Amiodarone Ratiopharm Italia

Italy
Brand name Amiodarone Ratiopharm Italia
Form tablets
Active substance / Dosage
AMIODARONE HYDROCHLORIDE
Prescription type Prescription only
ATC code
C01BD01
Registration number 035729
Manufacturer TEVA B.V.

Table of Contents

Package leaflet: Information for the patient

Amiodarone ratiopharm Italia 200 mg tablets

amiodarone hydrochloride
Generic medicine
Read this entire leaflet carefully before taking this medicine, as 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 other people, even if their symptoms are the same as yours, as it could be harmful.
  • If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What Amiodarone ratiopharm Italia is and what it is used for
  2. What you need to know before taking Amiodarone ratiopharm Italia
  3. How to take Amiodarone ratiopharm Italia
  4. Possible side effects
  5. How to store Amiodarone ratiopharm Italia
  6. Contents of the pack and other information

1. What Amiodarone ratiopharm Italia is and what it is used for

Amiodarone ratiopharm Italia contains amiodarone, a substance that belongs to a group of medicines
called class III antiarrhythmics, used to treat disorders of the heart rhythm (arrhythmias).
In particular, this medicine is used:

  • for the prevention and treatment of serious heart rhythm disorders, especially when other medicines have not been effective (both paroxysmal and non-paroxysmal supraventricular tachycardias, atrial extrasystoles, atrial flutter and atrial fibrillation);
  • for the treatment of certain conditions characterized by an increased heart rate (paroxysmal reciprocating supraventricular tachycardias, such as those occurring in Wolff-Parkinson-White Syndrome);
  • for the treatment of other heart rhythm disorders, such as abnormal heartbeat (extrasystoles) and increased heart rate (ventricular tachycardias);
  • prevention of angina pectoris, chest pain that occurs when the heart muscles do not receive enough blood.

2. What you need to know before taking Amiodarone ratiopharm Italia

Do not take Amiodarone ratiopharm Italia

  • if you are allergic to amiodarone, iodine, or any of the other ingredients of this medicine (listed in section 6);
  • if you have a slow heart rate due to heart problems (sinus bradycardia);
  • if you suffer from heart disorders (sinoatrial block, pre-existing QT interval prolongation);
  • if you do not have a pacemaker and suffer from severe heart rhythm disorders known as conduction disturbances (second- or third-degree atrioventricular blocks, bi- or trifascicular blocks) or sinus node disease;
  • if you have low levels of potassium in your blood (hypokalemia);
  • if you are being treated with monoamine oxidase inhibitors (MAOIs) or other medicines that may cause heart rhythm disturbances known as “Torsade de pointes” (See also “Other medicines and Amiodarone ratiopharm Italia”);
  • if you or a family member suffer from thyroid problems (dysfunction), or have previously had thyroid problems; if thyroid dysfunction is suspected, tests must be performed before starting treatment;
  • during pregnancy, except in cases of absolute necessity (See section “Pregnancy and breastfeeding”);
  • during breastfeeding with breast milk (See section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Amiodarone ratiopharm Italia.
Before starting treatment with this medicine, your doctor will perform a chest X-ray, blood tests, and medical examinations to assess the function of your lungs, heart, thyroid, and liver. These tests should be repeated during treatment.
Pay special attention and consult your doctor before taking Amiodarone ratiopharm Italia if:

  • you are elderly, as the effects of this medicine on the heart may be more pronounced and you may develop thyroid problems;
  • you have liver problems;
  • there is a family history of thyroid disorders or if you suspect you may have thyroid problems;
  • you have heart problems (e.g., cardiomyopathy or severe coronary artery disease);
  • your respiratory function is impaired;
  • you have a pacemaker or an “implantable cardioverter defibrillator”;
  • you are scheduled for surgery; in this case, inform the anesthesiologist that you are being treated with this medicine; anesthesia administered during treatment with amiodarone may lead to serious complications such as low blood pressure (hypotension), disturbances in heart function (bradycardia, conduction disorders, reduced cardiac output), or severe breathing difficulties, sometimes even fatal;
  • you are taking medicines used to lower cholesterol levels in the blood (statins), as the risk of muscle disorders (myopathy) increases significantly;
  • you are taking other medicines, especially heart medications; ensure there are no known interactions between this medicine and others you may be taking (See section “Other medicines and Amiodarone ratiopharm Italia”);
  • you are currently taking a medicine containing sofosbuvir for the treatment of hepatitis C, as this may cause a potentially life-threatening slowing of the heartbeat. Your doctor should therefore consider alternative treatments. If treatment with amiodarone and sofosbuvir is necessary, additional cardiac monitoring may be required.

