Prospect: Information for the user.

Levobupivacaína Altan 7.5 mg/ml injectable solution and for perfusion EFG

Levobupivacaína

1. What is Levobupivacaína Altan 7.5 mg/ml and how is it used

2. What you need to know before starting to useLevobupivacaína Altan 7.5 mg/ml

3. How to use Levobupivacaína Altan 7.5 mg/ml
4. Possible adverse effects

5. Storage of Levobupivacaína Altan 7.5 mg/ml

6. Contents of the package and additional information

Levobupivacaína Altan 7.5 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:

Levobupivacaína Altan 7.5 mg/ml is used as a local anesthetic to anesthetize parts of the body before major surgery (except in cases of cesarean section) and minor surgery (such as eye or mouth surgery).

It is also used for

• pain reliefafter major surgery

Children:

Levobupivacaína Altan 7.5 mg/ml can also be used in children to anesthetize parts of the body before anoperation and for pain relief after minor surgery, such as an inguinal hernia.

Levobupivacaína Altan 7.5 mg/ml has not been tested in children under 6 months.

No use Levobupivacaína Altan 7,5 mg/ml

• If you are allergic (hypersensitive) to levobupivacaine, to any local anesthetic similar or to any of the other components of this medication (see section 6)

• If you have very low blood pressure

• To anesthetize a part of the body by injecting Levobupivacaína Altan 7,5 mg/ml intravenously.
•For the treatment of pain during childbirth

Warnings and precautions

Inform your doctor before they administer Levobupivacaína Altan 7,5 mg/ml if you have any of the conditions or diseases listed below. You may need closer monitoring or a lower dose.

• If you suffer from heart disease
• If you suffer from a nervous system disease
• If you are weak or ill
• If you are elderly
• If you have liver disease.

Use of Levobupivacaína Altan 7,5mg/ml with other medications:

Inform your doctor or nurse if you are using, have used recently or may need to use any other medication. Inform them especially if you are taking medications for:

• Arrhythmias (such as mexiletine)

• Fungal infections (such as ketoconazole) as they may affect the metabolism of Levobupivacaína Altan 7,5 mg/ml

• Asthma (such as theophylline) as it may affect how long Levobupivacaína Altan 7,5 mg/ml remains in your body.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, consult your doctor or nurse before using this medication.Levobupivacaína 7,5 mg/ml should not be administered to relieve pain during childbirth or as a local anesthetic during cesarean section. The effects of Levobupivacaína Altan 7,5 mg/ml on the fetus during the early stages of pregnancy are unknown. Therefore, Levobupivacaína Altan 7,5 mg/ml should not be used during the first three months of pregnancy, unless your doctor considers it necessary.

The passage of levobupivacaine through breast milk is unknown. However, based on experience with similar medications, it is expected that only small amounts of levobupivacaine will pass through breast milk.

Therefore, breastfeeding is possible after using a local anesthetic.

Driving and operating machinery

The use of Levobupivacaína Altan 7,5 mg/ml may have a significant effect on your ability to drive and operate machinery. Do not drive or operate machinery until the effects of Levobupivacaína Altan 7,5 mg/ml and surgery have passed. Ensure that you are advised on this by your doctor or nurse before leaving the hospital.

Important information about some of the components of Levobupivacaína Altan:

Patients with a low-sodium diet should note that this product contains 3.5 mg/ml of sodium in the solution of the bag or ampoule.

Levobupivacaína Altan 7,5 mg/ml can be injected into the parts of the body whose area you want to anesthetize, such as the eye, arm, or leg. Your doctor and nurse will closely monitor you while Levobupivacaína Altan 7,5 mg/ml is being administered to you.

Dose

The amount of Levobupivacaína Altan 7,5 mg/ml that will be administered to you and the frequency with which it will be done will depend on what it is being used for and your physical condition, age, and weight. You will be administered the minimum dose that achieves the required anesthesia in the area. The dose will be carefully chosen by your doctor.

If you are administered more Levobupivacaína Altan7,5 mg/ml than you shouldIf you are administered more Levobupivacaína Altan 7,5 mg/ml than you should, you could experience tongue numbness, dizziness, blurred vision, muscle contraction, severe breathing difficulties (including respiratory arrest) and even seizures. If you notice any of these symptoms, inform your doctor immediately.

