Marcaine - adrenaline 0.5%

Package leaflet: Information for the user

MARCAINE-ADRENALINE 0.5%, (5 mg + 0.005 mg)/ml, solution for injection
Bupivacaine hydrochloride + Epinephrine
Please read all of this leaflet carefully before the medicine is administered, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or nurse.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse immediately. See section 4.

Leaflet contents

1. What Marcaine-Adrenaline 0.5% is and what it is used for
2. Important information before receiving 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 pack and other information

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

Bupivacaine is an amide-type local anaesthetic with a long duration of action. The effect of Marcaine-Adrenaline 0.5% is to temporarily block the transmission of pain, heat, or cold sensations through nerves. However, touch and pressure may still be felt in the anaesthetized area. In most cases, nerves controlling muscle function in the anaesthetized area are also blocked, resulting in reduced muscle strength or complete loss of mobility in that region.

The adrenaline (epinephrine) contained in Marcaine-Adrenaline 0.5% causes constriction of blood vessels and reduces blood flow in the anaesthetized area. This helps the medicine remain at the site of injection longer, thereby prolonging the numbing effect. This same mechanism reduces bleeding during surgery at the site where the medicine was administered.

Marcaine-Adrenaline 0.5% is used for:

• Infiltration anaesthesia, which involves injecting the medicine around the area where a surgical procedure will be performed;
• Peripheral nerve block, i.e. injecting the medicine near a nerve responsible for sensation in the area where a surgical procedure will be performed, e.g. injecting the medicine in the axillary region before a forearm or hand procedure;
• Epidural anaesthesia, i.e. an injection into the back near the spinal column, when anaesthetizing the lower part of the body is required.

Marcaine-Adrenaline 0.5% is used in adults and adolescents over 12 years of age to induce anaesthesia of a body region, resulting in elimination or relief of pain. It may be used for:

• Anaesthetizing a body region 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 anaesthetics of the amide group, or any of the other ingredients of this medicine (listed in section 6).
• if the patient has hypersensitivity to methyl- and/or propylparahydroxybenzoate (methyl-/propylparaben) or para-aminobenzoic acid (PABA).
• if the patient has hypersensitivity to sodium metabisulphite.
• in intravenous regional anaesthesia (Bier’s block).
• in special anaesthetic techniques (e.g. penile block, Obersta block) performed in body areas supplied by end arteries.

Warnings and precautions
Before starting treatment with Marcaine-Adrenaline 0.5%, discuss the following with your doctor or nurse:

• if the patient has experienced a hypersensitivity reaction (allergy) during or after anaesthesia,
• if the patient has known allergy to local anaesthetic agents,
• 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 heart conduction block),
• if the patient has circulatory system disorders,
• if the patient is taking antiarrhythmic medicines, such as amiodarone,
• if the patient has severe or untreated hypertension,
• if the patient has hyperthyroidism,
• if the patient has cerebrovascular disease (e.g. history of stroke, unexplained loss of consciousness),
• if the patient has diabetes.

Liver function disorders, manifested by increased liver enzyme activity, may occur, especially during prolonged treatment with this medicine. If this occurs and symptoms of liver damage appear, the doctor may discontinue treatment.
Inform the doctor about any recent surgical procedures on a joint.
Continuous epidural infusion is not an approved route of administration for Marcaine-Adrenaline 0.5%.
Rarely, certain types of nerve blocks may lead to nerve damage, sometimes permanent. Some types of eye region injections may very rarely cause transient blindness or prolonged eye muscle disturbances.

Children
The safety and efficacy of Marcaine-Adrenaline 0.5% in children under 12 years of age have not been established. Use of another medicine with lower concentration may be more appropriate.

Marcaine-Adrenaline 0.5% and other medicines
Inform your doctor about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription.
This is particularly important if the patient is concurrently using other local anaesthetics or antiarrhythmic drugs structurally similar to Marcaine-Adrenaline 0.5% (e.g. lidocaine, tocainide, amiodarone), due to the risk of additive effects. Inform the doctor if the patient is taking:

• tricyclic antidepressants, due to the risk of severe, prolonged hypertension,
• ergot derivatives used in migraine treatment, due to the risk of severe, prolonged hypertension and other cardiac or cerebrovascular complications,
• non-selective beta-adrenergic blockers used in the treatment of hypertension, such as propranolol, due to the risk of severe hypertension and slowed heart rate (bradycardia),
• neuroleptic medicines such as phenothiazines.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Marcaine-Adrenaline 0.5% should not be used during early pregnancy unless the benefits outweigh the risks.
Bupivacaine, when administered in therapeutic doses, passes into human milk, but in such small amounts that it does not pose a risk to the breastfed infant.

Driving and operating machinery
Depending on the dose, local anaesthetics may affect mental function and may also influence muscle strength and motor coordination. It is recommended not to drive or operate machinery on the day when anaesthesia was administered.