Please note that during treatment with this medicine, symptoms of toxicity (see also “Pulmonary toxicity”) or serious adverse reactions may occur, which may lead your doctor to reduce the dose or discontinue treatment.
Your doctor will closely monitor your clinical condition and may adjust the dosage or discontinue treatment if you experience:

  • changes in heart function manifesting as electrocardiographic changes (prolongation of the QT interval and appearance of U waves), second- or third-degree atrioventricular block, sinoatrial or bifascicular block, onset or worsening of disturbances in normal heart contraction (arrhythmias such as slowed heart rate, sinus bradycardia);
  • weight loss, heat intolerance, increased sweating, onset or worsening of disturbances in heart function (arrhythmias such as tachycardia, angina pectoris, congestive heart failure), tremors, nervousness, and decreased levels of the TSH hormone measured by ultra-sensitive methods, as these may be symptoms of overactivity of the thyroid gland (hyperthyroidism); changes in levels of hormones released by the thyroid;
  • weight gain, cold intolerance, fatigue, excessive reduction in heart rate (bradycardia), and increased levels of the TSH hormone measured by ultra-sensitive methods, as these may be symptoms of reduced thyroid activity (hypothyroidism);
  • acute (severe hepatocellular insufficiency or liver failure, sometimes fatal) or chronic disturbances in liver function, which may manifest as enlargement of the liver (hepatomegaly), yellowing of the skin and whites of the eyes (cholestatic jaundice), increased levels of liver enzymes known as transaminases (1.5 to 5 times the upper normal limit), liver infection (hepatitis), or severe liver inflammation (cirrhosis);
  • disturbances in the function of certain nerves (peripheral sensorimotor neuropathy), structural and functional changes in muscles (myopathy), breakdown of muscle fibers (rhabdomyolysis);
  • blurred vision, decreased vision, or severe eye disorders such as optic neuropathy or optic neuritis. You should undergo regular ophthalmologic examinations during treatment with amiodarone.

Please note that adverse reactions affecting the thyroid, liver, or neuromuscular system are usually reversible, and recovery is possible after discontinuation of treatment. It is particularly important that you inform your doctor of any symptoms or discomfort occurring during treatment with this medicine so that they can determine the lowest effective dose suitable for your clinical condition, minimizing unwanted effects.
Pulmonary toxicity
Pulmonary toxicity is a frequent and serious adverse effect, as it may lead to death, especially if not diagnosed promptly. It may occur shortly after starting the medicine, after months or years, and in some cases even weeks after discontinuation of treatment. This medicine must be used with extreme caution to detect symptoms immediately, especially if you have heart problems (cardiomyopathy or severe coronary artery disease), as identifying symptoms of pulmonary toxicity may be more difficult in these cases.
Symptoms of pulmonary toxicity include:

  • dry cough (non-productive cough), difficulty breathing (dyspnea);
  • fever;
  • weight loss. These may be signs of serious lung disorders such as inflammation of the alveoli (pulmonary alveolitis or allergic alveolitis), lung inflammation (pneumonitis), and other lung problems (interstitial lung disease, bronchiolitis obliterans, pulmonary fibrosis, pleuritis), breathing difficulties due to narrowing of the bronchi (bronchial asthma). Note that these symptoms may be mistaken for those commonly associated with the conditions for which this medicine is indicated. The risk of toxicity associated with amiodarone use increases if you are elderly or require high daily doses of amiodarone (greater than 400 mg/day); however, toxicity may also develop at lower doses. To prevent pulmonary toxicity, periodic checks such as chest X-rays or other specific tests are necessary. Symptoms generally improve within 2–4 weeks after discontinuation of amiodarone treatment.

Severe bradycardia and heart block (see section “Other medicines and Amiodarone ratiopharm Italia”)
Cases of severe, potentially fatal bradycardia and heart block have been observed when amiodarone is used in combination with sofosbuvir, used for the treatment of hepatitis C (HCV). Therefore, concomitant administration of this agent with amiodarone is not recommended.
If concomitant use with amiodarone cannot be avoided, your doctor will closely monitor you when starting sofosbuvir treatment. If you are at high risk of bradyarrhythmia, you must be continuously monitored for at least 48 hours in an appropriate clinical setting and daily for the following 2 weeks after starting concomitant treatment with sofosbuvir.
Similarly, if you have recently discontinued amiodarone treatment (within a few months), your doctor will ensure adequate monitoring if you start therapy with sofosbuvir.
Inform your doctor immediately if you are taking a medicine containing sofosbuvir for hepatitis C treatment and during treatment develop:

  • slow or irregular heartbeat or heart rhythm disturbances;
  • shortness of breath or worsening of pre-existing breathlessness;
  • chest pain;
  • lightheadedness;
  • palpitations;
  • feeling faint or fainting.

