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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. 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 medicines called anti-arrhythmic medicines. 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 you have low blood pressure, if you have electrolyte disturbances (e.g. potassium) in the blood; if you have severe obstructive pulmonary disease; if you have been diagnosed with a disease called myasthenia gravis; if you are taking ritonavir (an antiviral medicine used to treat HIV infection).

Warnings and Precautions

Before starting treatment with Tonicard, tell your doctor or pharmacist:

Your doctor may perform an ECG and measure your blood pressure before and during treatment to monitor your individual dose. If you need to have surgery, tell your surgeon or dentist that you are taking this medicine. Tonicard may affect anesthesia or other medicines used.

Children

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

Tonicard and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, including medicines obtained without a prescription. It is especially important to tell your doctor about:

• other medicines used to treat heart conditions and high blood pressure or medicines that may affect the heart rate, including beta-blockers (e.g. propranolol, metoprolol, amiodarone, digoxin, quinidine)
• medicines to prevent blood clots (e.g. phenprocoumon, warfarin)
• antibiotics and antifungals (e.g. erythromycin, rifampicin, ketoconazole)
• cyclosporin (an immunosuppressant used after transplant operations and to treat arthritis and psoriasis)
• medicines 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 (medicines used to treat schizophrenia, e.g. thioridazine)
• phenobarbital (a medicine used to treat epilepsy)
• theophylline (a medicine used to treat asthma)
• local anesthetics used, e.g. in pacemaker implantation, dental surgery, or other minor surgical procedures (e.g. lidocaine)
• cimetidine (a medicine used to treat stomach ulcers)
• muscle relaxants
• ritonavir (an antiviral medicine used to treat HIV) (see "When not to take Tonicard" above).

Tonicard with Food and Drink

Do not take Tonicard with grapefruit juice, as this may increase the levels of propafenone in your blood.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pregnancy Do not take propafenone during pregnancy unless your doctor considers it necessary. Breastfeeding Tell your doctor if you are breastfeeding or planning to breastfeed. Propafenone should be used with caution in breastfeeding women, as it may pass into breast milk.

Driving and Using Machines

Before driving, operating machinery, or performing other activities that require concentration, make sure you know how this medicine affects you. Tonicard may cause blurred vision, dizziness, fatigue, and low blood pressure in some people. Be particularly careful at the start of treatment with propafenone, when changing your medicine, or when taking it with alcohol.

Tonicard Contains Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to Take Tonicard

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is: Adults From one Tonicard 150 mg tablet three times a day to one Tonicard 300 mg tablet three times a day. The dose will be determined individually by your doctor. Elderly patients, or those with kidney or liver problems, or with low body weight, may need a lower dose of Tonicard. Use in Children and Adolescents The dose of Tonicard will be determined individually by your 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 Swallow the coated tablet (without chewing or sucking) after a meal with a drink of water (e.g. a glass of water). Do not take the tablet with grapefruit juice. The 300 mg tablet can be divided into equal doses.

Take a Higher Dose of Tonicard than Recommended

If you have taken more Tonicard than your doctor recommended, IMMEDIATELYcontact your doctor, pharmacist, or the nearest hospital. Take the Tonicard tablets in their original packaging and this leaflet with you. Symptoms of overdose include: rapid heartbeat, irregular heartbeat, cardiac arrest, and low blood pressure, which in severe cases can lead to cardiogenic shock. You may also experience: metabolic acidosis, headache, dizziness, blurred vision, tingling or numbness of the skin (paresthesia), tremor, 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.

Miss a Dose of Tonicard

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. In this case, take your next dose at the usual time.

Stop Taking Tonicard

It is important to continue taking Tonicard until your doctor tells you to stop. Do not stop treatment just because you feel better. Stopping treatment without your doctor's advice may worsen your condition. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

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

Stop Taking Tonicard and IMMEDIATELYTell Your Doctor if You Experience Any of the Following:

easy bruising or sore throat with high fever. Treatment may affect the number of white blood cells and platelets in your blood, skin rash or yellowing of the skin and/or eyes, as this may indicate liver problems, 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, headache, change in taste or bitter taste, blurred vision, slow or fast heartbeat (bradycardia, tachycardia), irregular heartbeat, shortness of breath, chest pain, nausea or vomiting, diarrhea, constipation, dry mouth, liver problems, chest pain, fatigue or weakness (asthenia, fatigue), fever, Uncommon (may affect up to 1 in 100 people): decreased platelet count, which may increase 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, bloating with gas, skin redness or itching, impotence, Rare (may affect up to 1 in 1,000 people): large decrease in white blood cell count, which increases the risk of infection (agranulocytosis, granulocytopenia, leukopenia), disorientation, seizures, tremor or stiffness, anxiety, especially motor anxiety, life-threatening heart rhythm disorders (ventricular fibrillation), heart problems that may cause shortness of breath or swelling of the ankles (heart failure), drop in blood pressure when standing up, which may 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 you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the 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 You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Tonicard

Keep this medicine out of the sight and reach of children. There are no special storage instructions for this medicine. DO NOTtake this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Tonicard Contains

• The active substance 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: maize 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 a diameter 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 a diameter 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