Pankaine Spinal Heavi

Leaflet attached to the packaging: information for the user

Pankaine Spinal Heavy, 5 mg/mL, solution for injection

Bupivacaine hydrochloride

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.
• In case of 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 Pankaine Spinal Heavy and what is it used for
• 2. Important information before using Pankaine Spinal Heavy
• 3. How to use Pankaine Spinal Heavy
• 4. Possible side effects
• 5. How to store Pankaine Spinal Heavy
• 6. Contents of the packaging and other information

1. What is Pankaine Spinal Heavy and what is it used for

Pankaine Spinal Heavy contains the active substance bupivacaine hydrochloride. This medicine belongs to
a group of medicines called local anesthetics.
Pankaine Spinal Heavy is used for anesthesia of a part of the body during surgery in adults and children of
any age. This medicine blocks the pain that occurs during the surgical procedure: urological procedures or
procedures on the lower limbs, including the hip joint, and procedures in the lower part of the abdominal
cavity (including cesarean section).

2. Important information before using Pankaine Spinal Heavy

When not to use Pankaine Spinal Heavy:

• if the patient is allergic to bupivacaine hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to any other local anesthetic of the same class (such as lidocaine or ropivacaine),
• if the patient has a skin infection at the injection site,
• if the patient has sepsis (blood poisoning),
• if the patient has cardiogenic shock (a severe condition in which the heart is unable to supply enough blood to the rest of the body),
• if the patient has hypovolemic shock (very low blood pressure leading to fainting),
• if the patient has bleeding disorders,
• if the patient has heart or spinal cord diseases, such as meningitis, polio, or spinal arthritis,
• if the patient has severe headache caused by bleeding in the skull (intracranial hemorrhage),
• if the patient has spinal cord disorders caused by anemia,
• if the patient has recently had trauma, has tuberculosis, or has spinal cord tumors.

If the patient has any of the above conditions, this medicine should not be used. In case of doubt, the patient should consult a doctor or nurse before receiving this medicine.

Warnings and precautions

Before using Pankaine Spinal Heavy, the patient should discuss it with their doctor or nurse.
if the patient is elderly and generally weakened,
if the patient has heart, liver, or kidney disorders. The dose of this medicine may need to be modified by the doctor.
if the patient has been diagnosed with decreased blood volume (hypovolemia),
if the patient has fluid in the lungs.
Bupivacaine should not be injected into inflamed or infected areas.
In addition, the doctor must exercise special caution if the patient suffers from certain nerve disorders, such as multiple sclerosis (tissue changes in the brain and spinal cord),
hemiplegia (one-sided paralysis), quadriplegia (two-sided paralysis), or other neuromuscular disorders.
In case of doubt as to whether any of these situations apply to the patient, they should consult a doctor or nurse before receiving this medicine.

Pankaine Spinal Heavy and other medicines

The patient should tell their doctor or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The use of certain medicines together may be harmful. It should be remembered that the doctor in the hospital may not know that the patient has recently started a treatment cycle for another disease.
In particular, the patient should inform their doctor about taking the following medicines:
other local anesthetics (such as lidocaine),
medicines that control heart rhythm (including mexiletine, tocainide),
cimetidine (a medicine used to treat heartburn, stomach ulcers, or duodenal ulcers),
verapamil (a medicine used to treat heart disorders, migraines, etc.),
angiotensin-converting enzyme inhibitors (medicines used to control blood pressure and heart disease, such as enalapril, ramipril, etc.).
The use of bupivacaine and propofol (a medicine used for general anesthesia) together may increase the sedative effect of propofol.
In addition, the patient must inform their doctor or nurse if they have taken any other medicines related to heart disease.

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.
Pankaine Spinal Heavy may be used during pregnancy and breastfeeding. In the case of advanced pregnancy, the doctor will adjust the dose.

Driving and using machines

Pankaine Spinal Heavy may cause drowsiness and affect reaction speed. After receiving Pankaine Spinal Heavy, the patient should not drive vehicles or operate tools or machines until the next day.

Pankaine Spinal Heavy contains sodium.

This medicine contains less than 1 mmol (23 mg) of sodium per ampoule, which means the medicine is considered "sodium-free".

3. How to use Pankaine Spinal Heavy

Pankaine Spinal Heavy is administered to the patient by a doctor who selects the appropriate dose.
It is administered in the form of an injection into the lower part of the spine.
The dose depends on the patient's age and weight. The dose is determined by the doctor.
Pankaine Spinal Heavy, after injection, blocks the transmission of pain information through the nerves to the brain.

Use in children and adolescents

Pankaine Spinal Heavy is injected slowly into the spinal canal (part of the spinal cord) by a doctor experienced in anesthesia techniques in this age group.

