AMPRES 10 mg/ml INJECTABLE SOLUTION

2. What you need to know before you use Ampres

Do not use Ampres

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

Warnings and precautions

If you identify with any of the following situations, you should discuss it with your doctor beforeyou are given this medicine.

• if you have ever had an adverse reaction to an anesthetic in the past
• if you have signs of skin infection or inflammation at the proposed injection site or in its vicinity
• if you suffer from any of the following disorders:
• • central nervous system diseases such as meningitis, polio, or spinal cord problems due to anemia
  • severe headache
  • brain, spinal, or other tumors
  • spinal tuberculosis
  • recent spinal trauma
  • very low blood pressure or low blood volume
  • blood coagulation problems
  • acute porphyria
  • fluid in the lungs
  • septicemia (blood poisoning)
• if you have heart disease
• if you suffer from neurological disorders such as multiple sclerosis, hemiplegia, paraplegia, or muscle disorders.

Other medicines and Ampres

Tell your doctor, pharmacist, or nurse if you are using or have recently used or might use any other medicines. Especially if you are taking any medicine for irregular heartbeat (class III antiarrhythmics), for the treatment of low blood pressure (vasopressors), and pain relief.

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 you are given this medicine. Ampres is not recommended as a local or regional anesthetic during pregnancy and should only be administered during pregnancy if it is absolutely necessary. This does not prevent the use of Ampres during childbirth.

It is not known if chloroprocaine is excreted in breast milk. If you are breastfeeding, inform your doctor, who will decide whether you should use Ampres or not.

Driving and using machines

Ampres has a major influence on the ability to drive and use machines.

Your doctor is responsible for deciding in each case whether you can drive or use machines.

Ampres contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose (maximum dose equal to 5 ml of Ampres solution for injection), so it is considered "sodium-free".

3. How to use Ampres

This medicine will be administered to you by your doctor.

Regional anesthesia should only be administered by a doctor with the necessary knowledge and experience. The doctor in charge is responsible for taking the necessary measures to avoid injection into a blood vessel and for recognizing and treating undesirable effects.

The equipment, medicines, and personnel capable of dealing with an emergency must be immediately available.

Your doctor will decide what the correct dose is for you. It is usually 4-5 ml (40-50 mg of chloroprocaine hydrochloride).

In patients with impaired general condition (e.g., vascular occlusion, arteriosclerosis, diabetic polyneuropathy), a reduced dose is indicated.

Use in children and adolescents

The safety and efficacy of Ampres in children and adolescents have not been established. No data are available.

Ampres is injected intrathecally (spinally) where the planned surgical procedure should not exceed 40 minutes.

If you have any further questions on the use of this product, 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 to look out for:

Sudden life-threatening allergic reactions (such as anaphylaxis) are rare and affect up to 1 user in 1,000.

Possible symptoms include sudden onset of itching, erythema (redness of the skin), edema (swelling), sneezing, vomiting, dizziness, excessive sweating, elevated temperature; and shortness of breath, wheezing, or difficulty breathing. If you think Ampres is causing an allergic reaction, tell your doctor immediately.

In addition, in case of persistent motor, sensory, and/or autonomic deficit (control of sphincters) of some lower segments of the spinal cord, inform your doctor immediately to avoid permanent neurological damage.

Other possible side effects:

Very common: affects more than 1 in 10 patients

Decrease in blood pressure, feeling of discomfort (nausea)

Common: affects up to 1 in 10 patients

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

Uncommon: affects up to 1 in 100 patients

Drop in blood pressure (with high doses), slow heartbeat, tremors, convulsions, numbness of the tongue, hearing problems, visual problems, speech problems, loss of consciousness.

Rare: affects up to 1 in 1,000 patients

Neuropathy, somnolence up to unconsciousness and respiratory arrest, spinal block (including total spinal block), decrease in blood pressure due to spinal block, loss of control of the bladder and intestines, loss of perineal sensation and sexual function, arachnoiditis, cauda equina syndrome, and permanent neurological damage.

Double vision, irregular heartbeats (arrhythmias).

Depression of the myocardium, cardiac arrest (the risk increases with high doses or accidental intravascular injection).

Respiratory depression.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ampres

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label of the ampoule and on the outer carton. The expiry date is the last day of the month stated.

Do not store above 25°C. Do not refrigerate or freeze. Keep in the original packaging to protect from light.

The medicine should be used immediately after its first opening. Valid for single use only.

Do not use Ampres if you notice that the solution does not have a clear and particle-free appearance.

Since this medicine is limited to hospital use, disposal is carried out directly by the hospital. Medicines should not be disposed of via wastewater. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Ampres

The active substance is chloroprocaine hydrochloride.

1 ml of solution for injection contains 10 mg of chloroprocaine hydrochloride.

1 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, and water for injections.

Appearance of the product and pack contents

This medicine is presented as a solution for injection. The solution is clear and colorless.

It is presented in clear glass ampoules of type I.

Box of 10 ampoules. Each ampoule contains 5 ml of solution for injection.

Marketing authorization holder and manufacturer

Marketing authorization holder

B.Braun Medical, S.A.

Ctra. de Terrassa, 121

08191 (Rubí) Barcelona Spain

Manufacturer

Sirton Pharmaceuticals SpA

Piazza XX Settembre, 2

22079 Villa Guardia (CO)

Italy

Or

Sintetica GmbH

Albersloher Weg 11

48155 Münster

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of last revision of this leaflet:January 2022

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products: http://www.aemps.gob.es.

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This information is intended only for healthcare professionals:

The Summary of Product Characteristics of the medicine is attached to the end of the printed leaflet as a separate section.