Sanergy heavy

Package leaflet: Information for the patient

Sanergy Heavy, 5 mg/mL, solution for injection
Bupivacaini hydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or nurse.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. See section 4.

Table of contents of the leaflet

1. What Sanergy Heavy is and what it is used for
2. Important information before using Sanergy Heavy
3. How to use Sanergy Heavy
4. Possible adverse reactions
5. How to store Sanergy Heavy
6. Contents of the package and other information

1. What Sanergy Heavy is and what it is used for

Sanergy Heavy 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 anaesthetize lower limbs undergoing surgery,
in urological procedures, or in procedures involving the abdominal cavity.
The medicine temporarily blocks nerve signals at the injection site and reduces sensation or
causes loss of sensation in a specific part of the body.

2. Important information before using Sanergy Heavy

When not to use Sanergy Heavy

• if the patient is allergic to bupivacaine hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other local anaesthetics of the same group (such as mepivacaine, lidocaine).

Spinal anaesthesia should not be used if:

• the patient has acute active diseases of the brain or spinal cord, such as meningitis, polio, or ankylosing spondylitis;
• the patient has severe headache caused by bleeding inside the skull (intracranial haemorrhage);
• the patient has blood infection (sepsis);
• the patient has a local purulent infection at or near the injection site;
• the patient has recently suffered a severe trauma (e.g. spinal fracture);
• the patient has tuberculosis or tumours of the spine;
• the patient has spinal canal stenosis (narrowing of the spinal canal);
• the patient is in a severe condition where the heart is unable to deliver sufficient blood to the body (cardiogenic shock);
• the patient has very low blood pressure leading to collapse (hypovolemic shock);
• the patient has heart failure (circulatory failure);
• the patient's blood does not clot properly or if the patient is taking medicines that prevent blood clotting;
• the patient has a neurological disorder associated with anaemia.

Warnings and precautions
Before starting treatment with Sanergy Heavy, discuss this with your doctor or nurse if the patient:

• has a heart arrhythmia called second- or third-degree atrioventricular block;
• has liver disease;
• has kidney disease;
• is elderly or debilitated;
• is pregnant (especially in advanced pregnancy).

Neurological disorders are not considered to be aggravated by anaesthesia, however caution should be exercised.
Sanergy Heavy and other medicines
You must tell your doctor about all medicines currently used or recently used, as well as any medicines the patient intends to use.
Sanergy Heavy may interact with other medicines, such as:

• other local anaesthetics;
• medicines with a structure similar to that of Sanergy Heavy, e.g. medicines used in cardiac arrhythmias (antiarrhythmics).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
Sanergy Heavy may be used during pregnancy and breastfeeding. The dose will be adjusted by the doctor if the patient is in advanced pregnancy.
Driving and operating machinery
On the day of the procedure, the patient should not drive or operate machinery, as Sanergy Heavy may affect reaction ability and motor coordination.
Sanergy Heavy contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per ampoule, meaning this medicine is considered "sodium-free".

3. How to use Sanergy Heavy

Sanergy Heavy will be administered to the patient by a doctor, who will determine the correct dose. It will be given as an injection into the lower part of the patient's spine. The dosage depends on the type of procedure, the patient's age and body weight, and will be determined by the doctor.

Use in children and adolescents
Sanergy Heavy is slowly injected into the spinal canal (spinal region) by a doctor experienced in administering anaesthesia in children.

Administration of a higher than recommended dose of Sanergy Heavy
It is unlikely that a patient will receive too high a dose of this medicine, as it will be administered in a hospital setting and given by medical personnel. If the patient is concerned that they have received too high a dose, or have any questions regarding the dose received, they should speak to the doctor or nurse.

Usually, the first symptoms of an overdose of Sanergy Heavy are as follows:

• High arterial blood pressure;
• Low heart rate;
• Irregular heartbeat;
• Dizziness or a feeling of emptiness in the head;
• Numbness of the lips and area around the mouth;
• Tongue numbness;
• Hearing problems;
• Vision problems.

