BUPISEN 2.5 mg/ml Roztwór do wstrzykiwań

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1. BUPISEN 2.5 mg/ml injectable solution, 5 mg/ml injectable solution, hyperbaric 5 mg/ml injectable solution, hyperbaric 7.5 mg/ml injectable solution, hyperbaric 10 mg/ml injectable solution
   1. What is BUPISEN and what is it used for
   2. What you need to know before you are given BUPISEN
   3. How to use BUPISEN
   4. Possible side effects
   5. How to store BUPISEN
   6. Contents of the pack and other information

BUPISEN 2.5 mg/ml injectable solution, 5 mg/ml injectable solution, hyperbaric 5 mg/ml injectable solution, hyperbaric 7.5 mg/ml injectable solution, hyperbaric 10 mg/ml injectable solution

Bupivacaine hydrochloride
Equivalent medicinal product

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What BUPISEN is and what it is used for
• 2. What you need to know before you use BUPISEN
• 3. How to use BUPISEN
• 4. Possible side effects
• 5. How to store BUPISEN
• 6. Contents of the pack and other information

1. What is BUPISEN and what is it used for

BUPISEN contains the active ingredient bupivacaine hydrochloride and belongs to a class of medicines called local anesthetics,
used before a surgical procedure to induce anesthesia.
BUPISEN can be used to induce peripheral anesthesia (local infiltration, nerve block, loco-regional, sympathetic block, sacral peridural, spinal -subarachnoid).
BUPISEN is indicated, either alone or in combination with other narcotic medicines, in the following procedures:

• general surgery;
• bones and joints (orthopedics);
• eyes (ophthalmology);
• ear and throat (otorhinolaryngology);
• oral cavity (dentistry);
• genitals and during childbirth (obstetrics-gynecology);
• skin (dermatology).

2. What you need to know before you are given BUPISEN

You must not be given BUPISEN:

• if you are allergic to bupivacaine hydrochloride, to similar substances (amido-type anesthetics) or to any of the other ingredients of this medicine (listed in section 6);
• if you are to undergo a type of anesthesia near a regional vein (Bier Block);
• if you suffer from diseases of the central nervous system (meningitis, tumors, poliomyelitis, intracranial hemorrhages, spinal stenosis), diseases of the spine (spondylitis, tuberculosis, tumor) orif you have recently suffered a trauma (fractures);
• if you suffer from infections characterized by the presence of bacteria in the blood (septicemia);
• if you have a vitamin B12 deficiency (pernicious anemia), associated with problems with the spinal cord(subacute degeneration of the spinal cord);
• if you have a skin infection caused by bacteria (pyogenic) at the injection site or in the surrounding area;
• if you have had a block in the functioning of the heart (cardiogenic shock) or if you have a reduced blood volumedue to bleeding or fluid loss (hypovolemic shock);
• if you suffer from blood clotting disorders or if you are taking medicines used to prevent theformation of blood clots (anticoagulants).

Hyperbaric BUPISEN 7.5 mg/ml injectable solution must not be used in epidural anesthesia

during labor (obstetric epidural anesthesia).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given BUPISEN.
In case of epidural anesthesia or peripheral nerve block, this medicine must be given to you
under the direct supervision of a doctor, as serious side effects may occur, such as:

• blockage of heart function, and death; these effects may occur especially withthe use of hyperbaric BUPISEN 7.5 mg/ml injectable solution.

In addition, during treatment with BUPISEN, problems with the central nervous system,
heart and blood vessels (cardiovascular problems, ventricular arrhythmias, ventricular fibrillation, sudden cardiovascular collapse) and death may occur, when this medicine is present in high concentrations in the blood,
especially when accidentally administered into the blood (intravascularly) or in areas rich in blood vessels (highly vascularized). When BUPISEN is used at the recommended doses, the concentrations of
this medicine in the blood do not reach high levels.
Following the use of similar medicines (local anesthetics), serious side effects have been reported,
including death. Therefore, this medicine will only be given to you under strict medical control
and by specialized personnel and in facilities equipped with the emergency measures necessary for emergency treatment.
This medicine must be given to you with great caution and under strict medical supervision if:

