Package leaflet: information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Cordarone
200 mg, tablets
Amiodarone hydrochloride
Please read the entire leaflet carefully before using this 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 doubts, please consult your doctor or nurse.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse effects, including any not listed in this leaflet, inform the doctor or nurse immediately. See section 4.

Table of contents of the leaflet

What Cordarone is and what it is used for
Important information before taking Cordarone
How to take Cordarone
Possible side effects
How to store Cordarone
Contents of the pack and other information

1. What Cordarone is and what it is used for

Cordarone is available in the form of tablets and contains amiodarone hydrochloride as the active substance. Amiodarone is a potent antiarrhythmic medicine used to treat irregular heartbeat.
It is used to treat life-threatening heart rhythm disorders:

rhythm disorders associated with Wolff-Parkinson-White syndrome;
atrial fibrillation and atrial flutter, paroxysmal supraventricular tachyarrhythmias: supraventricular and nodal tachycardias, when other medicines cannot be used;
ventricular rhythm disorders (ventricular tachycardia, ventricular fibrillation), when other antiarrhythmic medicines are ineffective.

2. Important information before using Cordarone

When not to use Cordarone:

if the patient is allergic to iodine, amiodarone, or to any of the other ingredients of this medicine (listed in section 6); if symptoms of allergy occur, such as itchy rash, difficulty swallowing or breathing, or swelling of the lips, face, throat, or tongue, contact a doctor immediately;
in patients with heart diseases: sinus bradycardia, sinoatrial block, sick sinus syndrome, except in patients with implanted pacemakers (risk of sinus node inhibition);
in patients with second- or third-degree atrioventricular block, except in patients with implanted pacemakers;
concurrently with medicines that may cause life-threatening arrhythmias – torsade de pointes (see: Cordarone and other medicines);
if the patient has thyroid disease;
if the patient is pregnant or breastfeeding.

Warnings and precautions
Before starting treatment with amiodarone, it is recommended to perform ECG, TSH hormone level, and serum potassium concentration tests (low blood potassium levels increase the risk of cardiac arrhythmias).
The pharmacological action of amiodarone causes changes in the ECG: QT interval prolongation (due to prolonged repolarization phase) with possible appearance of U waves.
However, these changes do not cause toxic effects.
Heart function may significantly decrease in elderly patients.
If second- or third-degree atrioventricular block, sinoatrial block, or bifascicular block occurs, treatment with Cordarone should be discontinued.
Cordarone has proarrhythmic effects. Cases of new-onset cardiac arrhythmias or worsening of treated arrhythmias, sometimes leading to death, have been reported.
Proarrhythmic effects of Cordarone are reported less frequently than with other antiarrhythmic drugs. Proarrhythmia associated with amiodarone occurs particularly as a result of interaction with QT-prolonging drugs and/or in the presence of electrolyte disturbances (see section Cordarone and other medicines and section 4). Despite QT interval prolongation, Cordarone has low activity in inducing torsade de pointes arrhythmias.
Amiodarone may affect the performance of a pacemaker or an implanted cardioverter-defibrillator, especially during long-term antiarrhythmic therapy.
Therefore, device function should be monitored before and during amiodarone treatment.
Oral Cordarone is not contraindicated in patients with heart failure, but caution is required during treatment, as it may exacerbate heart failure. In such cases, Cordarone may be used in combination with other medicines.
Before starting Cordarone, discuss with a doctor or pharmacist if the patient is currently taking a medicine containing sofosbuvir, used in the treatment of hepatitis C virus infection, as this may cause life-threatening slowing of heart rate. The doctor may consider alternative treatment options. If treatment with both amiodarone and sofosbuvir is necessary, additional cardiac monitoring may be required.
Contact a doctor immediately if the patient is taking a medicine containing sofosbuvir for hepatitis C and during treatment experiences:

slow or irregular heartbeat or arrhythmias,
shortness of breath or worsening of existing shortness of breath,
chest pain,
dizziness,
palpitations,
near-syncope or fainting.

