Leaflet:information for the patient

Biocoryl 100 mg/ml injectable solution

procainamide 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.
• 1. If you have any doubts, consult yourdoctoror nurse.

-This medicine has been prescribedonlyfor you, and you must not give it to others even if they havethe same symptomsas you, as it may harm them.

• If you experience any side effects,consult your doctor, pharmacist or nurse,evenif they are not listed in this leaflet. See section 4.

1.What Biocoryl is and what it is used for

2.What you need to knowbeforestarting touse Biocoryl

3.How to use Biocoryl

4.Possible side effects

5.Storage of Biocoryl

6.Contents of the pack and additional information

This medication contains procainamide as its active ingredient, which belongs to a group of medications known as class IA antiarrhythmics.

Biocoryl is used for the treatment in adults of a type of heart rhythm alteration, ventricular arrhythmias.

Do not use Biocoryl:

• if you are allergic to procainamide or any of the other ingredients of this medication (listed in section 6),
• if you have systemic lupus erythematosus (a disease in which the body's immune system attacks healthy tissue by mistake. This can affect the skin, joints, kidneys, brain, and other organs),
• if you have torsades de pointes (a serious heart rhythm problem),
• if you have complete atrioventricular block.

Warnings and precautions

Consult your doctor before starting to use Biocoryl:

• if you have first- or second-degree atrioventricular block,
• if you have congestive heart failure,
• if you have acute ischemic cardiomyopathy,
• if you have atrial flutter or fibrillation,
• if you have prolonged QT interval (a heart problem that is observed on an electrocardiogram),
• if you have renal insufficiency (your kidneys do not function properly),
• if you have myasthenia gravis (a disease that causes extreme weakness of certain muscles).

Children and adolescents

Biocoryl is not recommended for children and adolescents.

Use of Biocoryl with other medications

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

Especially, inform your doctor if you are taking:

• a medication for peptic ulcer or gastroesophageal reflux disease called cimetidine,
• a muscle relaxant,
• a medication for myasthenia gravis, such as neostigmine and pyridostigmine,
• a medication to control blood pressure,
• a medication that prolongs the QT interval,
• a medication that causes hypokalemia (low potassium levels in the blood),
• a medication to control some types of arrhythmias, such as amiodarone and Class I antiarrhythmics,
• a medication to treat infections, such as trimethoprim and ofloxacin,
• a medication that contains para-aminobenzoic acid.

Use of Biocoryl with food, drinks, and alcohol

Do not drink alcohol while taking this medication, as it may reduce the effectiveness of the treatment.

Pregnancy,breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Procainamide is not recommended during pregnancy or breastfeeding.

Driving and operating machinery

The effect of Biocoryl on the ability to drive and operate machinery is unknown.

Biocoryl contains alcohol benzyl, sodium bisulfite, and sodium

This medication contains 100 mg of alcohol benzyl in each vial (10 ml). Alcohol benzyl may cause allergic reactions.

This medication may cause severe allergic reactions and bronchospasm (sudden feeling of choking) due to sodium bisulfite.

This medication contains less than 1 mmol of sodium (23 mg) per 10 ml of this medication; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor again.

Your doctor will decide how much Biocoryl to administer and how often you need it.

Biocoryl should only be administered via intramuscular or intravenous routes.Intravenous administration should be reserved for emergency cases.

• Intramuscular Route:

The recommended dose via intramuscular injection is 0.5 g of procainamide (5 ml of Biocoryl) followed by 0.5 to 1.0 g at intervals of 1-6 hours according to response.

• Intravenous Route:

The dose via intravenous administration ranges from 0.2 g to 1.0 g of procainamide.The injection should be administered very slowly (no more than 1 ml of Biocoryl per minute) while monitoring blood pressure and having a vasoconstrictor (such as adrenaline) on hand in case of hypotension.A time interval of 4-6 hours should elapse before administering, if necessary, a new dose.

Use in Children and Adolescents

It is recommended not to use Biocoryl in children and adolescents.

If You Take More Biocoryl Than You Should

Consult your doctor immediately if you take more Biocoryl than you should.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Information for the Doctor:

The treatment of overdose or toxic manifestations includes general supportive measures, strict monitoring, vital sign control, and possibly the administration of intravenous pressor agents and mechanical cardiopulmonary support.

Generally, if necessary, it can be treated by administering vasopressor agents after adequate volume replacement.IV infusion of 1/6 M sodium lactate has been described to reduce the cardiotoxic effects of procainamide.It can be removed from the circulation through hemodialysis, but not through peritoneal dialysis.No specific antidote is known for procainamide overdose.

If You Forget to Use Biocoryl

Do not administer a double dose to compensate for the missed doses.

If You Interrupt Treatment with Biocoryl

Your doctor will indicate the duration of your treatment with this medication.Do not discontinue treatment before.

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

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

The observed adverse effects are described below according to their frequency of appearance:

• Frequent (affects at least 1 in 100 patients):

Lupus-like syndrome (symptoms similar to a disease that can affect the skin, joints, kidneys, brain, and other organs).

• Infrequent (affects at least 1 in 1,000 patients):

Hypotension.

• Rare (affects at least 1 in 10,000 patients):

Neutropenia, thrombocytopenia, hemolytic anemia, agranulocytosis, second-degree atrioventricular block.

• Unknown frequency (cannot be estimated from available data):

Decreased appetite, depression, psychotic disorder (delusions and hallucinations), hallucination, dizziness, alteration of balance, dysgeusia (change in sense of taste), warmth, nausea, vomiting, abdominal pain, diarrhea, hepatomegaly (inflammation of the liver), angioedema (inflammation of the skin), urticaria, pruritus (itching), maculopapular rash (skin eruption), asthenia (weakness or fatigue), elevation of transaminases (increase in certain liver enzymes called transaminases).

Reporting Adverse Effects

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

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

This medication does not require special conditions for preservation.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Biocoryl

• The active principle is procainamide hydrochloride.
• The other components (excipients) are benzyl alcohol, sodium bisulfite (E222), and water for injectable solutions.

Appearance of the product and contents of the packaging

Biocoryl is presented as a colorless or slightly yellowish and transparent injectable solution.

Biocoryl is presented in containers of 1 vial.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Mana Pharma, S.L.

Carretera de Fuencarral, 22

Alcobendas, 28108 Madrid

Spain

Responsible for manufacturing

B. Braun Medical, S.A.

Ronda de Los Olivares, parcela 11

23009 Jaén

Spain

Date of the last review of thisleaflet:April2022.

Other sources of information

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