If you are on a waiting list for a heart transplant, your doctor may modify your treatment. This is because amiodarone use prior to heart transplantation has been associated with an increased risk of potentially fatal complications (primary graft dysfunction), in which the transplanted heart fails to function properly within the first 24 hours after surgery.
Cardiac devices
This medicine may negatively affect the function of pacemakers and similar devices (implantable cardioverter defibrillators). Therefore, if you have such a device implanted, your doctor will perform regular medical checks, both after starting treatment and after any dose adjustment of amiodarone, to ensure proper device function.
Severe blistering reactions
Severe and potentially fatal skin disorders (skin reactions) may occur due to conditions known as Stevens-Johnson syndrome and toxic epidermal necrolysis (see section “Possible side effects”), manifesting as progressive skin redness (skin rash), often accompanied by blisters and bullae, which may also affect mucous membranes. In such cases, discontinue treatment with amiodarone and contact your doctor immediately.
Protect your skin from sunlight
During treatment with this medicine, avoid exposure to sunlight or UV tanning lamps; your skin will be more sensitive to sunlight and may experience adverse effects (photosensitivity reactions). Therefore, use high-protection sunscreen, especially on the face. Sun protection is necessary for some time even after discontinuation of amiodarone.
Children
Use of this medicine in children is not recommended.
Other medicines and Amiodarone ratiopharm Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
DO NOT take amiodarone with any of the following medicines, as they may cause heart rhythm disturbances known as “Torsade de pointes”:

  • antiarrhythmic medicines (such as Class IA agents) used to treat heart rhythm disorders such as quinidine and procainamide;
  • beta-blockers used for various cardiovascular diseases such as sotalol;
  • calcium antagonists used to relieve and control angina such as bepridil;
  • non-antiarrhythmic medicines such as vincamine (a vasodilator), sultopride (an antipsychotic), cisapride (a medicine used to treat gastric reflux, i.e., backflow of stomach contents into the esophagus), erythromycin (an antibiotic) administered intravenously, and pentamidine administered parenterally;
  • medicines that may cause a specific type of heart rhythm disturbance known as QT interval prolongation;
  • monoamine oxidase inhibitors (MAOIs, used as antidepressants);
  • medicines used for depression such as lithium or tricyclic antidepressants;
  • a class of antibiotics, the fluoroquinolones;
  • antibacterial agents such as erythromycin, moxifloxacin, co-trimoxazole, or pentamidine;
  • antipsychotics such as sertindole, chlorpromazine, thioridazine, pimozide, and haloperidol;
  • antimalarials such as chloroquine.

Avoid using amiodarone together with the following medicines:

  • beta-blockers and certain calcium antagonists (used for high blood pressure or other heart conditions) such as verapamil and diltiazem, as they may cause excessive slowing of the heartbeat (bradycardia) and heart conduction disturbances;
  • stimulant laxatives (used to treat constipation), as they increase the risk of low potassium levels in the blood (hypokalemia), leading to a risk of “Torsade de pointes”;
  • sofosbuvir, used for the treatment of hepatitis C.

Exercise particular caution and inform your doctor if you are taking any of the following medicines, which may cause decreased potassium levels in the blood (hypokalemia):

  • medicines used to treat high blood pressure (diuretics such as hydrochlorothiazide and furosemide), whether taken alone or in combination;
  • medicines used to treat inflammatory diseases (systemic glucocorticoids and mineralocorticoids, tetracosactide);
  • amphotericin B when administered intravenously, a medicine used to treat fungal infections. Cardiac monitoring is necessary to prevent decreased potassium levels in the blood (hypokalemia).