Cordarone may cause hypothyroidism or hyperthyroidism, especially in patients with a history of thyroid disorders.
Clinical and biological monitoring (including TSH levels) is recommended before starting treatment in all patients. Monitoring should continue during treatment every 6 months and for several months after treatment ends. This is particularly important in elderly patients.
In patients with a history indicating increased risk of thyroid disorders, regular monitoring of thyroid function is recommended.
Hyperthyroidism may occur during treatment or several months after discontinuation of amiodarone.
Clinical symptoms, usually mild, such as weight loss, onset of arrhythmias, dyspnea, or congestive heart failure, should alert the physician. Diagnosis is based on markedly reduced serum TSH levels.
In such cases, Cordarone should be discontinued. Symptoms usually resolve several months after stopping Cordarone; clinical improvement is preceded by normalization of laboratory thyroid function tests. Severe cases of hyperthyroidism, sometimes fatal, require immediate appropriate therapeutic intervention. Treatment should be individually tailored: antithyroid drugs (which are not always effective), corticosteroids, beta-blockers.
The onset of dyspnea and non-productive cough may be related to pulmonary toxicity, such as interstitial pneumonitis. In patients who develop exertional dyspnea, either as the sole symptom or associated with worsening general condition (fatigue, weight loss, fever), a chest X-ray should be performed. Continuing Cordarone therapy should be reconsidered, as interstitial pneumonitis is usually reversible if treatment is promptly discontinued (clinical symptoms usually resolve within 3 to 4 weeks, radiological changes and lung function improvement occur over several months). Consideration should be given to corticosteroid therapy.
Periodic monitoring of liver function (measurement of aminotransferase activity) is recommended during Cordarone treatment.
The dose of Cordarone should be reduced or treatment discontinued if aminotransferase activity increases threefold above normal values, which may indicate acute or chronic liver dysfunction.
Clinical symptoms of chronic liver dysfunction may be mild (possible hepatomegaly, aminotransferase activity increased 1.5 to 5 times above normal). These abnormalities usually resolve after discontinuation of Cordarone; however, fatal cases have been reported.
Cordarone treatment should be immediately discontinued if severe skin reactions occur during its use (e.g., progressive rash with blisters or mucosal lesions, fever and joint pain, severe rapidly progressing illness with ruptured subcutaneous bullae, extensive skin erosions, sloughing of large epidermal sheets, and fever – see also section 4). These symptoms may be life-threatening.
Cordarone may cause sensory-motor peripheral neuropathy and/or myopathy.
Symptoms usually resolve within several months after discontinuation of Cordarone, but sometimes may persist.
If blurred vision or worsening of vision occurs, a complete ophthalmological examination, including fundus examination, should be performed immediately. If optic nerve damage and/or optic neuritis is diagnosed, Cordarone must be discontinued due to the risk of vision loss.
Concurrent use of amiodarone with the following medicines is not recommended: beta-blockers, calcium channel blockers reducing heart rate (verapamil, diltiazem), laxatives that may cause hypokalemia.
Avoid exposure to sunlight and use sun-protective measures during treatment. Cordarone causes photosensitivity, which may persist for several months after discontinuation of treatment.
The most common symptoms are tingling, burning, and erythema affecting skin areas exposed to sunlight.
Phototoxic reactions and rash are rarely observed.
Before surgery, inform the anesthesiologist that the patient is taking amiodarone; cases of severe cardiovascular and respiratory complications (sometimes fatal) have been reported in patients undergoing general anesthesia and oxygen therapy.
If the patient is on a heart transplant waiting list, the treating physician may change the treatment regimen before transplantation. This is because amiodarone use before heart transplantation increases the risk of a life-threatening complication (primary graft dysfunction), in which the transplanted heart fails to function properly within the first 24 hours after surgery.

Cordarone and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines planned for use.
Do not use Cordarone concurrently with medicines that may cause life-threatening arrhythmias (type torsade de pointes). These include:

antiarrhythmic medicines (for irregular heartbeat): quinidine, disopyramide, procainamide, sotalol, bretylium, bepridil,
intravenous erythromycin (antibiotic), cotrimoxazole (antimicrobial agent), or the antiprotozoal agent pentamidine,
antipsychotic medicines such as: chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpride, sertindole,
some medicines used for other psychiatric disorders: lithium preparations and tricyclic antidepressants, e.g. doxepin, amitriptyline,
some antihistamines used for allergies: terfenadine, astemizole, mizolastine,
antimalarial medicines: quinine, chloroquine, mefloquine, halofantrine,
a medicine used for cerebral circulation disorders, dizziness, tinnitus, memory and learning disorders, especially in the elderly – vincamine,
neuroleptics,
a medicine used for delayed gastric emptying – cisapride.

