Levobupivacaine Molteni

Leaflet accompanying the packaging: patient information

LEVOBUPIVACAINE MOLTENI 2.5 mg/ml solution for injection/infusion

LEVOBUPIVACAINE MOLTENI 5 mg/ml solution for injection/infusion

Levobupivacaine

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Levobupivacaine Molteni and what is it used for
• 2. Important information before using Levobupivacaine Molteni
• 3. How to use Levobupivacaine Molteni
• 4. Possible side effects
• 5. How to store Levobupivacaine Molteni
• 6. Contents of the packaging and other information

1. What is Levobupivacaine Molteni and what is it used for

Levobupivacaine Molteni belongs to a group of medicines called local anesthetics.
These types of medicines are used to numb or relieve pain in a specific area of the body.

What is Levobupivacaine Molteni used for

This medicine is used in adults and adolescents (aged 12 years and above):

• To numb a part of the body before a major surgical procedure, for example, as epidural anesthesia before a cesarean section.
• To numb a part of the body before a minor procedure, for example, in the eye or mouth.
• To relieve pain after surgery.
• To relieve pain during childbirth.

This medicine is used in children (under 12 years of age):

• To numb a part of the body before surgery.
• To relieve pain after a minor surgical procedure, for example, a hernia repair.

2. Important information before using Levobupivacaine Molteni

When not to use Levobupivacaine Molteni:

• if you are allergic to levobupivacaine, any other similar local anesthetic, or any of the other ingredients of this medicine (listed in section 6)
• if you have very low blood pressure
• as a type of anesthesia injected into the area around the cervix during childbirth (cervical block)
• to numb a part of the body by injecting the medicine into a vein

Warnings and precautions

Before starting treatment with Levobupivacaine Molteni, discuss with your doctor if you have any of the following conditions, as you may need to be monitored more closely or have a lower dose of the medicine:

• you have heart disease
• you have a disease affecting the nervous system
• you are weak or frail
• you are elderly
• you have liver function disorders. If any of these conditions apply to you (or if you are unsure), consult your doctor before using the medicine.

Levobupivacaine Molteni and other medicines

Tell your doctor or nurse about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription and herbal medicines.
In particular, tell your doctor or nurse if you are taking medicines for:

• heart rhythm disorders (e.g., mexiletine)
• fungal infections (e.g., ketoconazole) - this may affect how long Levobupivacaine Molteni stays in your body
• asthma (e.g., theophylline) - this may affect how long Levobupivacaine Molteni stays in your body
• If any of these conditions apply to you (or if you are unsure), consult your doctor before using the medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Reasons:

• Levobupivacaine Molteni should not be used to relieve pain during childbirth by injecting it into the area around the cervix (cervical block).
• Levobupivacaine Molteni should not be used during the first three months of pregnancy, unless your doctor considers it necessary. This is because the effect of the medicine on the fetus during early pregnancy is not known. It is not known whether Levobupivacaine Molteni passes into breast milk. However, based on experience with a similar medicine, it is expected that only small amounts of Levobupivacaine Molteni will pass into breast milk. Therefore, you can breastfeed after receiving the local anesthetic. If you are breastfeeding, talk to your doctor.

Driving and using machines

Do not drive or use machines while being treated with this medicine, as it may affect your ability to perform these activities. Wait until the effects of the medicine and the surgical procedure have worn off. Before leaving the hospital, discuss this with your doctor or nurse.

Levobupivacaine Molteni contains sodium

This medicine contains sodium. You should be aware of this if you are on a low-sodium diet.

• Levobupivacaine Molteni 2.5 mg/ml contains approximately 3.3 mg of sodium in 1 ml of solution, which corresponds to a sodium content of approximately 33 mg in a 10 ml ampoule.
• Levobupivacaine Molteni 5 mg/ml contains approximately 3.1 mg of sodium in 1 ml of solution, which corresponds to a sodium content of approximately 31 mg in a 10 ml ampoule.

3. How to use Levobupivacaine Molteni

Dose

The dose and frequency of administration of the medicine depend on the reason for its use, as well as the patient's health, age, and weight. The smallest dose that provides effective anesthesia should be used. The dose will be carefully determined by your doctor.
If this medicine is used to relieve pain during childbirth or a cesarean section (epidural anesthesia), the dose of the medicine will be carefully controlled.

Method of administration

Levobupivacaine Molteni is administered by a doctor via injection:

• using a needle or through a small catheter placed in the lower back (epidural anesthesia) or
• into other parts of the body to numb them (e.g., into the eye, hand, or foot). The doctor and nurse will closely monitor you while the medicine is being administered.

