Levobupivacaine Altan 1.25 mg/ml solution for infusion EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the User Levobupivacaine Altan 1.25 mg/ml solution for infusion EFG

Levobupivacaine

Package leaflet:

1. What Levobupivacaine Altan 1.25 mg/ml is and what it is used for
2. What you need to know before using Levobupivacaine Altan 1.25 mg/ml
3. How to use Levobupivacaine Altan 1.25 mg/ml
4. Possible side effects
5. How to store Levobupivacaine Altan 1.25 mg/ml
6. Contents of the pack and other information

1. What Levobupivacaína Altan 1.25 mg/ml is and what it is used for

Levobupivacaína Altan 1.25 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 1.25 mg/ml is for use in adults only.

Levobupivacaína Altan 1.25 mg/ml is used for the treatment of pain:

• after major surgery
• during childbirth

2. What you need to know before using Levobupivacaine Altan 1.25 mg/ml

Do not use Levobupivacaine Altan 1.25 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 injection into the area around the cervix during early labour (paracervical block).

• For anaesthetizing a part of the body by intravenous administration of Levobupivacaine Altan 1.25 mg/ml.

Warnings and precautions

Tell your doctor before you are given Levobupivacaine Altan 1.25 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 a disease of the Nervous System
• If you are weak or unwell
• If you are elderly
• If you have liver disease.

Use of Levobupivacaine Altan 1.25 mg/ml with other medicines:

Tell 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 these may affect the metabolism of Levobupivacaine Altan 1.25 mg/ml
• Asthma (such as theophylline), as these may affect how long Levobupivacaine Altan 1.25 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 1.25 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 1.25 mg/ml on the foetus during early pregnancy are unknown. Therefore, Levobupivacaine Altan 1.25 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 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 may have a considerable effect on the ability to drive and use machines. You must not drive or operate machinery until all effects of Levobupivacaine Altan and 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 Levobupivacaine Altan 1.25 mg/ml: This medicine contains 15 mmol (345 mg) of sodium per 100 ml bag and 30 mmol (690 mg) of sodium per 200 ml bag, which should be taken into account in patients on a low-sodium diet.

3. How to use Levobupivacaine Altan 1.25 mg/ml

Your doctor will administer Levobupivacaine Altan 1.25 mg/ml to you as an injection through a needle or through a small tube inserted into your back (epidural). Your doctor and nurse will carefully monitor you while you are receiving Levobupivacaine Altan 1.25 mg/ml.

Dosage Adults: The amount of Levobupivacaine Altan 1.25 mg/ml that 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 Altan 1.25 mg/ml is used to relieve labour pain, the dose administered will be carefully controlled.

Children:

Use in children is not recommended.

If you are given more Levobupivacaine Altan 1.25 mg/ml than you should

If you are given more Levobupivacaine Altan 1.25 mg/ml than you should, 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, too much Levobupivacaine Altan 1.25 mg/ml can also cause hypotension, bradycardia or tachycardia, and changes in your heart rhythm. Your doctor may need to give you other medications to help stop these symptoms.

4. Possible adverse effects

Like all medicines, it may cause adverse effects, although not everyone experiences them. Some of the adverse effects of Levobupivacaine Altan 1.25 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 people):

• feeling tired or weak, difficulty breathing, paleness (all signs of anemia)
• 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 not known, cannot be estimated from available data):

• serious allergic reactions (hypersensitivity) causing severe difficulty breathing, 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 feces
• 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 center 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 that may be observed on an ECG (electrocardiogram) have also been reported as adverse effects.

In very rare cases, some adverse effects may 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 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 1.25 mg/ml

.

This medicinal product does not require special storage conditions.

Keep out of the reach and sight of children.

Do not use Levobupivacaine Altan after the expiry date stated on the container following Exp. The expiry date refers to the last day of the month indicated.

Your doctor will keep this medicine for you.

The solution should be used immediately after opening.

Do not use Levobupivacaine Altan 1.25 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 that you no longer need. This helps protect the environment.

6. Composition of Levobupivacaine Altan 1.25 mg/ml infusion solution

Composition of Levobupivacaine Altan 1.25 mg/ml infusion solution

The active substance is levobupivacaine (as hydrochloride). Levobupivacaine Altan 1.25 mg/ml: one ml contains 1.25 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 1.25 mg/ml is a clear, transparent solution.

Each polypropylene or polyolefin bag free of PVC contains 100 ml or 200 ml of solution. It is supplied in packs of 5 bags and 24 bags of 100 ml solution or in packs of 12 bags of 200 ml solution.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder:

Altan Pharmaceuticals, S.A.

C/ Cólquide 6, portal 2, 1st floor, office F, Edificio Prisma
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 medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

This information is intended for healthcare professionals only:

Instructions for use / handling

Levobupivacaine Altan 1.25 mg/ml is for single use only and 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 medicinal products, 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) with the addition of 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 of the product during use prior to administration are the responsibility of the user and normally should not exceed 24 hours at 2–8 °C, unless the solution has been prepared under controlled and validated aseptic conditions.

Levobupivacaine Altan 1.25 mg/ml must not be mixed with other medicinal products except those listed above. Mixing with alkaline solutions such as sodium bicarbonate may result in 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 Summary of Product Characteristics.

Careful aspiration before injection is recommended to prevent intravascular injection. If toxic symptoms occur, discontinue the injection immediately.