Bupivacaine Aguettant

Patient Information Leaflet

Bupivacaine Aguettant 5 mg/mL injection solution

bupivacaine hydrochloride
Equivalent medicine
Read this leaflet carefully before you are given 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.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

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

1. What Bupivacaine Aguettant is and what it is used for

Bupivacaine Aguettant contains the active substance bupivacaine hydrochloride. It is a local anaesthetic
used to numb (anaesthetize) the lower parts of the body during surgical procedures in adults and children of all ages. It is used, for example, to numb the legs prior to surgery, in urological surgery or in lower abdominal surgery.
The medicine temporarily blocks nerve signals in the area where it is injected and temporarily reduces or
eliminates sensation in certain parts of the body.

2. What you need to know before being given Bupivacaine Aguettant

Do not be given Bupivacaine Aguettant:

• if you are allergic to bupivacaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to other local anaesthetics of the same class (e.g. mepivacaine, lidocaine).

Intrathecal anaesthesia must not be administered if:

• you have acute active diseases of the brain or spinal cord, such as meningitis, poliomyelitis or spondylitis
• you have severe headache caused by internal bleeding in the head (intracranial haemorrhage)
• you have blood poisoning (septicaemia)
• you have purulent infections at or near the injection site
• you have recently suffered trauma (e.g. a spinal fracture)
• you have tuberculosis or a tumour of the spine
• you have spinal stenosis (narrowing of the spinal canal)
• you have a life-threatening condition in which the heart is unable to supply sufficient blood to the body (cardiogenic shock)
• you have very low blood pressure leading to collapse (hypovolemic shock)
• your blood does not clot properly or you are taking medicines to prevent blood clots from forming
• you have spinal cord problems due to anaemia.

Warnings and precautions
Talk to your doctor before being given Bupivacaine Aguettant if:

• you have a heart arrhythmia called AV block II or III
• you have liver problems
• you have kidney problems
• you are elderly or debilitated
• you are pregnant, especially in late pregnancy
• you have a heart condition (aortic stenosis)
• you have chronic back pain
• you have pre-existing headache
• you have low blood pressure (hypotension)
• you suffer from persistent sensations such as numbness, tingling, prickling (paraesthesia).

Neurological diseases are not believed to be worsened by anaesthesia, but caution is required.
Other medicines and Bupivacaine Aguettant
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Bupivacaine Aguettant may interact with other medicines, such as:

• other local anaesthetics
• medicines structurally similar to Bupivacaine Aguettant, for example medicines for heart arrhythmias (antiarrhythmics).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor for advice before this medicine is administered.
Bupivacaine Aguettant may be used during pregnancy and breastfeeding. Your doctor will adjust the dose if pregnancy is advanced.
Driving and using machines
On the day of the procedure, you must not drive or operate machinery, as Bupivacaine Aguettant may affect your reaction ability and muscle coordination.
Bupivacaine Aguettant contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How Bupivacaine Aguettant is administered

Bupivacaine Aguettant will be administered by a doctor, who will determine the correct dose.
The medicine is injected into the lower part of the spine.
The dosage depends on the type of procedure, the patient's age and weight, and will be determined by the doctor.
Use in children and adolescents
Bupivacaine Aguettant is slowly injected into the spinal canal (lower part of the spine) by an anaesthetist experienced in paediatric anaesthetic techniques.
If you have been given too much Bupivacaine Aguettant
It is unlikely that you will receive an excessive dose of this medicine, as it is administered in a hospital setting by healthcare professionals. If you suspect that you have been given too high a dose, or if you have any concerns about the dose administered, speak to your doctor.
The first signs of an overdose of Bupivacaine Aguettant are usually the following:

• Low blood pressure
• Slow pulse
• Irregular heartbeat
• Dizziness or feeling faint
• Numbness of the lips and mouth
• Numbness of the tongue
• Hearing problems
• Vision problems

To reduce the risk of serious side effects, your doctor will stop administering Bupivacaine Aguettant as soon as these signs appear.
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Serious side effects
If you experience any of the following symptoms, stop treatment and contact a doctor immediately:

• Signs of central nervous system toxicity, such as numbness, tingling, loss of movement (paresis), muscle weakness, or dysesthesia (abnormal sensation) (uncommon side effects, may affect up to 1 in 100 people)
• Sudden stopping of the heartbeat and loss of consciousness (cardiac arrest) (rare side effect, may affect up to 1 in 1,000 people)
• Slow and shallow breathing (respiratory depression) (rare side effect, may affect up to 1 in 1,000 people)
• Severe allergic reaction with symptoms such as difficulty breathing, swelling of the lips, throat and tongue, and low blood pressure (anaphylactic shock) (rare side effect, may affect up to 1 in 1,000 people)

Other side effects
Very common (may affect more than 1 in 10 people)

• Nausea (feeling unwell)
• Low blood pressure
• Slow heart rate (bradycardia)

Common (may affect up to 1 in 10 people)

• Headache
• Vomiting
• Difficulty urinating (urinary retention)
• Involuntary urination (urinary incontinence)

Uncommon (may affect up to 1 in 100 people)

• Back pain
• Tingling, burning sensation, or numbness of the skin (paresthesia)

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

• Involuntary blockage of spinal nerves (spinal block), which may cause temporary loss of sensation in the abdomen and/or lower part of the body, respiratory depression, and even loss of consciousness.
• Bilateral paralysis, often in the lower part of the body or both legs (paraplegia)
• Pain and sensory disturbances due to nerve inflammation (neuropathy)
• Loss of voluntary movement (paralysis)
• Inflammation of a membrane surrounding the spinal cord (arachnoiditis), which may cause lower back pain, or pain, numbness, or weakness in the legs.
• Allergic reactions

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. 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 Bupivacaine Aguettant

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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.
After opening, the medicine must be used immediately.
Do not use the medicine if you notice any discoloration of the contents or if particles or precipitates are present.
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 Bupivacaine Aguettant contains

• The active substance is bupivacaine hydrochloride. Each mL contains bupivacaine hydrochloride monohydrate equivalent to 5 mg of bupivacaine hydrochloride. Each 4 mL vial contains bupivacaine hydrochloride monohydrate equivalent to 20 mg of bupivacaine hydrochloride.
• The other components are glucose monohydrate, sodium hydroxide (for pH adjustment) and water for injections.

Description of the appearance of Bupivacaine Aguettant and package contents
Bupivacaine Aguettant is a clear, transparent injectable solution in a transparent glass vial.
Each pack contains 5 vials, each containing 4 mL of solution. The vials are packaged in a sealed blister pack with a removable blister lid.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratoire Aguettant
1 rue Alexander Fleming
69007 Lyon
France

Manufacturer
Cenexi
52 rue Marcel et Jacques Gaucher
94120 Fontenay-sous-Bois
France

This medicinal product is authorised in the European Economic Area Member States under the following names:
AT, DE: Bupivacain Aguettant
BE, NL, LU: Bupivacaine Glucose Aguettant
DK, NO: Bupivacaine Aguettant
FI, IS, SE: Bupivacaine Spinal Tung Aguettant
IE: Bupivacaine Heavy
IT: Bupivacaina Aguettant
PT, ES: Bupivacaína Hiperbárica