Ampres

Package Leaflet: Information for the User

Ampres, 10 mg/mL, Solution for Injection

Chloroprocaine hydrochloride

Read the package leaflet carefully before receiving the medicine, as it contains important information for the patient.

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

Table of Contents of the Leaflet

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

1. What is Ampres and what is it used for

Ampres contains the active substance chloroprocaine hydrochloride. It is a type of local anesthetic belonging to the ester group and is a solution for injection. Ampres is used for anesthesia of certain parts of the body and to prevent pain during surgical procedures.
Ampres is indicated for use only in adults.

2. Important information before using Ampres

When not to use Ampres:

Warnings and precautions

In case of any of the following conditions, discuss them with your doctor before
using this medicine.

• central nervous system diseases, such as meningitis, polio, or spinal cord problems caused by anemia
• severe headache
• brain, spinal cord, or other tumors
• spinal cord tuberculosis
• recent spinal cord injury
• very low blood pressure or low blood volume
• blood coagulation disorders
• acute porphyria
• fluid in the lungs
• septicemia (blood poisoning)

Ampres and other medicines

Tell your doctor, pharmacist, or nurse about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Especially if you are taking medicines for irregular heart rhythm (class III anti-arrhythmic medicines), medicines for low blood pressure (vasopressor medicines), and painkillers.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before receiving this medicine. Ampres is not recommended for local or epidural anesthesia in pregnant women. The use of Ampres in pregnant women should be considered only when absolutely necessary. This does not exclude the use of Ampres during delivery.
It is not known whether chloroprocaine passes into breast milk. If you are breastfeeding, tell your doctor, who will decide whether you can receive Ampres or not.

Driving and using machines

Ampres has a significant impact on the ability to drive and use machines.
Your doctor is responsible for deciding whether you can drive or use machines.

Ampres contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose (maximum dose equivalent to 5 mL of Ampres solution for injection), which means the medicine is considered "sodium-free".

3. How to use Ampres

This medicine will be administered to you by your doctor.
Regional anesthetics can only be administered by a doctor with the necessary knowledge and experience. The doctor is responsible for taking the necessary actions to avoid injecting the anesthetic into a blood vessel and should be able to recognize and treat side effects.
Equipment, medicines, and personnel able to act in an emergency must be immediately available.
Your doctor will decide what dose is right for you. Usually, it will be 4-5 mL (40-50 mg of chloroprocaine hydrochloride).
In patients in poor general condition (e.g., vascular occlusion, atherosclerosis, diabetic polyneuropathy), a dose reduction is recommended.

Use in children and adolescents

The safety and efficacy of Ampres in children and adolescents have not been established.
Data are not available.
Ampres is injected epidurally (spinally) when the duration of the planned surgical procedure should not exceed 40 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, Ampres can cause side effects, although not everybody gets them.

Important side effects are:

Sudden, life-threatening allergic reactions (such as anaphylaxis) are rare, occurring in no more than 1 in 1,000 patients.
Possible symptoms include sudden itching, redness (skin rash), swelling (edema), sneezing, vomiting, dizziness, excessive sweating, elevated temperature; shortness of breath, wheezing, and difficulty breathing. If you think that Ampres has caused an allergic reaction, tell your doctor immediately.
Additionally, in case of prolonged disturbances of movement, sensation, and/or autonomic nervous system disorders (control of sphincters) affecting the lower segments of the spinal cord, tell your doctor immediately to avoid permanent neurological damage.
Other side effects:

Very common: may affect more than 1 in 10 patients

Low blood pressure, feeling of nausea (nausea).

Common: may affect up to 1 in 10 patients

Anxiety, restlessness, paresthesia, dizziness, vomiting, difficulty urinating.

Uncommon: may affect up to 1 in 100 patients

Decrease in arterial blood pressure (at high doses), slow heart rate, chills, seizures, numbness of the tongue, hearing problems, vision problems, speech problems, loss of consciousness.

Rare: may affect up to 1 in 1,000 patients

Neuropathy, transient somnolence leading to loss of consciousness and respiratory arrest, spinal block (including total spinal block), low blood pressure after spinal block, loss of bladder control and involuntary bowel movement, loss of sensation in the perineal area and loss of sexual function, arachnoiditis, cauda equina syndrome, and permanent neurological damage.
Double vision, irregular heartbeat.
Cardiac depression, cardiac arrest (the risk increases with high doses or unintended intravascular injection).
Respiratory depression.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor 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.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ampres

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the ampoule label and carton. The expiry date refers to the last day of that month.
Do not store above 25°C. Do not store in the refrigerator or freeze.
Store the ampoule in the outer packaging to protect from light.
Use immediately after first opening. For single use only.
Do not administer Ampres if you notice that the solution is not clear and free of particles.
Due to the restriction to hospital use, leftover medicine is disposed of directly by the hospital. Medicines should not be disposed of via wastewater. This will help protect the environment.

6. Contents of the pack and other information

What Ampres contains

The active substance is chloroprocaine hydrochloride.
One mL of solution for injection contains 10 mg of chloroprocaine hydrochloride.
One ampoule with 5 mL of solution contains 50 mg of chloroprocaine hydrochloride.
The other ingredients are: hydrochloric acid 3.7% (for pH adjustment), sodium chloride, water for injections.

What Ampres looks like and contents of the pack

This medicine is a solution for injection. The solution is clear and colorless.
It is provided in ampoules made of colorless glass type I.
Box of 10 ampoules containing 5 mL of solution for injection.

Marketing authorization holder and manufacturer

Marketing authorization holder

• B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany

Manufacturer

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

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

Country NameMember State

Medicine Name
Austria
Ampres 10 mg/ml Injektionslösung
Ampres 10 mg/ml Solution for injection -
Oplossing voor injectie – Solution injectable -
Injektionslösung
Belgium
France
Clorotekal 10 mg/ml solution pour injection
Spain
Ampres 10 mg/ml solución inyectable
Ireland
Ampres 10 mg/ml solution for injection
Germany
Ampres 10 mg/ml Injektionslösung
Poland
Ampres
United Kingdom
(Northern Ireland)
Ampres 10 mg/ml solution for injection
Italy
Decelex

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:
The SmPC is added at the end of the printed patient leaflet as a detachable part.