Opacorden

Package leaflet: Information for the patient

Opacorden, 200 mg, coated tablets
Amiodaroni hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Opacorden is and what it is used for
2. Important information before taking Opacorden
3. How to take Opacorden
4. Possible side effects
5. How to store Opacorden
6. Contents of the pack and other information

1. What Opacorden is and what it is used for

Opacorden contains amiodarone – a substance belonging to the group of antiarrhythmic drugs, which help restore normal heart rhythm.
Opacorden is used in the treatment and prevention of:

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

2. Important information before using Opacorden

When not to use Opacorden:

• if the patient is allergic to amiodarone or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to iodine (each Opacorden tablet contains 75 mg of iodine); if symptoms of allergy occur, such as itchy rash, difficulty swallowing or breathing, or swelling of the lips, face, throat, or tongue, contact a doctor immediately;
• if the patient has had or currently has thyroid disease; thyroid function tests should be performed before treatment with amiodarone;
• if the patient is taking medicines that may cause torsades de pointes (a life-threatening irregular heartbeat);
• if the patient has sinus bradycardia (very slow heartbeat, less than 50 beats per minute), sinoatrial block, or sick sinus syndrome, except in patients with a pacemaker (risk of sinus node suppression);
• if the patient has second- or third-degree atrioventricular block, except in patients with a pacemaker;
• during pregnancy and breastfeeding.

Warnings and precautions
Before starting treatment with Opacorden, discuss this with your doctor or pharmacist.
Exercise particular caution when using this medicine:

• in patients with heart failure;
• in elderly patients, patients with a history of thyroid disorders, goitre, or other thyroid diseases, due to the risk of hypothyroidism or hyperthyroidism. Thyroid function tests should be performed before treatment in all patients, periodically during treatment, and several months after discontinuation;
• in patients after coronary artery bypass surgery (by-pass), hypotension may develop during amiodarone treatment;
• in patients undergoing surgical procedures, due to the risk of developing acute respiratory distress syndrome.

If the patient is on a heart transplant waiting list, the treating physician may change the treatment before transplantation. This is because amiodarone use prior to heart transplantation increases the risk of a life-threatening complication (primary graft dysfunction), in which the transplanted heart fails to function properly within the first 24 hours after surgery.
If the patient is taking a medicine containing sofosbuvir used in the treatment of hepatitis C and amiodarone simultaneously, this may cause a life-threatening slowing of the heartbeat. The doctor may consider alternative treatment. If treatment with both amiodarone and sofosbuvir is necessary, additional cardiac monitoring may be required.
Contact your doctor immediately if the patient is taking a medicine containing sofosbuvir for hepatitis C and experiences any of the following during treatment:

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

Before undergoing surgery, it is essential to inform the anaesthesiologist that the patient is taking Opacorden. Patients treated with amiodarone undergoing anaesthesia are at risk of adverse effects such as slow heartbeat, low blood pressure, and cardiac dysfunction.
Treatment with Opacorden causes harmless changes in the ECG.
Before starting amiodarone treatment, ECG and serum potassium levels should be checked. ECG monitoring is also recommended during treatment.
Excessive doses of Opacorden, especially in elderly patients or those taking cardiac glycosides, may lead to severe bradycardia (very slow heartbeat) and conduction disturbances. In such cases, the doctor will advise discontinuing Opacorden.
Treatment with amiodarone must be stopped immediately if skin reactions occur that may indicate Stevens-Johnson syndrome (SJS) (progressive rash with blisters or mucosal lesions, fever, and joint pain), toxic epidermal necrolysis (TEN) (a severe, rapidly progressing illness with large subepidermal blisters, extensive skin erosions, peeling of large areas of skin, and fever), bullous dermatitis, or drug reaction with eosinophilia and systemic symptoms (DRESS). These symptoms may be life-threatening and may even lead to death.
In most patients (especially with long-term use), amiodarone or its metabolites deposit in the cornea of the eye, although this usually does not cause pathological symptoms.
Some patients may experience visual disturbances (e.g. seeing rainbow-coloured halos around light sources, photophobia, or dry eyes). If blurred vision or decreased visual acuity occurs, consult an ophthalmologist immediately for a comprehensive eye examination.
During treatment, the doctor will recommend liver function tests (measurement of AspAT and AlAT enzyme activity), as liver function parameters may change. Additionally, acute liver dysfunction, sometimes accompanied by jaundice, may occur. These changes are reversible and resolve after discontinuation of treatment. With prolonged treatment, chronic liver failure may develop.
Due to the drug's toxic effect on the lungs, a thorough clinical evaluation is recommended before starting treatment, and the doctor may consider a chest X-ray. If breathlessness or cough develops during treatment, which may indicate toxic lung effects, contact your doctor, who may recommend additional pulmonary function tests (spirometry).
The medicine may cause severe peripheral neuropathy (nerve disease) and myopathy (muscle disease). Symptoms usually resolve several months after stopping treatment, but in some cases, recovery may not be complete.
In patients with an implanted cardioverter-defibrillator or cardiac pacemaker, regular device function checks are recommended after starting treatment or changing the dose.
Sunlight
Avoid exposure to sunlight and use sun protection measures during treatment. Opacorden causes photosensitivity, which may persist for several months after stopping treatment. The most common symptoms of photosensitivity are tingling, burns, and erythema.
With prolonged use, the skin may develop a blue-grey discoloration.
Children
The safety and efficacy of use in children have not been established. Therefore, use in these patients is not recommended.
Opacorden and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Do not take Opacorden simultaneously with:

• medicines used for heart rhythm disorders (such as: sotalol, quinidine, procainamide, disopyramide, bepridil, or bretylium);
• anti-infective medicines (intravenous erythromycin, cotrimoxazole, pentamidine [administered by injection], moxifloxacin);
• vincamine or cisapride;
• medicines used in schizophrenia (chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpiride, or sertindole);
• medicines for other psychiatric disorders (lithium products, tricyclic antidepressants, e.g. doxepin, maprotiline, amitriptyline);
• medicines used for malaria (quinine, mefloquine, chloroquine, halofantrine);
• antihistamines (terfenadine, astemizole, mizolastine).

Inform your doctor if you are taking:

• medicines that prolong the QT interval on ECG (electrocardiogram), e.g. fluoroquinolone antibiotics used for infections (ciprofloxacin, ofloxacin, levofloxacin);
• medicines used for heart diseases, e.g. beta-blockers (propranolol);
• calcium channel blockers used for chest pain (angina pectoris) or blood pressure reduction (verapamil, diltiazem);
• certain laxatives (used for constipation treatment), such as bisacodyl or senokot;
• sofosbuvir (a medicine used in the treatment of hepatitis C).

The following medicines may increase adverse effects when used concomitantly with Opacorden:

• intravenous amphotericin B – an antifungal medicine;
• anti-inflammatory medicines – systemic corticosteroids, e.g. hydrocortisone, betamethasone, prednisolone;
• diuretics;
• medicines used in general anaesthesia or high concentrations of oxygen administered during surgical procedures;
• tetracosactide (a medicine used to diagnose certain hormonal disorders).

Opacorden may enhance the effects 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 – anti-migraine medicines;
• midazolam, triazolam – medicines used for anxiety and sedation before surgical procedures;
• colchicine – a medicine used for gout;
• flecainide – a medicine used to treat arrhythmias: treatment will be conducted under close supervision;
• lidocaine – a medicine mainly used for local anaesthesia;
• warfarin, dabigatran – medicines regulating blood clotting;
• phenytoin – a medicine used to treat epileptic seizures;
• digoxin – a medicine used for heart conditions.