To prevent the occurrence of severe adverse effects, the doctor will immediately discontinue administration of this medicine as soon as any of the symptoms of overdose appear.
If in doubt about any further aspects concerning the use of this medicine, consult the doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Serious adverse reactions
If any of the following symptoms occur, treatment must be stopped immediately and you should contact your doctor without delay:

• Symptoms of central nervous system toxicity such as numbness, tingling, restricted movement (paresis), muscle weakness, or dysesthesia (abnormal sensation perception) (uncommon adverse reactions, may occur in more than 1 in 100 people);
• Sudden and unexpected cardiac arrest with loss of consciousness (cardiac arrest) (rare adverse reaction, may occur in more than 1 in 1,000 people);
• Slowed and shallow breathing (rare adverse reaction, may occur in more than 1 in 1,000 people);
• Severe allergic reaction with symptoms such as difficulty breathing, swelling of lips, throat and tongue, and low blood pressure (anaphylactic shock) (rare adverse reaction, may occur in more than 1 in 1,000 people).

Other adverse reactions
Very common: (may occur in more than 1 in 10 people)

• Nausea;
• Low blood pressure;
• Slow heart rate (bradycardia).

Common: (may occur in not more than 1 in 10 people)

• Headache;
• Vomiting;
• Difficulty passing urine (urinary retention);
• Involuntary urination (urinary incontinence).

Uncommon: (may occur in not more than 1 in 100 people)

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

Rare: (may occur in more than 1 in 1,000 people)

• Accidental blockage of spinal nerves (spinal block), which may cause transient loss of sensation in the abdominal area and/or lower body, respiratory depression, or even loss of consciousness;
• Bilateral paralysis, often in the lower part of the body or both legs (transverse myelitis);
• Pain and sensory disturbances due to nerve inflammation (neuropathy);
• Loss of ability to perform movements (paralysis);
• Inflammation of the membrane surrounding the spinal cord (meningitis), which may cause lower back pain or pain, numbness, or weakness in the legs;
• Allergic reactions.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Sanergy Heavy

Keep this medicine out of sight and reach of children.
There are no special storage conditions for this medicine.
Do not use this medicine after the expiry date stated on the label and the carton after:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Sanergy Heavy contains

• The active substance is bupivacaine hydrochloride. Each 1 mL of solution contains 5 mg of bupivacaine hydrochloride (anhydrous form).
• The other components are: glucose monohydrate, sodium hydroxide (for pH adjustment), and water for injections.

What Sanergy Heavy looks like and contents of the pack
Ampoules made of colourless borosilicate glass of hydrolytic class with a single break point.
The ampoules are packed in a blister and placed in a cardboard box.
Pack size: 5 ampoules

Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53, Rīga, LV-1057, Latvia
Tel.: +371 67083205
Fax: +371 67083505
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Sweden: Bupivacaine Spinal Tung Grindeks 5 mg/ml solution for injection
Austria: Mofecet 5 mg/ml injection solution
Bulgaria: Бемевакс 5 mg/ml инжекционен разтвор / Bemevax 5 mg/ml solution for injection
Czech Republic: Salvudex
Germany: Bupivacain hyperbar Grindeks 5 mg/ml Injektionslösung
Estonia: Bemevax
Hungary: Salvudex 5 mg/ml oldatos injekció
Italy: Salvudex
Latvia: Bupivacaine Grindeks 5 mg/ml šķīdums injekcijām ar glikozi
Lithuania: Mofecet 5 mg/ml injekcinis tirpalas
Netherlands: Bupivacaine Grindeks Glucose 5 mg/ml solution for injection
Poland: Sanergy Heavy
Romania: Bemevax 5 mg/ml soluție injectabilă
Slovakia: Salvudex 5 mg/ml injekčný roztok
Slovenia: Mofecet 5 mg/ml raztopina za injiciranje

Other sources of information
Detailed information about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB):
http://www.urpl.gov.pl

Information intended exclusively for healthcare professionals:

The solution should be used immediately after opening.
As with all parenterally administered medications, the solution should be inspected before use.
Only clear solutions without visible particles should be used.
It is not recommended to add other substances to solutions intended for intrathecal administration.
Medicines must not be disposed of via wastewater or household waste.