Cordarone

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Cordarone

200 mg, tablets

Amiodarone hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Cordarone and what is it used for
• 2. Important information before using Cordarone
• 3. How to use Cordarone
• 4. Possible side effects
• 5. How to store Cordarone
• 6. Contents of the packaging and other information

1. What is Cordarone and what is it used for

Cordarone is available in tablet form and contains amiodarone hydrochloride as the active substance. Amiodarone is a powerful anti-arrhythmic medicine used to treat irregular heartbeats.
It is used to treat life-threatening heart rhythm disorders:

• arrhythmias in Wolff-Parkinson-White syndrome;
• atrial fibrillation and atrial flutter, paroxysmal supraventricular tachycardias: supraventricular tachycardias and nodal tachycardias, when other medicines cannot be used;
• ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), when other anti-arrhythmic medicines are ineffective.

2. Important information before using Cordarone

When not to use Cordarone:

• in patients with heart diseases: sinus bradycardia, sinoatrial block, sick sinus syndrome, except for patients with a pacemaker (risk of inhibition of sinus node activity);
• in patients with atrioventricular block of second or third degree, except for patients with a pacemaker;
• concomitantly with medicines that may cause life-threatening arrhythmias - type torsade de pointes(see: Cordarone and other medicines);

Warnings and precautions

Before starting treatment with amiodarone, it is recommended to perform ECG, TSH hormone level and potassium level in serum (decreased potassium level in the blood increases the risk of arrhythmias).
The pharmacological effect of amiodarone causes changes in the ECG: prolongation of the QT interval (related to prolongation of the repolarization period) with possible formation of a U wave.
However, these changes do not cause toxic effects.
Heart function may decrease significantly in elderly patients.
In case of second or third degree atrioventricular block, sinoatrial block or bifascicular block, treatment with Cordarone should be discontinued.
Cordarone has a pro-arrhythmic effect. There have been reports of new types of arrhythmias or worsening of treated arrhythmias, sometimes leading to death.
Pro-arrhythmic effects of Cordarone are less common than with other anti-arrhythmic medicines. The pro-arrhythmic effect of amiodarone occurs especially as a result of interactions with medicines prolonging the QT interval and (or) in case of electrolyte disorders (see subsection Cordarone and other medicines and section 4). Regardless of the prolongation of the QT interval, Cordarone has low activity causing arrhythmias of the torsade de pointestype.
Amiodarone may affect the effectiveness of a pacemaker or an implantable cardioverter-defibrillator, especially in the case of long-term use of anti-arrhythmic medicines.
Therefore, it is recommended to check its function before and during treatment with amiodarone.
Cordarone taken orally is not contraindicated in patients with heart failure, but caution should be exercised during treatment, as it may worsen it. In such cases, Cordarone may be used in combination with other medicines.
Before starting to take Cordarone, the patient should discuss it with their doctor or pharmacist if they are currently taking a medicine containing sofosbuvir, used to treat hepatitis C, as it may cause life-threatening bradycardia. The doctor may consider alternative treatment methods. If treatment with amiodarone and sofosbuvir is necessary, additional monitoring of heart function may be required.
The doctor should be informed immediatelyif the patient is taking a medicine containing sofosbuvir, used to treat hepatitis C, and if any of the following occur during treatment:

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

Cordarone may cause hypothyroidism or hyperthyroidism, especially in patients with a history of thyroid disorders.
Clinical and biological (including TSH) monitoring is recommended before starting treatment in all patients. Monitoring should be performed during treatment, every 6 months, and for several months after the end of treatment. This is especially important in elderly patients.
In patients with a history indicating an increased risk of thyroid disorders, regular monitoring of its function is recommended.
During treatment or up to several months after the end of treatment with amiodarone, hyperthyroidism may occur. Clinical symptoms, usually mild, such as weight loss, arrhythmias, shortness of breath, congestive heart failure, should alert the doctor. The diagnosis is based on a significant decrease in TSH hormone activity in serum.
Then, Cordarone should be discontinued. The symptoms usually resolve within a few months after the end of treatment with Cordarone; clinical improvement is preceded by normal laboratory test results of thyroid function. Severe cases of hyperthyroidism, sometimes leading to death, require immediate therapeutic intervention. Treatment should be individualized for each patient: anti-thyroid medicines (which are not always effective), corticosteroids, beta-adrenergic blockers.
The occurrence of shortness of breath and non-productive cough may be related to toxic effects on the lungs, such as the occurrence of interstitial pneumonia. In patients who have developed shortness of breath on exertion, both as the only symptom and in association with worsening of the patient's general condition (fatigue, weight loss, fever), a chest X-ray should be performed. Further treatment with Cordarone should be considered, as interstitial pneumonia is usually reversible if therapy is discontinued quickly (clinical symptoms usually resolve within 3 to 4 weeks, radiological changes and improvement of lung function occur within several months). The use of corticosteroids should be considered.
Periodic monitoring of liver function (determination of aminotransferase activity) is recommended during treatment with Cordarone. The dose of Cordarone should be reduced or treatment discontinued in case of increased aminotransferase activity 3 times above normal values, which may indicate acute or chronic liver function disorders.
Clinical symptoms of chronic liver function disorders may be mild (possible liver enlargement, increased aminotransferase activity 1.5 to 5 times above normal values). These abnormalities usually resolve after discontinuation of Cordarone; however, cases of death have been reported.
Treatment with Cordarone should be discontinued immediately if severe skin reactions occur (e.g. progressive rash with blisters or changes in mucous membranes, fever and joint pain, severe rapidly progressing disease characterized by large subcutaneous blisters, extensive skin erosions and fever - see also section 4). These symptoms may be life-threatening for the patient.
Cordarone may cause sensory-motor peripheral neuropathy and (or) myopathy.
Symptoms usually resolve within a few months after discontinuation of Cordarone, but sometimes some symptoms may persist.
In case of blurred vision or worsening of vision, a complete ophthalmological examination, including a fundus examination, should be performed immediately. Detection of damage and (or) inflammation of the optic nerve requires discontinuation of Cordarone due to the risk of vision loss.
Concomitant use of amiodarone with the following medicines is not recommended:

• beta-adrenergic blockers, calcium channel antagonists that reduce heart rate (verapamil, diltiazem), laxatives that may cause hypokalemia;
• Caution should be exercised when using the following medicines concomitantly with Cordarone:

Cordarone may cause photosensitivity, which may persist for several months after discontinuation of treatment.
The most common symptoms are: tingling, burns and redness, occurring on the surface of the skin that has been exposed to sunlight.
Phototoxic reactions and rashes have been rarely observed.
Before surgery, the anesthesiologist should be informed about the patient's use of amiodarone; there have been reports of severe cardiovascular and respiratory disorders (sometimes leading to death) in patients undergoing general anesthesia and oxygen therapy.
If the patient is on the waiting list for a heart transplant, the attending physician may change the treatment before the transplant. This is because taking amiodarone before a heart transplant increases the risk of a life-threatening complication (primary graft dysfunction), in which the transplanted heart stops working properly within the first 24 hours after surgery.

Cordarone and other medicines

The doctor should be told about all medicines currently being taken or recently taken, as well as any medicines that the patient plans to take.
Cordarone should not be used concomitantly with medicines that may cause life-threatening arrhythmias (type torsade de pointes). These medicines include:

• medicines used to treat arrhythmias (irregular heartbeats): quinidine, disopyramide, procainamide, sotalol, bretylium, bepridil,
• intravenous administration of erythromycin (antibiotic), cotrimoxazole (anti-infective medicine) or the antiprotozoal medicine pentamidine,
• antipsychotic medicines, such as: chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpride, sertindole,
• certain medicines used to treat other mental disorders: lithium preparations and tricyclic antidepressants, e.g. doxepin, amitriptyline,
• certain antihistamine medicines used to treat allergies: terfenadine, astemizole, mizolastine,
• medicines used to treat malaria: quinine, chloroquine, mefloquine, halofantrine,
• a medicine used to treat circulatory disorders of the brain, dizziness, tinnitus, memory and learning disorders, especially in the elderly - vincamine,
• neuroleptic medicines,
• a medicine used to treat delayed gastric emptying - cisapride.

It is not recommended to use Cordarone concomitantly with:

• fluoroquinolones - anti-infective medicines: ciprofloxacin, ofloxacin, levofloxacin,
• beta-adrenergic blockers - used to treat heart diseases, e.g. propranolol,
• calcium channel antagonists that reduce heart rate - used to treat angina pectoris (heart disease) or hypertension (high blood pressure): verapamil, diltiazem,
• antiviral medicines used to treat hepatitis C, e.g. sofosbuvir, daclatasvir, simeprevir or ledipasvir, due to the risk of bradycardia;
• certain laxatives (used to treat constipation) that may cause hypokalemia: bisacodyl, senna,
• cholesterol-lowering medicines - statins, e.g. simvastatin, atorvastatin, lovastatin.

Caution should be exercised when using the following medicines concomitantly with Cordarone:

• diuretics, e.g. furosemide,
• systemic corticosteroids, e.g. hydrocortisone, prednisolone,
• tetracosactide - a medicine used to test certain hormonal disorders,
• the antifungal medicine amphotericin B administered intravenously,
• agents used in general anesthesia or high oxygen concentrations administered during surgical procedures (see Warnings and precautions in section 2 and section 4). Before surgery, the anesthesiologist should be informed about the use of Cordarone,
• phenytoin - used to treat epileptic seizures: close monitoring of the patient is necessary and the dose of phenytoin should be reduced immediately in case of symptoms of overdose and the phenytoin concentration in serum should be determined,
• digoxin - used to treat heart diseases: the doctor will order determination of digoxin concentration in serum and perform an ECG and change the dose of digoxin; the patient should be monitored for symptoms of digitalis toxicity,
• anticoagulant medicines - warfarin, dabigatran: regular coagulation tests are necessary to adjust the oral doses of anticoagulant medicines, both during and after treatment with Cordarone; it may be necessary to adjust the dose of dabigatran,
• medicines used to prevent transplant rejection - cyclosporine, tacrolimus and sirolimus,
• flecainide - used to treat arrhythmias: treatment will be carried out under close medical supervision; the doctor will change the dose of flecainide,
• fentanyl - a strong painkiller,
• lidocaine - an anesthetic agent,
• sildenafil - used to treat impotence,
• midazolam - used to treat anxiety and to sedate before surgical procedures,
• triazolam - used to treat insomnia,
• dihydroergotamine and ergotamine - medicines used to treat migraines,
• colchicine - used to treat acute gout attacks.

Pregnancy, breastfeeding and fertility

In pregnancy and during breastfeeding, or if there is a suspicion that the woman is pregnant, or if she plans to become pregnant, the use of this medicine should be discussed with a doctor before administration.
Due to the effect of Cordarone on the fetal thyroid, the use of the medicine during pregnancy is contraindicated, unless the doctor recommends otherwise. Before using the medicine, the doctor should be consulted.
The use of Cordarone during breastfeeding is contraindicated.
There are no data on the effect of amiodarone on fertility in humans.

Driving and using machines

In light of the safety data on the use of amiodarone, the medicine does not limit the ability to drive vehicles and use machines.

Cordarone contains lactose monohydrate

Patients with hereditary galactose intolerance, Lapp 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 doctor. In case of doubts, the doctor should be consulted.
Treatment with Cordarone should be started in a hospital and then continued under the supervision of a specialist.
Loading dose:
usually 600 mg per day (3 times 200 mg) for a week.
Maintenance dose:
the minimum effective dose should be used (allowing control of arrhythmias); depending on individual sensitivity, the dose is from 100 to 200 mg per day.
Cordarone may be used every other day in a dose of 200 mg per day or daily in a dose of 100 mg per day; it is also possible to take breaks in taking the medicine (two days a week).

Use in children

The safety and efficacy of Cordarone in children have not been established. Therefore, the use of the medicine in these 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 may require dose adjustment.
However, elderly patients may be more prone to bradycardia and conduction disorders when using high doses. Particular attention should be paid to thyroid function.
If it is felt that the effect of Cordarone is too strong or too weak, the doctor should be consulted.

Use of a higher than recommended dose of Cordarone

There are few reports of amiodarone overdose. Bradycardia or ventricular tachycardia, arrhythmias of the torsade de pointestype, as well as decreased blood pressure and liver damage may occur.
Overdose requires professional medical help; treatment is symptomatic.
Both amiodarone and its metabolites are not removed during dialysis.
In case of taking a higher than recommended dose of Cordarone, the doctor or pharmacist should be consulted immediately.

Missing a dose of Cordarone

In case of missing a dose of Cordarone, it should be taken as soon as possible, unless the next dose is approaching. Two doses of the medicine should not be taken at the same time or at short intervals.
In case of doubts, the doctor should be consulted.

Discontinuation of Cordarone

In case of any further doubts related to the use of this medicine, the doctor or nurse should be consulted.

4. Possible side effects

Like all medicines, Cordarone can cause side effects, although not everybody gets them.
Treatment with Cordarone should be discontinued and medical advice should be sought immediately if any of the following occur:

• anaphylactic shock (a set of clinical symptoms, when the body's self-regulatory mechanisms are unable to ensure proper blood flow through vital organs and tissues, caused by a rapidly progressing allergic reaction) manifested by confusion, weakness, fainting;
• anaphylactic reactions - severe allergic reactions affecting several organs, usually: cardiovascular, respiratory and skin, occurring immediately after contact with the allergen;
• angioedema - a severe allergic reaction causing swelling in the face, difficulty breathing or dizziness;
• life-threatening skin reactions characterized by rash, blisters and peeling of the skin and mucous membranes, fever and joint pain, severe rapidly progressing disease characterized by large subcutaneous blisters, extensive skin erosions and fever (see also Warnings and precautions in section 2). These symptoms may be life-threatening for the patient;
• irregular heartbeat, which may be a symptom of life-threatening arrhythmia of the torsade de pointestype (see Warnings and precautions and Cordarone and other medicines in section 2);
• coughing up blood as a symptom of pulmonary hemorrhage;
• abdominal pain and constipation that may be a symptom of acute pancreatitis;
• seeing, hearing or feeling things that are not there (hallucinations);
• a higher than usual number of infections may occur. This may be due to a decrease in the number of white blood cells (neutropenia);
• a significant decrease in the number of white blood cells, which increases the likelihood of infections (agranulocytosis). Frequency not known (frequency cannot be estimated from the available data)
• yellowing of the eyes and skin (jaundice), abdominal pain, loss of appetite, fatigue, fever, high aminotransferase activity in blood tests; these are symptoms of life-threatening acute liver failure or liver failure;
• shortness of breath and cough without expectoration; these may be symptoms of life-threatening interstitial pneumonia or pulmonary fibrosis, pleuritis, bronchiolitis obliterans with pulmonary involvement (see Warnings and precautions in section 2) or bronchospasm and (or) apnea in case of severe respiratory failure and especially in patients with asthma;
• decreased sexual desire. Uncommon (may occur in less than 1 in 100 patients)
• arrhythmias or their exacerbation, sometimes with cardiac arrest (see Warnings and precautions and Cordarone and other medicines in section 2), conduction disorders in the heart muscle (sinoatrial block, atrioventricular block of various degrees);
• numbness, muscle weakness, tingling and burning; these may be symptoms of sensory-motor peripheral neuropathy (nerve disease) and (or) myopathy (muscle disease), usually reversible after discontinuation of Cordarone. Rare (may occur in less than 1 in 10,000 patients)
• blurred vision or worsening of vision; these may be symptoms of optic nerve damage, which can lead to vision loss (see Warnings and precautions in section 2);
• dizziness, fatigue and shortness of breath; these may be symptoms of significant bradycardia, sinus node arrest, especially in patients with sinoatrial node dysfunction and (or) elderly patients;
• skin rash as a symptom of vasculitis;
• headache worsening in the morning or after exertion, nausea, seizures, fainting, vision disturbances or disorientation, which may be symptoms of cerebral function disorders due to increased intracranial pressure (pseudotumor cerebri);
• coordination disorders.

Other side effects of Cordarone may occur with the following frequency:
Very common (occurring in at least 1 in 10 patients):

• microdeposits in the cornea, forming just below the pupil. They may be accompanied by colored halos around objects when looking at bright lights or blurred vision. They consist of complex lipid deposits and resolve after discontinuation of amiodarone treatment;
• mild gastrointestinal disorders (nausea, vomiting, taste disturbances) usually occurring during the loading dose of Cordarone and resolving after reduction of the amiodarone dose;
• increased aminotransferase activity in blood tests, which is usually moderate (1.5 to 3 times above the upper limit of normal), occurring at the beginning of treatment. These abnormalities may return to normal after reduction of the dose or on their own;
• photosensitivity.

Common (may occur in less than 1 in 10 patients)

• bradycardia, usually moderate and dose-dependent;
• hypothyroidism (manifested by severe fatigue, weight gain, constipation and muscle pain), hyperthyroidism (manifested by agitation and restlessness, weight loss, increased sweating), sometimes fatal;
• extrapyramidal tremors, nightmares, sleep disorders;
• blue-gray or bluish discoloration of the skin during long-term use of high doses of amiodarone, which resolves slowly after discontinuation of the medicine;
• constipation;
• pruritic rash.

Uncommon (may occur in less than 1 in 100 patients)

• dry mouth.

Rare (may occur in less than 1 in 10,000 patients)

• hemolytic anemia, aplastic anemia (anemias manifested by pallor of the skin and mucous membranes, fatigue, weakness and dizziness), thrombocytopenia (decreased platelet count, manifested by a tendency to bruise and bleed);
• syndrome of inappropriate antidiuretic hormone secretion (SIADH) manifested by malaise, weakness, disorientation, nausea, loss of appetite;
• chronic liver diseases (pseudoalcoholic hepatitis, liver cirrhosis), sometimes fatal;
• increased creatinine levels in the blood;
• headache;
• epididymitis, impotence;
• bronchospasm in patients with severe respiratory failure and especially in patients with asthma, acute respiratory distress syndrome, sometimes fatal, especially immediately after surgery (possible interaction with high oxygen concentrations) (see Warnings and precautions and Cordarone and other medicines in section 2);
• rumination;
• skin rash, usually non-specific, desquamative dermatitis.

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

• urticaria;
• neutropenia, agranulocytosis;
• pancreatitis, acute pancreatitis, dry mouth, constipation;
• granuloma, including granuloma of the bone marrow;
• stiffness; tremor and restlessness (parkinsonism); abnormal movements;
• abnormal sense of smell (parosmia);
• decreased appetite;
• decreased libido;
• confusion (including disorientation), hallucinations;
• lupus-like syndrome (a disease in which the immune system damages various parts of the body and leads to pain, stiffness and swelling of the joints, as well as redness of the skin, sometimes in the shape of butterfly wings on the face);
• life-threatening complication after heart transplant (primary graft dysfunction), in which the transplanted heart stops working properly (see Warnings and precautions in section 2).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Cordarone

Store in a temperature below 30°C. Protect from light.
The medicine should be stored in a place 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 month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Cordarone contains

• The active substance of Cordarone is amiodarone hydrochloride. One tablet contains 200 mg of amiodarone hydrochloride.
• The other ingredients are: cornstarch, lactose monohydrate, magnesium stearate, povidone, colloidal silica anhydrous.

What Cordarone looks like and contents of the pack

White tablets with a score line on one side.
One pack contains 30 tablets in PVC/Aluminum blisters, in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Bulgaria, the country of export:

sanofi-aventis groupe
54 rue La Boétie
75008 Paris
France

Manufacturer:

Sanofi Winthrop Industrie
1, rue de la Vierge
Ambares et Lagrave
33565 Carbon Blanc Cedex
France
Opella Healthcare Hungary Ltd.
2112 Veresegyház
Lévai utca 5
Hungary
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 by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export:9800028

Parallel import authorization number: 128/23

Date of approval of the leaflet: 30.06.2023

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