Levobupivacaine Altan 2,5 mg/ml solution for injection and infusion EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet.

Levobupivacaine Altan 2.5 mg/ml solution for injection and infusion EFG

Levobupivacaine

Package leaflet contents:

1. What Levobupivacaine Altan 2.5 mg/ml is and what it is used for
2. What you need to know before using Levobupivacaine Altan 2.5 mg/ml
3. How to use Levobupivacaine Altan 2.5 mg/ml
4. Possible side effects
5. Storage of Levobupivacaine Altan 2.5 mg/ml
6. Contents of the pack and other information

1. What Levobupivacaine Altan 2.5 mg/ml is and what it is used for

Levobupivacaine Altan 2.5 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.

Adults: Levobupivacaine Altan 2.5 mg/ml is used as a local anaesthetic to numb parts of the body before major surgery (for example, epidural anaesthesia in 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:

Levobupivacaine Altan 2.5 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.

Levobupivacaine Altan 2.5 mg/ml has not been studied in children under 6 months of age.

2. What you need to know before using Levobupivacaine Altan 2.5 mg/ml

Do not use Levobupivacaine Altan 2.5 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 2.5 mg/ml intravenously

Warnings and precautions

Inform your doctor or nurse before you are given Levobupivacaine Altan 2.5 mg/ml if you have any of the following conditions or diseases. 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 2.5 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, including those obtained without a prescription. 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 2.5 mg/ml
• Asthma (such as theophylline), as this may affect how long Levobupivacaine Altan 2.5 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 2.5 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 2.5 mg/ml on the fetus during early pregnancy are unknown. Therefore, Levobupivacaine Altan 2.5 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 would pass into breast milk. Breastfeeding is therefore possible after using a local anaesthetic.

Driving and using machines

The use of Levobupivacaine Altan 2.5 mg/ml 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 2.5 mg/ml and of the surgery have worn off. Make sure you have been advised about this by your doctor or nurse before leaving the hospital.

Important information about some of the components of Levobupivacaine Altan:

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

3. How to use Levobupivacaine Altan 2.5 mg/ml

Your doctor will administer Levobupivacaine Altan 2.5 mg/ml by injection through a needle or through a small tube inserted into your back (epidural). Levobupivacaine Altan 2.5 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 you are receiving Levobupivacaine Altan 2.5 mg/ml.

Dosage

The amount of Levobupivacaine Altan 2.5 mg/ml 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 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 Levobupivacaine Altan 2.5 mg/ml than you should:

If you are given more Levobupivacaine Altan 2.5 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, excessive Levobupivacaine Altan 2.5 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 stop 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 can cause adverse effects, although not everyone experiences them. Some of the adverse effects of Levobupivacaine Altan 2.5 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 people):

• feeling tired or weak, difficulty breathing, paleness (all are 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

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

• serious allergic reactions (hypersensitivity) causing severe breathing difficulties, 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 bowel movements
• paralysis
• tingling, numbness, or other unusual sensations
• prolonged penile erection, which may be painful
• nervous system disorders that may include eye closure, small pupils (the 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 persist for a long time or 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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines at the 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 2.5 mg/ml

No special storage conditions are required.

Keep out of the sight and reach of children.

Do not use Levobupivacaine Altan 2.5 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 2.5 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 properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Levobupivacaine Altan 2.5 mg/ml

The active substance is levobupivacaine (as hydrochloride).

One millilitre of solution contains 2.5 mg of levobupivacaine (as hydrochloride). Each 10 ml vial contains 25 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 packaged in Type I glass vials.

Each vial contains 25 mg 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 FORMULATIONS

Levobupivacaine Altan 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 the most recent revision of this leaflet: 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 healthcare professionals only:

Instructions for use/handling

Levobupivacaine Altan 2.5 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 this is not possible, the storage time and conditions of the product after opening are the responsibility of the user.

Experience regarding the safety of treatment with levobupivacaine for longer 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 medications, the solution/dilution should be inspected visually before use. Only clear solutions without visible particles should be used.

Standard dilutions of levobupivacaine solutions should be prepared 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. In-use chemical and physical stability has been demonstrated with clonidine, morphine, or fentanyl for 40 hours at 20–22 °C.

Levobupivacaine Altan 2.5 mg/ml should 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 by a physician with appropriate training and experience, or under their supervision.

For information on dosage, refer to the Summary of Product Characteristics. Careful aspiration should be performed 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 signs of toxicity occur, the injection should be stopped immediately.