Amiodarone Zentiva: detailed information

Patient Information Leaflet

Amiodarone Zentiva 200 mg tablets

Equivalent medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Amiodarone Zentiva is and what it is used for
What you need to know before taking Amiodarone Zentiva
How to take Amiodarone Zentiva
Possible side effects
How to store Amiodarone Zentiva
Contents of the pack and other information

1. What Amiodarone Zentiva is and what it is used for

Amiodarone Zentiva contains the active substance amiodarone hydrochloride, which belongs to a class of medicines called "class III antiarrhythmics" that work by regulating the heartbeat.
Amiodarone Zentiva is indicated for:

the treatment and prevention of serious heart rhythm disorders when other medicines have not worked: excessively fast heartbeat, sometimes characterized by sudden stopping and restarting (paroxysmal and non-paroxysmal supraventricular tachycardias), irregular heartbeat characterized by premature contraction of the heart muscle disrupting the regular sequence of beats (atrial extrasystoles), irregular and excessively rapid heartbeat (atrial flutter), and irregular and accelerated heartbeat (atrial fibrillation).
sudden and abrupt changes in heartbeat with increased frequency (paroxysmal reciprocating supraventricular tachycardias) in patients affected by conditions such as Wolff-Parkinson-White syndrome, a disorder characterized by rapid heartbeat, dizziness, fainting, easy fatigue, and anxiety. Heart rhythm disturbances involving extra beats that interfere with normal heart rhythm, sometimes causing a sensation of missed heartbeat in the chest area (ventricular extrasystoles), and heart rhythm disorders characterized by very rapid heartbeat (ventricular tachycardias).
the preventive treatment of angina pectoris attacks, a heart disease caused by reduced blood flow to the heart, mainly manifested by chest pain.

2. What you need to know before taking Amiodarone Zentiva

Do not take Amiodarone Zentiva

if you are allergic to amiodarone, iodine, or any of the other ingredients of this medicine (listed in section 6);
if you have a slower than normal heart rate (sinus bradycardia) or a condition known as sino-atrial block, characterized by delayed formation of heartbeats;
if you suffer from severe disorders in the generation of heartbeats and do not have a pacemaker (severe atrioventricular blocks, bi- or trifascicular blocks);
if you suffer from a condition affecting heart rhythm and do not have a pacemaker, with risk of abnormal heartbeats (sinus arrest);
if you are taking medicines that can cause heart rhythm abnormalities (torsades de pointes) (see “Other medicines and Amiodarone Zentiva”);
if you currently have or have previously had thyroid disorders (thyroid dysfunction). In doubtful cases (uncertain previous history, family history of thyroid disorders), your doctor will perform a thyroid examination before starting treatment with this medicine;
if you are pregnant, except in exceptional cases where your doctor prescribes it (see “Pregnancy and breastfeeding”);
if you are breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Amiodarone Zentiva:

if you have a pacemaker or an implanted cardioverter defibrillator. In such cases, your doctor will check that the device is functioning properly before and during treatment;
if you are elderly. Your doctor will monitor you more closely;
if you have severe heart conditions (cardiomyopathies and severe coronary artery disease) and during treatment develop productive cough (with sputum), breathing difficulties, fever, or weight loss;
if you are on a waiting list for a heart transplant, your doctor may modify your treatment. This is because taking amiodarone before heart transplantation has been associated with an increased risk of potentially life-threatening complications (primary graft dysfunction), where the transplanted heart fails to function properly within the first 24 hours after surgery;
if you are scheduled for surgery under general anesthesia;
if you have liver problems; your doctor will perform careful monitoring of liver function, both at the beginning and during treatment. In case of severe liver function abnormalities, your doctor will discontinue the medicine and initiate appropriate therapy;
if you have vision problems, particularly reduced blood supply or inflammation of the optic nerve (optic neuropathy and optic neuritis). In such cases, your doctor will discontinue the medicine;
if you have muscle problems;
if you have thyroid problems;
if you are taking other medicines (see “Other medicines and Amiodarone Zentiva”).

