BIOCORYL 100 MG/ML INJECTABLE SOLUTION

2. What you need to know before starting to use Biocoryl

Do not use Biocoryl:

• if you are allergic to procainamide or any of the other components of this medicine (listed in section 6),
• if you have systemic lupus erythematosus (a disease in which the body's immune system attacks healthy tissue by mistake, which 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 heart disease or cardiomyopathy,
• if you have atrial flutter or fibrillation,
• if you have a prolonged QT interval (a heart problem that can be seen on an electrocardiogram),
• if you have renal failure (your kidneys do not work properly),
• if you have myasthenia gravis (a disease that causes extreme weakness of certain muscles).

Children and adolescents

Biocoryl is not recommended for use in children and adolescents.

Using Biocoryl with other medicines

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Especially, tell your doctor if you are taking:

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

Using Biocoryl with food, drinks, and alcohol

Do not drink alcohol while being treated with this medicine, as it may reduce the effectiveness of the treatment.

Pregnancy, breastfeeding, and fertility

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.

Procainamide is not recommended during pregnancy or breastfeeding.

Driving and using machines

The effect of Biocoryl on the ability to drive and use machines is not known.

Biocoryl contains benzyl alcohol, sodium bisulfite, and sodium

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

This medicine may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sodium bisulfite.

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

3. How to use Biocoryl

Follow the administration instructions for this medicine exactly as indicated by your doctor. If in doubt, consult your doctor again.

Your doctor will decide what dose of Biocoryl you should receive and how often you need it.

Biocoryl should only be administered intramuscularly or intravenously. The intravenous route should be reserved for emergency cases.

• Intramuscular route:

The recommended dose by intramuscular route 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 by intravenous route 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. An interval of 4-6 hours should elapse before administering, if necessary, a new dose.

Use in children and adolescents

Biocoryl is not recommended for use in children and adolescents.

If you use more Biocoryl than you should

If you take more Biocoryl than you should, consult your doctor immediately.

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

It is recommended to take the package and leaflet of the medicine to the healthcare professional.

Information for the doctor:

Treatment of overdose or toxic manifestations includes general supportive measures, close monitoring, control of vital signs, and possibly administration of intravenous pressor agents and mechanical cardiorespiratory support.

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

If you forget to use Biocoryl

Do not administer a double dose to make up for forgotten doses.

If you stop using Biocoryl

Your doctor will indicate the duration of your treatment with this medicine. Do not stop treatment before.

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

4. Possible side effects

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

The side effects observed are described below according to their frequency of occurrence:

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

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

• Uncommon (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.

• Frequency not known (cannot be estimated from the available data):

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

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Biocoryl

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

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.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the package and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Biocoryl

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

Appearance of the product and package contents

Biocoryl is a colorless or slightly yellowish, transparent injectable solution.

Biocoryl is available in packs of 1 vial.

Marketing authorization holder and manufacturer

Marketing authorization holder

Mana Pharma, S.L.

Carretera de Fuencarral, 22

Alcobendas, 28108 Madrid

Spain

Manufacturer

• Braun Medical, S.A.

Ronda de Los Olivares, parcela 11

23009 Jaén

Spain

Date of the last revision of this leaflet:April 2022.

Other sources of information

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/).