Cordarone

Leaflet attached to 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

Before taking the medicine, the patient should carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or nurse.
• This medicine has been prescribed for a specific 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, pharmacist, 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 anti-arrhythmic drug used to treat irregular heartbeats.
It is used to treat life-threatening heart rhythm disorders:

• rhythm disorders in Wolff-Parkinson-White syndrome;
• atrial fibrillation and atrial flutter, paroxysmal supraventricular tachycardias: supraventricular tachycardias and nodal tachycardias, when other drugs cannot be used;
• ventricular rhythm disorders (ventricular tachycardia, ventricular fibrillation), when other anti-arrhythmic drugs 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 patient should contact their doctor 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 drugs that may cause life-threatening heart rhythm disorders - 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 heart rhythm disorders).
The pharmacological action of amiodarone causes changes in the ECG: prolongation of the QT interval (related to the 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 heart rhythm disorders or worsening of treated heart rhythm disorders, sometimes leading to death.
Pro-arrhythmic effects of Cordarone are less common than with other anti-arrhythmic drugs.
The pro-arrhythmic effect of amiodarone occurs especially as a result of interactions with drugs that prolong 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 a low activity of causing heart rhythm disorders 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 drugs. 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 drugs.
Before starting treatment with Cordarone, the patient should discuss it with their doctor or pharmacist if they are currently taking a drug containing sofosbuvir, used to treat hepatitis C, 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 patient should immediately inform their doctorif they are taking a drug containing sofosbuvir, used to treat hepatitis C, and if any of the following occur during treatment:

• slow or irregular heartbeat or heart rhythm disorders,
• 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 of thyroid disorders, regular monitoring of thyroid 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, heart rhythm disorders, shortness of breath, congestive heart failure, should alert the doctor. The diagnosis is based on a significant decrease in TSH hormone activity in the serum.
Cordarone should be discontinued. The symptoms usually resolve after 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 drugs (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 development of interstitial pneumonia. In patients who have developed shortness of breath, both as the only symptom and in association with worsening of the patient's general condition (fatigue, weight loss, fever), a radiological examination of the chest 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 a threefold increase in aminotransferase activity above normal values, which may indicate the occurrence of 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 bursting giant blisters, extensive skin erosion, and fever - see also section 4). These symptoms can 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 drugs is not recommended:

• beta-adrenergic blockers, calcium channel antagonists that slow heart rate (verapamil, diltiazem), laxatives that may cause hypokalemia;

The patient should avoid exposure to sunlight and use sun protection during treatment with Cordarone. Cordarone causes photosensitivity, which may persist for several months after discontinuation of treatment.
The most common symptoms are: tingling, burning, and redness, occurring on the skin surface that has been exposed to sunlight.
Phototoxic reactions and rashes have been rarely observed.
Before surgery, the patient should inform the anesthesiologist about the 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 treating doctor may change the type of 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 patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Cordarone should not be taken concomitantly with medicines that may cause life-threatening heart rhythm disorders (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 drug), or the antiprotozoal drug pentamidine;
• antipsychotic drugs, such as: chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpride, sertindole;
• certain drugs used in other mental disorders: lithium preparations and tricyclic antidepressants, e.g., doxepin, amitriptyline;
• certain antihistamine drugs used to treat allergies: terfenadine, astemizole, mizolastine;
• anti-malarial drugs: quinine, chloroquine, mefloquine, halofantrine;
• a drug used to treat circulatory disorders of the brain, dizziness, tinnitus, memory and learning disorders, especially in the elderly - vincamine;
• neuroleptic drugs;
• a drug used to treat delayed gastric emptying - cisapride.

Concomitant use of Cordarone with the following drugs is not recommended:

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

Caution should be exercised when taking the following drugs concomitantly with Cordarone:

• diuretics, e.g., furosemide;
• systemic corticosteroids, e.g., hydrocortisone, prednisolone;
• tetracosactide - a drug used to test certain hormonal disorders;
• the antifungal drug amphotericin B administered intravenously;
• agents used in general anesthesia or high concentrations of oxygen administered during surgical procedures (see "Warnings and precautions" in section 2 and section 4). Before surgery, the patient should inform the anesthesiologist 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 the phenytoin level in the serum should be determined;
• digoxin - used to treat heart diseases: the doctor will order determination of digoxin level in the serum and performance of an ECG, and will change the dose of digoxin; the patient should be monitored for symptoms of digoxin toxicity;

Cordarone may interact with other medicines. The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken.