• you are elderly or debilitated;
• you suffer from heart problems (partial or complete heart block), as this medicine may decrease the contraction of the heart (cardiac conduction);
• you have a severe liver disease or if you have a severe impairment of kidney function;
• you are in the late stages of pregnancy;
• you have a reduced blood volume (hypovolemia), as this medicine during intrathecal anesthesia, may cause a severe and sudden drop in blood pressure (hypotension);
• you are taking medicines used for heart rhythm disorders (Class III antiarrhythmics), such as amiodarone. In this case, the doctor may decide to monitor the functioning of the heart (electrocardiogram);
• you suffer from nervous system disorders (multiple sclerosis, hemiplegia, paraplegia) or disorders of the nerves and muscles (neuromuscular);
• you have suffered a trauma to the joints (major intra-articular) or if you have undergone joint surgery and BUPISEN is to be administered by the intra-articular route;
• you have reduced heart and blood vessel function (reduced cardiovascular function) and BUPISEN is to be administered by the epidural route;
• you are taking medicines used for the treatment of mood disorders (MAOIs, tricyclic antidepressants);
• you are to undergo an anesthesia called stellate ganglion block.

The doctor will monitor you during treatment with this medicine as some anesthesia techniques can cause even serious side effects:

• epidural anesthesia or central nervous system block, alterations in heart and blood vessel function (cardiovascular depression) may occur, especially if a reduction in blood volume is already present (hypovolemia). In addition, a decrease in blood pressure (hypotension) and a slowing of the heartbeat (bradycardia) may occur. A decrease in blood pressure may require immediate intravenous administration of medicines used to stimulate the heart (sympathomimetics);

• stellate ganglion blockmay cause side effects similar to those of central nervous system block as well as cardiac toxicity with an increase or decrease in heart rate up to cardiac arrest.
• injections into the eyes (retrobulbar), very rarely temporary loss of vision (temporary blindness), blockage of heart and circulation (cardiovascular collapse), difficulty breathing (apnea) and convulsions may occur, which must be treated immediately;
• injections into the eyes (retrobulbar) or around the eyes (peribulbar), persistent disorders of the eye muscles may occur; therefore, the lowest doses and concentrations of anesthetic should be used;
• paracervical block, a decrease or increase in the fetal heart rate may occur. Therefore, during the use of this medicine, the fetal heart rate must be monitored;
• spinal anesthesia, total or high spinal block may occur, with blockage of heart function and circulation (cardiovascular depression) and blockage of breathing (respiratory depression). These effects may be more likely if you are elderly or in the late stages of pregnancy; in this case, the dose should be reduced;
• intrathecal anesthesia, rare damage to the brain (paresthesia, anesthesia, motor weakness and paralysis) may occur, which in some cases may be permanent;

In case of local anesthesia in areas such as fingers, root of the penis, bupivacaine without
adrenaline will be administered to you to prevent tissue damage (ischemic necrosis).
Before using this medicine, the doctor must check the condition of blood circulation.
The doctor may decide to use a test dose of this medicine in association with adrenaline, to
avoid accidental intravenous or intrathecal injection.
During administration, the doctor will carefully monitor you, immediately stopping
treatment at the first sign of alarm, for example if you experience changes in
sensitivity or drowsiness (altered sensorium).
Rare cases of severe reactions, even in non-allergic people, have been reported; therefore, during the use of
this medicine, immediate availability of equipment, medicines and
specialized personnel for emergency treatment is necessary.

Children
The safety and efficacy of Bupisen in children <1 year of age have not been established. Only limited
data are available.
In epidural anesthesia, the dose must be adjusted to weight and age.

Other medicines and BUPISEN
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take
any other medicines.
Use this medicine with caution and tell your doctor if you are taking:

• other medicines used to reduce pain during surgery (amido-type local anesthetics, such as lidocaine);
• medicines similar to BUPISEN, such as some medicines used to treat heart rhythm disorders, mexiletine and tocainide;
• medicines used to treat depression (MAOIs, tricyclic antidepressants).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.
Pregnancy

If you are in the late period of pregnancy, the dose in case of spinal anesthesia must be reduced.
Paracervical anesthesia is associated with an increased risk of adverse effects on the fetus (see
Warnings and precautions).
Breastfeeding
Use this medicine with caution if you are breastfeeding, as BUPISEN passes into
breast milk in small amounts.

Driving and using machines
BUPISEN impairs the ability to drive vehicles or operate machinery.
BUPISEN may cause mild disturbances to the mind and control of movements (coordination). If you experience
these symptoms, avoid driving vehicles and operating machinery.

