Decelex

PACKAGE LEAFLET: INFORMATION FOR THE USER

Decelex 10 mg/ml Injection Solution
{chloroprocaine hydrochloride}
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Decelex is and what it is used for

Decelex contains the active substance chloroprocaine hydrochloride. It is a type of medicine called a local anaesthetic, belonging to the ester class, and is available as an injectable solution. Decelex is used to anaesthetize (numb) specific parts of the body and to prevent pain caused during surgical procedures.
Decelex is indicated only for adults.

2. What you should know before using Decelex

Do not use Decelex

• if you are allergic to chloroprocaine hydrochloride, to medicines in the PABA ester group (para-aminobenzoic acid), to any other local anaesthetic of the ester type, or to any of the other ingredients of this medicine (listed in section 6),
• if you have serious heart conduction problems,
• if you suffer from severe anemia,
• if you have general or specific contraindications to the method of administration.

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Warnings and precautions
If you suffer from any of the following conditions, you should speak with your doctor before
receiving this medicine.

• If you have previously experienced a severe adverse reaction to an anesthetic
• If you have signs of infection or inflammation of the skin at or near the injection site
• If you suffer from any of the following conditions:
  o Diseases of the central nervous system such as meningitis, poliomyelitis, or spinal problems due to anemia
  o Severe headaches
  o Brain, spinal or other tumors
  o Spinal tuberculosis
  o Recent spinal trauma
  o Very low blood pressure or low blood volume
  o Blood clotting disorders
  o Acute porphyria
  o Fluid in the lungs
  o Septicemia (blood poisoning)
• If you have heart problems
• If you suffer from neurological disorders such as multiple sclerosis, hemiplegia, paraplegia, or neuromuscular disorders.

Other medicines and Decelex
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. In particular, inform them if you are taking any medicines for irregular heartbeat (class III antiarrhythmics), for treatment of low blood pressure (vasopressors), or medicines for pain relief.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine. Decelex is not recommended for local or regional anesthesia during pregnancy and should be administered during pregnancy only if absolutely necessary. This does not preclude the use of Decelex during childbirth.
It is not known whether chloroprocaine passes into breast milk. If you are breastfeeding, you must inform your doctor, who will decide whether to administer Decelex.
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Driving and using machines
Decelex has a major influence on the ability to drive or use machinery.
Your doctor is responsible for deciding, depending on the circumstances, whether you may drive or use machinery.
Decelex contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose (maximum dose equivalent to 5 ml of Decelex injectable solution), i.e. essentially "sodium-free".

3. How to use Decelex

This medicine will be administered to you by your doctor.
Regional anaesthesia must be administered only by a doctor with the necessary expertise and experience. The responsible doctor is responsible for taking measures to avoid intravascular injection and must know how to recognize and treat side effects.
Equipment, medicines and personnel capable of managing an emergency must be immediately available.
Your doctor will decide the correct dose for you. This is normally between 4 and 5 ml (40–50 mg of chloroprocaine hydrochloride).
In patients with compromised general conditions (for example, vascular occlusion, arteriosclerosis, diabetic polyneuropathy), a reduced dose is recommended.
Use in children and adolescents
The safety and efficacy of Decelex in children have not been established. No data are available.
Decelex is injected intrathecally (spinally) when the planned surgical procedure does not exceed a duration of 40 minutes.
If you have any further questions concerning this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, Decelex can cause side effects, although not everybody gets them.
Important side effects to be aware of:
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Potentially life-threatening sudden allergic reactions (such as anaphylaxis) are rare, occurring in 1 patient out of 1,000.
Possible symptoms include sudden onset of itching, erythema (skin redness), edema (swelling), sneezing, vomiting, dizziness, excessive sweating, high temperature, shortness of breath, wheezing or difficult breathing. If you think Decelex is causing you an allergic reaction, inform your doctor immediately.
Additionally, if you experience persistent motor, sensory, and/or autonomic (sphincter control) deficits in some lower spinal segments, inform your doctor immediately to avoid permanent neurological damage.