Pregnancy, breastfeeding, and fertility

In pregnancy and during breastfeeding, or if the patient is pregnant or plans to become pregnant, they should consult their doctor before taking this medicine.
Due to the effect of Cordarone on the fetal thyroid, the use of this medicine during pregnancy is contraindicated, unless the doctor recommends otherwise. The patient should consult their doctor before taking the medicine.
The use of Cordarone during breastfeeding is contraindicated.
There is no data on the effect of amiodarone on human fertility.

Driving and using machines

Based on the safety data of amiodarone, the medicine does not affect the ability to drive 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 take Cordarone

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor.
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 heart rhythm disorders); 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 this 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 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. Slow heart rate or ventricular tachycardia, heart rhythm disorders 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 dose of Cordarone than recommended, the patient should immediately consult their doctor or pharmacist.

Missed dose of Cordarone

In case of missing a dose of Cordarone, the patient should take it as soon as possible, unless it is close to the time of the next dose. The patient should not take two doses of the medicine at the same time or at short intervals.
In case of doubts, the patient should consult their doctor.

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) 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 skin peeling, pain [toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), bullous dermatitis, drug rash with eosinophilia and systemic symptoms (DRESS)], changes in mucous membranes (see also "Warnings and precautions" in section 2). These symptoms can be life-threatening for the patient and even lead to death;
• 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, which may be symptoms of acute pancreatitis;
• seeing, hearing, or feeling things that are not there (hallucinations);
• increased risk of infections. This may be due to a decrease in the number of white blood cells (neutropenia);
• significant decrease in the number of white blood cells, which increases the risk of infections (agranulocytosis).

Frequent (may occur in more than 1 in 10 patients):

• jaundice and skin discoloration, abdominal pain, loss of appetite, fatigue, fever, high aminotransferase activity in blood tests; these are symptoms of life-threatening acute liver failure or liver dysfunction;
• 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) apnea in case of severe respiratory failure and especially in patients with asthma;
• decreased libido.

Uncommon (may occur in more than 1 in 100 patients):

• heart rhythm disorders 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 (nerve disease) and (or) myopathy (muscle disease), usually reversible after discontinuation of Cordarone.

Rare (may occur in more 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 slowing of the heart rate, cardiac arrest, especially in patients with sick sinus syndrome 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 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 more than 1 in 10 patients):

• corneal microdeposits, 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 usually 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 Cordarone dose or spontaneously;
• photosensitivity.

Frequent (may occur in more than 1 in 10 patients):

• bradycardia (slow heart rate), 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 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 more than 1 in 100 patients):

• dry mouth.

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

• hemolytic anemia, aplastic anemia (anemia manifested by pallor, fatigue, weakness, and dizziness), thrombocytopenia (decreased platelet count, manifested by bruising and bleeding);
• syndrome of inappropriate antidiuretic hormone secretion (SIADH) manifested by malaise, weakness, disorientation, nausea, loss of appetite, irritability;
• chronic liver diseases (pseudoalcoholic hepatitis, liver cirrhosis), sometimes fatal;
• increased creatinine level 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 concentrations of oxygen);
• 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 tremors 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 skin rash, sometimes in the shape of butterfly wings on the face);
• 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. 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
phone: +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, in the original packaging.
The medicine should be stored 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 specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist 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, magnesium stearate, povidone K 90 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 patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Sanofi Romania SRL
Str. Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9
Sector 2, Bucharest, Romania

Manufacturer:

Sanofi Winthrop Industrie
1, rue de la Vierge, Ambarès et Lagrave
33565 Carbon Blanc Cedex
France
Opella Healthcare Hungary Limited Liability Company
Lévai u. 5, 2112 Veresegyház
Hungary

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
Romanian marketing authorization number: 11070/2018/02

Parallel import authorization number: 312/14

Date of leaflet approval: 18.09.2024

[Information about the trademark]