Opacorden with food, drink, and alcohol
Do not drink grapefruit juice during treatment with Opacorden.
Alcohol consumption should be limited during treatment with Opacorden, as it increases the risk of liver disorders. Inform your doctor about the amount of alcohol consumed.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.
This medicine must not be taken during pregnancy, as it may cause fetal harm.
This medicine must not be taken during breastfeeding.
Driving and operating machinery
Opacorden may affect the ability to drive and operate machinery due to possible adverse effects such as visual disturbances.
Opacorden contains cochineal carmine, lac (E124)
This medicine may cause allergic reactions.

3. How to use Opacorden

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

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

Adults
The lowest effective dose (allowing control of heart rhythm disturbances) should be used.

• The usual loading dose is 200 mg (1 tablet) three times daily for one week.
• Depending on the patient's condition and response to treatment, the doctor may decide to increase or decrease the dose. The maintenance dose ranges from 100 mg to 200 mg per day. Amiodarone may be administered every other day at a dose of 200 mg per day or daily at a dose of 100 mg per day; intermittent treatment regimens (e.g., two days per week) may also be used.

Use in children
There is insufficient data on the safety and efficacy of this medicine in children.
The doctor will determine the appropriate dose.

Elderly patients
The doctor may prescribe a lower dose of Opacorden. Regular monitoring of heart and thyroid function is recommended.

Taking more than the recommended dose of Opacorden
If you take more than the recommended dose of Opacorden, seek immediate medical advice from your doctor or the nearest hospital for further instructions.
The following adverse effects have been reported after overdose: confusion, weakness or fatigue, slow heartbeat, and liver function disturbances.

Missed 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 a missed dose.

Stopping treatment with Opacorden
Do not stop taking Opacorden without consulting your doctor. Do not discontinue treatment even if you feel better. Stopping the medicine may lead to potentially dangerous heart rhythm disturbances.

Laboratory tests
Your doctor may recommend regular thyroid function tests, as Opacorden contains iodine, which may affect thyroid function.
Your doctor may also recommend a chest X-ray, ECG, serum potassium levels, and eye examinations before and during treatment with Opacorden.
Your doctor may recommend regular liver function tests during treatment with Opacorden and will decide, based on the results, whether to continue therapy.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You must stop taking Opacorden and seek immediate medical advice
if any of the following adverse reactions occur.

Common (affects less than 1 in 10 patients)

• yellowing of the eyes and skin (jaundice), abdominal pain, loss of appetite, fatigue, fever, increased blood aminotransferase activity; these are symptoms of life-threatening acute liver dysfunction or liver failure;
• shortness of breath and cough without sputum production; these may be symptoms of life-threatening interstitial lung disease or pulmonary fibrosis, pleuritis, bronchiolitis obliterans organising pneumonia with pneumonia (see Warnings and precautions in section 2), or occurrence of bronchospasm and (or) apnoea in case of severe respiratory insufficiency, especially in patients with bronchial asthma.

Uncommon (affects less than 1 in 100 patients)

• cardiac arrhythmias or worsening of existing arrhythmias, sometimes with cardiac arrest (see Warnings and precautions and Opacorden with other medicines in section 2), conduction disturbances in the heart muscle (sinus-node block, atrioventricular block of varying degrees);
• numbness, muscle weakness, tingling and burning sensations; these may be symptoms of sensorimotor peripheral neuropathy (nerve disease) and (or) myopathy (muscle disease), usually reversible after discontinuation of Opacorden therapy.

Very rare (affects less than 1 in 10,000 patients)

• blurred vision or reduced visual acuity; these may be symptoms of optic neuropathy, which may lead to 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 arrest, especially in patients with sinus node dysfunction and (or) elderly patients;
• skin rashes indicating vasculitis;
• headache worsening in the morning or after exertion, nausea, seizures, fainting, visual disturbances or disorientation; these may be symptoms of brain dysfunction due to increased intracranial pressure (pseudotumour cerebri);
• disturbances in motor coordination.