Marcaine-Adrenaline 0.5% contains sodium metabisulphite (E 223) and sodium
This medicine may rarely cause severe hypersensitivity reactions and bronchospasm.
The medicine contains 69.8 mg of sodium (a major component of table salt) per vial. This corresponds to 3.5% of the maximum recommended daily sodium intake in the diet of adults.

3. How to use Marcaine-Adrenaline 0.5%

Marcaine-Adrenaline 0.5% will be administered by authorized medical personnel, and the appropriate dose will be determined by a physician.
Marcaine-Adrenaline 0.5% is given by injection. The usual dose of Marcaine-Adrenaline 0.5% ranges from 7.5 to 150 mg of bupivacaine. The dose depends on the patient's age and body weight, general condition, site of administration, and the desired 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 injected near the site of surgery. The drug prevents pain sensation. In the anesthetized area of the body, numbness is felt. This sensation gradually subsides after surgery. In the case of major surgical procedures, anesthesia may be performed by an injection into the back, which may take several minutes. Administration of the drug results in anesthesia and a feeling of numbness in the lower half of the body, which usually lasts 3 to 4 hours.
Typically, a single dose is sufficient; however, in the case of prolonged procedures, additional doses may be necessary. The drug may also be administered during the postoperative period for pain management.

Use in adolescents above 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 experienced in anesthesia for this age group. The dose depends on the patient's age and body weight and will be determined by the physician.

Use of a higher than recommended dose of Marcaine-Adrenaline 0.5%
Severe adverse effects resulting from overdose are extremely rare and require specialized management. The physician is adequately trained and has the necessary equipment available for such situations.
The first signs that an overdose may have occurred include dizziness, numbness around the mouth, tongue numbness, blurred vision, and auditory hypersensitivity. You should inform the doctor immediately if such symptoms occur.
In the case of severe overdose, seizures or loss of consciousness and respiratory arrest may occur.
Severe adverse effects are rare and are associated with high plasma concentrations of bupivacaine.
Immediate discontinuation of the drug upon the appearance of the first signs of overdose reduces the risk of severe adverse effects.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Severe allergic reactions (rare, occurring in no more than 1 in 1,000 patients):
If a severe allergic reaction occurs, you must immediately inform your
doctor.
Symptoms may include sudden onset of:

• swelling of the face, lips, tongue or throat. This may cause difficulty swallowing
• severe or sudden swelling of hands, feet or ankles
• difficulty breathing
• intense skin itching (with raised rash)
• very low blood pressure, which may cause fainting or collapse

Other adverse reactions
Very common (occur in more than 1 in 10 patients)

• nausea
• significant drop in blood pressure (hypotension)

Common (occur in no more than 1 in 10 patients)

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

Uncommon (occur in no more than 1 in 100 patients)
symptoms of central nervous system toxicity (seizures, numbness around the mouth,
tongue numbness, auditory hypersensitivity, visual disturbances, loss of consciousness,
muscle tremors, dizziness, tinnitus, speech disturbances)
Rare (occur in no more than 1 in 1,000 patients)

• neuropathy, i.e. nerve disease causing tingling, numbness or muscle weakness in the innervated muscle
• nerve damage
• meningitis (inflammation of the meninges)
• double vision
• cardiac arrest
• heart rhythm disturbances
• respiratory arrest

Additional adverse reactions in children
Adverse reactions occurring in children are similar to those observed in adults.
Reporting adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to gather more information on the safety of using the medicine.

5. How to store Marcaine-Adrenaline 0,5%

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the vial
after: "EXP". The expiry date refers to the last day of the stated month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Store the vial in the outer packaging.
Hospital staff are responsible for the proper storage, preparation, and administration of Marcaine-Adrenaline 0,5% in the hospital.

6. Contents of the pack and other information

What Marcaine-Adrenaline 0.5% contains

• The active substances are bupivacaine hydrochloride and adrenaline as adrenaline bitartrate. Each ml of solution contains 5 mg bupivacaine hydrochloride and 5 micrograms of adrenaline (as adrenaline bitartrate). A 20 ml vial contains 100 mg bupivacaine hydrochloride and 100 micrograms of adrenaline (as adrenaline bitartrate).
• Other components: sodium chloride, sodium pyrosulfite (E 223), hydrochloric acid and/or sodium hydroxide (to adjust pH), water for injections.

What Marcaine-Adrenaline 0.5% looks like and contents of the pack
Marcaine-Adrenaline 0.5% is a clear, colourless solution for injection, free from visible solid particles.
Marcaine-Adrenaline 0.5% is supplied in Type I colourless glass vials, closed with a bromobutyl rubber stopper and aluminium cap, packed in a cardboard box.
Pack size: 5 vials of 20 ml each.
Marketing Authorisation Holder
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland
Tel: +48 22 104 21 00
Manufacturer
Astrea Monts
18 Rue de Montbazon
Monts, 37260
France