Marcaine - Adrenaline 0,5%

Leaflet accompanying the packaging: information for the user

MARCAINE-ADRENALINE 0.5%, (5 mg + 0.005 mg)/ml, solution for injection
Bupivacaine hydrochloride + Epinephrine

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Marcaine-Adrenaline 0.5% and what is it used for
• 2. Important information before using Marcaine-Adrenaline 0.5%
• 3. How to use Marcaine-Adrenaline 0.5%
• 4. Possible side effects
• 5. How to store Marcaine-Adrenaline 0.5%
• 6. Contents of the packaging and other information

1. What is Marcaine-Adrenaline 0.5% and what is it used for

Bupivacaine is a local anesthetic of the amide type, characterized by a long duration of action. The action of Marcaine-Adrenaline 0.5% involves the temporary blockade of the transmission of pain, heat, or cold by nerves. However, in the anesthetized area, touch and pressure can still be felt. In most cases, the nerves responsible for muscle function in the anesthetized area are also blocked, which is felt as a decrease in muscle strength or complete loss of mobility in that area.
Epinephrine in Marcaine-Adrenaline 0.5% causes vasoconstriction and reduced blood flow in the anesthetized area. Therefore, the medicine remains in the injection site for longer, which can cause the numbness to last longer. Through the same mechanism, epinephrine reduces bleeding during surgery at the site where the medicine was administered.
Marcaine-Adrenaline 0.5% is used in:

• infiltration anesthesia, which involves injecting the medicine into the area where the surgical procedure will be performed,
• peripheral nerve anesthesia, i.e., administering the medicine in the area of the nerve responsible for sensation in the area where the surgical procedure will be performed, e.g., administering the medicine in the axillary region before a procedure on the forearm or hand,
• extradural anesthesia, i.e., puncture in the back in the spinal area, if there is a need to anesthetize the lower part of the body.

Marcaine-Adrenaline 0.5% is used in adults and adolescents over 12 years of age to induce anesthesia of a body part. It causes the elimination or alleviation of pain. It can be used for:

• anesthesia of a body part during surgical procedures,
• pain relief.

2. Important information before using Marcaine-Adrenaline 0.5%

When not to use Marcaine-Adrenaline 0.5%

• if the patient is allergic to bupivacaine, other local anesthetics of the amide group, or any of the other ingredients of this medicine (listed in section 6).
• if the patient has been found to be hypersensitive to methyl- and/or propylhydroxybenzoate (methyl-/propylparaben) or para-aminobenzoic acid (PABA).
• if the patient has been found to be hypersensitive to sodium metabisulfite.
• in intravenous regional anesthesia (Bier's block).

Warnings and precautions

Before starting treatment with Marcaine-Adrenaline 0.5%, the patient should discuss it with their doctor or nurse:

• if the patient has experienced an allergic reaction during or after anesthesia,
• if the patient has been found to be allergic to local anesthetics,
• if the patient is breastfeeding,
• if the patient has liver or kidney function disorders,
• if the patient has heart disease (e.g., partial or complete conduction block in the heart muscle),
• if the patient has circulatory disorders,
• if the patient is taking antiarrhythmic drugs, i.e., amiodarone,
• if the patient has severe or uncontrolled hypertension,
• if the patient has hyperthyroidism,
• if the patient has cerebrovascular disease (e.g., a history of stroke, loss of consciousness for unknown reasons),
• if the patient has diabetes.

Liver function disorders may occur, manifested by increased liver enzyme activity, especially in the case of long-term treatment with this medicine. If this occurs and symptoms of liver damage appear, the doctor may discontinue treatment.
The patient should inform their doctor about any recent surgical procedure on the joint.
Continuous infusion is not an approved method of administering Marcaine-Adrenaline 0.5%.
Rarely, in the case of certain types of anesthesia, nerve damage may occur, sometimes permanent. Some types of punctures in the eye area can very rarely cause transient blindness and prolonged eye muscle disorders.

Children

The safety and efficacy of Marcaine-Adrenaline 0.5% have not been established in children under 12 years of age. A more suitable medicine with a lower concentration may be used.

Marcaine-Adrenaline 0.5% and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines available without a prescription.
This is especially important if the patient is taking other local anesthetics or antiarrhythmic drugs with a similar structure to Marcaine-Adrenaline 0.5% (e.g., lidocaine, tocainide, amiodarone), due to the possibility of additive effects of these medicines. The patient should inform their doctor if they are taking:
tricyclic antidepressants, due to the possibility of severe, prolonged hypertension,
ergotamine derivatives used to treat migraines, due to the possibility of severe, prolonged hypertension and other cardiovascular and cerebrovascular complications,
non-selective beta-adrenergic blockers used to treat hypertension, such as propranolol, due to the possibility of severe hypertension and bradycardia (slow heart rate),
neuroleptic drugs, such as phenothiazines.

Pregnancy and breastfeeding

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.
Marcaine-Adrenaline 0.5% should not be used in early pregnancy unless the benefits of its use outweigh the risks.
Bupivacaine used in therapeutic doses passes into human milk, but in such small amounts that it does not pose a risk to the breastfed child.

Driving and operating machinery

Depending on the dose, local anesthetics may affect mental functions and may also affect muscle strength and coordination. It is recommended that the patient does not drive or operate machinery on the day of anesthesia.

