Bupivacaine Grindex

Package leaflet: Information for the patient

Bupivacaine Grindeks 5 mg/ml solution for injection

bupivacaine hydrochloride
Equivalent medicine
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 or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

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

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

Bupivacaine Grindeks contains the active substance bupivacaine hydrochloride. It belongs to a group of
medicines called local anaesthetics.
Bupivacaine Grindeks is used to numb (anaesthetize) parts of the body. It is used to block the
sensation of pain or to relieve pain. It can be used:

• to numb parts of the body during surgical procedures in adults and adolescents over 12 years of age;
• to relieve pain in adults and children over 1 year of age.

2. What you should know before Bupivacaine Grindeks is administered to you

Do not be given Bupivacaine Grindeks:

• 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 similar local anaesthetics (e.g. lidocaine or ropivacaine), as the risk of allergy to Bupivacaine Grindeks is increased;
• if you have a skin infection at the site where the anaesthetic is to be administered;
• if you have cardiogenic shock (a condition in which the heart does not supply enough blood to the body);
• if you have hypovolemic shock (very low blood pressure leading to collapse);
• if you have blood clotting problems;
• if you have inflammation of the spinal cord or brain (meningitis, poliomyelitis or spondylitis);
• if you have persistent headache caused by bleeding in the brain;
• if you have spinal cord problems due to anaemia;
• if you have blood poisoning (septic inflammation of the blood);
• if you have recently suffered spinal trauma, spinal tuberculosis or a spinal tumour;
• if you are undergoing obstetric paracervical block (a type of anaesthesia administered during labour).

If any of the above conditions apply to you, your doctor must not administer this medicine to you.
If in doubt, ask your doctor before this medicine is administered to you.
Warnings and precautions
Talk to your doctor before using Bupivacaine Grindeks

• if you suffer from heart, kidney or liver disease, as your doctor may need to adjust the dose of the medicine;
• if you are elderly or debilitated;
• if you suffer from partial or complete block of the heart's conduction system;
• if you are in an advanced stage of pregnancy;
• if you are being treated with class III antiarrhythmic drugs (e.g. amiodarone);
• if you have fluid retention in the abdominal area;
• if you have a stomach tumour;
• if you have a reduced blood volume (hypovolemia);
• if you have fluid in the lungs.

Children
Children over 12 years of age require special attention because certain regional anaesthesia procedures (loss of pain sensation) using Bupivacaine Grindeks during surgical procedures have not been fully evaluated in this population.
The safety and efficacy of Bupivacaine Grindeks in children up to 1 year of age have not been established.
Other medicines and Bupivacaine Grindeks
Inform your doctor if you are taking, have recently taken, or might take any other medicines. This is important because Bupivacaine Grindeks may affect other medicines and other medicines may affect Bupivacaine Grindeks.
In particular, inform your doctor about the following medicines:

• medicines used to treat irregular heartbeat (arrhythmia), e.g. medicines containing lidocaine, mexiletine or amiodarone;
• medicines used to prevent blood clotting (anticoagulants).

Your doctor must have a complete overview of all other medicines to correctly calculate the required dose.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before this medicine is administered to you.
Driving and using machines
After administration of Bupivacaine Grindeks, you may experience drowsiness and your reaction speed may be impaired. Your doctor will decide whether you may actively participate in traffic or operate machinery and tools.
Bupivacaine Grindeks contains sodium
This medicine contains 31.48 mg of sodium (the main component of table salt) in each vial (10 ml). This corresponds to 1.57% of the maximum daily recommended intake of sodium for an adult.

3. How Bupivacaine Grindeks is administered to you

Your doctor will administer Bupivacaine Grindeks to you. The required dose will be calculated by your doctor based on the degree of pain relief needed and the part of the body where the medicine will be administered. It will also depend on your body weight, age, and general health status. Usually, a single dose is sufficient; however, during prolonged surgical procedures, an additional dose may be given or the medicine may be administered as a slow infusion.

The site of administration depends on the purpose for which the medicine is being given. Your doctor will administer the medicine at one of the following sites:

• near the part of the body that needs to be numbed;
• in an area distant from the part of the body that needs to be numbed. This applies in cases where you are receiving an epidural injection (an injection into the spine, around the spinal cord).

When Bupivacaine Grindeks is injected in one of these ways, nerve fibres stop conducting impulses/pain signals to the brain. At the end of the surgical procedure, this effect gradually wears off.

Use in children and adolescents
Depending on the desired analgesia (loss of pain perception), Bupivacaine Grindeks is slowly administered into the epidural space (the area surrounding the spinal canal) or into other parts of the body by an anaesthetist experienced in anaesthetic techniques for children. The dose depends on the patient's age and body weight and is determined by the anaesthetist.

