Tonicard

Package leaflet: Information for the patient

Tonicard, 150 mg, coated tablets
Tonicard, 300 mg, coated tablets
Propafenoni hydrochloridum
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Tonicard is and what it is 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 Tonicard is and what it is used for

Tonicard belongs to a group of medicines called antiarrhythmic agents. The active substance is
propafenone hydrochloride. Tonicard slows down the heart's activity and helps regulate heart rhythm.
Tonicard is used to treat certain heart rhythm disorders (arrhythmias):

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

2. Important information before using Tonicard

When not to use Tonicard:

• if the patient is allergic to propafenone hydrochloride or any of the other ingredients of this medicine (listed in section 6);

• if the patient has a heart condition called Brugada syndrome, which may cause a potentially life-threatening heart rhythm;

• if the patient has heart failure or other heart disorders apart from abnormal heart rhythm:

  • if the patient has suffered a myocardial infarction (heart attack) within the last 3 months,
  • if the patient has uncontrolled heart failure,
  • if the patient has cardiogenic shock, unless caused by arrhythmia,
  • if the patient has a very slow heart rate,
  • if the patient has conduction disorders of the heart (sinus node dysfunction, sinoatrial conduction disturbances, second- or higher-degree atrioventricular block, bundle branch block, or distal block in patients without a pacemaker),

• if the patient has low blood pressure,

  • if the patient has been diagnosed with electrolyte imbalances (e.g. potassium) in the blood;
  • if the patient has severe obstructive lung disease;
  • if the patient has been diagnosed with a disease called myasthenia gravis;
  • if the patient is taking ritonavir (an antiviral drug used in the treatment of HIV infection).

Warnings and precautions
Before starting treatment with Tonicard, consult a doctor or pharmacist:

• if the patient has breathing problems, e.g. asthma (see section: "When not to use Tonicard" above),
• if the patient has ever had heart problems,
• if the patient has a cardiac pacemaker (reprogramming may be required),
• if the patient has impaired liver and/or kidney function,
• if the patient is elderly,
• if the patient is pregnant or planning to become pregnant, or is breastfeeding (see section: "Pregnancy and breastfeeding" below).

The doctor may perform an ECG and measure blood pressure before and during treatment to monitor the appropriate individual dose.
If surgery is required, inform the surgeon or dentist that the patient is taking this medicine.
Tonicard may affect anaesthesia or other medicines used.

Children
Tonicard IS NOT suitable for children with body weight below 45 kg.

Tonicard with other medicines
Inform the doctor or pharmacist about all medicines currently used, recently taken, or planned for use, including over-the-counter medicines.
It is especially important to inform the doctor about the use of:

• other medicines used to treat heart conditions and high blood pressure, or medicines that may affect heart function, including beta-blockers (e.g. propranolol, metoprolol), amiodarone, digoxin, quinidine);
• anticoagulant medicines (e.g. phenprocoumon, warfarin);
• antibiotics and antifungal medicines (e.g. erythromycin, rifampicin, ketoconazole);
• cyclosporine (an immunosuppressive medicine used after organ transplantation and in the treatment of 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 anaesthetics used, e.g. during 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 drug used in the treatment of HIV) (see section: "When not to use Tonicard" above).

Tonicard with food and drink
Do not take Tonicard with grapefruit juice, as concomitant use may lead to increased propafenone levels.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Propafenone should not be used during pregnancy unless the doctor considers it necessary.

Breastfeeding
Inform the doctor if the patient is breastfeeding or intends to start breastfeeding.
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 tasks requiring concentration, ensure how this medicine affects the patient.
Tonicard may cause blurred vision, dizziness, fatigue, and low blood pressure in some individuals.
This should be particularly considered at the beginning of propafenone treatment, after a dose change, or when combined with alcohol.

Tonicard contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to take Tonicard