BUPISEN 2.5 mg/ml and 5mg/ml injectable solution contains sodium
This medicine contains 3.15 mg/ml (0.137 mmol/ml) of sodium. This should be taken into consideration in people
with impaired kidney function or who are following a low-sodium diet.

3. How to use BUPISEN

This medicine will be administered to you by a doctor or specialized personnel during surgical procedures. If you have any doubts, consult your doctor, pharmacist or nurse.
The dose and method of administration will be established by the doctor based on needs and age.
The vials and syringes do not contain preservative excipients and must be used for a single administration, discarding the residual medicine.

Use in adults and children over 12 years of age
The dose should be the minimum possible that allows adequate anesthesia, the recommended dose ranges from 2-3 mg to 100-150 mg.
Do not exceed the maximum dose of 150 mg, corresponding to 30 ml of the 5 mg/ml solution and 60 ml of the 2.5 mg/ml solution.

Use in children from 1 to 12 years of age
The doctor will adjust the dose based on body weight.

If you use more BUPISEN than you should
Accidental injection into a vessel may cause toxic effects after a few seconds or minutes.
Following the administration of an excessive dose of this medicine, toxic effects (systemic toxic reactions) may occur 15-60 minutes after the injection.

It is unlikely that hyperbaric BUPISEN, if administered under the recommended conditions, can cause general toxicity. However, if other medicines similar to

hyperbaric BUPISEN are administered simultaneously, the toxic effects may be additive.
In case of accidental use/ingestion of an excessive dose of this medicine, immediately notify your doctor or go to the Emergency Room of the nearest hospital.

If you forget to use BUPISEN
This medicine will be administered to you by a doctor or a nurse, so it is unlikely that a dose will be forgotten.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist 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:

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

• decrease in blood pressure (hypotension);
• nausea.

Common(may affect up to 1 in 10 people):

• sensory disturbances of legs and arms or other parts of the body (paresthesia), dizziness, headache (after puncture of the dura mater, post-dural puncture headache);
• slowing of the heartbeat (bradycardia);
• increase in blood pressure (hypertension);
• vomiting;
• inability of the bladder to empty (urinary retention), involuntary loss of urine (urinary incontinence).

Uncommon(may affect up to 1 in 100 people):

• central nervous system toxicity: convulsions, sensory disturbance around the mouth (paresthesia in the circumoral region), numbness of the tongue, intolerance to sounds (hyperacusis), vision disturbances, loss of consciousness, tremor, feeling of emptiness in the head, perception of ringing in the ears (tinnitus), speech disorders (dysarthria), contraction disorder of one or more muscles (paresis), sensory disturbance (dysesthesia);
• muscle weakness, back pain.

Rare(may affect up to 1 in 1,000 people):

• allergic reactions, severe allergic reaction (anaphylactic shock);
• inflammation of the nerves (neuropathy), nerve damage (peripheral nerve lesion), inflammation of the membrane surrounding the brain and spinal cord (arachnoiditis), loss of the ability to contract one or more muscles (paresis), movement and sensory disturbances of the lower limbs (paraplegia), total spinal block (unintentional), decrease or loss of contraction of one or more muscles (paralysis).
• double vision (diplopia);
• heart block (cardiac arrest), heart rhythm disturbances (cardiac arrhythmias);
• breathing problems (respiratory depression).

Not known(frequency cannot be estimated from available data)

• excitation, disorientation, pupil dilation (mydriasis), increased metabolism and body temperature, contraction of the jaw muscles (trismus), sweating, increased respiratory rate (tachypnea), bronchial dilation (bronchodilation), increased blood vessel volume (vasodilation);
• allergic reactions with local manifestations such as skin irritation (urticaria, pruritus) or systemic bronchial muscle contraction (bronchospasm);

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store BUPISEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BUPISEN 2.5 mg/ml injectable solution contains

• The active ingredient is bupivacaine hydrochloride: 1 ml of solution contains 2.5 mg of bupivacaine hydrochloride.
• The other ingredients are: sodium chloride, water for injections.

What BUPISEN 5 mg/ml injectable solution contains

• The active ingredient is bupivacaine hydrochloride: 1 ml of solution contains 5 mg of bupivacaine hydrochloride.
• The other ingredients are: sodium chloride, water for injections.

What BUPISEN hyperbaric 5 mg/ml injectable solution contains

• The active ingredient is bupivacaine hydrochloride: 4 ml of solution contains 20 mg of bupivacaine hydrochloride.
• The other ingredients are: glucose, water for injections.