Use of a higher than recommended dose of Pankaine Spinal Heavy

Severe side effects resulting from the use of a higher than recommended dose of Pankaine Spinal Heavy require special treatment. The doctor treating the patient is trained in the procedures for such situations. The first symptoms of receiving too high a dose of Pankaine Spinal Heavy are usually:
low blood pressure,
slow heart rate,
irregular heartbeat,
dizziness or feeling of fainting,
numbness of the lips and the area around the mouth,
numbness of the tongue,
hearing problems,
vision disorders.
To reduce the risk of severe side effects, the doctor will stop administering Pankaine Spinal Heavy as soon as these symptoms occur.
This means that if any of these symptoms occur or if the patient thinks they have received too high a dose of Pankaine Spinal Heavy, they should immediately tell their doctor.
Other severe side effects after using too high a dose of Pankaine Spinal Heavy include convulsions, seizures, and heart disorders.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions(rare, may occur in no more than 1 in 1000 people)
If a severe allergic reaction occurs, the patient should immediately tell their doctor.
Symptoms may include:
swelling of the face, lips, tongue, or throat. This may cause difficulty swallowing.
severe or sudden swelling of the hands, feet, or ankles,
difficulty breathing,
severe itching of the skin (with a raised rash),
very low blood pressure causing fainting or loss of consciousness.
Other possible side effects:
Very common(may occur in more than 1 in 10 people)
low blood pressure. This may cause dizziness or feeling of fainting,
nausea,
slow heart rate.
Common(may occur in no more than 1 in 10 people)
headache,
vomiting,
urination problems or incontinence.
Uncommon(may occur in no more than 1 in 100 people)
itching, numbness, burning, or tingling of the skin,
back pain,
temporary muscle weakness.
Rare(may occur in no more than 1 in 1000 people)
heart attack,
breathing difficulties,
weakness or loss of sensation or mobility in the lower part of the body,
prolonged back or leg pain,
limited sensation or abnormal sensation or feeling in the skin.
Some symptoms may occur in case of incorrect administration of the injection or if this medicine is administered together with other local anesthetics. These include seizures, dizziness or feeling of fainting, tremors, and numbness of the tongue.
Possible side effects observed with the use of other local anesthetics, which may also be caused by Pankaine Spinal Heavy, include:
nerve damage. Rarely (may occur in no more than 1 in 1000 people), this may cause permanent problems.
If too high a dose of Pankaine Spinal Heavy is administered into the cerebrospinal fluid, total body anesthesia may occur.

Reporting side effects

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

5. How to store Pankaine Spinal Heavy

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 after EXP.
The expiry date refers to the last day of the month stated.
Pankaine Spinal Heavy is intended for single use only. It should be used immediately after opening. Any unused solution should be discarded.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Pankaine Spinal Heavy contains

• The active substance is bupivacaine hydrochloride. Each mL of the solution for injection contains 5 mg of bupivacaine hydrochloride (as bupivacaine hydrochloride monohydrate).
• The other ingredients are glucose monohydrate, sodium hydroxide, and hydrochloric acid (for pH adjustment), water for injections.

What Pankaine Spinal Heavy looks like and contents of the pack

Pankaine Spinal Heavy is a clear and colorless solution for injection. It is packaged in glass ampoules containing 4 mL of solution (corresponding to 20 mg of bupivacaine hydrochloride).
The packaging contains 1, 5, or 10 ampoules. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

PANPHARMA

Z.I. du Clairay
35133 Luitré
FRANCE
+33 (0) 2 99 97 92 12

Manufacturer

PANPHARMA GmbH

Bunsenstrasse 4
22946 Trittau
GERMANY

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark
Pankaine Spinal tung
Hungary
Pankaine Spinal heavy 5 mg/ml oldatos injekció
Ireland
Bupivacaine Heavy 5 mg/ml, solution for injection
Finland
Pankaine Spinal tung 5 mg/ml, injektioneste, liuos
Poland
Pankaine Spinal Heavy
Netherlands
Pankaine Glucose 5 mg/ml, solution for injection
Norway
Pankaine Spinal tung 5 mg/ml injeksjonsvæske, oppløsning
Romania
Bupivacaină Spinal Heavy Panpharma 5 mg/ml soluţie injectabilă
Sweden
Pankaine Spinal tung 5 mg/ml injektionsvätska, lösning

Date of last revision of the leaflet:

The following information is intended for healthcare professionals only:
This medicinal product is intended for spinal use only (see section 3).
As with all medicines administered parenterally, the solution should be inspected before use. Only clear solutions without visible particles should be used.
For single use only.
The solution should be used immediately after opening the ampoule.
Any unused solution should be discarded.
Medicines should not be disposed of via wastewater or household waste.