Opacorden

Leaflet accompanying the packaging: patient information

Opacorden, 200 mg, coated tablets

Amiodarone hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• 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 as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Opacorden and what is it used for
• 2. Important information before taking Opacorden
• 3. How to take Opacorden
• 4. Possible side effects
• 5. How to store Opacorden
• 6. Package contents and other information

1. What is Opacorden and what is it used for

Opacorden contains amiodarone, a substance belonging to the group of antiarrhythmic drugs that help restore regular heart function.
Opacorden is used to treat and prevent:

• heart rhythm disorders in Wolff-Parkinson-White syndrome (WPW);
• atrial fibrillation and atrial flutter, paroxysmal supraventricular tachycardia: supraventricular tachycardia and nodal tachycardia, when other drugs cannot be used;
• life-threatening ventricular rhythm disorders (ventricular tachycardia, ventricular fibrillation), when other antiarrhythmic drugs are ineffective.

2. Important information before taking Opacorden

When not to take Opacorden:

torsades de pointes(life-threatening irregular heartbeat);
• during pregnancy and breastfeeding.

Warnings and precautions

Before starting Opacorden, discuss it with your doctor or pharmacist.
Particular caution should be exercised when taking the medicine:

• in patients with heart failure;
• in elderly patients, patients with a history of thyroid dysfunction, goiter or other thyroid diseases, due to the possibility of hypothyroidism or hyperthyroidism. Before starting treatment, and periodically during treatment, as well as several months after its completion, the doctor will order thyroid function tests;
• in patients after coronary artery bypass grafting (bypass surgery) taking amiodarone may develop hypotension;
• in patients after surgical procedures, due to the possibility of acute respiratory failure.

If you are on the waiting list for a heart transplant, your doctor may change the treatment before transplantation. This is because taking amiodarone before heart transplantation 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.
If you are taking a drug containing sofosbuvir used to treat hepatitis C and amiodarone, it may cause life-threatening slow heartbeat. Your doctor may consider alternative treatment. If amiodarone and sofosbuvir treatment is necessary, additional heart monitoring may be required.
You should immediately inform your doctor if you are taking a drug containing sofosbuvir for the treatment of hepatitis C, and during treatment, you experience:

• slow or irregular heartbeat or rhythm problems;
• shortness of breath or worsening of existing shortness of breath;
• chest pain;
• dizziness;
• palpitations;
• near-fainting or fainting.

Before surgery, you must inform the anesthesiologist that you are taking Opacorden. In patients treated with amiodarone undergoing anesthesia, there is a risk of adverse reactions such as slow heartbeat, low blood pressure, and heart rhythm disturbances.
Taking Opacorden causes harmless changes in the ECG test.
Before starting treatment with amiodarone, it is recommended to perform ECG and potassium level tests. ECG monitoring is also recommended during treatment.
Excessive doses of Opacorden, especially in elderly patients or those taking digitalis glycosides, may cause severe bradycardia (very slow heartbeat) and conduction disorders. In such cases, the doctor will recommend discontinuing Opacorden.
Amiodarone treatment should be stopped immediately if skin reactions occur that may indicate the development of Stevens-Johnson syndrome (ang. SJS - Stevens-Johnson syndrome) (progressive rash with blisters or mucous membrane changes, fever, and joint pain) or toxic epidermal necrolysis (ang. TEN - Toxic Epidermal Necrolysis) (severe, rapidly progressing disease characterized by bursting giant subepidermal blisters, extensive skin erosion, and fever), blistering skin rash, and drug rash with eosinophilia and systemic symptoms (DRESS). These symptoms can be life-threatening and even lead to death.
In most patients taking the medicine (especially long-term), amiodarone or its metabolites accumulate in the cornea of the eye, usually without causing any pathological symptoms.
In some patients, vision disturbances may occur (e.g., seeing a rainbow-colored halo around a light source, photophobia, or dry eye). If you experience blurred vision or decreased visual acuity, you should immediately consult an ophthalmologist who will perform a comprehensive eye examination.
During treatment, the doctor will recommend liver function tests (determination of AspAT, AlAT enzyme activity), as liver function parameters may change. Additionally, acute liver function disorders may occur, sometimes simultaneously with jaundice. These disorders are reversible and disappear after discontinuing treatment. During long-term treatment, chronic liver failure may occur.
Due to the toxic effect of the medicine on the lungs, a thorough clinical examination of patients is recommended before starting treatment, and the doctor may consider a radiological examination of the lungs. If you experience shortness of breath or cough during treatment, which may indicate toxic effects of the medicine on the lungs, you should contact your doctor, who will recommend additional pulmonary function tests (spirometry).
The medicine may cause peripheral neuropathy (nerve disease) and myopathy (muscle disease) with a severe course. The disappearance of symptoms usually occurs after a few months after discontinuing treatment, but in some cases, it may not be complete.
In patients with an implanted cardioverter-defibrillator or pacemaker, it is recommended to regularly check the proper functioning of the device after starting treatment or changing the dosage.