If you are given more Bupivacaine Grindeks than you should
Serious side effects from an overdose of Bupivacaine Grindeks are unlikely. Such side effects require special treatment, and the doctor administering this medicine to you is familiar with managing such situations. The first symptoms of overdose with Bupivacaine Grindeks are generally:

• dizziness, mental confusion;
• numbness of the lips and around the mouth;
• numbness of the tongue;
• hearing disturbances;
• visual disturbances.

To reduce the risk of serious side effects, your doctor will stop administering Bupivacaine Grindeks as soon as any of these signs appear. This means that if you experience any of these symptoms, you must inform your doctor immediately.

More serious effects of Bupivacaine Grindeks overdose include muscle twitching, muscle spasms, and loss of sensation.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe allergic reactions (rare, may affect up to 1 in 1,000 people)
If you have a severe allergic reaction, inform your doctor immediately. Signs may include sudden onset of:

• swelling of the face, lips, tongue or throat, making it difficult to swallow;
• severe or sudden swelling of hands, feet and ankles;
• difficulty breathing;
• intense skin itching with blisters.

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

• low blood pressure – this may make you feel dizzy and confused;
• malaise (nausea).

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

• skin tingling sensation;
• dizziness;
• slowing of the heartbeat;
• high blood pressure;
• vomiting;
• problems with fluid elimination (fluid retention in the body).

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

• seizures (fits);
• numbness of the tongue or around the mouth;
• difficulty speaking;
• confusion;
• ringing in the ears or sensitivity to sound;
• blurred vision;
• loss of consciousness;
• tremor;
• muscle contractions.

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

• nerve damage that may cause altered sensation or muscle weakness (neuropathy), including peripheral nerve damage;
• inflammation of the membrane surrounding the spinal cord (arachnoiditis). Symptoms of inflammation include sharp or burning pain in the lower back or legs, and tingling, numbness or weakness in the legs;
• leg weakness or complete leg paralysis;
• double vision;
• irregular heartbeat (arrhythmia) – this may be life-threatening;
• slowed or stopped breathing or stopped heartbeat – this may be life-threatening.

Other possible side effects observed with other local anaesthetics that may also occur with Bupivacaine Grindeks:

• liver enzyme problems – these complications may occur if you receive the medicine for a prolonged period;
• nerve damage – rarely, this may lead to permanent problems;
• temporary blindness or eye muscle problems that may take a long time to resolve – these may occur if the anaesthetic is administered near the eye.

Side effects in children are similar to those in adults.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or nurse. You can also report side effects directly via the 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 Grindeks

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton following "Exp". The expiry date refers to the last day of that month.
Do not freeze.
Bupivacaine Grindeks is usually stored by the doctor or hospital. The staff are responsible for the proper storage, handling and use of Bupivacaine Grindeks.

6. Package contents and other information

What Bupivacaine Grindeks contains

• The active substance is bupivacaine hydrochloride. Each ml of injection solution contains 5 mg of bupivacaine hydrochloride. One vial (10 ml) contains 50 mg of bupivacaine hydrochloride.
• The other components are: sodium chloride, sodium hydroxide or hydrochloric acid (for pH adjustment), water for injections.

Description of the appearance of Bupivacaine Grindeks and contents of the pack
Clear, colourless liquid, practically free from visible particles.
10 ml of injectable solution in a type I borosilicate glass vial, colourless, with break-off ring or single point break.
5 vials are packaged in a polyvinyl chloride film container.
1 container is packaged in a cardboard box.
Marketing Authorisation Holder
AS Grindeks
Krustpils iela 53,
Rīga, LV-1057,
Latvia
Manufacturer
AS Grindeks
Krustpils iela 53,
Rīga, LV-1057,
Latvia
This medicinal product is authorised in the European Economic Area Member States under the following names:
Czech Republic: Bupivacaine Grindeks
Romania: Bupivacaină Grindeks 5 mg/ml soluţie injectabilă
Slovakia: Bupivacaine Grindeks 5 mg/ml injekčný roztok
Austria: Bupivacain Grindeks 5 mg/ml Injektionslösung
Bulgaria: Бупивакаин Гриндекс 5 mg/ml инжекционен разтвор
Germany: Bupivacain Grindeks 5 mg/ml Injektionslösung
Hungary: Bupivacaine Grindeks 5 mg/ml oldatos injekció
Italy: Bupivacaina Grindeks
Slovenia: Bupivakain Grindeks 5 mg/ml raztopina za injiciranje