquide, Nº 6, Portal 2, 1st Floor, Office F. Edificio Prisma,

28230 Las Rozas (Madrid) – Spain

Manufacturer:

Altan Pharmaceuticals, S.A.

Avda. de la Constitución, 198-199, Polígono Industrial Monte Boyal,

Casarrubios del Monte, 45950 Toledo – Spain

Altan Pharmaceuticals, S.A.

Polígono Industrial de Bernedo s/n 01118 Bernedo Álava-Spain

OTHER PRESENTATIONS
Levobupivacaine Altan 2.5 mg/ml solution for injection and infusion EFG
Levobupivacaine Altan 7.5 mg/ml solution for injection and infusion EFG
Levobupivacaine Altan 1.25 mg/ml solution for infusion EFG
Levobupivacaine Altan 0.625 mg/ml solution for infusion EFG

Date of latest review of this leaflet: 07/2023

Detailed and up-to-date 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:

Instructions for use/handling

Levobupivacaine Altan 5 mg/ml is for single use only. Any unused solution should 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 user's responsibility.

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 diluted with 0.9% sodium chloride for 7 days at 20–22°C. As with all parenteral medicinal products, the solution/dilution should be visually inspected prior to use. Only clear solutions without visible particles should be used.

Dilutions of standard levobupivacaine solutions should be performed 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 Altan 5 mg/ml 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 his/her supervision.

For information on dosage, refer to the Product Information Leaflet.

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.