Cordarone

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is 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 you need to.
• 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 their symptoms 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 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 taking Cordarone

When not to take 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 tests (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 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 interaction 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 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 anti-arrhythmic medicines.
Therefore, it is recommended to monitor 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 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 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 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, 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 then 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 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 with the medicine 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 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 on 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;
• medicines that may cause life-threatening arrhythmias (type torsade de pointes);

Cordarone should be used with caution when taken concomitantly with the following medicines:

• diuretics, e.g. furosemide;
• systemic corticosteroids, e.g. hydrocortisone, prednisolone;
• tetracosactide - a medicine used to diagnose 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 patient's use of Cordarone;
• phenytoin - used to treat epileptic seizures: close monitoring of the patient is required and the dose of phenytoin should be reduced immediately after the occurrence of overdose symptoms and the phenytoin level in serum should be determined;
• digoxin - a cardiac glycoside used to treat heart diseases: the doctor will order tests to determine the digoxin level in serum and perform an ECG and change the dose of the cardiac glycoside; the patient should be monitored for symptoms of digitalis toxicity;
• anticoagulant medicines - warfarin, dabigatran: regular blood coagulation tests are required 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 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 - anti-migraine medicines;
• 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 thyroid gland of the fetus, 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 cause a restriction of the ability to drive vehicles and 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 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 hypotension 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 time for the next dose is near. 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, 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 on mucous membranes (see also "Warnings and precautions" in section 2). These symptoms may 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 or pancreatitis.
• 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). Common (may occur in up to 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 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) apnea in case of severe respiratory failure and especially in patients with asthma.

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 light or blurred vision. They consist of complex lipid deposits and disappear after discontinuation of amiodarone treatment;
• mild gastrointestinal disorders (nausea, vomiting, taste disorders) 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 medicine dose or on their own;
• photosensitivity.

Common (may occur in up to 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);
• extrapyramidal tremors, nightmares, sleep disorders;
• blue-gray or blue 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 up to 1 in 100 patients)

• dry mouth.

Very rare (may occur in up to 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, irritability;
• chronic liver diseases (pseudo-alcoholic hepatitis, liver cirrhosis), sometimes leading to death;
• increased creatinine level in the blood;
• headaches;
• epididymitis, impotence;
• bronchospasm in patients with severe respiratory failure and especially in patients with asthma, acute respiratory distress syndrome, sometimes leading to 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):

• hives;
• 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 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 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 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, 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 out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". 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 required. 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 200 mesh, magnesium stearate, povidone K 90 F, anhydrous colloidal silica.

What Cordarone looks like and contents of the pack

White tablets with a dividing line on one side.
1 pack contains 30 tablets in Al/PVC 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 Boetie
75008 Paris
France

Manufacturer:

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

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in Bulgaria, the country of export: 9800028
Parallel import authorization number: 251/23

Date of leaflet approval: 31.10.2023

[Information about the trademark]