Pankaine spinal heavy

Package leaflet: Information for the user

Pankaine Spinal Heavy, 5 mg/mL, solution for injection
Bupivacaini hydrochloridum
Please read all of 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 further questions, please ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Pankaine Spinal Heavy is and what it is used for
2. What you need to know before you use 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 pack and other information

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

Pankaine Spinal Heavy contains the active substance bupivacaine hydrochloride. This medicine belongs to a group of medicines called local anaesthetics.
Pankaine Spinal Heavy is used to numb a part of the body during surgery in adults and children of all ages. This medicine blocks pain during surgical procedures: urological procedures, procedures on the lower limbs including the hip joint, and procedures in the lower abdomen (including caesarean 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 anaesthetic agent of the same class (such as lidocaine or ropivacaine),
• if the patient has a skin infection at the site of injection,
• if the patient has sepsis (blood poisoning),
• if the patient is experiencing cardiogenic shock (a severe condition in which the heart is unable to pump sufficient blood to the body),
• if the patient is experiencing hypovolemic shock (very low blood pressure leading to collapse),
• if the patient has blood clotting disorders,
• if the patient has heart or spinal cord diseases, such as meningitis, polio, or spinal arthritis,
• if the patient has a severe headache caused by bleeding within the skull (intracranial haemorrhage),
• if the patient has spinal cord disorders caused by anaemia,
• if the patient has recently suffered trauma, or has tuberculosis or spinal tumours.

If any of the above conditions apply to the patient, this medicine should not be used.
If in doubt, consult a doctor or nurse before receiving this medicine.

Warnings and precautions

Before using Pankaine Spinal Heavy, discuss with a doctor or nurse if:

• the patient is elderly and generally weakened,
• the patient has heart, liver, or kidney disorders. The doctor may need to adjust the dose of this medicine,
• the patient has been diagnosed with reduced blood volume (hypovolemia),
• the patient has fluid in the lungs.

Bupivacaine should not be injected into areas affected by inflammation or infection.

Additionally, the doctor must exercise special caution if the patient suffers from certain neurological conditions such as multiple sclerosis (tissue changes in the brain and spinal cord), hemiplegia (one-sided paralysis), quadriplegia (paralysis of all four limbs), or other neuromuscular disorders.

If in doubt whether any of the above conditions apply to the patient, consult a doctor or nurse before receiving this medicine.

Pankaine Spinal Heavy and other medicines

Inform the doctor or nurse about all medicines currently taken or recently used, as well as any medicines the patient plans to use. Concurrent use of certain medicines may be harmful. Bear in mind that hospital staff may not be aware that the patient has recently started treatment for another condition.

In particular, inform the doctor if the patient is taking any of the following medicines:

• other local anaesthetics (such as lidocaine),
• medicines controlling heart function (including mexiletine, tocainide),
• cimetidine (a medicine used to treat heartburn, stomach or duodenal ulcers),
• verapamil (a medicine used for heart disorders, migraine, etc.),
• angiotensin-converting enzyme (ACE) inhibitors (medicines used to control blood pressure and in heart diseases, such as enalapril, ramipril, etc.).

Concurrent use of bupivacaine and propofol (a medicine used for general anaesthesia) may enhance the sedative effect of propofol.

Additionally, it is essential to inform the doctor or nurse if the patient has taken any other medicines related to heart disease.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Pankaine Spinal Heavy may be used during pregnancy and breastfeeding. In patients with 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 or operate tools or machinery until the following day.

Pankaine Spinal Heavy contains sodium.

This medicine contains less than 1 mmol (23 mg) of sodium per ampoule, meaning 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 given as an injection into the lower part of the spine.
The dose depends on the patient's age and body weight. The doctor determines the dose.
After injection, Pankaine Spinal Heavy blocks the transmission of pain signals through nerves to the brain.

Use in children and adolescents
Pankaine Spinal Heavy is slowly injected into the spinal canal (a part of the spinal cord) by a doctor experienced in anaesthetic techniques for this age group.

Administration of a higher than recommended dose of Pankaine Spinal Heavy
Severe adverse effects resulting from administration of a higher than recommended dose of Pankaine Spinal Heavy require specific treatment. The treating physician is trained to manage such situations. The first signs of receiving too high a dose of Pankaine Spinal Heavy are usually the following:
low blood pressure,
slowed heart rate,
irregular heartbeat,
dizziness or feeling lightheaded,
numbness of the lips and area around the mouth,
tongue numbness,
hearing disturbances,
visual disturbances.

To reduce the risk of severe adverse effects, the doctor will stop administering Pankaine Spinal Heavy immediately if any of these symptoms occur.
This means that if any of these symptoms appear, or if the patient believes they have received too high a dose of Pankaine Spinal Heavy, they should immediately inform the doctor.
Other severe adverse effects following administration of an excessive dose of Pankaine Spinal Heavy include tremors, seizures, and cardiac disturbances.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Severe allergic reactions (rare, may occur in no more than 1 in 1,000 people)
If a severe allergic reaction occurs, you must immediately inform your doctor.
Symptoms may include:
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 itching of the skin (with raised rash),
very low blood pressure causing faintness or collapse.

Other possible adverse reactions:
Very common (may affect more than 1 in 10 people)
low blood pressure. This may cause dizziness or feeling lightheaded,
nausea,
slow heart rate.

Common (may affect up to 1 in 10 people)
headache,
vomiting,
problems passing urine or urinary incontinence.

Uncommon (may affect up to 1 in 100 people)
itching, numbness, burning or tingling sensation of the skin,
back pain,
temporary muscle weakness.

Rare (may affect up to 1 in 1,000 people)
heart attack,
difficulty breathing,
weakness or loss of sensation or movement in the lower part of the body,
long-lasting back or leg pain,
reduced sensation or unusual sensation or feeling in the skin.

Some symptoms may occur if the injection is accidentally administered incorrectly or if this medicine is given together with other local anaesthetics. These include seizures, dizziness or feeling lightheaded, tremors and numbness of the tongue.

Possible adverse reactions observed with other local anaesthetics, which may also be caused by Pankaine Spinal Heavy, include:
nerve damage. Rare (may occur in up to 1 in 1,000 people), this may lead to permanent problems.

If too high a dose of Pankaine Spinal Heavy is administered into the cerebrospinal fluid, it may result in anaesthesia of the entire body.

Reporting of adverse reactions
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 marketing authorisation holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Pankaine Spinal Heavy

Keep the medicine out of the 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 stated month.
Pankaine Spinal Heavy is intended for single use only. It should be used
immediately after opening. Any unused portion of the solution must be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures help protect
the environment.

6. Contents of the pack and other information

What Pankaine Spinal Heavy contains

• The active substance is bupivacaine hydrochloride. Each mL of injection solution contains 5 mg of bupivacaine hydrochloride (as bupivacaine hydrochloride monohydrate).
• The other ingredients are monohydrate glucose, 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, colourless injection solution. It is packed in glass ampoules containing 4 mL of solution (corresponding to 20 mg of bupivacaine hydrochloride).
Pack sizes of 1, 5 or 10 ampoules. Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries 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

The following information is intended for healthcare professionals only:
This medicinal product is intended for intrathecal administration only (see section 3).
As with all parenteral medicinal products, the solution should be inspected visually before use. Only clear solutions free from visible particles should be used.
For single use only.
The solution should be used immediately after opening the ampoule.
Any unused portions of the solution must be discarded.
Medicines should not be disposed of via wastewater or household waste.