Label: Information for the User

Ampres 10 mg/ml Injectable Solution

Chlorprocaine Hydrochloride

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

If you experience any adverse effects, consult your doctor, pharmacist, or nurse,eveniftheydo not appear in this label. See section 4.

Ampres contains the active ingredient chloroprocaine hydrochloride. It is a type of medication called a local anesthetic, which belongs to the category of esters, and is an injectable solution. Ampres is used to anesthetize (put to sleep) specific parts of the body and prevent pain during surgery.

Ampres is indicated only for adults.

No use Ampres

• If you are allergic to chloroprocaine hydrochloride, to medications in the PABA ester group (paraaminobenzoic acid), to other local anesthetics of the ester type, or to any of the other components of this medication (listed in section 6),
• If you have severe heart conduction problems,
• If you have 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 must inform your doctorbeforethe administration of this medication.

• 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 conditions:
• • Central nervous system disorders such as meningitis, polio, or spinal cord problems due to anemia
  • Severe headache
  • Brain, spinal, or other tumors
  • Spinal tuberculosis
  • Recent spinal cord trauma
  • Very low blood pressure or low blood volume
  • Blood clotting problems
  • Acute porphyria
  • Pulmonary edema
  • Sepsis (blood intoxication)
• If you have heart disease
• If you suffer from neurological disorders such as multiple sclerosis, hemiplegia, paraplegia, or muscle disorders.

Other Medications and Ampres

Inform your doctor, pharmacist, or nurse if you are using or have recently used or may need to use any other medication. Especially if you are taking medications for irregular heart rhythm (class III antiarrhythmics), 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 become pregnant, ask your doctor for advice before receiving this medication. Ampres is not recommended as a local or regional anesthetic during pregnancy and should only be administered during pregnancy if absolutely necessary. This does not preclude the use of Ampres during delivery.

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

Driving and Using Machines

Ampres has a significant 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 medication contains less than 1 mmol of sodium (23 mg) per dose (maximum dose equal to 5 ml of Ampres injectable solution), making it considered “sodium-free”.

This medication will be administered by your doctor.

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

The equipment, medications, and personnel capable of handling an emergency must be immediately available.

Your doctor will decide what the correct dose is for you. Normally it will be 4–5 ml (40–50 mg of chlorprocaine hydrochloride).

In patients with general condition impairment (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 (spinal) where the planned surgical procedure should not exceed 40 minutes.

If you have any other questions about the use of this product, ask your doctor, pharmacist, or nurse.

Like all medications, Ampres may have adverse effects, although not all people may experience them.

Important secondary effects to be aware of:

Sudden allergic reactions that put your life at risk (such as anaphylaxis) are rare and affect up to 1 user in every 1,000.

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

Additionally, in case of persistent motor, sensory, and/or autonomic (control of sphincters) deficits in some lower segments of the spine, inform your doctor immediately to avoid permanent neurological damage.

Other possible adverse effects:

Very common: affects more than 1 in 10 patients

Decreased blood pressure, feeling of discomfort (nausea)

Common: affects up to 1 in 10 patients

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

Uncommon: affects up to 1 in 100 patients

Drop in blood pressure (with high doses), slow heart rate, tremors, seizures, tongue numbness, hearing problems, visual problems, speech problems, loss of consciousness.

Rare: affects up to 1 in 1,000 patients

Neuropathy, somnolence up to unconsciousness, respiratory arrest, spinal block (including total spinal block), decreased blood 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.

Dual vision, irregular heartbeats (arrhythmias).

Depressed myocardium, cardiac arrest (the risk increases with high doses or involuntary intravascular injection).

Respiratory depression.

Reporting adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es . By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the ampoule label and on the outer box. The expiration date is the last day of the month indicated.

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

The medication must be used immediately after its first opening. Valid for single use only.

Do not use Ampres if you observe that the solution does not have a clear appearance and is free of particles.

Since this medication is limited to hospital use, the hospital will dispose of it directly. Medications should not be disposed of through wastewater. These measures will help protect the environment.

Composition of Ampres

The active principle is chloroprocaine hydrochloride.

1 ml of injectable solution contains 10 mg of chloroprocaine hydrochloride.

1 vial with 5 ml of solution contains 50 mg of chloroprocaine hydrochloride.

The other components are hydrochloric acid 3.7% (for pH adjustment), sodium chloride, and water for injectable preparations.

Appearance of the product and contents of the package

This medication is presented as an injectable solution. The solution is clear and colorless.

It is presented in clear, colorless type I glass vials.

Box of 10 vials. Each vial contains 5 ml of injectable solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

B.Braun Medical, S.A.

Ctra. de Terrassa, 121

08191 (Rubí) Barcelona Spain

Responsible for manufacturing

Sirton Pharmaceuticals SpA

Piazza XX Settembre, 2

22079 Villa Guardia (CO)

Italy

O

Sintetica GmbH

Albersloher Weg 11

48155 Münster

Germany

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

Last review date of this leaflet:January 2022

Other sources of information

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices:http://www.aemps.gob.es.

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This information is intended solely for doctors or healthcare professionals:

The Technical Data Sheet of the medication is attached at the end of the printed prospectus as a separate section.