PROCAINE SERRA 10 mg/mL INJECTABLE SOLUTION

Contents of thepackage leaflet

1. What Procaína Serra is and what it is used for
2. What you need to know before Procaína Serra is administered to you
3. How Procaína Serra is administered
4. Possible side effects
5. Storage of Procaína Serra
6. Package contents and additional information

1. What Procaína Serra is and what it is used for

Procaine is a medicine 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).

2. What you need to know before Procaína Serra is administered to you

Do not useProcaína Serra

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

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

In case of doubt, consult your doctor.

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 produce intense myocardial depression (decrease in heart muscle activity) as well as prolonged arrhythmias (disorder of the 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 stiffness that can even trigger death) in case supplementary general anesthesia is required.

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

It is not advisable to apply this medicine to inflamed or infected areas, as it may alter the effect of the anesthetic.

Children

This medicine is not indicated for use in children, as it presents a higher probability of systemic toxicity (generalized toxicity of the circulatory blood system) and there is not enough information about the relationship between age and the effects of Procaine.

Elderly patients

This medicine should be administered with caution in elderly patients, as it presents a higher probability of systemic toxicity and the possibility of accumulation with repeated doses. It is recommended to use reduced doses based on their physical condition.

Other medicines and Procaína Serra

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

Some medicines, when administered at the same time as Procaína Serra, may affect the mechanism of action of procaine:

• Sulfonamides (a group of antibiotic medicines).

• Anticholinesterases and, especially, ecotiopate in ophthalmology (medicines used to treat glaucoma or to produce pupil contraction).

• Muscle relaxants.

• Hypercalcemia (increased calcium concentration in the blood) decreases the action of local anesthetics.

• Acetazolamide (a diuretic medicine): concomitant administration increases the duration of procaine in the blood, which may increase its effect and toxicity.

Using Procaína Serra with food, drinks, and alcohol

No interactions with food or drinks are known.

Pregnancy, breastfeeding, and fertility

Pregnancy

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

Local anesthetics quickly cross the placenta. The safety of use in pregnant women, except during childbirth, has not been established. As a precaution, it is preferable to avoid the use of Procaína Serra during pregnancy.

Breastfeeding

Consult your doctor or pharmacist before using a medicine.

It is unknown whether procaine or its metabolites are excreted in breast milk and whether this could affect the child; however, no problems have been described in humans. The risk in newborns/children cannot be excluded.

Driving and using machines

Procaína Serra may temporarily alter locomotor function and coordination, depending on the anesthetized area; therefore, tasks that require special attention should not be performed until your doctor indicates.

3. How Procaína Serra is administered

In case of doubt, consult your doctor or pharmacist.

This medicine 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 based on the needs of each patient. The maximum daily dose is 1 gram.

Elderly patients and other cases that may require lower doses

In elderly patients and patients with acute or debilitating diseases, and in those with heart or liver 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

It is not indicated in children.

If you think the effect of Procaína Serra is too strong or too weak, tell your doctor or pharmacist.

If you have been administered more Procaína Serra than you should

At usual doses, procaine intoxication is very rare. In case of accidental local overdose, numbness or decreased sense of touch inside and around the mouth may be an early symptom of systemic toxicity. Other signs and symptoms that may appear are excitement, agitation, dizziness, ringing in the ears, blurred vision, tremors, and convulsions, depression with somnolence, difficulty breathing, and coma, myocardial depression, hypotension, bradycardia, arrhythmia, and cardiac arrest.

Absorption of the anesthetic can be reduced by applying a tourniquet. Respiratory problems may require assisted breathing. Convulsions should be controlled with short-acting barbiturates, such as thiopental sodium. The decrease in blood pressure can be treated with noradrenaline. Allergic reactions, such as those mentioned above, are very unlikely; however, 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

Common side effects: may affect up to 1 in 10 people

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

Uncommon side effects: may affect up to 1 in 1,000 people

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

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

• Depression with somnolence and coma
• Respiratory depression (slow or insufficient breathing).
• Methemoglobinemia (a defect in the iron of hemoglobin that makes it unable to transport oxygen effectively to tissues).
• Myocardial depression, hypotension, bradycardia, arrhythmia, and cardiac arrest.

If you notice side effects not mentioned in this package leaflet or if you suffer from any of the side effects described in a severe form, tell your doctor or pharmacist.

Reporting side effects

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

5. Storage of Procaína Serra

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

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

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

Do not use this medicine after the expiration date stated on the package, after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. If in doubt, ask your pharmacist how to dispose of the package and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Procaína Serra 10 mg/ml injectable solution:

The active substance is procaine hydrochloride.

Each milliliter of solution contains 10 milligrams of procaine hydrochloride.

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

Appearance of the product and package contents

Clear and colorless injectable solution.

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

Other presentations

Procaína Serra 20 mg/ml injectable solution

Marketing authorization holder and manufacturer:

Laboratorios Serra Pamies, S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Date of the last revision of this package leaflet: October 2021

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

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This information is intended only for healthcare professionals:

Posology and method of administration

To reduce the risk of accidental intravascular administration, the procaine solution should be injected slowly, with frequent aspirations, before each injection and during the injection.

Adults

Local anesthesia by infiltration: in general, 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 infiltration anesthesia, is 1 gram in adults. Usually, the doses are 1 or 2 ml of Procaína Serra 10 mg/ml injectable solution in infiltration anesthesia and in dental practice.

Elderly patients and other diseases

In elderly patients and patients with acute or debilitating diseases, and in those with heart or liver disease, lower doses should be used. Lower doses are also required when injections are repeated and for nerve blocks in highly vascularized areas to avoid high plasma concentrations.

Pediatric patients

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

Contraindications

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

Interactions

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

The use of anticholinesterases and, especially, ecotiopate in ophthalmology, results in a lower capacity for hydrolysis of procaine, making its association hazardous.

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 procaine concomitantly with acetazolamide (a diuretic), increases the plasma half-life of procaine.

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