Patient Information Leaflet

PROCAÍNA SERRA 20 mg/ml injectable solution

Procaína hydrochloride

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, ask 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.

Table of Contents

1. What Procaína Serra is and what it is used for
2. What you need to know before you receive Procaína Serra
3. How to administer Procaína Serra
4. Possible side effects
5. Storage of Procaína Serra
6. Contents of the pack and additional information

Procaína is a medication that belongs to the group of local anesthetics of the ester type and is indicated for local anesthesia by infiltration (pain associated with wounds, minor surgery, burns, abrasions) and peripheral nerve block anesthesia (consisting of injecting the anesthetic over the nerves to anesthetize a larger area).

No useProcaine Sulfate

If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).

If you are allergic to para-aminobenzoic acid (PABA), parabens, or local anesthetics of the ester type (tetracaine, etc.) due to the risk of cross-allergy.

Consult your doctor in case of doubt.

Warnings and Precautions

Consult your doctor or pharmacist before Procaína Serra is administered to you:

• If your liver does not function properly, as your doctor will need to adjust the dose.
• If your kidneys do not function properly, as it may increase the risk of toxicity.
• In epilepsy: it may cause tremors and/or convulsions.
• In heart failure, as it may cause intense myocardial depression (decrease in heart muscle activity) as well as prolonged arrhythmias (prolonged disturbance of normal heart rhythm).

Local anesthetics may contribute to the development of malignant hyperthermia (a syndrome consisting of a rapid increase in body temperature and muscle rigidity that can even lead to death) in the case of supplementary general anesthesia.

There is a risk of severe shock, decreased heart rate, or cardiac block if, due to the site of application or the use of high doses, high blood levels are reached.

It is not recommended to apply this medication to inflamed or infected areas, as it may modify the effect of the anesthetic.

Children

This medication is not indicated for use in children due to a higher probability of systemic toxicity (generalized circulatory system toxicity) and insufficient information on the relationship between age and the effects of Procaína.

Older Adults

This medication should be administered with caution in older adults due to a higher probability of systemic toxicity and the possibility of accumulation with repeated doses. Reduced doses are recommended based on their physical condition.

Other Medications andProcaine Sulfate

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Some medications, when administered at the same time as Procaine Sulfate, may affect the mechanism of action of procaine:

• Sulfonamides (a group of antibiotic medications).

• Cholinesterase inhibitors and, especially, ecotiopato in ophthalmology (medications used for the treatment of glaucoma or to produce pupil contraction).

• Muscle relaxants.

• Hypocalcemia (decrease in calcium concentration in the blood) decreases the action of local anesthetics.

• Acetazolamide (diuretic medication): simultaneous administration increases the time of procaine presence in the blood, potentially increasing its effect and toxicity.

Use ofProcaine Sulfate with Food, Beverages, and Alcohol

No interactions with food or beverages are known.

Pregnancy, Breastfeeding, and Fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.Your doctor must evaluate the benefits against the risks of this type of medication.

Local anesthetics rapidly cross the placenta. The safety of use in pregnant women, except during delivery, has not been established. As a precaution, it is preferable to avoid the use of Procaine Sulfate during pregnancy.

Breastfeeding

Consult your doctor or pharmacist before using a medication.

The safety of Procaine or its metabolites in breast milk and their potential effect on the infant is unknown; however, no problems have been described in humans.No risk can be excluded in newborns/infants.

Driving and Operating Machines

Procaine Sulfate may temporarily alter locomotor function and coordination depending on the anesthetized area,therefore, tasks that may require special attention should not be performed until your doctor advises you.

In case of doubt, consult your doctor or pharmacist.

This medication is administered by your doctor as an injection under the skin or into a muscle.

The recommended dose is as follows:

Adults

The dose will be established by the doctor according to the needs of each patient. The maximum daily dose is 1 gram.

Patients of advanced age and other cases that may require lower doses

In patients of advanced age and patients with acute or debilitating diseases and those with cardiac or hepatic disease, lower doses should be used. Lower doses are also required when injections are repeated and for nerve blocks in highly vascularized areas.

Use in children

This is not indicated for children.

If you estimate that the action of Procaína Serra is too strong or too weak, inform your doctor or pharmacist.

If you have been given more Procaína Serra than you should have

At usual doses, systemic toxicity due to procaína is very rare. In case of accidental local overdose, numbness or decreased sense of touch within and around the mouth may be the first symptom of systemic toxicity. Other signs and symptoms that may appear are excitement, agitation, dizziness, tinnitus, blurred vision, tremors, and convulsions, depression with somnolence, difficulty breathing, and coma, myocardial depression (heart's inability to contract effectively), hypotension (low blood pressure), bradycardia (abnormal and slow heart rhythm), arrhythmia (alteration of normal heart rhythm), and cardiac arrest.