Be cautious when using this medicine and inform your doctor if you are taking any of the following medicines, as specific precautions may be required:

  • medicines used to prevent blood clot formation taken orally (oral anticoagulants such as dicoumarol, warfarin, phenprocoumon, and dabigatran);
  • medicines used in cases of reduced heart function (heart failure), known as cardioactive glycosides such as digoxin;
  • phenytoin, a medicine used to treat epilepsy;
  • flecainide, a medicine used to treat heart rhythm disorders;
  • medicines metabolized by cytochrome P450 3A4 such as lidocaine (an anesthetic), tacrolimus, sirolimus (used after organ transplants to prevent rejection), sildenafil (used for erectile dysfunction), midazolam (a sedative), triazolam (used for insomnia), dihydroergotamine, ergotamine (used to treat migraines), and colchicine (used for gout);
  • medicines used to lower cholesterol levels in the blood, known as statins such as simvastatin, atorvastatin, and lovastatin;
  • cyclosporine, a medicine used in organ transplantation to prevent rejection;
  • fentanyl (a potent painkiller);
  • medicines metabolized by cytochromes CYP1A2, CYP2C9, CYP2D6, and medicines that inhibit CYP3A4 and CYP2C8;
  • medicines that are substrates of P-glycoprotein;
  • anesthetics, medicines used during surgical procedures. Your doctor will help you determine whether any of the medicines you are taking belong to the above-mentioned categories.

Amiodarone ratiopharm Italia with food and drinks
Do not drink grapefruit juice while taking this medicine, as it may increase the concentration of amiodarone in your blood, increasing the likelihood 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 this medicine during pregnancy unless your doctor considers it strictly necessary, as amiodarone may harm the fetal thyroid.
Breastfeeding
Do not take this medicine if you are breastfeeding, as amiodarone passes into breast milk.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
Amiodarone ratiopharm Italia contains lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Amiodarone ratiopharm Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Due to the high individual variability in response to amiodarone therapy, your doctor will assess and determine
the appropriate initial and maintenance doses based on your health status and the condition being treated.
The recommended doses are as follows:

Heart rhythm disorders
The recommended initial dose is 600 mg per day for 2 weeks.
Thereafter, your doctor will reduce the amiodarone dosage until reaching a maintenance dose of 100–400 mg
daily, taken 5 days per week. If your doctor cannot establish an effective daily maintenance dose compatible
with your clinical condition, intermittent therapy may be considered, involving taking this medicine for 2–3
weeks per month or 5 days per week.

Prophylactic treatment of angina pectoris
The recommended initial dose is 600 mg per day for 7 days.
The recommended maintenance dose ranges from 100 to 400 mg, taken either continuously every day or
intermittently (5 days per week or 2–3 weeks per month).
Always follow your doctor’s instructions.

Use in children
Amiodarone ratiopharm Italia must not be used to treat children.
The safety and efficacy of amiodarone in children have not been established.

The tablet may be divided into equal doses.

If you take more Amiodarone ratiopharm Italia than you should
If you take more Amiodarone ratiopharm Italia than prescribed, contact your doctor or go immediately to the
nearest emergency department.
Long-term therapy with this medicine may cause overdose effects, including disturbances in heart function
(sinus bradycardia, cardiac arrest, episodes of ventricular tachycardia resolving spontaneously, "torsades de
pointes"), circulatory failure, and liver damage.

If you forget to take Amiodarone ratiopharm Italia
Do not take a double dose to make up for the missed dose.

If you stop taking Amiodarone ratiopharm Italia
Continue taking Amiodarone ratiopharm Italia until your doctor tells you to stop. Do not stop taking Amiodarone
ratiopharm Italia just because you feel better.

If you have any questions about the use of 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.
If you experience any of the following symptoms (which may occur with unknown frequency), stop taking the tablets and contact your doctor or go immediately to the nearest hospital:

  • severe allergic reaction (anaphylactic reaction, anaphylactic shock);
  • difficulty breathing or swallowing, swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema);
  • life-threatening skin reactions characterized 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)).

Other side effects include:
Very common (may affect more than 1 in 10 people)

  • formation of microdeposits of fat in the cornea, under the pupil, accompanied by perception of colored halos in bright light or blurred vision;
  • nausea, vomiting, altered taste perception (dysgeusia);
  • increased levels of certain liver enzymes (transaminases), usually moderate (1.5 to 3 times above normal values);
  • sensitivity to sunlight manifesting as a rash accompanied by itching (photosensitivity reaction).