Amiodarone Zentiva will only be administered after your doctor has carefully evaluated your health status. Your doctor will closely monitor you during treatment.
Before starting treatment with Amiodarone Zentiva, your doctor will perform an electrocardiogram (ECG), a test that analyzes heart activity, and will check your blood potassium levels. During treatment with this medicine, you will undergo blood tests for liver function (transaminases) and ECGs.
Since the risk of adverse effects (see “Possible side effects”) increases with higher doses of the medicine (dose-dependent), your doctor will prescribe the lowest effective dose to control your heart rhythm. If your heart rhythm disturbances worsen or new ones appear, your doctor will determine whether this is due to loss of medicine efficacy or progression of the underlying disease.
If you are currently taking or have taken amiodarone in the past few months, consult your doctor or pharmacist before taking sofosbuvir/valpatasvir (a medicine used to treat chronic viral liver infection known as hepatitis C in adults aged 18 years and older), as this may cause a life-threatening slowing of the heart rate. Your doctor may consider alternative treatments. If treatment with sofosbuvir/valpatasvir is necessary, you may require additional cardiac monitoring.
During treatment with Amiodarone Zentiva, or even long after stopping treatment, you may develop increased thyroid activity with symptoms such as weight loss, heart rhythm disturbances, and chest pain. Your doctor will perform careful monitoring and, if necessary, discontinue the medicine.
Amiodarone Zentiva can cause serious muscle problems (sensory-motor peripheral neuropathy and myopathy). In such cases, your doctor will discontinue the medicine.
Skin disorders (skin reactions), including very severe and potentially fatal conditions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (see “Possible side effects”), may occur. These manifest as progressive skin redness (rash), often accompanied by blisters and bullae, and may also affect mucous membranes. In such cases, stop taking amiodarone immediately and contact your doctor without delay.
If during treatment with Amiodarone Zentiva you develop dry cough, fever, breathing difficulties associated with severe general malaise, your doctor will perform chest X-rays and other tests to assess your lung function. This is because pulmonary toxicity may occur during treatment with Amiodarone Zentiva, which, if not diagnosed promptly, can be life-threatening. If necessary, your doctor may reduce the dose or discontinue the medicine and initiate appropriate therapy.
Avoid sun exposure and use protective measures (apply sunscreen with high protection factor, wear a hat, and wear clothing covering arms and legs) during treatment with this medicine (see “Possible side effects”).

Children
The use of Amiodarone Zentiva is not recommended in children.

Other medicines and Amiodarone Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The combination of Amiodarone Zentiva with the following medicines is contraindicated:

medicines that can cause a specific type of heart rhythm disturbance (torsades de pointes), such as antiarrhythmics of Class IA, sotalol, bepridil, vincamine (an antibiotic), medicines used to treat mental disorders (e.g., sultopride), cisapride (a medicine used to treat gastric reflux, i.e., backflow of stomach contents into the esophagus), intravenous erythromycin (an antibiotic), intravenous pentamidine (used for certain types of pneumonia);
antibiotics known as fluoroquinolones;
medicines used to treat depression (MAO inhibitors).

The combination of Amiodarone Zentiva with the following medicines is not recommended:

medicines that slow heart rate (beta-blockers and calcium antagonists) such as verapamil and diltiazem;
medicines that may cause low blood potassium levels (hypokalemia), such as stimulant laxatives (medicines that increase intestinal motility and evacuation);
sofosbuvir, a medicine used in combination with others for the treatment of chronic hepatitis C, because serious, potentially life-threatening side effects may occur (see section “Warnings and precautions”).

The combination of Amiodarone Zentiva with the following medicines requires caution:

medicines that may cause a specific heart rhythm alteration known as QT prolongation;
medicines that promote urine production (diuretics), alone or in combination;
medicines used to control inflammation and allergies (systemic glucocorticoids and mineralocorticoids);
tetracosactide, used to investigate certain hormonal disorders;
intravenous amphotericin B, used to treat fungal infections.

The effects of Amiodarone Zentiva may be influenced by, or may influence, the following medicines:

general anesthesia and high oxygen doses during surgery;
digoxin, used to increase the force of heart contraction;
dabigatran and warfarin, anticoagulants used to thin the blood;
phenytoin, a medicine used to treat epilepsy;
flecainide, a medicine used to control heart rhythm;
statins, used to reduce blood cholesterol levels, such as simvastatin, atorvastatin, and lovastatin; their combination increases the risk of muscle disorders (e.g., rhabdomyolysis). Your doctor will prescribe the appropriate statin to take with amiodarone;
cyclosporine, tacrolimus, and sirolimus, used to suppress the immune system and help prevent transplant rejection;
fentanyl and ergotamine, medicines used to control pain;
lidocaine, used as an anesthetic;
sildenafil, used to treat erectile dysfunction;
midazolam and triazolam, used to treat anxiety or help relaxation;
dihydroergotamine, used to treat certain types of headache (migraine);
colchicine, used to treat joint inflammation causing pain and swelling (gout).