Other possible side effects:
Very common: affect more than 1 in 10 people
Lowering of blood pressure, discomfort (nausea)

Common: affect up to 1 in 10 people
Anxiety, agitation, paresthesia, dizziness, vomiting, difficulty in urination

Uncommon: affect up to 1 in 100 people
Sudden drop in arterial pressure (with high doses), slow heart rate, tremors, seizures, numbness of the tongue, hearing difficulties, visual and speech disturbances, loss of consciousness

Rare: affect up to 1 in 1,000 people
Neuropathy, drowsiness, fainting and respiratory arrest, spinal block (including total spinal block), drop in arterial pressure due to spinal block, loss of bladder and bowel control, loss of perineal sensation and sexual function, arachnoiditis, cauda equina syndrome and permanent neurological damage.
Double vision, irregular heartbeat (arrhythmias).
Myocardial depression, cardiac arrest (risk is increased with high doses or unintentional intravascular injection).
Respiratory depression.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or nurse. 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 Decelex

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Keep Decelex out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vials and on the outer carton.
The expiry date refers to the last day of that month.
Do not store above 25°C. Do not refrigerate or freeze. Store in the original packaging to protect
the medicine from light.
Use immediately after first opening. For single use only.
Decelex must not be used if the solution is not clear and free from particles.
Since this medicine is used only within a hospital setting, disposal of any residues is carried out
directly by the hospital. Do not dispose of any medicine via wastewater.
This will help protect the environment.

6. Package contents and other information

What Decelex contains
The active substance is chloroprocaine hydrochloride.
1 ml of injectable solution contains 10 mg of chloroprocaine hydrochloride.
One 5 ml vial of injectable solution contains 50 mg of chloroprocaine hydrochloride.
The other components are hydrochloric acid 3.7% (to adjust pH), sodium chloride, water for
injections.

Description of the appearance of Decelex and package contents
This medicine is presented as an injectable solution. The solution is clear and colourless.
The medicine is available in colourless, transparent glass vials, Type I.
Pack: 10 vials, each containing 5 ml of injectable solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
B. Braun Melsungen AG
Carl-Braun-Straße, 1
34212 Melsungen
Germany

Manufacturer
Sintetica GmbH
Albersloher Weg 11, 48155 Münster
Germany
Sirton Pharmaceuticals S.p.A.
Piazza XX Settembre, 2
22079 Villa Guardia Como
Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

The following information is intended exclusively for doctors or healthcare professionals:
"The summary of product characteristics is attached as a separate section at the end
of the package leaflet."
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PACKAGE LEAFLET: INFORMATION FOR THE USER

Decelex 20 mg/ml injectable solution

Chloroprocaine hydrochloride
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, consult your doctor, pharmacist, or nurse.
• If you experience any side effects, including those not listed in this leaflet, please consult your doctor, pharmacist, or nurse. See section 4. Contents of this leaflet:
  1. What Decelex is and what it is used for
  2. What you need to know before using Decelex
  3. How to use Decelex
  4. Possible side effects
  5. How to store Decelex
  6. Contents of the pack and other information

1. What Decelex is and what it is used for

Decelex contains the active substance chloroprocaine hydrochloride. It is a type of medicine called a local anaesthetic, belonging to the class of amino benzoic acid esters. Decelex is used to anaesthetize (numb) specific parts of the body and prevent pain caused during surgical procedures by injecting the solution near selected nerves.
Decelex is indicated for use in adults only.

2. What you need to know before using Decelex

Do not use Decelex:

• if you are allergic to chloroprocaine hydrochloride, to medicines in the para-aminobenzoic acid (PABA) ester group, to other local anaesthetics of the ester type, or to any of the excipients of this medicine (listed in section 6),
• if there are general or specific contraindications to regional anaesthesia regardless of the local anaesthetic used,
• if you have been diagnosed with reduced blood volume (hypovolemia),
• if you have severe cardiac conduction disorders.

Warnings and precautions
If you suffer from any of the following conditions, you should speak with your doctor before
this medicine is administered.

• If you have ever previously experienced a severe adverse reaction to an anaesthetic

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• If you have signs of infection or inflammation of the skin or near the injection site
• If you suffer from any of the following conditions:
• liver disease or kidney problems
• very low blood pressure
• blood coagulation disorders
• fluid in the lungs
• sepsis (blood poisoning)
• if you have heart problems (e.g. complete or partial heart block, heart failure, arrhythmia)
• if you are in a generally compromised condition.

Other medicines and Decelex
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other
medicines. In particular, inform them if you are taking any medicines for irregular heartbeat (class III antiarrhythmic agents), for treatment of low blood pressure (vasopressors), or for pain relief.
Also inform your doctor if you are taking any of the following medicines:

• cholinesterase inhibitors (such as anticholinesterases, cyclophosphamide)
  Because your body may take longer to eliminate Decelex if you are taking these medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding,
ask your doctor for advice before using this medicine. Decelex is not recommended for local or regional anaesthesia during pregnancy and should only be used during pregnancy if absolutely necessary.
It is not known whether chloroprocaine passes into breast milk. If you are breastfeeding, you must inform your doctor, who will decide whether or not Decelex should be administered.
Driving and using machines
Decelex may impair your ability to drive or operate machinery.
Your doctor is responsible for deciding, depending on the circumstances, whether you may drive or operate machinery.
Decelex contains sodium
This medicine contains 37 mg of sodium (a main component of table salt) per 20 ml vial.
This corresponds to 1.85% of the maximum daily recommended dietary intake for an adult.