Common (may affect up to 1 in 10 people)

  • feeling of extreme restlessness or agitation, weight loss, increased sweating, and inability to tolerate heat. These could be signs of a condition called "hyperthyroidism", sometimes fatal;
  • feeling of tiredness, weight gain. These could be signs of a condition called "hypothyroidism";
  • tremor;
  • nightmares;
  • sleep disturbances;
  • slow heartbeat (bradycardia);
  • symptoms of pulmonary toxicity (alveolar, interstitial pneumonia or fibrosis, pleuritis, obliterative bronchiolitis with organizing pneumonia), sometimes fatal, such as non-productive cough, fatigue, difficulty breathing (dyspnea), fever, and weight loss;
  • liver disorder (acute hepatopathy), even fatal, accompanied by yellowing of the skin and/or the white part of the eye (jaundice) and increased transaminase levels in the blood; in this case, discontinuation of treatment and monitoring of liver function is recommended;
  • constipation;
  • skin discoloration appearing as slate-gray or bluish hue;
  • itching, red-colored skin rash (eczema);
  • decreased sexual desire.

Uncommon (may affect up to 1 in 100 people)

  • altered function of certain nerves (sensory-motor peripheral neuropathy), and/or structural and functional changes in muscles (myopathy);
  • changes in heart function (various degrees of atrioventricular block, sinoatrial block);
  • onset or worsening of pre-existing abnormalities in normal heart contraction (arrhythmias), sometimes followed by cardiac arrest;
  • dry mouth;
  • fatigue;
  • changes in heart function (torsades de pointes).

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

  • low hemoglobin concentration in the blood due to destruction of red blood cells (hemolytic anemia);
  • insufficient production in the bone marrow of all types of blood cells (aplastic anemia);
  • reduced number of blood cells called platelets (thrombocytopenia);
  • altered secretion of antidiuretic hormone (SIADH);
  • lack of coordination of voluntary muscle movements caused by cerebellar damage (cerebellar ataxia);
  • abnormally increased pressure within the skull (idiopathic intracranial hypertension or pseudotumor cerebri);
  • headache;
  • serious vision problems (optic neuropathy and optic neuritis);
  • changes in heart function in patients with pre-existing heart conditions and/or elderly patients (marked bradycardia or sinus arrest);
  • inflammation of blood vessels (vasculitis);
  • breathing difficulties in patients with severe respiratory insufficiency, especially in asthmatic patients (bronchospasm);
  • severe respiratory failure in adult patients generally as a consequence of surgery (acute respiratory distress syndrome);
  • chronic changes in liver function (pseudo-alcoholic hepatitis, cirrhosis), sometimes fatal;
  • skin irritation (erythema) during radiotherapy;
  • skin eruptions (cutaneous rash);
  • redness, skin peeling, and itching are symptoms of conditions such as exfoliative dermatitis;
  • hair loss (alopecia);
  • inflammation of a part of the male genital tract called the epididymis (epididymitis);
  • inability to achieve or maintain an erection (impotence);
  • increased blood levels of creatinine.

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

  • granulomas (nodules) in the bone marrow;
  • you may get more infections than usual. This could be caused by a reduced number of white blood cells (neutropenia), or a severe reduction in white blood cells making infections more likely (agranulocytosis);
  • reduced appetite;
  • altered sensation in limbs (paresthesia);
  • 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);
  • sudden inflammation of the pancreas (acute pancreatitis);
  • formation of granulomas in the liver (granulomatous disease);
  • lung hemorrhage;
  • urticaria;
  • potentially life-threatening complication after heart transplantation (primary graft dysfunction), in which the transplanted heart fails to function properly (see section 2, "Warnings and precautions").
  • lupus-like syndrome, a disease in which the immune system attacks various parts of the body, leading to joint pain, stiffness, swelling, and skin redness, sometimes in a butterfly-shaped rash on the face.

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 ratiopharm Italia

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect the medicine from light and moisture.
Do not use this medicine after the expiry date stated on the carton after "Exp.".
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Amiodarone ratiopharm Italia contains

  • The active substance is amiodarone. One tablet contains 200 mg of amiodarone hydrochloride.
  • The other components are: monohydrate lactose, maize starch, povidone K 90, anhydrous colloidal silica, magnesium stearate, pregelatinized starch.

Description of the appearance of Amiodarone ratiopharm Italia and package contents
Amiodarone ratiopharm Italia 200 mg tablets are available in blisters of 10 tablets. The package contains two blisters.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva B.V. - Swensweg 5 - 2031 GA Haarlem - The Netherlands
Manufacturer
Merckle GmbH - Ludwig-Merckle Strasse, 3 D-89143 Blaubeuren - Germany