Leaflet: information for the user

Takipril hiperbárica 20 mg/ml injectable solution

Prilocaína hidrocloruro

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• • If you have any questions, consult your doctor or pharmacist.
  • If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Takipril is and what it is used for

2. What you need to know before starting to use Takipril

3. How to use Takipril

4. Possible side effects

5. Storage of Takipril

6. Contents of the pack and additional information

Takipril hiperbárica 20 mg/ml is a type of medication called a local anesthetic, which belongs to the category of amides. Takipril hiperbárica is an injectable solution that is used to anesthetize (put to sleep) specific parts of the body and prevent pain during surgery in adults.

Takipril hiperbárica is injected into the lower part of your spine. This quickly stops pain from the waist down for a limited period of time (short-duration surgeries).

You should not be administered Takipril hiperbárica

• if you are allergic (hypersensitive) to chlorhydrate of prilocaine, to other local anesthetics of amide type or to any of the other components of this medication (included in section 6)
• if you have severe heart conduction problems
• if you suffer from severe anemia
• if you have decompensated heart failure
• if you have cardiogenic and hypovolemic shock
• if you suffer from congenital or acquired methemoglobinemia.
• if you have specific or general contraindications for the spinal anesthesia technique

Takipril hiperbárica cannot be administered in blood vessels.

Takipril hiperbárica cannot be used in children under 6 months.

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 a skin infection at the proposed injection site or in its vicinity
• if you suffer from any of the following conditions:
• 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 trauma to the spine
• very low blood pressure or low blood volume
• blood coagulation problems
• acute porphyria
• fluid in the lungs
• septicemia (blood intoxication)
• if you have a heart disease (for example, a total or partial heart block, heart failure or arrhythmia)
• if you have liver or kidney problems
• if you suffer from neurological disorders such as multiple sclerosis, hemiplegia, paraplegia or muscle disorders.
• if you are in a state of general poor health

Spinal anesthesia should only be administered by a doctor with the necessary knowledge and experience. The doctor is responsible for taking the necessary measures to avoid infection in the blood vessel and to recognize and treat adverse effects.

Children and adolescents

Takipril hiperbárica is not recommended for use in children and adolescents. The efficacy and safety of Takipril hiperbárica in pediatric population have not been established. No data are available.

The use of Takipril in children under 6 months is contraindicated due to the higher risk of

developing methemoglobinemia.

Other medications and Takipril

Inform your doctor if you are using, have used recently or may have to use any other medication, even those purchased without a prescription. Especially if you are taking any medication for irregular heart rhythm (class III antiarrhythmics) and pain relief.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, your doctor will decide whether to administer the Takipril hiperbárica injection. Prilocaine should not be administered as local or regional anesthesia during childbirth.

It is not known if prilocaine is excreted in breast milk. If it is necessary to administer it during breastfeeding, breastfeeding can be resumed 24 hours after treatment.

Driving and operating machines

Do not drive or operate tools or machines, as Takipril hiperbárica may temporarily interfere with your muscular coordination and reactions.

Takipril hiperbárica contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose (maximum dose equal to 4 ml of Takipril hiperbárica), so it is considered essentially “sodium-free”.

This medication will be administered by your doctor, who will decide what the correct dose is for you. The usual dose in adults is 40 – 60 mg of prilocaína hydrochloride (2-3 ml of Takipril hiperbárica); the maximum dose is 80 mg of prilocaína hydrochloride (4 ml of Takipril hiperbárica).

Your doctor will administer Takipril hiperbárica to the lower part of your spine while you are seated or lying down.

Use in children and adolescents

Takipril hiperbárica is not recommended for use in children and adolescents. The safety and efficacy of Takipril hiperbárica in the pediatric population have not been established. The use of Takipril hiperbárica in children under 6 months is contraindicated due to a higher risk of developing methemoglobinemia.

In patients with compromised general condition and established concomitant diseases (e.g., vascular occlusion, arteriosclerosis, diabetic polyneuropathy), a reduced dose is indicated.

In cases of compromised liver or kidneys, a lower dose range is recommended.

Takipril hiperbárica is administered via the intrathecal route.