Using a higher dose of Levobupivacaine Molteni than recommended

If you think you have been given too much medicine, tell your doctor immediately.
Symptoms may include:

• numbness of the tongue
• dizziness
• blurred vision
• muscle twitching
• serious breathing problems
• seizures (fits) If you experience any of these symptoms, tell your doctor immediately. Sometimes, using a higher dose of Levobupivacaine Molteni than recommended may cause a decrease in blood pressure, an increase or decrease in heart rate, and changes in heart rhythm. Your doctor may need to give you other medicines to treat these symptoms. If you have any further questions about using this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur while using this medicine:
If you experience any of the following side effects, tell your doctor immediately:
Very common:may affect more than 1 in 10 people

• feeling tired or weak, shortness of breath, pale skin (these are symptoms of anemia)
• low blood pressure
• nausea

Common:may affect up to 1 in 10 people:

• dizziness
• headache
• feeling sick (vomiting)
• problems for the unborn baby
• back pain
• high body temperature (fever)
• post-operative pain

Frequency not known:frequency cannot be estimated from the available data

• severe allergic reactions, which can cause serious breathing problems, swallowing difficulties, hives, and very low blood pressure
• allergic reactions with red, itchy skin, sneezing, increased sweating, rapid heart rate, fainting, or swelling of the face, lips, mouth, tongue, or throat
• fainting
• drowsiness
• blurred vision
• breathing stop
• heart block or cardiac arrest
• tingling in some parts of the body
• numbness of the tongue
• weakness or twitching of muscles
• loss of control over the bladder or bowels
• paralysis
• seizures (fits)
• tingling, numbness, or other unusual sensations
• prolonged and painful erection of the penis
• nervous system problems, which can cause drooping eyelids, reduced pupil size, sunken eyes, sweating, and/or redness on one side of the face.

The following side effects have also been reported as observed in ECG: rapid, slow, or irregular heartbeat and changes in heart rhythm.
Rarely, some side effects may be long-lasting or permanent.
If any of the side effects get worse, or if you experience any side effects not listed in this leaflet, tell your doctor or nurse immediately.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309.
Website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levobupivacaine Molteni

Keep the medicine out of the sight and reach of children.
Do not use Levobupivacaine Molteni after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Shelf life after first opening: the medicinal product should be used immediately.
Do not use this medicine if the solution contains any visible particles or is not clear.
Medicines should not be disposed of via wastewater or household waste. This will help protect the environment.

6. Contents of the packaging and other information

What Levobupivacaine Molteni contains

The active substance of the medicine is levobupivacaine (as hydrochloride).

• Levobupivacaine Molteni 2.5 mg/ml, solution for injection/infusion: one ml of solution contains 2.5 mg of levobupivacaine (as hydrochloride). One 10 ml ampoule contains 25 mg of levobupivacaine.
• Levobupivacaine Molteni 5 mg/ml, solution for injection/infusion: one ml of solution contains 5 mg of levobupivacaine (as hydrochloride). One 10 ml ampoule contains 50 mg of levobupivacaine.

The other ingredients of the medicine are water for injections, sodium chloride, sodium hydroxide (for pH adjustment) or a small amount of hydrochloric acid (for pH adjustment).
Levobupivacaine Molteni contains a known ingredient (sodium). See section 2.

What Levobupivacaine Molteni looks like and contents of the packaging

Levobupivacaine Molteni solution for injection/infusion is a clear, colorless solution in polypropylene ampoules. Each ampoule contains 10 ml of solution.
The medicine is available in packs of 10 ampoules.

Marketing authorization holder and manufacturer

• L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67, Fraz. Granatieri, 50018 Scandicci (Firenze), Italy Tel: +3905573611 Fax: +39055720057 e-mail: [email protected]

This medicinal product has been authorized in the EEA member states under the following names:

France LEVOBUPIVACAINE MEDAC

Italy Levobupivacaina Molteni

Netherlands Levobupivacaine Molteni

Date of last revision of the leaflet:

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The following information is intended for healthcare professionals only:

Levobupivacaine Molteni 2.5 mg/ml or 5 mg/ml solution for injection/infusion

Instructions for use and preparation of the medicine

Levobupivacaine Molteni 2.5 mg/ml or 5 mg/ml solution for injection/infusion is for single use only. Any unused solution should be discarded.
From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions and duration of the prepared solution.
There is limited experience with the safety of levobupivacaine when used for longer than 24 hours.
Shelf life after dilution with sodium chloride 0.9% solution: chemical and physical stability of the solution has been demonstrated for 7 days at 20-22°C. Chemical and physical stability of the prepared solution with clonidine, morphine, or fentanyl has been demonstrated for 40 hours at 20-22°C.
As with all parenteral products, the solution should be inspected visually before use. Only clear solutions without visible particles should be used.
Dilutions of standard levobupivacaine solutions should be prepared with sodium chloride 9 mg/ml (0.9%) solution for injection using aseptic technique.
Compatibility of levobupivacaine injection solution with sodium chloride 9 mg/ml (0.9%) has been demonstrated with clonidine 8.4 μg/ml, morphine 0.05 mg/ml, and fentanyl 4 μg/ml.
Levobupivacaine Molteni should not be mixed with other medicines, except for those mentioned above. Dilution in alkaline solutions, such as sodium bicarbonate, may result in precipitation.