What BUPISEN hyperbaric 7.5 mg/ml injectable solution contains

• The active ingredient is bupivacaine hydrochloride: 3 ml of solution contains 22.5 mg of bupivacaine hydrochloride.
• The other ingredients are: glucose, water for injections.

What BUPISEN hyperbaric 10 mg/ml injectable solution contains

• The active ingredient is bupivacaine hydrochloride: 2 ml of solution contains 20 mg of bupivacaine hydrochloride.
• The other ingredients are: glucose, water for injections.

Description of the appearance of BUPISEN and contents of the pack
BUPISEN 2.5 mg/ml and 5 mg/ml injectable solution:
Pack of 10 vials of 1 ml, 2 ml, 5 ml, 10 ml.
Pack of 5 vials of 20 ml.
Pack of 1 pre-filled single-dose syringe of 5 ml and 10ml.

BUPISEN hyperbaric 5 mg/ml injectable solution:

Sterile pack containing 1 vial of 4 ml.

BUPISEN hyperbaric 7.5 mg/ml injectable solution:

Sterile pack containing 1 vial of 3 ml.

BUPISEN hyperbaric 10 mg/ml injectable solution:

Sterile pack containing 1 vial of 2 ml.

Marketing authorisation holder and manufacturer
Industria Farmaceutica Galenica Senese - Via Cassia Nord 351 - Monteroni d’Arbia (SI)

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The following information is intended exclusively for doctors or healthcare professionals
Special warnings and precautions for use
Adults and children over 12 years of age
Dosage and method of administration
BUPISEN is usually used in minimum dosages, varying according to the indications, from 2-3 mg to 100-150 mg,
as indicated for guidance in the table:

Warning:As it does not contain preservative excipients, the vials and syringes must be used for a single
administration. Any remaining contents must be discarded.
The maximum dose for an adult and for single administration should not exceed 150 mg,
corresponding to 30 ml of the 5 mg/ml solution and 60 ml of the 2.5 mg/ml solution. More generally, the
safety dose that is advisable not to exceed, both in adults and children, is 2 mg/kg for single
administration.
In prolonged analgesic therapy, doses usually range from 0.25 to 1 mg/kg of body weight;
administration can be repeated 2-3 times within 24 hours.
N.B. When performing prolonged blocks for successive bolus administration, the risk of reaching toxic plasma concentrations or of inducing local neuronal damage must be considered.
The dose to be administered must be calculated based on the doctor's experience and knowledge
of the patient's clinical condition. The lowest doses that can allow adequate anesthesia should be used. Individual variations may occur regarding the onset and duration of action. The degree of anesthesia spread can be difficult to predict but is influenced by the volume of drug administered, especially with regard to isobaric solutions.
To prevent accidental intravascular injection, aspiration should be performed before and during the
administration of the main dose, which should be injected slowly or in increasing doses. During the
procedure, carefully monitor the patient's vital functions and maintain verbal contact. If epidural anesthesia is required, it is recommended to precede a test dose of 3-5 ml of
bupivacaine with adrenaline. An accidental intravascular injection can be recognised by a temporary increase
in heart rate; an accidental intrathecal injection is recognised by signs of spinal block. At the first sign of toxicity, immediately stop administration.
The specific gravity of Bupisen 2.5 mg/ml and 5 mg/ ml is 1.006 at 20°C and 0.997 at 37°C.
Any overdose of anesthetic must be avoided and never administer two maximum doses of
the latter without an interval of at least 24 hours having elapsed.
It is still necessary to use the lowest doses and concentrations that can allow to obtain
the desired effect.

BUPISEN 5 mg/ml hyperbaric injectable solution

Neonates, infants and children over 40 kg.

BUPISEN 5 mg/ml hyperbaric solution can be used in children. One of the differences between small children

and adults is the relatively high volume of cerebrospinal fluid (CSF) in infants and neonates, which

requires a relatively larger dose/kg to produce the same level of block compared to adults.

Pediatric regional anesthesia procedures must be performed by qualified physicians who are

familiar with this population and with the technique.

The doses in the table should be considered as guidelines for use in pediatrics. Individual variations may occur

Reference texts should be consulted regarding both the aspects that affect specific

blocking techniques and the individual needs of the patient.

The lowest dose necessary for adequate anesthesia should be used.

Recommended dose in neonates, infants and children
For further information, see the Summary of Product Characteristics.