Concurrent use of Cordarone is not recommended with:

fluoroquinolones – antimicrobial agents: ciprofloxacin, ofloxacin, levofloxacin,
beta-blockers – used for heart diseases, e.g. propranolol,
calcium channel blockers slowing heart rate – used for angina (heart disease) or hypertension (high blood pressure): verapamil, diltiazem,
antiviral medicines used for hepatitis C virus infection, e.g. sofosbuvir, daklatasvir, symeprevir, or ledipasvir, due to the risk of bradycardia,
certain laxatives (used for constipation) causing low blood potassium: bisacodyl, sena,
cholesterol-lowering medicines – statins, e.g. simvastatin, atorvastatin, lovastatin.

Use caution when using the following medicines concurrently with Cordarone:

diuretics, e.g. furosemide,
anti-inflammatory medicines – systemic corticosteroids, e.g. hydrocortisone, prednisolone,
tetracosactide – a medicine used to diagnose certain hormonal disorders,
antifungal medicine – intravenous amphotericin B,
anaesthetic agents used in general anaesthesia or high oxygen concentrations during surgical procedures (see Warnings and precautions in section 2 and section 4). Inform the anaesthesiologist about Cordarone use before surgery,
phenytoin – used for epileptic seizures: close monitoring is required and phenytoin dose should be reduced immediately if signs of overdose occur; serum phenytoin levels should be measured,
cardiac glycosides, e.g. digoxin – used for heart diseases: the doctor will order serum digoxin level tests and ECG, and may adjust the digoxin dose; monitor for signs of digoxin toxicity,
anticoagulants – warfarin, dabigatran: regular blood coagulation tests are required to adjust oral anticoagulant doses during and after Cordarone treatment; dabigatran dose adjustment may be necessary,
immunosuppressants to prevent transplant rejection – cyclosporine, tacrolimus, sirolimus,
flecainide – used for arrhythmias: treatment must be under strict medical supervision; the doctor will adjust the flecainide dose,
fentanyl – a strong analgesic,
lidocaine – a local anaesthetic,
sildenafil – used for erectile dysfunction,
midazolam – used for anxiety and preoperative sedation,
triazolam – used for insomnia,
dihydroergotamine and ergotamine – antimigraine agents,
colchicine – used for acute gout attacks.

Pregnancy, breastfeeding, and effects on fertility
During pregnancy, breastfeeding, if pregnancy is suspected, or when planning pregnancy, consult a doctor before using this medicine.
Due to the effect of Cordarone on the fetal thyroid, use during pregnancy is contraindicated unless otherwise directed by a doctor. Consult a doctor before use.
Use of Cordarone during breastfeeding is contraindicated.
There are no data on the effect of amiodarone on human fertility.

Driving and operating machinery
Based on safety data regarding amiodarone use, the medicine does not impair the ability to drive or operate machinery.

Cordarone contains monohydrate lactose
Patients with hereditary galactose intolerance, Lapp-type lactase deficiency, or glucose-galactose malabsorption syndrome should not take this medicine.