Dosage and administration

Levobupivacaine should only be administered by a doctor or under their supervision.
Aspiration should be performed carefully before injection and during injection to avoid intravascular administration.
Aspiration should be repeated before and during administration of the bolus dose, which should be injected slowly in divided doses at a rate of 7.5-30 mg/min, closely monitoring the patient's vital signs and maintaining verbal contact.
If signs of toxicity occur, the injection should be stopped immediately.
Maximum dose:

The maximum dose should be adjusted according to the patient's size, body build, and health status, as well as the concentration of the anesthetic and the site of administration.

There is variability in the onset of block and duration of action. Clinical experience suggests that the onset of sensory block suitable for surgery occurs within 10-15 minutes of epidural administration, and the duration of action is 6-9 hours.
The maximum recommended single dose is 150 mg. If it is necessary to maintain motor and sensory block due to a prolonged surgical procedure, additional doses may be required. The maximum recommended dose within 24 hours is 400 mg.
In the treatment of post-operative pain, do not exceed a dose of 18.75 mg/hour.
Obstetrics

• For cesarean section, do not use a concentration greater than 5.0 mg/ml (see section 4.3). The maximum recommended dose is 150 mg. When used for pain relief during labor, do not exceed a dose of 12.5 mg/hour.

Children and adolescents

The maximum recommended dose in analgesia (femoral nerve block/lumbar plexus block) is 1.25 mg/kg/side in children.
The maximum dose should be adjusted according to the patient's size, body build, and health status.
The safety and efficacy of levobupivacaine in children have not been established for other indications.
Special patient groups

Patients in poor general health, elderly patients, and patients with acute disease should be given reduced doses of levobupivacaine, according to their health status.
In the treatment of post-operative pain, the dose administered during surgery should be taken into account.
The following table provides dosage recommendations for the most commonly used blocks. In analgesia (e.g., epidural administration for pain relief), smaller concentrations and doses are recommended.

Dosage table

Adults and children (≥12 years)

Concentration (mg/ml)

Dose
Motor block
Anesthesia for
surgical procedure

Epidural anesthesia in (slow) bolus

for surgical
procedure

• - Adults5.0–7.5 10–20 ml (50–150 mg) Moderate to complete

Epidural anesthesia in slow

injection for
cesarean section
5.0
15–30 ml
(75–150 mg)
Moderate to
complete

Epidural anesthesia

Moderate to
complete

Peripheral nerve block

5.0
3 ml (15 mg)
2.5–5.0
1–40 ml
(2.5–150 mg
max.)
Moderate to
complete

Ophthalmic procedures (peribulbar block)

Moderate to
complete

Local infiltration anesthesia

• - Adults7.5 5–15 ml (37.5–112.5 mg)

2.5
1–60 ml
(2.5–150 mg
max.)
Not applicable

Pain relief

Pain relief during labor (epidural

2.5
6–10 ml
(15–25 mg)
Minimal to
moderate
anesthesia in bolus)

Pain relief during labor (epidural

anesthesia in infusion)
1.25
4–10 ml/h
(5–12.5 mg/hour)
Minimal to
moderate
Post-operative pain
1.25
2.5
10–15 ml/h
(12.5–18.75
mg/hour)
5–7.5 ml/h
(12.5–18.75
mg/hour)
Minimal to
moderate

Children under 12 years of age

Surgical anesthesia

Femoral nerve block/lumbar
plexus block
2.5
5.0
0.5 ml/kg/side
(1.25
mg/kg/side)
0.25 ml/kg/side
(1.25
mg/kg/side)
Moderate to
complete
Not applicable

Levobupivacaine, solution for injection/infusion, is available in concentrations of 2.5, 5.0, and 7.5 mg/ml.
Over a period of 5 minutes (see also text).
Administered over 15-20 minutes.
If levobupivacaine is combined with other agents, e.g., opioids for pain relief, the dose of levobupivacaine should be reduced, and a lower concentration (e.g., 1.25 mg/ml) is preferred.
The minimum recommended interval between injections is 15 minutes.
For information on dilution, see section 6.6.
For further information, refer to the Summary of Product Characteristics.