Cordarone

Package Leaflet: Information for the Patient

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 taking Cordarone
• 3. How to take Cordarone
• 4. Possible side effects
• 5. How to store Cordarone
• 6. Contents of the pack 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 drug 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 drugs cannot be used;
• ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), when other antiarrhythmic 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 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;
• with drugs that may cause life-threatening arrhythmias of the 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 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 proarrhythmic effect. There have been reports of new types of arrhythmias or worsening of treated arrhythmias, sometimes leading to death.
Proarrhythmic effects of Cordarone are less common than with other antiarrhythmic drugs.
The proarrhythmic effect of amiodarone occurs especially as a result of interactions with drugs that prolong the QT interval and (or) in the case of electrolyte disturbances (see subsection Cordarone and other medicines and section 4). Regardless of the prolongation of the QT interval, Cordarone has a low activity of 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 antiarrhythmic 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 to take 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 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 drug containing sofosbuvir, used to treat hepatitis C virus infection, and if the following symptoms 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.
Diagnosis is based on a significant decrease in TSH hormone activity in serum.
Cordarone should then be discontinued.
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: antithyroid 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 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 with the drug is discontinued quickly (clinical symptoms usually resolve within 3 to 4 weeks, radiological changes and improvement of lung function occur within several months).
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 three-fold 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 under the skin, extensive erosions on the skin, 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 reduce heart rate (verapamil, diltiazem), laxatives that may cause hypokalemia,
• drugs that lower cholesterol levels – statins, e.g., simvastatin, atorvastatin, lovastatin.

Caution should be exercised when using 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,
• amphotericin B – an antifungal drug 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 patient's 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 after the occurrence of overdose symptoms, and phenytoin levels in serum should be determined,
• digitalis glycosides, e.g., digoxin – used to treat heart diseases: the doctor will order determination of digoxin levels in serum and perform an ECG, and change the dose of digitalis glycosides; the patient should be monitored for symptoms of digitalis glycoside poisoning,
• anticoagulant drugs – warfarin, dabigatran: regular blood coagulation tests will be necessary to adjust oral doses of anticoagulant drugs, both during and after treatment with Cordarone; it may be necessary to adjust the dose of dabigatran,
• drugs 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 pain reliever,
• 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 – antimigraine drugs,
• 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 fetus's thyroid gland, 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 human fertility.

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 operate machinery.

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 a 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 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 taking 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.

Overdose 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 dose of the medicine than recommended, the doctor or pharmacist should be consulted immediately.

Missed dose of Cordarone

In case of missing a dose of the medicine, 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.
The use of Cordarone should be discontinued, and medical advice should be sought immediately if the following occur:
Frequency not known (frequency cannot be estimated from the available data)

• anaphylactic shock (a set of clinical symptoms when the body's autoregulatory 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 at the same time, 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, and 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);
• hemoptysis as a symptom of pulmonary hemorrhage;
• abdominal pain and constipation, which may be symptoms of acute pancreatitis or pancreatitis.
• hallucinations, hearing or seeing things that are not there;
• 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 more than 1 in 10 patients)

Very common (may occur in more than 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 are reversible 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 the medicine or spontaneously;
• photosensitivity.

Frequent (may occur in more than 1 in 100 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 ending in death;
• extrapyramidal tremors, nightmares, sleep disturbances;
• blue-gray or dark discoloration of the skin during long-term use of high doses of amiodarone, which resolves slowly after discontinuation of the medicine;
• constipation;
• pruritic red rash (exanthema).

Uncommon (may occur in more than 1 in 1000 patients)

• dry mouth.

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

• hemolytic anemia, aplastic anemia (anemia manifested by pallor of the skin and mucous membranes, 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 ending in death;
• increased creatinine levels in the blood;
• headaches;
• epididymitis, impotence;
• bronchospasm in patients with severe respiratory failure and especially in patients with asthma, acute respiratory distress syndrome, sometimes ending in death, 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 confusion), 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 a butterfly 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 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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 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 room temperature (15°C-25°C), protect from light.
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 month stated.
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 pack and other information

What Cordarone contains

• The active substance of Cordarone is amiodarone hydrochloride. 1 tablet contains 200 mg of amiodarone hydrochloride.
• The other ingredients are: cornstarch, lactose monohydrate, magnesium stearate, povidone K 90 F, colloidal silica anhydrous.

What Cordarone looks like and contents of the pack

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

Marketing authorization 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.
Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Belgian marketing authorization number:BE048885

Parallel import authorization number: 385/24

Date of leaflet approval: 05.11.2024

[Information about the trademark]