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

Patient Information Leaflet

Introduction

Patient Information Leaflet

Levobupivacaine Altan 0.625 mg/ml solution for infusion EFG

Levobupivacaine

Package leaflet:

1. What Levobupivacaine Altan 0.625 mg/ml is and what it is used for
2. What you need to know before using Levobupivacaine Altan 0.625 mg/ml
3. How to use Levobupivacaine Altan 0.625 mg/ml
4. Possible side effects
5. How to store Levobupivacaine Altan 0.625 mg/ml
6. Contents of the pack and other information

1. What Levobupivacaína Altan 0.625 mg/ml is and what it is used for

Levobupivacaína Altan 0.625 mg/ml 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 Altan 0.625 mg/ml solution for infusion is for use in adults only.

Levobupivacaína Altan 0.625 mg/ml is used for the treatment of pain:

• after major surgery,
• during childbirth.

2. What you need to know before using Levobupivacaína Altan 0.625 mg/ml

Do not use Levobupivacaína Altan 0.625 mg/ml

• If you are allergic (hypersensitive) to levobupivacaine, to any other similar local anaesthetic, or to any of the other ingredients of this medicine (see section 6)
• If you have very low blood pressure
• To relieve pain by administering it via injection around the cervix during early labour (paracervical block)
• To anaesthetize a part of the body by injecting Levobupivacaína Altan 0.625 mg/ml intravenously.

Warnings and precautions

Inform your doctor or nurse before receiving Levobupivacaína Altan 0.625 mg/ml if you have any of the following conditions or diseases. You may require closer monitoring or a lower dose.

• If you suffer from a nervous system disorder
• If you are weak or unwell
• If you are elderly
• If you have liver disease

Use of Levobupivacaína Altan 0.625 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. Especially inform them if you are taking medicines for:

• Arrhythmias (such as mexiletine)
• Fungal infections (such as ketoconazole), as they may affect the metabolism of Levobupivacaína Altan 0.625 mg/ml
• Asthma (such as theophylline), as they may affect how long Levobupivacaína Altan 0.625 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. Levobupivacaína Altan 0.625 mg/ml should not be administered to relieve pain by injection around the cervix during labour (known as paracervical block).

The effects of Levobupivacaína Altan 0.625 mg/ml on the fetus during early pregnancy are unknown. Therefore, Levobupivacaína Altan 0.625 mg/ml 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 medicines, it is expected that only small amounts of levobupivacaine pass into breast milk. Breastfeeding is therefore possible after using a local anaesthetic.

Driving and using machines

The use of Levobupivacaína Altan may have a significant effect on the ability to drive and use machines. You should not drive or operate machinery until all effects of Levobupivacaína and surgery have worn off. Make sure you have received advice about this from your doctor or nurse before leaving the hospital.

Important information about some of the components of Levobupivacaína Altan 0.625 mg/ml: This medicine contains 15 mmol (3.5 mg/ml) of sodium per 100 ml bag, which should be taken into consideration in patients on low-sodium diets.

3. How to use Levobupivacaine Altan 0.625 mg/ml

Your doctor will administer Levobupivacaine Altan 0.625 mg/ml by injection through a needle or via a small tube inserted into your back (epidural). Your doctor and nurse will carefully monitor you while Levobupivacaine Altan 0.625 mg/ml is being given.

Dosage Adults:

The amount of Levobupivacaine Altan 0.625 mg/ml that you will be given and how often it is administered will depend on the intended use and on your physical condition, age, and weight. The lowest dose required to achieve anesthesia in the desired area will be administered. Your doctor will carefully select the dose.

When Levobupivacaine Altan 0.625 mg/ml is used to relieve labor pain, the dose will be carefully controlled.

Children:

Use in children is not recommended.

If you are given more Levobupivacaine Altan 0.625 mg/ml than you should:

If you are given more Levobupivacaine Altan 0.625 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.

Excessive amounts of Levobupivacaine Altan 0.625 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.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. Some of the adverse effects of Levobupivacaine Altan 0.625 mg/ml solution for infusion 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 people):

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

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

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

Unknown frequency (frequency cannot be estimated from 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.

• loss of consciousness.
• drowsiness
  • 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
  • seizures
  • tingling, numbness, or other unusual sensations
  • prolonged penile erection, which may be painful
  • nervous system disorders that may include eyelid closure, small pupils (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 may become permanent.

If you consider that any of the adverse effects you experience worsen, or if you notice any adverse effects not listed 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines 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 0.625 mg/ml

This medicine does not require special storage conditions.

Keep out of the reach and sight of children.

Do not use Levobupivacaine Altan 0.625 mg/ml 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 Levobupivacaine Altan 0.625 mg/ml 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 containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Levobupivacaine Altan 0.625 mg/ml solution for infusion

The active substance is levobupivacaine (as hydrochloride).

Levobupivacaine Altan 0.625 mg/ml: one ml contains 0.625 mg of levobupivacaine (as hydrochloride).

The other components are water for injection, sodium chloride, sodium hydroxide, and a small amount of hydrochloric acid.

Appearance of the product and contents of the container

Levobupivacaine Altan 0.625 mg/ml is a clear, transparent solution. Each polypropylene or polyolefin bag, free of PVC, contains 100 ml of solution. It is supplied in packs of 5 bags and 24 bags of 100 ml solution.

Marketing Authorization Holder and Manufacturer

Holder: Altan Pharmaceuticals, S.A.
C/ Cólquide 6, Portal 2, 1st Floor, Office F, Edificio Prisma, Las Rozas,
28230 Madrid (Spain).

Manufacturer:
Altan Pharmaceuticals, S.A.
P.I. Bernedo S/N.
01118 Bernedo, Álava-Spain

This leaflet was last reviewed in 07/2023

Detailed and up-to-date information on this medicine 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 medical or healthcare professionals only:

Instructions for use/handling

Levobupivacaine Altan 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 intact. Any unused solution should be discarded.

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

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

Shelf life after dilution with 0.9% sodium chloride solution:

Chemical and physical in-use stability has been demonstrated for both concentrations of levobupivacaine (0.625 mg/ml and 1.25 mg/ml) when combined with 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 both concentrations of levobupivacaine (0.625 mg/ml and 1.25 mg/ml) with sufentanil added at a concentration of 0.4 micrograms/ml, stored for 30 days at 2–8 °C or 20–22 °C.

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

Levobupivacaine Altan 0.625 mg/ml solution for infusion must not be mixed with other medicinal products except those listed above. Mixing 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 Leaflet (SmPC).

Careful aspiration should be performed prior to injection to prevent intravascular injection. If signs of toxicity occur, the injection must be stopped immediately.