LEVOBUPIVACAINE ALTAN 5 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User.

Levobupivacaine Altan 5 mg/ml Solution for Injection and Perfusion EFG

Levobupivacaine

Contents of the pack:

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

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

Levobupivacaine Altan 5 mg/ml 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 Altan 5 mg/ml is used as a local anesthetic to anesthetize parts of the body before major surgery (e.g., epidural for cesarean section) and minor surgery (such as eye or mouth surgery).

It is also used for pain relief

• after major surgery
• during childbirth

Children:

Levobupivacaine Altan 5 mg/ml can also be used in children to anesthetize parts of the body before surgery and for pain relief after minor surgery, such as inguinal hernia repair.

Levobupivacaine Altan 5 mg/ml has not been tested in children under 6 months.

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

Do not use Levobupivacaine Altan 5 mg/ml

• If you are allergic (hypersensitive) to levobupivacaine, to any other local anesthetic, or to any of the other ingredients of this medicine (see section 6)
• If you have very low blood pressure
• To relieve pain by injecting it into the area around the cervix during the early stages of labor (paracervical block).
• To anesthetize a part of the body by injecting Levobupivacaine Altan 5 mg/ml intravenously.

Warnings and precautions

Tell your doctor before you are given Levobupivacaine Altan 5 mg/ml if you have any of the following conditions or diseases. 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 Altan 5 mg/ml with other medicines:Tell your doctor or nurse if you are using, have recently used, or might use any other medicines. Especially, 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 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 or nurse before using this medicine. Levobupivacaine Altan 5 mg/ml should not be administered to relieve pain by injecting it into the area around the cervix during labor (paracervical block).

The effects of Levobupivacaine Altan 5 mg/ml on the fetus during the first stages of pregnancy are not known. Therefore, Levobupivacaine Altan 5 mg/ml 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 medicines, 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 Altan 5 mg/ml may have a considerable effect on your ability to drive and use machines. Do not drive or use machinery until all the effects of Levobupivacaine Altan 5 mg/ml and 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 Altan:

Patient with low sodium diets should note that this medicine contains 3.5 mg/ml of sodium in the solution of the bag or ampoule.

3. How to use Levobupivacaine Altan 5 mg/ml

Your doctor will give you Levobupivacaine Altan 5 mg/ml by injection through a needle or through a small tube inserted into your back (epidural). Levobupivacaine Altan 5 mg/ml 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 given Levobupivacaine Altan 5 mg/ml.

Dose

The amount of Levobupivacaine Altan 5 mg/ml that will be given to you and how often it will be given will depend on what it is used for and your physical condition, age, and weight. You will be given the minimum dose that achieves anesthesia in the required area. The dose will be carefully chosen by your doctor.

When Levobupivacaine Altan 2.5 mg/ml is used to relieve pain during childbirth or for cesarean section (epidural), the dose used will be carefully controlled.

If you are given too much Levobupivacaine Altan 5 mg/ml

If you are given too much Levobupivacaine Altan 5 mg/ml, you may experience numbness of the tongue, dizziness, blurred vision, muscle contraction, severe breathing difficulties (including respiratory arrest), and even convulsions. If you notice any of these symptoms, tell your doctor immediately.

Sometimes too much Levobupivacaine Altan 5 mg/ml can also cause low blood pressure, slow heart rate, or fast heart rate and changes in your heart rhythm. Your doctor may need to give you other medicines to help stop these symptoms.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, Levobupivacaine Altan 5 mg/ml can cause side effects, although not everybody gets them. Some of the side effects of Levobupivacaine Altan 5 mg/ml can be serious.

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

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

• Feeling tired or weak, difficulty breathing, pale skin (these are all signs of anemia)
• Low blood pressure
• Nausea

Common side 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):

• Severe allergic reactions (hypersensitivity) that cause severe breathing difficulties, difficulty swallowing, hives, and very low blood pressure.
• Allergic reactions (hypersensitivity) recognizable by red and irritated skin, sneezing, excessive sweating, increased heart rate, fainting, or swelling of the face, lips, mouth, tongue, or throat.
• Convulsions
• Loss of consciousness
• Somnolence
• Blurred vision
• Respiratory arrest
• Cardiac arrest or heart block
• Localized tingling
• Numb tongue
• Muscle weakness or tremors
• Loss of control of urine and feces
• Paralysis
• Tingling, numbness, or other unusual sensations
• Prolonged erection of the penis, which can be painful.
• Nervous system disorders that can include drooping eyelids, small pupils (black center of the eye), sunken eye socket, sweating, and/or flushing of one side of the face.

Bradyarrhythmia, tachyarrhythmia, irregular heartbeats, and changes in heart rhythm that can be seen on an ECG (electrocardiogram) have also been reported as side effects.

In very rare cases, some side effects can persist for a long time or become permanent. If you think you are experiencing any of the side effects mentioned above, or if you notice any side effects not mentioned in this leaflet, tell your doctor or nurse.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side 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 sight and reach of children.

Do not use Levobupivacaine Altan 5 mg/ml after the expiration date stated on the packaging after EXP. The expiration date is 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 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 no longer required. This will help 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 milliliter of solution contains 5 mg of levobupivacaine (as hydrochloride). Each 10 ml ampoule contains 50 mg.

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

Appearance and packaging

It is a clear, transparent solution packaged in type I glass ampoules.

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

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Altan Pharmaceuticals, S.A.

C/ Cólquide, Nº 6, Portal 2, 1ª Planta, Oficina 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-España

OTHER PRESENTATIONSLevobupivacaine Altan 2.5 mg/ml solution for injection and perfusion EFG Levobupivacaine Altan 7.5 mg/ml solution for injection and perfusion EFG Levobupivacaine Altan 1.25 mg/ml solution for perfusion EFG Levobupivacaine Altan 0.625 mg/ml solution for perfusion EFG

Date of last revision of this leaflet:07/2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es

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This information is intended only for healthcare professionals:

Instructions for use/handling

Levobupivacaine Altan 5 mg/ml 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 are the responsibility of the user.

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

Expiration after first opening: The product must be used immediately.

Expiration 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 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 and 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 0.9% sodium chloride injection. The chemical and physical stability in use has been demonstrated with clonidine, morphine, or fentanyl for 40 hours at 20-22°C.

Levobupivacaine Altan 5 mg/ml should not be mixed with other medicines except those listed above. Dissolution 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 should be performed 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 incremental doses at a rate of 7.5 - 30 mg/min, while monitoring the patient's vital functions and maintaining verbal contact with the patient.

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