Sunlight

Avoid exposure to sunlight and use sun protection during treatment. Opacorden causes photosensitivity, which can persist for several months after discontinuing treatment. The most common symptoms of photosensitivity are: tingling, burning, and redness.
As a result of long-term use of the medicine, the skin may turn blue-gray.

Children

The safety and efficacy of Opacorden in children have not been established. Therefore, the use of this medicine in these patients is not recommended.

Opacorden and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take Opacorden with:

• medicines used to treat heart rhythm disorders (such as: sotalol, quinidine, procainamide, disopyramide, bepridil, or bretylium);
• antibiotics (intravenous erythromycin), cotrimoxazole, pentamidine (injected), moxifloxacin);
• vincamine or cyzapride;
• medicines used to treat schizophrenia (chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpride, or sertindol);
• medicines used to treat other mental disorders (lithium products, tricyclic antidepressants, e.g., doxepin, maprotiline, amitriptyline);
• medicines used to treat malaria (quinine, mefloquine, chloroquine, halofantrine);
• antihistamines (terfenadine, astemizole, mizolastine).

Tell your doctor about taking:

• medicines that prolong the QT interval in the ECG (electrocardiogram), e.g., fluoroquinolones used in infections (ciprofloxacin, ofloxacin, levofloxacin);
• medicines used to treat heart diseases, e.g., beta-adrenergic blockers (propranolol);
• calcium channel blockers used to treat chest pain (angina pectoris) or lower blood pressure (verapamil, diltiazem);
• certain laxatives (used to treat constipation) such as bisacodyl or senna;
• sofosbuvir (a medicine used to treat hepatitis C).

The following medicines may increase the risk of side effects when taken with Opacorden:

• amphotericin B administered intravenously - an antifungal medicine;
• corticosteroids used systemically, e.g., hydrocortisone, betamethasone, prednisolone;
• diuretics;
• medicines used for general anesthesia or high oxygen concentrations administered during surgical procedures;
• tetracosactide (a medicine used to test certain hormonal disorders).

Opacorden may increase the effect of the following medicines:

• cyclosporine, tacrolimus, and sirolimus - medicines used to prevent transplant rejection;
• cholesterol-lowering medicines - statins, e.g., simvastatin, pravastatin.
• sildenafil - a medicine used to treat erectile dysfunction;
• fentanyl - a strong painkiller;
• dihydroergotamine, ergotamine - medicines used to treat migraines;
• midazolam, triazolam - medicines used to treat anxiety and sedation before surgery;
• colchicine - a medicine used to treat gout;
• flecainide - a medicine used to treat arrhythmia: treatment will be carried out under close supervision;
• lidocaine - a medicine used mainly for local anesthesia;
• warfarin, dabigatran - medicines that regulate blood clotting;
• phenytoin - a medicine used to treat epileptic seizures;
• digoxin - a medicine used to treat heart diseases.

Opacorden with food, drink, and alcohol

Do not drink grapefruit juice while taking Opacorden.
Limit alcohol consumption while taking Opacorden, as the risk of liver damage increases. Inform your doctor about the amount of alcohol you consume.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Do not take Opacorden during pregnancy, as it may harm the fetus.
Do not take Opacorden during breastfeeding.

Driving and using machines

Opacorden may affect your ability to drive and use machines, due to possible side effects such as vision disturbances.

Opacorden contains cochineal red, lake (E124)

The medicine may cause allergic reactions.

3. How to take Opacorden

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

• Take the medicine orally, with water.
• Swallow the tablet whole. Do not crush or chew the tablet.

Adults

Use the smallest effective dose (allowing control of heart rhythm disorders).

• Typically, a loading dose of 200 mg (1 tablet) is taken 3 times a day for a week.
• Depending on the patient's condition and response to treatment, the doctor may decide to increase or decrease the dose of the medicine. The maintenance dose is 100 mg to 200 mg per day. Amiodarone 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 treatment (two days a week).

Use in children

There is insufficient data on the safety and efficacy of Opacorden in children.
The doctor will decide on the appropriate dose of the medicine.

Elderly patients

The doctor may recommend a lower dose of Opacorden. Regular monitoring of heart and thyroid function is necessary.

Taking a higher dose of Opacorden than recommended

If you have taken a higher dose of Opacorden than recommended, contact your doctor or the nearest hospital immediately to find out what to do next.
After taking a higher dose than recommended, the following side effects have been reported: confusion, weakness or fatigue, slow heartbeat, liver function disorders.

Missing a dose of Opacorden

If you miss a dose, take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

Stopping Opacorden treatment

Do not stop taking Opacorden without consulting your doctor. Do not stop taking the medicine if you feel better. If you stop taking the medicine, heart rhythm disorders may occur, which can be life-threatening.

Laboratory tests

Your doctor may recommend regular thyroid function tests, as Opacorden contains iodine, which can affect thyroid function.
Your doctor may also recommend a radiological examination of the chest, ECG, potassium level in the blood, and eye examination before and during treatment with Opacorden.
Your doctor may recommend regular liver function tests during Opacorden treatment and, depending on the results, decide whether to administer the medicine.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Opacorden can cause side effects, although not everybody gets them.

