Bupivacaine with epinephrine

Italy
Brand name Bupivacaine with epinephrine
Form solution for injection
Active substance / Dosage
ADRENALINUM
Prescription type Prescription only – non-repeatable
ATC code
N01BB51
Registration number 032948
Manufacturer MONICO S.P.A.
Bupivacaine with epinephrine solution for injection

Table of Contents

PACKAGE LEAFLET: INFORMATION FOR THE USER

BUPICAIN 2.5 mg/ml WITH ADRENALINE 5 mcg/ml

Injectable solution
BUPICAIN 5 mg/ml WITH ADRENALINE 5 mcg/ml
Injectable solution
Bupivacaine hydrochloride
Adrenaline bitartrate
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
  • If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What BUPICAIN WITH EPINEPHRINE is and what it is used for

BUPICAIN WITH EPINEPHRINE contains the active substances bupivacaine hydrochloride and epinephrine bitartrate and belongs to a group of medicines called anesthetics, used prior to a surgical procedure to induce anesthesia.
BUPICAIN WITH EPINEPHRINE can be used in the following types of peripheral anesthesia: local infiltration, loco-regional, caudal epidural, sympathetic block, subarachnoid spinal.
BUPICAIN WITH EPINEPHRINE is indicated, either alone or in combination with other anesthetic medicines, for procedures in:

  • general surgery;
  • bones and joints (orthopedics);
  • eyes (ophthalmology);
  • ear, nose, and throat (otorhinolaryngology);
  • oral cavity (stomatology);
  • genital and female reproductive system (gynecology);
  • skin (dermatology).

2. What you should know before using BUPICAIN WITH ADRENALINE

Do not use BUPICAIN WITH ADRENALINE

  • if you are allergic to bupivacaine, adrenaline, other medicines of the same class as BUPICAIN WITH ADRENALINE, or any of the other ingredients of this medicine (listed in section 6);
  • for anesthesia of the uterus (paracervical block) or for regional intravenous anesthesia (Bier Block).

Due to the presence of adrenaline (a vasoconstrictor), do not use BUPICAIN WITH ADRENALINE:

  • if you are pregnant or suspect you may be pregnant (see section “Pregnancy and breastfeeding”);
  • if you have heart problems (cardiopathy);
  • if you have arterial diseases (arteriopathies);
  • if you have high blood pressure (hypertension);
  • if you have impaired blood flow to one or more organs (ischemia);
  • if you suffer from headaches (essential migraine);
  • if you have kidney problems (nephropathy);
  • if you have thyroid gland problems (hyperthyroidism);
  • if you have diabetes.

Warnings and precautions
Consult your doctor or nurse before being administered BUPICAIN WITH ADRENALINE.
BUPICAIN WITH ADRENALINE will be administered to you with particular caution if you are being treated with medicines used for depression (monoamine oxidase inhibitors, tricyclic antidepressants) (see section “Other medicines and Bupicain with adrenaline”).
Before administration, your doctor will check that your circulation is functioning properly.
For local anesthesia in areas such as fingers or the base of the penis, bupivacaine without adrenaline will be administered to prevent tissue damage (ischemic necrosis).
The lowest possible dose necessary to achieve the desired effect will be administered. At least 24 hours must elapse between the administration of two maximum doses.
Before administering the dose of BUPICAIN WITH ADRENALINE, a small test dose of bupivacaine, possibly combined with adrenaline, will be given as a preventive measure.
The solution of BUPICAIN WITH ADRENALINE will be administered slowly by small injections, following prior aspiration to promptly avoid accidental intravascular or intrathecal injection.
During administration, your doctor will closely monitor you and immediately discontinue treatment at the first sign of alarm, for example, if you experience sensory disturbances or drowsiness (altered sensorium).
Serious adverse reactions, including death, have been reported following the use of similar medicines (local anesthetics). Therefore, this medicine will be administered only under strict medical supervision by trained personnel and in facilities equipped with emergency measures necessary for urgent treatment.
This medicine must be administered with great caution and under close medical supervision if you are to receive a type of anesthesia called stellate ganglion block.
The stellate ganglion block may cause adverse effects similar to those of central nerve block, as well as cardiac toxicity with increased or decreased heart rate up to cardiac arrest.
Immediate availability of appropriate emergency equipment, medications, and trained personnel is required, as rare but serious reactions, sometimes with fatal outcomes, have been reported following the use of local anesthetics, even in the absence of individual hypersensitivity in the patient's history.
The vials do not contain preservatives (antiseptic excipients) and are therefore intended for single use only.
Any remaining medicine must be discarded.
Your doctor will determine the correct dose based on your health status, age, laboratory test results, and medical history (anamnesis).