The absorption of the anesthetic may be reduced by applying a tourniquet. Respiratory problems may require assisted respiration. Convulsions should be controlled with short-acting barbiturates, such as Sodium Thiopental. The decrease in blood pressure may be treated with noradrenaline. Allergic reactions, such as those mentioned, are very unlikely; if they occur, they should be treated like all allergic reactions: with adrenaline and antihistamines.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The adverse effects of procaine are generally infrequent but moderately important. In most cases, adverse effects are related to the dose, and may result from the administration of a high dose, rapid absorption, or intravascular injection, or also may result from an allergic reaction, idiosyncrasy, or decreased tolerance by the patient.

Frequent adverse effects: may affect up to 1 in 10 people

• Excitement, agitation, dizziness, ringing in the ears (tinnitus), blurred vision, tremors, and convulsions, numbness or decreased sense of touch inside and around the mouth.
• Nausea and vomiting.

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

• Urticaria due to allergic reaction.
• Anaphylactoid reaction (generalized allergic reaction).

Adverse effects of unknown frequency:cannot be estimated from available data

• Depression with somnolence and coma
• Respiratory depression (slow or insufficient breathing)
• Methemoglobinemia (defect in the iron of hemoglobin (the red blood pigment) that makes it ineffective in transporting oxygen to tissues)
• Myocardial depression (decrease in cardiac muscle activity), hypotension (low blood pressure), bradycardia (abnormal slow heart rhythm), arrhythmia (alteration of normal heart rhythm) and cardiac arrest.

If you notice adverse effects not mentioned in this prospectus or if you experience any of the described adverse effects severely, inform your doctor or pharmacist.

Adverse Effect Reporting

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not appearing in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance for Human Use Medications: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.

Store in the original packaging. No special storage conditions are required.

Use immediately once the packaging is opened and discard any remaining solutions.

Do not use this medication after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Procaína Serra 20 mg/ml injectable solution:

The active ingredient is procaína hydrochloride.

Each milliliter of solution contains 20 milligrams of procaína hydrochloride.

The other components (excipients) are hydrochloric acid (for pH adjustment) and water for injectable preparations.

Appearance of the product and contents of the package

Transparent and colorless injectable solution.

Procaína Serra 20 mg/ml is presented in 5 ml or 10 ml ampoules.

Other presentations

Procaína Serra 10 mg/ml injectable solution

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Serra Pamies, S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Date of the last review of this leaflet: October 2021

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

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This information is intended solely for healthcare professionals:

Dosage and administration

To reduce the risk of accidental intravascular administration, the Procaína solution must be injected slowly, performing frequent aspirations, before each injection and during the same.

Adults

Local anesthesia by infiltration: the dosage will depend on the required anesthetic action, the extent of the area to be anesthetized, etc. The maximum dose in 24 hours, in local anesthesia, is 1 gram in adults. Usually, the doses are, in local anesthesia and in dental practice, 1 or 2 ml of Procaína Serra 20 mg/ml injectable solution.

Peripheral nerve block anesthesia: the dosage will depend on the required anesthetic action, the plexuses, nerves, or fibers to be blocked, the patient's physical condition, etc.

The usual dose in peripheral nerve block anesthesia is 500 mg of Procaína, in a solution of 20 mg/ml concentration (equivalent to injecting 25 ml of 20 mg/ml solution). The maximum dose, in 24 hours, in peripheral nerve block anesthesia is 1 gram.

Patients of advanced age and other diseases

In the elderly and patients with acute or debilitating diseases and those with cardiac or hepatic disease, lower doses should be used. Also, lower doses are required when injections are repeated and for nerve blocks of highly vascularized areas, to avoid high plasma concentrations.

Pediatric patients

It is not indicated for use in pediatric population. No data are available.

Contraindications

It should not be administered to patients with sensitivity to procaína, PABA, parabens (sulfamides, preservatives of the type hydroxybenzoate) or to local anesthetics of the ester type (tetracaine, etc.) due to the risk of cross-allergy.

Interactions

After the absorption of Procaína, it is rapidly hydrolyzed by plasma cholinesterase to p-aminobenzoic acid and diethylaminoethanol. Due to the formation of p-aminobenzoic acid, Procaína is incompatible (antagonist) with sulfamides and vice versa.

The use of anticholinesterases and, especially, of ecotiopato in ophthalmology, leads to a lower ability to hydrolyze Procaína, making its association dangerous.

By displacement of muscle relaxants from their binding sites with plasma proteins and, in some cases, by metabolic competition, local anesthetics, in general, potentiate the action of muscle relaxants.

The increase in Ca2+ concentration decreases the action of local anesthetics.

The administration of Procaína concomitantly with acetazolamide (diuretic), increases the plasma half-life of Procaína.

The incorporation of a vasoconstrictor in the same formulation or applied separately, increases the duration of action of the local anesthetic.