Stop taking Opacorden and seek medical advice immediately if you experience any of the following side effects.

Common (affecting less than 1 in 10 people)

• yellowing of the eyes and skin (jaundice), abdominal pain, loss of appetite, fatigue, fever, increased liver enzyme 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, pleurisy, bronchiolitis obliterans with pulmonary involvement (see Warnings and precautions in section 2) or bronchospasm and (or) apnea in cases of severe respiratory failure, especially in patients with asthma.

Uncommon (affecting less than 1 in 100 people)

• heart rhythm disorders or their worsening, sometimes with cardiac arrest (see Warnings and precautions and Opacorden with other medicines in section 2), conduction disorders in the heart muscle (sinoatrial block, atrioventricular block of various degrees);
• numbness, muscle weakness, tingling, and burning; these may be symptoms of sensory-motor peripheral neuropathy (nerve disease) and (or) myopathy (muscle disease), usually reversible after discontinuing Opacorden treatment.

Rare (affecting less than 1 in 10,000 people)

• blurred vision or decreased visual acuity; these may be symptoms of optic neuropathy, which can cause blindness (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 rashes as 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.

Frequency not known (cannot be estimated from available data)

• swelling of the lips, face, or tongue, difficulty breathing and swallowing (angioedema); these are symptoms of allergic reactions;
• hives;
• 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 risk of infection (agranulocytosis);
• irregular heartbeat; may be a symptom of life-threatening torsades de pointesarrhythmia (see Warnings and precautions and Opacorden with other medicines in section 2);
• coughing up blood, as a symptom of pulmonary hemorrhage;
• bone marrow suppression, granuloma;
• severe allergic reactions (anaphylactic reaction, anaphylactic shock);
• sudden pancreatitis (acute pancreatitis);
• decreased appetite;
• stiffness, tremors, and restlessness (parkinsonism);
• abnormal sense of smell (parosmia);
• confusion (delirium);
• seeing, hearing, or feeling things that are not there (hallucinations);
• life-threatening skin reactions characterized by rash, blisters, skin peeling, and pain (toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), blistering skin rash, drug rash with eosinophilia and systemic symptoms (DRESS)).

Other side effects of Opacorden may occur with the following frequency:

Very common (affecting more than 1 in 10 people)

• microdeposits in the cornea, forming just below the pupil. They may be accompanied by seeing a colored halo around objects when looking at bright light or blurred vision. They consist of complex lipid deposits and disappear after discontinuing amiodarone treatment;
• mild gastrointestinal disorders (nausea, vomiting, taste disturbances) usually occurring during the loading dose of Opacorden and disappearing after reducing the amiodarone dose;
• increased liver enzyme activity in blood tests, which is usually moderate (1.5 to 3 times above the normal range) and occurs at the beginning of treatment. These abnormalities may return to normal after reducing the dose of the medicine or on their own;
• photosensitivity.

Common (affecting less than 1 in 10 people)

• decreased libido;
• slow heartbeat (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 gray skin discoloration during long-term use of high doses of the medicine, which disappears slowly after discontinuing treatment;
• constipation;
• itching, red rash (exanthema).

Uncommon (affecting less than 1 in 100 people)

• dry mouth.

Rare (affecting less than 1 in 10,000 people)

• 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;
• headache; dizziness;
• epididymitis, impotence;
• skurcz oskrzeli u pacjentów z ciężką niewydolnością oddechową, zwłaszcza u pacjentów z astmą oskrzelową, zespołem ostrej niewydolności oddechowej, czasami zakończone zgonem, szczególnie bezpośrednio po zabiegu operacyjnym (możliwa interakcja z tlenem w dużym stężeniu) (patrz Ostrzeżenia i środki ostrożności oraz Lek Opacorden a inne leki w punkcie 2);
• rumień podczas zabiegu radioterapii, wysypki skórne, zwykle niespecyficzne, złuszczające zapalenie skóry, łysienie;
• zwiększenie stężenia kreatyniny we krwi w badaniach diagnostycznych.

Frequency not known (cannot be estimated from available data)

• life-threatening complication after heart transplantation (primary graft dysfunction), in which the transplanted heart stops working properly (see section 2, Warnings and precautions).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Opacorden

Do not store above 25°C. Store in the original packaging.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT, it indicates the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Opacorden contains

• The active substance of the medicine is amiodarone. Each tablet contains 200 mg of amiodarone hydrochloride.
• Other ingredients are: tablet core: potato starch, gelatin, talc, anhydrous colloidal silica, magnesium stearate. Tablet coating: hypromellose, macrogol 6000, cochineal red, lake (E124), talc, propylene glycol, titanium dioxide.

What Opacorden looks like and what the package contains

Round, biconvex, pink tablets.
The package contains 60 tablets.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01.
Date of last revision of the leaflet:June 2025.