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 hypersensitivity reactions;
• urticaria;
• increased susceptibility to infections may occur. This may be due to a decrease in white blood cell count (neutropenia);
• marked decrease in white blood cells, increasing the likelihood of infections (agranulocytosis);
• irregular heartbeat; this may be a symptom of life-threatening torsades de pointes arrhythmia (see Warnings and precautions and Opacorden with other medicines in section 2);
• coughing up blood, as a sign of pulmonary haemorrhage;
• bone marrow suppression, granuloma;
• severe allergic reactions (anaphylactic reaction, anaphylactic shock);
• sudden onset of pancreatitis (acute pancreatitis);
• decreased appetite;
• stiffness, tremor and motor restlessness (parkinsonism);
• abnormal sense of smell (parosmia);
• confusion (delirium);
• seeing, hearing or feeling things that are not there (hallucinations);
• life-threatening skin reactions characterised by rash, blisters, skin peeling and pain (toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), bullous dermatitis, drug reaction with eosinophilia and systemic symptoms (DRESS)).

Other adverse reactions associated with Opacorden may occur with the following frequency:
Very common (affects more than 1 in 10 patients)

• corneal microdeposits, forming just beneath the pupil. These may be associated with seeing coloured halos around objects when looking at bright light or blurred vision. These deposits consist of complex lipid aggregates and resolve after discontinuation of amiodarone therapy;
• mild gastrointestinal disturbances (nausea, vomiting, taste disturbances), usually occurring during administration of the loading dose of the drug and resolving after reducing the amiodarone dose;
• increased blood aminotransferase activity, usually moderately elevated (1.5 to 3 times above the normal range) and occurring at the beginning of treatment. These abnormalities may return to normal values after dose reduction or spontaneously;
• photosensitivity.

Common (affects less than 1 in 10 patients)

• decreased libido;
• abnormally slow heartbeat (bradycardia), usually moderate and dose-dependent;
• hypothyroidism (manifesting as severe fatigue, weight gain, constipation and muscle pain), hyperthyroidism (manifesting as restlessness and motor agitation, weight loss, increased sweating), sometimes fatal;
• extrapyramidal tremors, nightmares, sleep disturbances;
• greyish-blue skin discoloration during long-term treatment with high doses of the drug, which slowly resolves after discontinuation of treatment;
• constipation;
• itchy, red rash (exanthema).

Uncommon (affects less than 1 in 100 patients)

• dry mouth.

Very rare (affects less than 1 in 10,000 patients)

• haemolytic anaemia, aplastic anaemia (anaemias manifesting as pallor of the skin and mucous membranes, fatigue, weakness and dizziness), thrombocytopenia (decreased platelet count, manifesting as tendency to bruising and bleeding);
• syndrome of inappropriate antidiuretic hormone secretion (SIADH), manifesting as malaise, weakness, disorientation, nausea, loss of appetite, nervousness;
• chronic liver diseases (pseudoalcoholic hepatitis, liver cirrhosis), sometimes fatal;
• increased blood creatinine concentration;
• headache; dizziness;
• epididymitis, impotence;
• bronchospasm in patients with severe respiratory insufficiency, especially in patients with bronchial asthma, acute respiratory distress syndrome, sometimes fatal, particularly immediately after surgery (possible interaction with high concentrations of oxygen) (see Warnings and precautions and Opacorden with other medicines in section 2);
• erythema during radiotherapy, skin rashes, usually nonspecific, exfoliative dermatitis, alopecia;
• increased blood creatinine concentration in diagnostic tests.

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse reactions
If you experience any adverse reactions, including any adverse reactions not listed
in this leaflet, consult your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Opacorden

Do not store above 25°C. Keep in the original packaging.
Keep the medicine out of 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 stated month.
The label on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Opacorden contains

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

What Opacorden looks like and contents of the pack
Round, biconvex, pink film-coated tablets.
Pack contains 60 tablets.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01