Procaine Serra 10 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

PROCAÏNE SERRA 10 mg/ml injectable solution

Procaine hydrochloride

Read the entire patient information leaflet carefully before you start using this medicine, as 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the 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. Contents of the package and additional information

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

Procaine is a medicine belonging to the group of ester-type local anesthetics, and is indicated for local infiltration anesthesia (pain associated with wounds, minor surgery, burns, abrasions).

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

Do not use Procaína 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 ester-type local anesthetics (such as tetracaine, etc.) due to the risk of cross-allergy.

If in doubt, consult your doctor.

Warnings and precautions

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

• if your liver is not functioning properly, as your doctor may need to adjust the dose.
• if your kidneys are not functioning properly, as this may increase the risk of toxicity.
• in epilepsy: may cause tremors and/or seizures.
• in heart failure, as it may cause severe myocardial depression (reduced activity of heart muscles) as well as prolonged arrhythmias (prolonged disturbance of normal heart rhythm).

Local anesthetic medicines may contribute to the development of malignant hyperthermia (a syndrome characterized by a rapid rise in body temperature and muscle rigidity that may even lead to death) if concomitant general anesthesia is required.

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

It is not advisable to apply this medicine to inflamed or infected areas, as the anesthetic effect may be altered.

Children

This medicine is not indicated for use in children due to the higher likelihood of systemic toxicity (widespread toxicity affecting the blood circulatory system) and insufficient data on the relationship between age and the effects of procaine.

Elderly patients

This medicine should be administered with caution in elderly patients due to an increased likelihood of systemic toxicity and potential accumulation with repeated doses. Reduced doses are recommended based on physical condition.

Other medicines and Procaína Serra

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some medicines, when administered simultaneously with Procaína Serra, may affect the mechanism of action of procaine:

• Sulfonamides (a group of antibiotic medicines).

• Anticholinesterases, and especially echothiophate in ophthalmology (medicines used for the treatment of glaucoma or to induce pupil constriction).

• Muscle relaxants.

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

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

Use of 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor must weigh the benefits against the risks of using this type of medication.

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

Breast-feeding

Consult your physician or pharmacist before using this medicinal product.

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

Driving and use of machines

Serra Procaine may temporarily alter motor function and coordination depending on the anesthetized area; therefore, tasks requiring special attention should not be performed until your physician advises otherwise.

3. How Procaína Serra is administered

If in 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 determined by the physician according to the individual needs of each patient. The maximum daily dose is 1 gram.

Elderly patients and other cases that may require lower doses

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

Use in children

Not indicated in children.

If you consider the effect of Procaína Serra to be 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, toxicity due to procaine is very rare. In case of accidental local overdose, numbness or reduced sense of touch inside and around the mouth may be the first sign of systemic toxicity. Other signs and symptoms that may occur include excitement, agitation, dizziness, tinnitus (ringing in the ears), blurred vision, tremors and convulsions, depression with somnolence, difficulty breathing and coma, myocardial depression (inability of the heart to contract effectively), hypotension (low blood pressure), bradycardia (abnormally slow heart rate), arrhythmia (disturbance of normal heart rhythm), and cardiac arrest.

Absorption of the anesthetic may be reduced by applying a tourniquet. Respiratory problems may require assisted ventilation. Seizures should be controlled with short-acting barbiturates, such as Sodium Thiopental. Low blood pressure may be treated with noradrenaline. Allergic hypersensitivity reactions, as described above, are very unlikely; however, if they occur, they should be treated as all allergic reactions: with adrenaline and antihistamines.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects of procaine are generally infrequent, although moderately significant. In most cases, adverse effects are dose-related and may result from administration of a high dose, rapid absorption, or intravascular injection. They may also result from an allergic reaction, idiosyncrasy, or reduced tolerance in the patient.

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

• Excitation, agitation, dizziness, tinnitus (ringing in the ears), blurred vision, tremors and seizures, numbness or reduced 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 the available data

• Depression with somnolence and coma.
• Respiratory depression (slow or inadequate breathing).
• Methemoglobinemia (a defect in the iron of hemoglobin (the red pigment in blood) causing blood to be unable to effectively transport oxygen to tissues).
• Myocardial depression (reduced activity of heart muscles), hypotension (low blood pressure), bradycardia (abnormally slow heart rate), arrhythmia (disturbance in normal heart rhythm), and cardiac arrest.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 after opening the container and discard any unused solution.

Do not use this medicine after the expiry date stated on the packaging, following EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Procaine Serra 10 mg/ml injectable solution:

The active substance is procaine hydrochloride.

Each millilitre 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 contents of the container

Clear, colourless injectable solution.

Procaine Serra 10 mg/ml is supplied in 5 ml or 10 ml ampoules.

Other presentations

Procaine Serra 20 mg/ml injectable solution

Marketing Authorisation Holder and Manufacturer:

Laboratorios Serra Pamies, S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Date of the most recent review of this leaflet: October 2021

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

This information is intended for healthcare professionals only:

Posology and method of administration

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

Adults

Local infiltration anaesthesia: dosage generally depends on the required anaesthetic effect, the extent of the area to be anaesthetized, etc. The maximum dose within 24 hours for infiltration anaesthesia is 1 gram in adults. Usual doses in infiltration anaesthesia and in dental practice are 1 or 2 ml of Procaine Serra 10 mg/ml injectable solution.

Elderly patients and patients with other diseases

Lower doses should be used in elderly and debilitated patients, those with acute illness, or in patients with cardiac or hepatic disease. Reduced doses are also required when repeated injections are administered and for nerve blocks in highly vascularized areas, in order to avoid high plasma concentrations.

Paediatric patients

Use in the paediatric population is not indicated. No data are available.

Contraindications

Do not administer to patients with hypersensitivity to procaine, PABA, parabens (sulphonamides, hydroxybenzoate-type preservatives), or ester-type local anaesthetics (e.g. tetracaine), due to the risk of cross-allergy.

Interactions

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

The use of anticholinesterase agents, particularly echothiophate in ophthalmology, reduces the hydrolysis capacity of procaine, making this combination dangerous.

By displacing muscle relaxants from their plasma protein binding sites and, in some cases, through metabolic competition, local anesthetics in general potentiate the action of muscle relaxants.

An increase in Ca²⁺ concentration reduces the effect of local anesthetics.

Concomitant administration of procaine with acetazolamide (a diuretic) increases the plasma half-life of procaine.

The addition of a vasoconstrictor, either in the same formulation or applied separately, prolongs the duration of action of the local anesthetic.