3. How to use Cordarone

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor.
Treatment with Cordarone should be initiated in a hospital setting and then continued under the
supervision of a specialist.
Loading dose:
typically 600 mg per day (three times 200 mg) for one week.
Maintenance dose:
the minimum effective dose (allowing control of arrhythmias) should be used; depending on
individual sensitivity, the dose ranges from 100 to 200 mg per day.
Cordarone may be administered every other day at a dose of 200 mg per day or daily at a dose of
100 mg per day; treatment interruptions (two days per week) may also be considered.
Use in children
The safety and efficacy of Cordarone in children have not been established. Therefore, the use of
this medicine in pediatric patients is not recommended.
Use in elderly patients
As with all patients, the minimum effective dose should be used.
There is no evidence that elderly patients require dose adjustment.
However, elderly patients may be more susceptible to bradycardia and conduction disturbances when
exposed to excessive doses. Particular attention should be paid to thyroid gland function.
If you feel that the effect of Cordarone is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Cordarone
There are few reports of amiodarone overdose. Symptoms may include slowing of heart contractions,
ventricular tachycardia, torsade de pointes arrhythmias, as well as hypotension and liver damage.
Overdose requires professional medical assistance; treatment is symptomatic.
Neither amiodarone nor its metabolites are removed during dialysis.
If a higher than recommended dose is taken, seek immediate medical advice from a doctor or
pharmacist.
Missed dose of Cordarone
If a dose is missed, take it as soon as possible, except when the next scheduled dose is approaching.
Do not take two doses at the same time or within a short interval.
In case of doubt, consult your doctor.
Discontinuation of Cordarone treatment
If you have any further questions regarding the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should stop taking Cordarone and seek immediate medical advice if any of the following occur:
Frequency unknown (frequency cannot be estimated from available data)

anaphylactic shock (a clinical syndrome of symptoms caused by a sudden allergic reaction, in which the body's autoregulatory mechanisms fail to ensure adequate blood flow to vital organs and tissues), manifesting as confusion, weakness, fainting;
anaphylactic reactions – severe allergic reactions affecting multiple organs simultaneously, usually the cardiovascular, respiratory and skin systems, occurring immediately after exposure to an allergen;
Quincke's oedema (angioedema) – a severe allergic reaction causing swelling of the face, breathing difficulties or dizziness;
life-threatening skin reactions characterised by rash, blisters, skin peeling and pain [toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), bullous dermatitis, drug reaction with eosinophilia and systemic symptoms (DRESS)], and mucosal lesions (see also "Warnings and precautions" in section 2). These symptoms may be life-threatening and may even lead to death;
irregular heartbeat, which may be a sign of the life-threatening arrhythmia torsade de pointes (see Warnings and precautions and Cordarone with other medicines in section 2);
coughing up blood as a sign of pulmonary haemorrhage;
abdominal pain and constipation, which may indicate acute pancreatitis or sudden onset of pancreatitis;
seeing, hearing or feeling things that are not there (hallucinations);
increased susceptibility to infections, possibly due to reduced white blood cell count (neutropenia);
marked decrease in white blood cells, increasing the risk of infections (agranulocytosis).

Frequent (may occur in up to 1 in 10 patients)

yellowing of the eyes and skin (jaundice), abdominal pain, loss of appetite, fatigue, fever, elevated liver enzyme levels (aminotransferases) in blood tests; these are symptoms of potentially life-threatening acute liver dysfunction or liver failure;
shortness of breath and dry cough; these may be symptoms of life-threatening interstitial pneumonitis or pulmonary fibrosis, pleuritis, bronchiolitis obliterans with pneumonia (see Warnings and precautions in section 2), or bronchospasm and/or respiratory arrest in patients with severe respiratory insufficiency, especially in patients with bronchial asthma;
decreased libido.

Uncommon (may occur in up to 1 in 100 patients)

heart rhythm disturbances or worsening of existing arrhythmias, sometimes leading to cardiac arrest (see Warnings and precautions and Cordarone with other medicines in section 2), conduction disturbances in the heart muscle (sinus node block, atrioventricular block of varying degrees);
numbness, muscle weakness, tingling and burning sensations; these may be symptoms of sensorimotor peripheral neuropathy (nerve disease) and/or myopathy (muscle disease), usually reversible after discontinuation of Cordarone.

Very rare (may occur in up to 1 in 10,000 patients)

blurred or worsening vision; these may be symptoms of optic nerve damage, which may lead to vision loss (see Warnings and precautions in section 2);
dizziness, fatigue and shortness of breath; these may be symptoms of marked bradycardia, sinus arrest, particularly in patients with sinus node dysfunction and/or elderly patients;
skin rash due to vasculitis (inflammation of blood vessels);
headaches worsening in the morning or after exertion, nausea, seizures, fainting, visual disturbances or disorientation; these may be symptoms of brain dysfunction due to increased intracranial pressure (pseudotumour cerebri);
impaired motor coordination.

