Tonicard

Package Leaflet: Information for the Patient

Tonicard, 150 mg, Coated Tablets

Tonicard, 300 mg, Coated Tablets

Propafenone Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Tonicard and What is it Used For
• 2. Important Information Before Taking Tonicard
• 3. How to Take Tonicard
• 4. Possible Side Effects
• 5. How to Store Tonicard
• 6. Contents of the Pack and Other Information

1. What is Tonicard and What is it Used For

Tonicard belongs to a group of medications called anti-arrhythmic medications. The active substance is propafenone hydrochloride. Tonicard slows down the heart rate and helps regulate the heartbeat. Tonicard is used to treat certain heart rhythm disorders (arrhythmia):

• Symptomatic supraventricular tachycardia requiring treatment.
• Severe symptomatic ventricular tachycardia, if considered life-threatening by the doctor.

2. Important Information Before Taking Tonicard

When Not to Take Tonicard:

• if the patient is allergic to propafenone hydrochloride or any of the other ingredients of this medication (listed in section 6);
• if the patient has a heart condition called Brugada syndrome, which can cause a potentially life-threatening heart rhythm;
• if the patient has heart failure or other heart disorders other than irregular heartbeat:
• if the patient has had a heart attack in the last 3 months,
• if the patient has uncontrolled heart failure,
• if the patient has cardiogenic shock, unless it is caused by arrhythmia,
• if the patient has a very slow heart rate,
• if the patient has conduction disorders (sinoatrial node disorders, atrioventricular conduction disorders, second- or third-degree atrioventricular block,

or bundle branch block or distal block in patients without a pacemaker),

• if the patient has low blood pressure,
• if the patient has electrolyte disorders (e.g., potassium) in the blood;
• if the patient has severe obstructive pulmonary disease;
• if the patient has been diagnosed with a condition called myasthenia gravis;
• if the patient is taking ritonavir (an antiviral medication used to treat HIV infection).

Warnings and Precautions

Before starting to take Tonicard, the patient should consult their doctor or pharmacist:

• if the patient has breathing difficulties, such as asthma (see "When Not to Take Tonicard" above),
• if the patient has ever had heart disorders,
• if the patient has a pacemaker (it may need to be reprogrammed),
• if the patient has liver or kidney function disorders,
• if the patient is elderly,
• if the patient is pregnant or plans to become pregnant or is breastfeeding (see "Pregnancy and Breastfeeding" below).

The doctor may perform an ECG and measure blood pressure before and during treatment to monitor individual dosage. If surgery is necessary, the surgeon or dentist should be informed about the use of this medication. Tonicard may affect anesthesia or other medications used.

Children

Tonicard is NOTsuitable for children with a body weight below 45 kg.

Tonicard and Other Medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take, including those available without a prescription. It is especially important to inform the doctor about taking:

• other medications used to treat heart conditions and high blood pressure or medications that may affect heart rate, including beta-blockers (e.g., propranolol, metoprolol, amiodarone, digoxin, quinidine)
• medications that prevent blood clots (e.g., phenprocoumon, warfarin)
• antibiotics and antifungal medications (e.g., erythromycin, rifampicin, ketoconazole)
• cyclosporine (an immunosuppressive medication used after transplant surgery and to treat arthritis and psoriasis)
• medications used to treat depression and/or generalized anxiety disorder (e.g., SSRIs such as fluoxetine or paroxetine or tricyclic antidepressants (e.g., desipramine), venlafaxine)
• narcotics or neuroleptics (medications used to treat schizophrenia, e.g., thioridazine)
• phenobarbital (a medication used to treat epilepsy)
• theophylline (a medication used to treat asthma)
• local anesthetics used, e.g., in pacemaker implantation, dental surgery, or other minor surgical procedures (e.g., lidocaine)
• cimetidine (a medication used to treat stomach ulcers)
• muscle relaxants
• ritonavir (an antiviral medication used to treat HIV) (see "When Not to Take Tonicard" above).

Tonicard with Food and Drink

Tonicard should not be taken with grapefruit juice, as concurrent use may lead to increased propafenone levels.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication. Pregnancy Do not take propafenone during pregnancy unless the doctor considers it necessary. Breastfeeding Inform the doctor if the patient is breastfeeding or plans to start breastfeeding. Propafenone should be used with caution in breastfeeding women, as it may pass into breast milk.

Driving and Operating Machinery

Before driving, operating machinery, or performing other activities that require concentration, the patient should make sure how the medication affects them. Tonicard may cause blurred vision, dizziness, fatigue, and low blood pressure in some individuals. This should be taken into account, especially at the beginning of treatment with propafenone, after changing the medication, or in combination with alcohol.

Tonicard Contains Sodium

This medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to Take Tonicard

This medication should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. The recommended dose is: Adults From one 150 mg Tonicard tablet three times a day to one 300 mg Tonicard tablet three times a day. The dose will be determined individually by the doctor. Elderly patients, those with kidney or liver function disorders, or those with low body weight may require a lower dose of Tonicard. Use in Children and Adolescents The dose of Tonicard will be determined individually by the doctor. The recommended average daily dose is from 10 to 20 mg of propafenone per kilogram of body weight, given in three to four divided doses. The pharmaceutical form of Tonicard is not suitable for children with a body weight below 45 kilograms. Taking Tonicard The coated tablet should be swallowed (without chewing or sucking) after a meal, washed down with a liquid (e.g., a glass of water). Do not wash the tablet down with grapefruit juice. The 300 mg tablet can be divided into equal doses.

