AMPRES 20 mg/ml INJECTABLE SOLUTION

2. What you need to know before you are given Ampres

Do not use Ampres:

• if you are allergic to chloroprocaine hydrochloride, to PABA (para-aminobenzoic acid) ester-type medicines, to other local anesthetics of the ester type, or to any of the other ingredients of this medicine (listed in section 6),
• if there are general and specific contraindications for regional anesthesia, regardless of the local anesthetic used,
• if you have been told you have a reduced blood volume (hypovolemia),
• if you have severe cardiac conduction problems.

Warnings and precautions

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

• if you have ever had a bad reaction to an anesthetic in the past.
• if you have signs of skin infection or inflammation at the proposed injection site or nearby.
• if you suffer from any of the following:
• liver disease or kidney problems.
• very low blood pressure.
• blood clotting problems.
• fluid in the lungs.
• septicemia (blood poisoning).
• if you have a heart condition (e.g., complete or partial heart block, heart failure, or arrhythmia).
• if your general health is poor.

Other medicines and Ampres

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

Tell your doctor if you are taking any of the following medicines:

• cholinesterase inhibitors (such as anticholinesterases or cyclophosphamide)

This is because your body takes longer to eliminate Ampres if you are taking these medicines.

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 for local or regional anesthesia during pregnancy and should only be administered during pregnancy if absolutely necessary.

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

Driving and using machines

The influence of Ampres on the ability to drive and use machines is important.

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

Ampres contains sodium

This medicine contains 37 mg of sodium (a major component of cooking/table salt) in each 20 ml vial. This is equivalent to 1.85% of the maximum recommended daily intake of sodium for an adult.

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 a medical emergency should be available immediately.

Your doctor will decide what dose is suitable for you. The dose will depend on your state of health, the part of the body where the medicine is injected, and what the medicine is used for.

The maximum dose for healthy adults should not exceed 800 mg.

In patients with impaired general condition and in patients with confirmed concomitant disorders (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 have not been established. No data are available.

Ampres may be used to achieve local anesthesia by injecting the solution around a peripheral nerve or a network of nerves (perineural use), and the planned surgical procedure should not exceed 60 minutes.

If you have any further questions on 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 to look out for:

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

Possible symptoms include sudden onset of itching, erythema (redness of the skin), 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, tell your doctor immediately.

Other possible side effects:

Very common: may affect more than 1 in 10 people

Decrease in blood pressure, nausea

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

Decrease in blood pressure (with high doses), high blood pressure (hypertension), slow heart rate, tremors, convulsions, numbness of the tongue, hearing problems, vision problems, speech problems, loss of consciousness.

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

Neuropathy, somnolence, leading to loss of consciousness and respiratory arrest, loss of bladder and bowel control, loss of perineal sensation and sexual function, and permanent neurological damage.

Double vision, irregular heartbeats (arrhythmias).

Myocardial depression, cardiac arrest (the risk increases with high doses or accidental intravascular injection).

Shortness of breath, wheezing, and difficulty breathing.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency's website: 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 vials and on the outer packaging, after EXP. The expiry date is the last day of the month shown.

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

Use immediately after first opening. For single use only.

Ampres should not be administered if the solution is not clear and free of particles.

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

6. Contents of the pack and other information

Composition of Ampres

The active substance is chloroprocaine hydrochloride.

1 ml of the injectable solution contains 20 mg of chloroprocaine hydrochloride.

1 vial with 20 ml of solution contains 400 mg of chloroprocaine hydrochloride.

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

Appearance and packaging

This medicine is presented as an injectable solution. The injectable solution is a clear, colorless solution.

It is presented in a 20 ml glass vial of type I.

The vial closures are bromobutyl rubber stoppers and the closures used are aluminum flip-off caps.

Box with 1 vial containing 20 ml of injectable solution.

Marketing authorization holder and manufacturer

Marketing authorization holder:

B.Braun Medical, S.A.

Ctra. de Terrassa, 121

08191 (Rubí) Barcelona

Spain

Manufacturer:

Sirton Pharmaceuticals S.p.A.

Piazza XX Settembre, 2

22079 Villa Guardia - Como

Italy

Sintetica GmbH

Albersloher Weg 11

48155 Münster

Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of this leaflet:January 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (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.