Other adverse reactions associated with Cordarone may occur with the following frequencies:
Very common (occur in at least 1 in 10 patients):

corneal microdeposits forming just beneath the pupil. These may be associated with coloured halos around objects when looking at bright lights or blurred vision. These deposits consist of complex lipid accumulations and usually resolve after discontinuation of amiodarone treatment;
mild gastrointestinal disturbances (nausea, vomiting, taste disturbances), usually occurring during the loading dose phase and resolving after dose reduction of amiodarone;
increased aminotransferase activity detected in blood tests, usually mild to moderate (1.5 to 3 times above the upper normal limit), occurring early in treatment. These abnormalities may return to normal after dose reduction or spontaneously;
photosensitivity.

Common (may occur in up to 1 in 10 patients)

abnormally slow heartbeat (bradycardia), usually moderate and dose-dependent;
hypothyroidism (manifesting as severe fatigue, weight gain, constipation and muscle pain), hyperthyroidism (manifesting as restlessness, agitation, weight loss, increased sweating), sometimes resulting in death;
extrapyramidal tremors, nightmares, sleep disturbances;
greyish-blue skin discoloration during long-term treatment with high doses of amiodarone, which slowly resolves after discontinuation of the drug;
constipation;
itchy red rash (exanthema).

Uncommon (may occur in up to 1 in 100 patients)

dry mouth.

Very rare (may occur in up to 1 in 10,000 patients)

haemolytic anaemia, aplastic anaemia (anaemias manifesting as pallor of the skin and mucous membranes, fatigue, weakness and dizziness), thrombocytopenia (reduced platelet count, manifesting as increased bruising and bleeding);
syndrome of inappropriate antidiuretic hormone secretion (SIADH), manifesting as malaise, weakness, disorientation, nausea, loss of appetite, nervousness;
chronic liver disease (pseudo-alcoholic hepatitis, cirrhosis), sometimes fatal;
increased blood creatinine levels;
headaches;
epididymitis, impotence;
bronchospasm in patients with severe respiratory insufficiency, especially in patients with bronchial asthma, adult respiratory distress syndrome (ARDS), sometimes fatal, particularly immediately after surgery (possible interaction with high concentrations of oxygen) (see Warnings and precautions and Cordarone with other medicines in section 2);
erythema during radiotherapy, skin rashes (usually nonspecific), exfoliative dermatitis, alopecia.

Frequency unknown (frequency cannot be estimated from available data):

urticaria;
neutropenia, agranulocytosis;
pancreatitis, acute pancreatitis, dry mouth, constipation;
granuloma, including bone marrow granuloma;
stiffness; tremor and motor restlessness (parkinsonism); unusual muscle movements;
abnormal sense of smell (parosmia);
decreased appetite;
decreased libido;
delirium (including confusion), hallucinations;
lupus-like syndrome (a condition in which the immune system attacks various parts of the body, causing joint pain, stiffness and swelling, and skin redness, sometimes in a butterfly-shaped rash on the face);
life-threatening complication after heart transplantation (primary graft dysfunction), in which the transplanted heart fails to function properly (see Warnings and precautions in section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Cordarone

Store at room temperature (15°C–25°C) and protect from light.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must 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 package and other information

What Cordarone contains

The active substance is amiodarone hydrochloride. One tablet contains 200 mg of amiodarone hydrochloride.
The other ingredients are: maize starch, monohydrate lactose, magnesium stearate, povidone K 90 F, colloidal anhydrous silica.

What Cordarone looks like and contents of the pack
White tablets with a score line on one side.
One pack contains 30 tablets in blisters, packed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Belgium, the country of export:
Sanofi Belgium
Leonardo Da Vincilaan 19
1831 Diegem
Belgium
Manufacturer:
Sanofi Winthrop Industrie
1, Rue de la Vierge- Ambarès et Lagrave
33565 Carbon Blanc Cedex
France
Sanofi-Aventis, S.A.
Ctra. C-35 (La Ballòria-Hostalric) Km. 63,09
17404 Riells i Viabrea (Girona)
Spain
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Belgium, the country of export: BE048885
Parallel import licence number: 385/24