Too much Levobupivacaína Altan 7,5 mg/ml can also sometimes cause hypotension, bradycardia, 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 other questions about the use of this medication, ask your doctor or nurse.

Like all medicines, it can have side effects, although not everyone will experience them. Some of the side effects of Levobupivacaína Altan 7.5 mg/ml can be severe.

If you consider that you are experiencing any of the side effects listed below, inform your doctor or nurse immediately.

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

• feeling of fatigue or weakness, difficulty breathing, paleness (all are signs of anemia)
• low blood pressure
• nausea

Common side 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) that cause severe difficulty breathing, severe difficulty swallowing, urticaria, 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
• seizures
• loss of consciousness
• drowsiness
• blurred vision
• respiratory arrest
• cardiac arrest or heart block
• localized numbness
• numb tongue
• muscle weakness or tremors
• loss of bladder and bowel control
• paralysis
• numbness, numbness, or other unusual sensations
• prolonged erection of the penis, which may be painful
• nervous system disorders that may include eye closure, small pupils (black center 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 that may be seen on an ECG (electrocardiogram) have also been reported as side effects.

In very rare cases, some side effects may persist for a long period or become permanent.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use Website:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

No special conservation conditions are required.

Keep out of sight and reach and out of sight of children.

Do not use Levobupivacaína Altan 7.5 mg/ml after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Your doctor will store this medication for you.

The solution must be used immediately after opening.

Do not use Levobupivacaína Altan 7.5 mg/ml if you observe particles within the solution.

Medicines should not be thrown into the drains or trash. Ask your pharmacist how to dispose of the packaging and medicines that you do not need. This will help protect the environment.

Composition of Levobupivacaína Altan 7.5 mg/ml

The active principle is levobupivacaína (as hydrochloride)

One milliliter of solution contains 7.5 mg of levobupivacaína (as hydrochloride). Each ampoule of 10 ml contains 75 mg.

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

Appearance of the product and contents of the package

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

Each ampoule contains 75 mg levobupivacaine in a 10 ml ampoule. It is supplied in packs of 5 and 10 ampoules.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Altan Pharmaceuticals, S.A.

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

28230 Las Rozas (Madrid) – Spain

Responsible for manufacturing:

Altan Pharmaceuticals, S.A.

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

Casarrubios del Monte, 45950 Toledo – Spain

Altan Pharmaceuticals, S.A.

Industrial Estate of Bernedo s/n

01118 Bernedo Álava-Spain

OTHER PRESENTATIONS
Levobupivacaína Altan 2.5 mg/ml injectable solution and for perfusion EFG
Levobupivacaína Altan5 mg/ml injectable solution and for perfusion EFG
Levobupivacaína Altan 1.25 mg/ml solution for perfusion EFG
Levobupivacaína Altan 0.625 mg/ml solution for perfusion EFG

Date of the last review of this leaflet:07/2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es
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This information is intended solely for doctors or healthcare professionals:

Instructions for use/manipulation

Levobupivacaína Altan 7.5 mg/ml is only for single use. Discard any unused solution.

From a microbiological point of view, the product must be used immediately after opening. If not, the storage time and conditions of the product in use before using it are the responsibility of the user.

The experience on the safety of treatment with levobupivacaína for more than 24 hours is limited.

Expiration date after the first opening: The product must be used immediately

Expiration date 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 for all parenteral medications, the solution/dilution must be visually inspected prior to use. Only clear solutions without visible particles should be used.

The dilutions of standard levobupivacaína solutions must be made with 0.9% sodium chloride injectable solution 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 levobupivacaína in 0.9% sodium chloride injectable solution. The chemical and physical stability in use has been demonstrated with clonidine, morphine, or fentanyl for 40 hours at 20-22 °C.

Levobupivacaína Altan 7.5 mg/ml should not be mixed with other medications except those listed above. Dissolution with alkaline solutions such as sodium bicarbonate may lead to precipitation.

Administration form

Levobupivacaína administration should be performed by a doctor with the necessary training and experience or under their supervision.

For information on dosage, consult the Technical Data Sheet of the product.

Careful aspiration before and during injection should be performed to prevent intravascular injection.

Aspiration should be repeated before and during administration of a bolus dose, which should be injected slowly and in increments of dose 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, interrupt the injection immediately.