Marcaine-Adrenaline 0.5% contains sodium metabisulfite (E 223) and sodium

The medicine may rarely cause severe allergic reactions and bronchospasm.
The medicine contains 69.8 mg of sodium (the main component of table salt) in each vial. This corresponds to 3.5% of the maximum recommended daily sodium intake in the diet for adults.

3. How to use Marcaine-Adrenaline 0.5%

Marcaine-Adrenaline 0.5% will be administered by authorized medical personnel, and the doctor will determine the appropriate dose.
Marcaine-Adrenaline 0.5% is administered by injection. The usual dose of Marcaine-Adrenaline 0.5% is 7.5 to 150 mg of bupivacaine. The dose depends on the patient's age, weight, general condition, injection site, and expected anesthetic effect.
Marcaine-Adrenaline 0.5% may be administered before minor or major surgical procedures. In the case of minor surgical procedures, the medicine is usually administered close to the operated area. The medicine causes the patient not to feel pain. In the anesthetized area, the patient feels numbness. This sensation disappears gradually after the operation. In the case of major surgical procedures, anesthesia may be performed through a puncture in the back, which may take several minutes. Administration of the medicine causes anesthesia and numbness in the lower half of the body, which usually lasts 3 to 4 hours.
Usually, one dose of the medicine is sufficient, but in the case of prolonged procedures, there may be a need to administer another dose. The medicine can also be administered during the postoperative period as pain treatment.

Use in adolescents over 12 years of age

Depending on the required anesthesia, Marcaine-Adrenaline 0.5% is slowly injected into the epidural space (part of the spine) or another part of the body by an anesthesiologist with experience in anesthesia in this age group. The dose depends on the patient's age and weight and will be determined by the doctor.

Use of a higher dose of Marcaine-Adrenaline 0.5% than recommended

Severe side effects due to overdose are extremely rare and require specialized treatment. The doctor is properly qualified and has the necessary equipment in such situations.
The first signs that an overdose of the medicine may have occurred are dizziness, a feeling of numbness around the mouth, numbness of the tongue, blurred vision, and hypersensitivity to sound. The patient should immediately inform their doctor if they experience such symptoms.
In the case of severe overdose, seizures or loss of consciousness and respiratory arrest may occur.
Severe side effects are rare and are associated with high concentrations of bupivacaine in the blood.
Discontinuation of the medicine as soon as the first symptoms of overdose appear reduces the risk of severe side effects.

4. Possible side effects

Like all medicines, Marcaine-Adrenaline 0.5% can cause side effects, although not everybody gets them.

Severe allergic reactions (rare, occurring in less than 1 in 1000 patients):

In the event of a severe allergic reaction, the patient should immediately inform their doctor.
Symptoms may include:

• swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing
• severe or sudden swelling of the hands, feet, or ankles
• difficulty breathing
• severe itching of the skin (with a papular rash)
• very low blood pressure, which may cause fainting or loss of consciousness

Very common (occurring in more than 1 in 10 patients)

• nausea
• significant decrease in blood pressure (hypotension)

Common (occurring in less than 1 in 10 patients)

• significant slowing of the heart rate (bradycardia)
• significant increase in blood pressure (hypertension)
• sensory disturbances (paresthesia)
• dizziness
• seizures
• vomiting
• urinary retention

Uncommon (occurring in less than 1 in 100 patients)

symptoms of central nervous system toxicity (seizures, numbness around the mouth, numbness of the tongue, hypersensitivity to sound, visual disturbances, loss of consciousness, muscle tremors, dizziness, tinnitus, speech disturbances)

Rare (occurring in less than 1 in 1000 patients)

• neuropathy, i.e., nerve disease causing a feeling of tingling, numbness, or weakness of the muscle innervated by the nerve
• nerve damage
• arachnoiditis (one of the meninges)
• double vision
• cardiac arrest
• arrhythmias
• respiratory arrest

Additional side effects in children

Side effects in children are similar to those observed in adults.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects allows for the collection of more information on the safety of the medicine.

5. How to store Marcaine-Adrenaline 0.5%

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the vial label after "EXP". The expiry date refers to the last day of the month.
Store in a refrigerator (2°C – 8°C). Do not freeze. Store the vial in the outer packaging.
Hospital personnel are responsible for the proper storage, preparation, and administration of Marcaine-Adrenaline 0.5% in the hospital.

6. Contents of the packaging and other information

What Marcaine-Adrenaline 0.5% contains

• The active substances of the medicine are bupivacaine hydrochloride and epinephrine as epinephrine bitartrate. Each ml of the solution contains 5 mg of bupivacaine hydrochloride and 5 micrograms of epinephrine (as epinephrine bitartrate). One 20 ml vial contains 100 mg of bupivacaine hydrochloride and 100 micrograms of epinephrine (as epinephrine bitartrate).
• The other ingredients are: sodium chloride, sodium metabisulfite (E 223), hydrochloric acid and/or sodium hydroxide (to adjust pH), water for injections.

What Marcaine-Adrenaline 0.5% looks like and what the packaging contains

Marcaine-Adrenaline 0.5% is a clear, colorless solution for injection, without visible particles.
Marcaine-Adrenaline 0.5% is packaged in Type I glass vials, closed with a bromobutyl rubber stopper and an aluminum cap, in a cardboard box.
Pack size: 5 vials of 20 ml each.

Marketing authorization holder

Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland
Tel: +48 22 104 21 00

Manufacturer

Recipharm Monts
Usine de Monts
18, rue de Montbazon,
F-37260 Monts, France

Date of last revision of the leaflet: