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.
• In case of any doubts, consult a doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 older):

• 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, such as a hernia repair.

2. Important information before using Levobupivacaine Molteni

When not to use Levobupivacaine Molteni:

• as a type of anesthesia injected into the cervix during childbirth (cervical block)
• to numb a part of the body by injecting Levobupivacaine Molteni into a vein

Warnings and precautions

Before starting to use Levobupivacaine Molteni, the patient should discuss with their doctor if they have any of the following conditions, as they may need to be monitored more closely or have a lower dose of the medicine:

• heart disease
• diseases affecting the nervous system
• being weak or ill
• being elderly
• liver function disorders If any of these conditions apply (or if there is any doubt), the patient should consult their doctor before using the medicine.

Levobupivacaine Molteni and other medicines

The patient should tell their doctor or nurse about all medicines they are taking, have recently taken, or plan to take, including those available without a prescription and herbal medicines.
In particular, they should tell their doctor or nurse if they are taking medicines for:

• heart rhythm disorders (e.g., mexiletine)
• fungal infections (e.g., ketoconazole) - this may affect how long Levobupivacaine Molteni stays in the body
• asthma (e.g., theophylline) - this may affect how long Levobupivacaine Molteni stays in the body
• If any of these conditions apply (or if there is any doubt), the patient should consult their doctor before using the medicine.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine. Reasons:

• Levobupivacaine Molteni should not be used to relieve pain during childbirth by injecting it into the cervix (cervical block).
• Levobupivacaine Molteni should not be used during the first three months of pregnancy, unless the doctor considers it necessary. This is because the effect of the medicine on the fetus in 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, breastfeeding can be continued after receiving the local anesthetic. If the patient is breastfeeding, they should discuss this with their doctor. There is no available data on the effect of this medicine on fertility.

Driving and using machines

The patient should not drive vehicles, ride bicycles, or use tools or machines during treatment with this medicine.
This is because the medicine can affect the patient's ability to perform these activities. The patient should wait until the effects of the medicine and the surgical procedure have worn off. Before leaving the hospital, the patient should discuss this with their doctor or nurse.

Levobupivacaine Molteni contains sodium

This medicine contains sodium. The patient should take this into account if they are on a low-sodium diet.

• Levobupivacaine Molteni 2.5 mg/ml contains approximately 3.3 mg of sodium per 1 ml of solution, which corresponds to a sodium content of approximately 33 mg per 10 ml ampoule.
• Levobupivacaine Molteni 5 mg/ml contains approximately 3.1 mg of sodium per 1 ml of solution, which corresponds to a sodium content of approximately 31 mg per 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 allows numbing of the body part should be used. The dose will be carefully determined by the 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 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 the patient during administration of the medicine.

Using a higher dose of Levobupivacaine Molteni than recommended

If the patient thinks they have been given too much medicine, they should tell their doctor immediately.
Symptoms may include:

• tingling of the tongue
• dizziness
• blurred vision
• muscle twitching
• serious breathing problems
• seizures (fits) If any of these symptoms occur, the patient should immediately inform their doctor. 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. The doctor may need to give the patient other medicines to treat these symptoms. If the patient has any further questions about using this medicine, they should ask their doctor or nurse.

4. Possible side effects

Like all medicines, Levobupivacaine Molteni can cause side effects, although not everybody gets them.
The following side effects may occur during use of this medicine:
If the patient experiences any of the following side effects, they should immediately inform their doctor:

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

Very common:may affect more than 1 in 10 people

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
• tingling 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 eyeball, sweating, and/or redness on one side of the face.

As side effects, changes in the ECG, such as fast, slow, or irregular heartbeat, and changes in heart rhythm, have also been reported.
Rarely, some side effects may be long-lasting or permanent.
If any side effect gets worse or if the patient experiences any side effects not listed in the leaflet, they should immediately inform their doctor or nurse.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309. Website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Levobupivacaine Molteni

The medicine should be stored out of 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 stated.
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 active substance (sodium). See section 2.

What Levobupivacaine Molteni looks like and contents of the pack

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 Levobupivacaine 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. Unused solution should be discarded.
From a microbiological point of view, the product should be used immediately. If the product is 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 a clear solution 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 in 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 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 who is experienced in the use of local anesthetics.
Aspiration should be carefully performed before injection and during injection to avoid intravascular administration.
Aspiration should be repeated before administration and during administration of the bolus dose, which should be injected slowly in divided doses at a rate of 7.5-30 mg/min, carefully monitoring the patient's vital signs and maintaining verbal contact.
If signs of toxicity occur, the injection of the medicine should be stopped immediately.
Maximum dose:

Children and adolescents

The maximum recommended dose for analgesia (femoral nerve block) in children is 1.25 mg/kg/side.
The maximum dose should be adjusted according to the patient's/child's weight, body size, and health status.
The efficacy and safety 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 given 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

Pain relief during labor (epidural

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

Children under 12 years of age

Surgical anesthesia

Block of the
femoral nerve/
ilioinguinal nerve
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 medicines, 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.