TAKIPRIL HIPERBARICA 20 mg/mL Injectable Solution

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

Takipril Hyperbaric must not be administered

• if you are allergic (hypersensitive) to prilocaine hydrochloride, to other local anesthetics of the amide type, or to any of the other components of this medicine (listed in section 6)
• if you have serious cardiac conduction problems
• if you have severe anemia
• if you have decompensated heart failure
• if you have cardiogenic or hypovolemic shock
• if you have congenital or acquired methemoglobinemia.
• if you have specific or general contraindications for subarachnoid anesthesia technique

Takipril Hyperbaric must not be administered into the bloodstream.

Takipril Hyperbaric should not be used in children under 6 months.

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 a skin infection at the proposed injection site or in the surrounding area
• 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 a heart condition (e.g., complete or partial heart block, decompensated 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 poor general 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 prevent infection in the bloodstream and to recognize and treat adverse effects.

Children and Adolescents

Takipril Hyperbaric is not recommended for use in children and adolescents. The efficacy and safety of Takipril Hyperbaric in the pediatric population have not been established. There are no available data.

The use of Takipril in children under 6 months is contraindicated due to the increased risk of developing methemoglobinemia.

Other Medicines and Takipril

Tell your doctor if you are using, have recently used, or might use any other medicines, including those obtained without a prescription. Especially if you are taking any medicine for irregular heartbeat (class III antiarrhythmics) and pain relief.

Pregnancy and Breastfeeding

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

It is not known whether prilocaine is excreted in breast milk. If it needs to be administered during breastfeeding, breastfeeding can be resumed 24 hours after treatment.

Driving and Using Machines

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

Takipril Hyperbaric contains Sodium

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

3. How to use Takipril Hyperbaric

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

Your doctor will administer Takipril Hyperbaric into the lower part of your spine while you are sitting or lying down.

Use in Children and Adolescents

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

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

In case of liver or kidney impairment, a lower dose range is recommended.

Takipril Hyperbaric is injected intrathecally.

Immediate availability of equipment, medicines, and qualified personnel should be ensured to handle an emergency. In rare cases, severe reactions have been reported after the use of local anesthetics, even in the absence of individual hypersensitivity in the patient's medical history.

If you are given more Takipril Hyperbaric than you should

The doctor administering Takipril Hyperbaric has experience in the use of local anesthetics via the intrathecal route, so it is unlikely that you will be given an overdose. However, if you are accidentally injected with the dose into the bloodstream, you may experience problems with your vision or hearing for a short period, muscle contraction, tremors, convulsions, and loss of consciousness. When you are given Takipril Hyperbaric and in case an overdose occurs, a team will be available to assist you.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Takipril Hyperbaric can cause side effects, although not everybody gets them.

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

You may feel nauseous and have low blood pressure or a slow heart rate. Other possible effects are post-operative headache, vomiting, and difficulty urinating.

These are the 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

Paresthesia, dizziness, vomiting

Uncommon: may affect up to 1 in 100 people

Convulsions, circumoral paresthesia, loss of consciousness, tremor, sensation of numbness affecting the tongue, speech problems, hearing problems, tinnitus, visual problems, back pain, temporary muscle weakness, slow heart rate. High 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 heartbeat. Respiratory depression.

It is unlikely that Takipril Hyperbaric solution for injection will cause serious side effects unless it is accidentally injected incorrectly or used in combination with other local anesthetics. If this happens, numbness of the tongue, feeling of fainting, dizziness, tremor, and convulsive attacks may occur. In extremely rare cases, prilocaine has been associated with heart attack, breathing difficulties, loss of sensation in the lower part of the body, and allergic reactions, which can cause skin rash, swelling, or very low blood pressure.

A rare but serious adverse reaction of intrathecal anesthesia is high or complete spinal block, with consequent cardiovascular and respiratory depression.

If you experience side effects, talk to your doctor or pharmacist or nurse, even if it is a side effect not listed in this leaflet.

Reporting of Side Effects

If you experience any adverse event, talk to your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Takipril Hyperbaric

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

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

Do not store Takipril Hyperbaric 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.

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

Any remaining product should be disposed of. Since its use is limited to hospitals, the disposal of medicinal waste is carried out directly by the hospital. This will help protect the environment.

6. Contents of the Pack and Other Information

Composition of Takipril Hyperbaric

• The active substance is Prilocaine Hydrochloride.

1 ml of injectable solution contains 20 mg of Prilocaine Hydrochloride (equivalent to 2%).

1 ampoule with 5 ml of solution contains 100 mg of prilocaine 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 Pack

Injectable solution. Clear and colorless solution.

Takipril Hyperbaric is presented in clear glass ampoules type I.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

• 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]

Manufacturer

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:

Date of Last Revision of this Leaflet:February 2020

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

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.