Amiodarone Zentiva with food and drink
Do not drink grapefruit juice while taking this medicine, as it may increase the risk of side effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Amiodarone Zentiva during pregnancy unless your doctor considers it necessary, as it may harm the fetus.
Breastfeeding
Do not take Amiodarone Zentiva if you are breastfeeding. Amiodarone Zentiva passes into breast milk and may harm your baby.

Driving and using machines
Amiodarone Zentiva does not impair your ability to drive or operate machinery.

Amiodarone Zentiva contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Amiodarone Zentiva

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Your doctor will determine the route of administration, the initial dose, and the maintenance dose based on the severity of your condition and your response to treatment.
The recommended doses are:
For the treatment of heart rhythm disorders
The initial dose is 600 mg (3 tablets) daily for at least two weeks. Afterwards, your doctor will reduce the dose until establishing a maintenance dose of 100–400 mg daily (from half a tablet to 2 tablets), or will establish an intermittent treatment regimen (e.g., taking Amiodarone Zentiva for 2 or 3 weeks per month or for 5 days per week).
For preventive treatment of episodes of chest pain
Initial dose: 600 mg (3 tablets) daily for approximately 7 days.
Maintenance dose: 100–400 mg daily (from half a tablet to 2 tablets daily) or intermittent therapy (5 days per week or 2 or 3 weeks per month).
Concomitant therapy with statins
If you are taking statins during treatment with Amiodarone Zentiva to reduce cholesterol levels in the blood, your doctor will prescribe a specific statin (see also “Other medicines and Amiodarone Zentiva”).
Use in children
The use of Amiodarone Zentiva is not recommended in children.
If you take more Amiodarone Zentiva than you should
There are no available data regarding overdose with Amiodarone Zentiva.
Possible adverse effects due to an overdose of this medicine include: slowed heartbeat (sinus bradycardia), cardiac arrest (cardiac arrest), rapid heartbeat (ventricular tachycardia), heart rhythm abnormalities (torsades de pointes), circulatory disturbances (circulatory failure), and liver damage (hepatic injury).
In case of accidental ingestion/overdose of Amiodarone Zentiva, contact your doctor immediately or go to the nearest hospital.
If you forget to take Amiodarone Zentiva
Do not take a double dose to make up for the forgotten tablet.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The following side effects may occur, according to the following frequency:

Very common (may affect more than 1 in 10 people):

Vision disturbances such as blurred vision or seeing coloured halos around lights, due to small deposits of fat in the eye; this side effect resolves upon discontinuation of treatment;
Allergic reactions to light (photosensitisation). See also “Warnings and precautions”;
At the beginning of treatment, changes in specific blood tests for liver monitoring (increase in transaminases) may occur. These tests usually return to normal with dose reduction or spontaneously, i.e. without any specific intervention;
Nausea, vomiting and altered sense of taste (dysgeusia), which generally resolve with dose reduction.

Common (may affect up to 1 in 10 people):

Slowed heartbeat (bradycardia); this side effect is generally mild and caused by increasing the dose. Cases of severe bradycardia and heart block have been observed when medicines containing sofosbuvir are used in combination with amiodarone and/or other medicines that reduce heart rate (see sections “Warnings and precautions” and “How to take Amiodarone Zentiva”);
Grayish or bluish skin discoloration, especially after prolonged treatment or high daily doses. These side effects resolve upon discontinuation of treatment;
Thyroid disorders (hypothyroidism and hyperthyroidism), sometimes life-threatening;
Liver disorders with abnormal liver function tests and yellowing of the skin and whites of the eyes. These disorders can be serious (liver failure) and sometimes life-threatening;
Decreased sexual desire;
Sleep disturbances and nightmares;
Hand tremors;
Constipation;
Itching, red skin rash (eczema);
Pulmonary toxicity: lung inflammation (pneumonitis) characterised by fever, cough, chest pain and difficulty breathing; severe lung disease characterised by scarring of the tissue lining the lungs, cough, difficulty breathing, weight loss and fatigue (pulmonary fibrosis); inflammation of the membrane covering the outer surface of the lungs (pleuritis); inflammatory lung disease with symptoms such as fever, cough, general malaise, loss of appetite, weight loss and difficulty breathing (bronchiolitis obliterans with organising pneumonia).