Other medicines and BUPICAIN WITH ADRENALINE
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Bupicain with adrenaline should be used with caution if you are taking medicines for depression (monoamine oxidase inhibitors or tricyclic antidepressants; see section “Warnings and precautions”).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use this medicine if you are known or presumed to be pregnant.

Driving and using machines
At recommended doses, BUPICAIN WITH ADRENALINE does not significantly or long-lastingly affect the ability to drive vehicles or operate machinery.

BUPICAIN WITH ADRENALINE contains sodium metabisulfite and sodium
This medicine contains sodium metabisulfite, which may rarely cause severe hypersensitivity reactions and bronchospasm (bronchial constriction).
This medicine contains less than 23 mg (1 mmol) of sodium per dose and is therefore practically sodium-free.

3. How to use BUPICAIN WITH EPINEPHRINE

The doctor will adjust the dose according to need, using the lowest possible dose.
Generally, the recommended dose ranges from 2-3 mg to 100-150 mg.
The maximum recommended dose for a single administration is 150 mg, equivalent to 30 ml of solution at a
concentration of 5 mg/ml, or 60 ml of solution at a concentration of 2.5 mg/ml.
For both adults and children, the dose must not exceed 2 mg per kilogram of body weight per single
administration.
In pain therapy (analgesic treatment), the recommended dose ranges from 0.25 to 1 mg per kg of body
weight; administration may be repeated 2–3 times within 24 hours.
If you are given more BUPICAIN WITH EPINEPHRINE than you should
This medicine will be administered by a doctor or nurse, so overdose is unlikely. However, if you think you have
been given an excessive amount of this medicine, inform your doctor immediately or go to the nearest hospital.
If you forget to use BUPICAIN WITH EPINEPHRINE
This medicine will be administered by a doctor, so it is unlikely that a dose will be missed.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, BUPICAIN WITH ADRENALINE may cause side effects, although not everybody experiences them.
The following side effects may occur:

  • allergic reactions (hypersensitivity, idiosyncrasy) to bupivacaine (anaesthetic) or adrenaline (vasoconstrictor);
  • excitation;
  • tremors;
  • disorientation;
  • dizziness;
  • pupil dilation (mydriasis);
  • increased metabolism and body temperature;
  • difficulty or inability to open the mouth (trismus) and seizures following administration of very high doses;
  • increased sweating;
  • changes in heart rhythm (arrhythmias);
  • increased blood pressure (hypertension);
  • increased respiratory rate (tachypnea);
  • increased bronchial dilation (bronchodilation);
  • nausea, vomiting;
  • slowed heart rate (bradycardia);
  • increased dilation of veins and arteries (vasodilation);
  • allergic reactions, especially if the patient is predisposed; in some cases, hypersensitivity reactions to this medicine may occur even if allergy tests were negative;
  • skin irritations (urticaria, skin rashes) and itching;
  • breathing problems (bronchospasm);
  • throat swelling due to fluid accumulation (laryngeal edema);
  • cessation of heart and respiratory function (cardiorespiratory collapse);
  • severe allergic reaction (anaphylactic shock).

Adrenaline (vasoconstrictor) may cause:

  • breathing problems (asthma, dyspnoea);
  • increased sweating;
  • changes in heart rhythm (cardiac arrhythmias);
  • increased blood pressure (hypertension), particularly severe in patients with pre-existing hypertension or hyperthyroidism;
  • headache (acute cephalalgia);
  • sensitivity to light (photophobia);
  • sore throat and retrosternal pain (pharyngeal and retrosternal discomfort);
  • vomiting.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via 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 BUPICAIN WITH ADRENALINE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “EXP.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BUPICAIN WITH ADRENALINE contains
BUPICAIN 2.5 mg/ml WITH ADRENALINE 5 mcg/ml Solution for injection

  • The active substances are bupivacaine hydrochloride and acid bitartrate adrenaline. 1 ml of solution contains 2.5 mg of bupivacaine hydrochloride and 0.005 mg of acid bitartrate adrenaline.
  • The other components are sodium chloride, sodium metabisulfite and water for injections.

BUPICAIN 5 mg/ml WITH ADRENALINE 5 mcg/ml Solution for injection

  • The active substances are bupivacaine hydrochloride and acid bitartrate adrenaline. 1 ml of solution contains 5 mg of bupivacaine hydrochloride and 0.005 mg of acid bitartrate adrenaline.
  • The other components are sodium chloride, sodium metabisulfite and water for injections.

Description of the appearance of BUPICAIN WITH ADRENALINE and pack contents
BUPICAIN 2.5 mg/ml WITH ADRENALINE 5 mcg/ml Solution for injection
Carton containing 10 glass vials of 5 ml or 10 ml.
BUPICAIN 5 mg/ml WITH ADRENALINE 5 mcg/ml Solution for injection
Carton containing 10 glass vials of 5 ml or 10 ml.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE - Italy