Overdose of Tonicard

In case of taking a higher dose of Tonicard than prescribed by the doctor, the patient should IMMEDIATELYcontact their doctor, pharmacist, or the nearest hospital. The patient should take the Tonicard tablets in their original packaging and this package leaflet with them. Symptoms of overdose include: rapid heartbeat, irregular heartbeat, cardiac arrest, and low blood pressure, which in severe cases can lead to cardiogenic shock. The following may also occur: metabolic acidosis, headaches, dizziness, blurred vision, tingling or numbness of the skin (paresthesia), tremors, nausea, constipation, dry mouth, and seizures after overdose. Death has also been reported. In severe cases of poisoning, seizures, paresthesia, drowsiness, coma, and respiratory arrest may occur.

Missing a Dose of Tonicard

The patient should not take a double dose to make up for a missed dose. If the patient forgets to take a dose, they should take it as soon as possible, unless it is almost time for the next dose. In this case, the patient should take the next dose at the usual time.

Stopping Tonicard Treatment

It is important to continue taking Tonicard until the doctor advises stopping it. The patient should not stop treatment just because they feel better. Stopping the medication without the doctor's advice may worsen the patient's condition. If the patient has any further questions about taking this medication, they should ask their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Tonicard can cause side effects, although not everybody gets them.

The Patient Should Stop Taking Tonicard and IMMEDIATELYInform Their Doctor if They Experience Any of the Following Symptoms:

easy bruising or sore throat with high fever. Treatment may affect the number of white blood cells and platelets, skin rash or yellowing of the skin and/or eyes, as this may indicate liver disorders, symptoms of an allergic reaction, such as:

• skin rash, itching, or redness,
• difficulty breathing,
• swelling of the face, lips, tongue, and/or throat,
• difficulty swallowing.

Other side effects associated with propafenone include: Very Common (may affect more than 1 in 10 people): Dizziness Irregular (slow or fast) heartbeat (conduction disorders) Palpitations (feeling of heartbeat) Common (may affect up to 1 in 10 people): Anxiety Difficulty sleeping Headaches Change in taste or bitter taste Blurred vision Slow or fast heartbeat (bradycardia, tachycardia) Irregular heartbeat Shortness of breath Abdominal pain Nausea or vomiting Diarrhea Constipation Dry mouth Liver function disorders Chest pain Fatigue or weakness (asthenia, fatigue) Fever Uncommon (may affect up to 1 in 100 people): Decreased platelet count, which increases the risk of bleeding or bruising Decreased appetite Nightmares Fainting Ataxia (disorders or loss of muscle movement coordination) Tingling or numbness of the skin (paresthesia) Dizziness (feeling of spinning) Heart rhythm disorders (ventricular tachycardia, arrhythmia) Low blood pressure Bloating Belching Skin redness or itching Impotence The following side effects have an unknown frequency (frequency cannot be estimated from the available data): Significant decrease in white blood cell count, which increases the risk of infection (agranulocytosis, granulocytopenia, leukopenia) Disorientation Seizures Tremors or stiffness Anxiety, especially motor Restlessness Life-threatening heart rhythm disorders (ventricular fibrillation) Heart disorders that can cause shortness of breath or ankle swelling (heart failure) Drop in blood pressure when standing up, which can cause dizziness or fainting (orthostatic hypotension) Nausea, gastrointestinal disorders Yellowing of the skin or whites of the eyes due to liver or blood disorders (liver cell damage, cholestasis, hepatitis, jaundice) Lupus-like syndrome (allergic reaction causing joint pain, skin rash, and fever) Decreased sperm count Pustular skin eruptions

Reporting Side Effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw tel.: +48 22 49 21 301 fax: +48 22 49 21 309 website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, it is possible to gather more information on the safety of the medication.

5. How to Store Tonicard

The medication should be stored out of sight and reach of children. There are no special precautions for storing the medication. DO NOTuse this medication after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month. Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Tonicard Contains

• The active substance of Tonicard is propafenone hydrochloride.

Tonicard, 150 mg, coated tablets: One tablet contains 150 mg of propafenone hydrochloride. Tonicard, 300 mg, coated tablets: One tablet contains 300 mg of propafenone hydrochloride. Other ingredients: Core: corn starch, hypromellose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate Coating: talc, hypromellose, titanium dioxide, macrogol 6000.

What Tonicard Looks Like and Contents of the Pack

Tonicard, 150 mg: white or almost white, round, biconvex, coated tablets with dimensions of approximately 9.05 mm x 3.75 mm, smooth on both sides. Tonicard, 300 mg: white or almost white, round, biconvex, coated tablets with dimensions of approximately 11.15 mm x 5.05 mm, with a score line on one side and smooth on the other side. The tablet can be divided into equal doses. Tonicard is available in aluminum/PVC/PVDC blisters containing 20, 30, 60, 90, and 100 coated tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder:

Accord Healthcare Polska Sp. z o.o. ul. Taśmowa 7 02-677 Warsaw Tel: +48 22 577 28 00

Manufacturer/Importer:

Accord Healthcare B.V. Winthontlaan 200 3526 KV Utrecht Netherlands Accord Healthcare Polska Sp.z o.o. ul. Lutomierska 50 95-200 Pabianice Poland Accord Healthcare Single Member S.A. 64th Km National Road Athens 32009 Lamia Greece

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Date of Last Revision of the Leaflet: January 2025