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Recommended dose:
Adults
From one Tonicard 150 mg tablet three times daily to one Tonicard 300 mg tablet three times daily.
The dose will be individually determined by the doctor.
Elderly patients, those with impaired kidney or liver function, or those with low body weight may require a lower dose of Tonicard.
Use in children and adolescents
The dose will be individually determined by the doctor.
The recommended average daily dose is 10 to 20 mg of propafenone per kilogram of body weight, administered in three to four divided doses.
The Tonicard formulation is not suitable for children weighing less than 45 kilograms.
How to take Tonicard
The coated tablet should be swallowed whole (without chewing or sucking) after a meal with fluid (e.g., a glass of water). Do not take the tablet with grapefruit juice.
The 300 mg tablet may be divided into equal doses.
Taking more Tonicard than recommended
If a dose higher than that recommended by the doctor has been taken, contact a doctor, pharmacist, or nearest hospital IMMEDIATELY. Bring the Tonicard tablets in their original packaging and this patient information leaflet with you.
Symptoms of overdose include: rapid heartbeat, irregular heart rhythm, cardiac arrest, and low blood pressure, which in severe cases may lead to cardiovascular shock.
Other symptoms may include: metabolic acidosis, headache, dizziness, blurred vision, tingling or prickling sensations in the skin (paresthesia), tremor, nausea, constipation, dry mouth, and seizures following overdose. Fatal outcomes have also been reported.
In severe cases of poisoning, seizures, paresthesia, drowsiness, coma, and respiratory arrest may occur.
Missing a dose of Tonicard
Do not take a double dose to make up for a missed dose. If a patient forgets to take a dose, it should be taken as soon as possible, provided that the time for the next dose is not approaching. In that case, take the next dose at the usual time.
Stopping Tonicard treatment
It is important to continue taking Tonicard until the doctor advises otherwise. Do not stop treatment just because the patient feels better. Stopping the medication without medical advice may worsen the patient's condition.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Treatment with Tonicard must be discontinued and the doctor should be informed IMMEDIATELY if the patient develops any of the following symptoms:
easy bruising or sore throat with high fever. The treatment may affect the number of white blood cells and platelets,
rash or yellowing of the skin and (or) eyes, as this may indicate liver disorders,
signs of allergic reaction such as:

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

Other adverse reactions associated with the use of propafenone include:
Very common (may affect more than 1 in 10 people):
Dizziness
Irregular (slow or fast) heartbeat (conduction disorders)
Palpitations (awareness of heart beat)
Common (may affect up to 1 in 10 people):
Anxiety
Sleep disturbances
Headaches
Taste disturbances or bitter taste
Blurred vision
Slow or fast heartbeat (bradycardia, tachycardia)
Irregular heart rhythm
Shortness of breath
Abdominal pain
Nausea or vomiting
Diarrhea
Constipation
Dry mouth
Liver function disorders
Chest pain
Fatigue or weakness (asthenia, tiredness)
Fever
Uncommon (may affect up to 1 in 100 people):
Decreased number of platelets, increasing the risk of bleeding or bruising
Loss of appetite
Nightmares
Fainting
Ataxia (impaired or loss of muscle coordination)
Tingling, numbness or pricking sensation of the skin (paresthesia)
Dizziness (spinning sensation)
Heart rhythm disorders (ventricular tachycardia, arrhythmia)
Low blood pressure
Bloating
Bloating with flatulence
Redness and itching of the skin
Impotence
The following adverse reactions are listed below with unknown frequency (frequency cannot be determined from available data):
Marked decrease in white blood cells, increasing the risk of infection (agranulocytosis, granulocytopenia, leukopenia)
Disorientation
Seizures
Tremor or stiffness
Restlessness, particularly motor restlessness
Life-threatening heart rhythm disorders (ventricular fibrillation)
Heart disorders which may cause shortness of breath or ankle swelling (heart failure)
Drop in blood pressure upon standing, which may cause dizziness or fainting (orthostatic hypotension)
Nausea, gastrointestinal disturbances
Yellowing of the skin or whites of the eyes, caused by disorders affecting the liver or blood (liver cell damage, cholestasis, hepatitis, jaundice)
Lupus-like syndrome (allergic reaction causing joint pain, skin rashes and fever)
Decreased sperm count
Acne-like skin eruptions
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tonicard

Keep this medicine out of the sight and reach of children.
No special storage instructions apply to this medicine.
DO NOT use this medicine after the expiry date stated on the blister and carton after EXP.
The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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:
Each tablet contains 150 mg of propafenone hydrochloride.
Tonicard 300 mg, coated tablets:
Each tablet contains 300 mg of propafenone hydrochloride.

Other ingredients:
Core: maize starch, hypromellose, microcrystalline cellulose, sodium croscarmellose,
magnesium stearate.
Coating: talc, hypromellose, titanium dioxide, polyethylene glycol 6000.

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

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

Manufacturer/Importer:
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
The Netherlands

Accord Healthcare Polska Sp. z o.o.
Lutomierska Street 50
95-200 Pabianice
Poland

Accord Healthcare Single Member S.A.
64th Km National Road Athens
32009 Lamia
Greece

This medicinal product is authorised in the European Economic Area under the following names: