Cordarone

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. 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 one person. It should not be passed 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 taking Cordarone
• 3. How to take 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 antiarrhythmic medicine used to treat irregular heartbeats.
It is used to treat life-threatening heart rhythm disorders:

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

2. Important information before taking Cordarone

When not to take Cordarone:

• if the patient is allergic to iodine, amiodarone, or any of the other ingredients of this medicine (listed in section 6). In case of allergic symptoms such as itching rash, difficulty swallowing and breathing, or swelling of the lips, face, throat, and tongue, the doctor should be contacted immediately.
• 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");
• 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 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 proarrhythmic effect. There have been reports of new types of arrhythmias or worsening of treated arrhythmias, sometimes leading to death.
Proarrhythmic effects of amiodarone are less common than with other antiarrhythmic medicines. Proarrhythmic effects of amiodarone occur especially as a result of interactions with medicines prolonging the QT interval and (or) in case of electrolyte disturbances (see subsection "Cordarone and other medicines" and section 4). Regardless of QT interval prolongation, Cordarone has low activity causing arrhythmias of the torsade de pointestype.
Amiodarone may affect the effectiveness of pacemakers or implantable cardioverter-defibrillators, especially in situations of long-term use of antiarrhythmic medicines. Therefore, it is recommended to monitor their 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 treatment with 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 virus infection, as it may cause life-threatening slowing of the heart rate. 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 virus infection, 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 treatment is discontinued. This is especially important in elderly patients.
In patients with a history indicating an increased risk of thyroid disorders, regular monitoring of thyroid function is recommended.
During treatment or for several months after 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.
Cordarone should be discontinued. Improvement usually occurs within a few months after discontinuation of Cordarone treatment; laboratory test results of thyroid function usually return to normal before clinical improvement. Severe cases of hyperthyroidism, sometimes leading to death, require immediate therapeutic intervention. Treatment should be individualized for each patient: antithyroid 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 interstitial pneumonia. In patients who experience exertional dyspnea, either as the only symptom or associated 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 dysfunction.
Clinical symptoms of chronic liver dysfunction 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 mucosal lesions, fever, and joint pain, severe, rapidly progressing disease characterized by large, blistering skin lesions, extensive skin peeling, 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 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 optic nerve damage and (or) inflammation 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 blockers that slow heart rate (verapamil, diltiazem), laxatives that may cause hypokalemia;
• medicines that may cause life-threatening arrhythmias (type torsade de pointes) - see "Cordarone and other medicines";
• certain antipsychotic medicines, such as: chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpride, sertindole;
• certain medicines used in other mental disorders: lithium preparations and tricyclic antidepressants, e.g., doxepin, amitriptyline;
• certain antihistamine medicines used to treat allergies: terfenadine, astemizole, mizolastine;
• antimalarial medicines: quinine, chloroquine, mefloquine, halofantrine;
• a medicine used to treat cerebral circulation disorders, dizziness, tinnitus, memory and learning disorders, especially in the elderly - vinpocetine;
• neuroleptic medicines;
• a medicine used to treat delayed gastric emptying - cisapride.

It is not recommended to take Cordarone concomitantly with:

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

Caution should be exercised when taking 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;
• an antifungal medicine - amphotericin B administered intravenously;
• general anesthetics 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 recommended, and the dose of phenytoin should be reduced immediately in case of symptoms of overdose, and phenytoin levels in serum should be determined;
• digitalis glycosides, e.g., digoxin - used in heart diseases: the doctor will order tests to determine digoxin levels in serum and perform an ECG, and adjust the dose of digitalis glycosides; the patient should be monitored for symptoms of digitalis glycoside toxicity;
• anticoagulant medicines - warfarin, dabigatran: regular blood coagulation tests are necessary to adjust oral anticoagulant doses, both during and after treatment with Cordarone; it may be necessary to adjust the dose of dabigatran;
• medicines 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 adjust the dose of flecainide;
• fentanyl - a strong pain reliever;
• lidocaine - an anesthetic;
• 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, during breastfeeding, or if pregnancy is suspected, or if the patient is planning to become pregnant, the patient should consult their doctor before taking this medicine.
Due to the effect of Cordarone on the fetal thyroid, the use of Cordarone during pregnancy is contraindicated, unless the doctor recommends otherwise. Before taking the medicine, the patient should consult their doctor.
The use of Cordarone during breastfeeding is contraindicated.
There are no data on the effect of amiodarone on human fertility.

Driving and using machines

In light of the safety data on the use of amiodarone, the medicine does not affect the ability to drive vehicles or operate 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 take Cordarone

This medicine should always be taken 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 one week.
Maintenance dose:
the minimum effective dose should be used (allowing control of arrhythmias); depending on individual sensitivity, the dose is 100 to 200 mg per day.
Cordarone may be taken 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 Cordarone 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 taking high doses. Particular attention should be paid to thyroid function.
If the patient feels that the effect of Cordarone is too strong or too weak, they should consult their doctor.

Overdose of Cordarone

There are few reports of amiodarone overdose. Bradycardia or ventricular tachycardia, arrhythmias of the torsade de pointestype, as well as hypotension and liver damage, may occur.
Overdose requires specialized medical care; treatment is symptomatic.
Both amiodarone and its metabolites are not removed during dialysis.
In case of overdose, the patient should immediately consult their doctor or pharmacist.

Missed dose of Cordarone

In case of a missed dose, the patient should take it as soon as possible, unless the next dose is near. The patient should not take two doses at the same time or in a short period.
In case of doubts, the doctor should be consulted.

Discontinuation of Cordarone

In case of any further doubts about the use of this medicine, the patient should consult their doctor or nurse.

4. Possible side effects

Like all medicines, Cordarone can cause side effects, although not everybody gets them.
The patient should stop taking Cordarone and seek medical advice immediately if they experience:

• anaphylactic shock (a set of clinical symptoms when the body's autoregulatory mechanisms are unable to ensure proper blood flow to vital organs and tissues, caused by a severe allergic reaction) characterized 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 skin peeling, pain [toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), bullous dermatitis, drug reaction with eosinophilia and systemic symptoms (DRESS)], mucosal lesions (see also "Warnings and precautions" in section 2). These symptoms may be life-threatening and even lead to death.

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

• 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);
• hemoptysis as a symptom of pulmonary hemorrhage;
• abdominal pain and constipation, which may be symptoms of acute pancreatitis or pancreatic necrosis;
• seeing, hearing, or feeling things that are not there (hallucinations);
• an increased 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).

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

• jaundice, abdominal pain, loss of appetite, fatigue, fever, high aminotransferase activity in blood tests; these are symptoms of life-threatening acute liver dysfunction 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 pneumonia (see "Warnings and precautions" in section 2) or bronchospasm and (or) dyspnea in case of severe respiratory failure and especially in patients with asthma;
• decreased libido.

Uncommon (may occur in up to 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, weakness, tingling, and burning; these may be symptoms of sensory-motor peripheral neuropathy and (or) myopathy, usually reversible after discontinuation of Cordarone.

Rare (may occur in up to 1 in 1,000 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 slowing of the heart rate, sinus node arrest, especially in patients with sinoatrial node dysfunction and (or) elderly patients;
• skin rash, which may be a symptom of vasculitis;
• headache worsening in the morning or after exertion, nausea, seizures, fainting, vision disturbances, or disorientation; these may be symptoms of cerebral dysfunction due to increased intracranial pressure (pseudotumor cerebri);
• coordination disorders.

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 light 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 dose reduction of amiodarone;
• 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 dose reduction of Cordarone or spontaneously;
• photosensitivity.

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

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

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

• dry mouth.

Rare (may occur in up to 1 in 1,000 patients):

• hemolytic anemia, aplastic anemia (anemia characterized by pallor of the skin and mucous membranes, fatigue, weakness, and dizziness), thrombocytopenia (decreased platelet count, characterized by bruising and bleeding);
• syndrome of inappropriate antidiuretic hormone secretion (SIADH) characterized by malaise, weakness, disorientation, nausea, loss of appetite, irritability;
• 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);
• radiation recall, skin rash, usually non-specific, desquamative dermatitis, alopecia.

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; extrapyramidal 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, leading to pain, stiffness, and swelling of the joints, as well as facial rash, sometimes in the shape of butterfly wings);
• life-threatening complication after heart transplantation (primary graft dysfunction), in which the transplanted heart stops working properly (see "Warnings and precautions" in section 2).

Reporting side effects

If 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 at 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 needed. 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 200 mesh, magnesium stearate, povidone K90 F, anhydrous colloidal 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 PVC/Al 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 Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Manufacturer:

Sanofi Winthrop Industrie
1, rue de la Vierge
Ambares et Lagrave
33565 Carbon Blanc Cedex
France
Opella Healthcare Hungary Ltd.
Lévai utca 5
2112 Veresegyház
Hungary
sanofi-aventis, S.A.
Ctra. C-35 (La Batllòria-Hostalric) Km. 63.09
17404 Riells i Viabrea (Girona)
Spain

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Bulgaria, the country of export: 9800028

Parallel import authorization number: 365/18

Date of leaflet approval: 28.11.2023

[Information about the trademark]