3. How to use Decelex

This medicine will be administered to you by your doctor.
Regional anaesthesia must be administered only by a doctor with the necessary skills and experience. The responsible doctor is responsible for taking measures to avoid injection into a blood vessel and must know how to recognize and treat side effects.
Equipment, medicines, and personnel capable of managing an emergency must be immediately available.
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Your doctor will decide the correct dose for you. The dose will depend on your health status, the area of the body where the medicine is injected, and the reason for using the medicine.
The maximum dose for healthy adults must not exceed 800 mg.
In patients with compromised general conditions and with concomitant confirmed diseases (e.g. vascular occlusion, arteriosclerosis, diabetic polyneuropathy), a reduced dose is recommended.
Use in children and adolescents
The safety and efficacy of Decelex in children have not been established. No data are available.
Decelex may be used to produce local anaesthesia by injecting the solution around a peripheral nerve or a network of nerves (perineural use) when the planned surgical procedure does not exceed 60 minutes.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Decelex can cause side effects, although not everyone experiences them.
Important side effects to be aware of:
Potentially life-threatening sudden allergic reactions (such as anaphylaxis) are rare, affecting 1 in 1,000 patients.
Possible symptoms include sudden onset of itching, erythema (skin redness), edema (swelling), sneezing, vomiting, dizziness, excessive sweating, high temperature, shortness of breath, wheezing or difficulty breathing. If you think Decelex is causing you an allergic reaction, inform your doctor immediately.

Other possible side effects:
Very common: may affect more than 1 in 10 people
Lowering of blood pressure, discomfort (nausea)

Common: may affect up to 1 in 10 people
Anxiety, restlessness, paresthesia, dizziness, vomiting, block failure, difficulty urinating.

Uncommon: may affect up to 1 in 100 people
Sudden drop in blood pressure (with high doses), high blood pressure (hypertension), slow heart rate, tremors, seizures, numbness of the tongue, hearing difficulties, visual and speech disturbances, loss of consciousness.

Rare: may affect up to 1 in 1,000 people
Neuropathy, drowsiness, loss of consciousness and respiratory arrest, urinary and fecal incontinence, loss of perineal sensation and sexual function, and permanent neurological damage.
Double vision, irregular heartbeat (arrhythmias).
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Myocardial depression, cardiac arrest (risk is increased with high doses or unintentional intravascular injection).
Shortness of breath, wheezing and breathing difficulty.

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

Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging. The expiry date refers to the last day of that month.
Do not store above 25 °C. Do not refrigerate or freeze. Store the vial in the original packaging to protect it from light.
Use immediately after first opening. For single use only.
Decelex must not be administered if the solution is not clear and free from particles.
Since the use of this medicine is restricted to hospital settings, disposal is carried out directly by the hospital. Do not dispose of any medicines via wastewater. This will help protect the environment.

6. Package contents and other information

What Decelex contains
The active substance is chloroprocaine hydrochloride.
1 ml of injectable solution contains 20 mg of chloroprocaine hydrochloride.
1 vial containing 20 ml of solution contains 400 mg of chloroprocaine hydrochloride.
The other components are hydrochloric acid 3.7% (for pH adjustment), sodium chloride, water for
injections.

Description of the appearance of Decelex and contents of the pack
The medicine is presented as an injectable solution. The injectable solution is a clear, colourless solution.
The medicine is available in a 20 ml colourless, transparent type I glass vial.
The vial closures are bromobutyl rubber stoppers and the seals are removable aluminium caps.
Pack of 1 vial containing 20 ml of injectable solution.

Marketing Authorization Holder
B. Braun Melsungen AG
Carl-Braun-Straße, 1
34212 Melsungen
Germany
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Manufacturer
Sirton Pharmaceuticals S.p.A.
Piazza XX Settembre, 2
22079 Villa Guardia - Como
Italy
Sintetica GmbH
Albersloher Weg 11
48155 Münster
Germany

This medicinal product is authorized in the European Economic Area countries under the following names:

The SmPC is attached at the end of the printed PI as a detachable section. 11/11