Uncommon (may affect up to 1 in 100 people):

Severe heart rhythm disorders (sino-atrial block, A-V block of varying degrees) (see also “Warnings and precautions”);
Onset or worsening of heart rhythm disorders, up to cardiac arrest (see also “Warnings and precautions” and “Other medicines and Amiodarone Zentiva”);
Deterioration or malfunction of peripheral nerves, manifesting as tingling, prickling, reduced ability to feel pain and numbness in hands and feet (sensory-motor peripheral neuropathy) and/or muscle disorders with symptoms such as loss of strength, fatigue, pain, cramps and muscle stiffness (myopathy), which generally resolve upon discontinuation of the drug (“Warnings and precautions”);
Dry mouth.

Very rare (may affect up to 1 in 10,000 people):

Breakdown of red blood cells (haemolytic anaemia);
Reduced ability of the bone marrow to produce red blood cells (aplastic anaemia);
Reduced number of blood platelets (thrombocytopenia);
Severe slowing of the heartbeat, especially in elderly patients (bradycardia);
Reduced blood supply and inflammation of the optic nerve (optic neuropathy and optic neuritis), up to loss of vision (see “Warnings and precautions”);
Redness and irritation of the skin following radiotherapy;
Skin irritations;
Skin inflammation with peeling (exfoliative dermatitis);
Hair loss (alopecia);
Long-term liver disorders (chronic hepatopathies such as pseudo-alcoholic hepatitis and cirrhosis), sometimes life-threatening;
Constriction of the bronchi and worsening of breathing difficulties (bronchospasm) in patients with breathing difficulties (severe respiratory failure) and especially in patients with asthma or severe lung disease where the lungs are unable to function properly (acute respiratory distress syndrome in adults), sometimes life-threatening, usually observed shortly after surgery (possible interaction with high oxygen concentration) (see “Warnings and precautions”);
Increased creatinine levels in the blood (a blood test);
Brain disorders such as loss of balance, tremor, difficulty controlling limb and eye movements, difficulty speaking and writing (cerebellar ataxia);
Increased pressure inside the skull (benign intracranial hypertension, pseudotumour cerebri);
Headache;
Inflammation of the epididymis, the small tube located behind the testicles that stores and transports sperm (epididymitis);
Inability of male patients to achieve and/or maintain an erection sufficient for satisfactory sexual intercourse (impotence);
Inflammation of blood vessels (vasculitis);
Excessive secretion of antidiuretic hormone (syndrome of inappropriate antidiuretic hormone secretion), with fluid retention in the body.

Not known (frequency cannot be estimated from available data):

Bone marrow abnormalities (granulomas);
You may get more infections than usual. This could be due to a decrease in the number of white blood cells (neutropenia);
Severe reduction in the number of white blood cells, making infections more likely (agranulocytosis);
Abnormal heart rhythms (torsade de pointes) (see also “Other medicines and Amiodarone Zentiva”);
Liver abnormalities (granulomas);
Severe bleeding in the lungs (pulmonary haemorrhage);
Swelling of the face, hands and feet, lips, tongue or throat (Quincke's oedema);
Itching (urticaria), life-threatening skin reactions characterised by rashes, blisters, skin peeling and pain (toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), bullous dermatitis, drug reaction with eosinophilia and systemic symptoms (DRESS));
Severe allergic reaction (anaphylactic reaction/anaphylactic shock);
Loss of appetite;
Sudden inflammation of the pancreas (pancreatitis (acute));
Unusual muscle movements, stiffness, agitation and restlessness (parkinsonism);
Altered sense of smell (parosmia);
Confusion (delirium);
Seeing, hearing or perceiving things that are not there (hallucinations);
Lupus-like syndrome (a disease in which the immune system attacks various parts of the body, causing joint pain, stiffness and swelling, and skin redness, sometimes in the shape of butterfly wings on the face);
Potentially fatal complication after heart transplant (primary graft dysfunction), in which the transplanted heart fails to function properly (see section 2, Warnings and precautions).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amiodarone Zentiva

Keep this medicine out of the sight and reach of children.
Store below 25°C and protect the medicine from light.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp". The expiry date refers to the last day of that month.
Do not dispose of this medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Amiodarone Zentiva contains
The active substance is amiodarone hydrochloride. One tablet of Amiodarone Zentiva contains 200 mg of amiodarone hydrochloride.
The other components are: monohydrate lactose, maize starch, povidone, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Amiodarone Zentiva and contents of the pack
Amiodarone Zentiva is available as tablets.

Box containing 2 blisters of 10 tablets each.

Marketing Authorization Holder
Zentiva Italia S.r.l. – Via P. Paleocapa 7 – 20121 Milan, Italy

Manufacturer
ZENTIVA SA
50, Theodor Pallady Blvd
3rd district
032266 Bucharest – Romania