Immediate access to equipment, medications, and qualified personnel should be available to address an emergency. Rarely, severe reactions have been reported following the use of local anesthetics, even in the absence of individual hypersensitivity in the patient's clinical history.

If you are administered more Takipril hiperbárica than you should

The doctor administering Takipril hiperbárica has experience with the use of local anesthetics via the intrathecal route, making it unlikely that you will be administered an overdose. However, if you are accidentally injected with the dose in the blood, you may experience problems with your vision or hearing for a short period, muscle contractions, tremors, seizures, and loss of consciousness. When Takipril hiperbárica is administered, and in the event of an overdose, a team will be available to assist you.

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

Like all medications, Takipril hiperbárica may cause adverse effects, although not everyone will experience them.

As occurs with all local anesthetics, a drop in blood pressure and a slowing of heart rate may occur.

You may feel like vomiting and have low blood pressure or a slow heart rate. Other possible effects are headache after surgery, vomiting, and difficulty urinating.

These are the possible adverse effects:

Very frequent: may affect more than 1 in 10 people

Decreased blood pressure, nausea

Frequent: may affect up to 1 in 10 people

Paresthesia, dizziness, vomiting

Infrequent: may affect up to 1 in 100 people

Seizures, circumoral paresthesia, loss of consciousness, tremor, numbness affecting the tongue, speech problems, hearing problems, tinnitus, visual problems, back pain, temporary muscle weakness, slow heart rate. Elevated blood pressure.

Rare: may affect up to 1 in 1000 people

Methemoglobinemia, cyanosis. Anaphylactic shock, anaphylactic reaction, itching. Arachnoiditis, neuropathy, peripheral nerve damage.

Diplopia. Cardiac arrest, irregular heartbeats. Respiratory depression.

It is unlikely that Takipril hiperbárica injectable solution will cause severe adverse effects unless it is accidentally injected incorrectly or used in combination with other local anesthetics. If this occurs, numbness of the tongue, feeling of faintness, dizziness, tremor, and convulsions may occur. In extremely rare cases, prilocaine has been associated with heart attack, respiratory difficulties, numbness in the lower part of the body, and allergic reactions, which may cause skin eruptions, swelling, or very low blood pressure.

A rare but severe adverse reaction to intrathecal anesthesia is high or complete spinal block, with subsequent cardiovascular and respiratory depression.

If you experience adverse effects, consult your doctor, pharmacist, or nurse even if they do not appear in this prospectus.

Reporting adverse effects

If you experience any type of adverse event, consult your doctor, pharmacist, or nurse, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: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 reach and sight of children.

Do not use Takipril hyperbaric 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 Takipril hyperbaric at a temperature 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.

Do not use Takipril hyperbaric if you observe that the solution does not present a clear appearance and is free of particles.

All remaining product must be discarded. Since its use is limited to hospitals, the disposal of the medication residues is carried out directly by the hospital. This will help protect the environment.

Composition of Takipril hyperbaric

• The active ingredient is Prilocaína hydrochloride.

1 ml of injectable solution contains 20 mg of Prilocaína hydrochloride (equivalent to 2%).

1 vial with 5 ml of solution contains 100 mg of prilocaína hydrochloride.

• The other components are: anhydrous glucose or glucose monohydrate, sodium hydroxide 1N (for pH adjustment) and water for injectable preparations.

Appearance of the product and contents of the package

Injectable solution. Clear and colorless solution.

Takipril hyperbaric is presented in clear, colorless type I glass vials.

Box of 10 vials, each containing 5 ml of injectable solution

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

B. Braun Medical, SA

Carretera de Terrassa, 121

08191 Rubí (Barcelona)

Spain

Phone: +34 93 582 95 80

Fax: +34 93 588 10 96

e-mail: [email protected]

Responsible for manufacturing

Sirton Pharmaceuticals S.P.A.

Piazza XX Settembre 2

22079 Villa Guardia

Italy

Sintetica GmbH

Albersloher Weg 11

48155 - Münster

Germany

This medicine is authorized in the EEA Member States with the following names:

Last review date of this leaflet:February 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

This information is intended solely for doctors or healthcare professionals:

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