Amiodarone EG

Italy
Brand name Amiodarone EG
Form tablets
Active substance / Dosage
AMIODARONE HYDROCHLORIDE
Prescription type Prescription only
ATC code
C01BD01
Registration number 047255
Manufacturer EG S.P.A.
Amiodarone EG tablets

Table of Contents

Package leaflet: Information for the user

AMIODARONE EG 200 mg tablets

Generic medicine
Please read 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, because 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 EG is and what it is used for
  2. What you need to know before taking Amiodarone EG
  3. How to take Amiodarone EG
  4. Possible side effects
  5. How to store Amiodarone EG
  6. Contents of the pack and other information

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

Amiodarone EG contains the active substance amiodarone hydrochloride, which belongs to a class of
medicines called “class III antiarrhythmics”.
It works by controlling irregular heartbeat (called “arrhythmia”). Taking the tablets may
help restore normal heart rhythm.
Amiodarone is indicated for

  • Treating irregular heartbeat when other medicines have not worked or cannot be used.
  • Treating a condition in which the heart beats unusually fast (Wolff-Parkinson-White syndrome) when other medicines have not worked or cannot be used. Treating other types of fast or irregular heartbeat known as “atrial flutter” or “atrial fibrillation”. Amiodarone EG is used only when other medicines cannot be used.
  • Treating rapid heartbeat that may occur suddenly and may also be irregular. Amiodarone EG is used only when other medicines cannot be used.

2. What you need to know before taking Amiodarone EG

Do not take Amiodarone EG

  • if you are allergic to iodine, amiodarone, or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue;
  • if you have a slower than normal heart rate (called "sinus bradycardia") or a condition called "sinoatrial block", characterized by delayed formation of heartbeats, or pre-existing QT interval prolongation;
  • if you have severe disorders in the conduction of heartbeats (severe atrioventricular blocks, bi- or trifascicular blocks) and do not have a pacemaker;
  • if you have low levels of potassium in your blood (hypokalaemia);
  • if you suffer or have suffered from sinoatrial node disease, characterized by reduced heart rate, and you do not have a pacemaker, as taking amiodarone in this case increases the risk of cardiac arrest;
  • if you have or have had thyroid disorders (dysfunctions). In doubtful cases (uncertain previous disorders, family history of thyroid problems), your doctor will perform a thyroid function test before starting treatment with this medicine;
  • if you are taking monoamine oxidase inhibitors (MAOIs) or other medicines that may increase the risk of heart rhythm abnormalities (torsades de pointes) (see "Other medicines and Amiodarone EG");
  • if you are pregnant, except in exceptional cases where your doctor prescribes the medicine (see "Pregnancy and breastfeeding");
  • if you are breastfeeding or feeding your baby with breast milk (see "Pregnancy and breastfeeding").

Do not take this medicine if any of the above apply to you. If you have any doubts, consult your doctor or pharmacist before taking Amiodarone EG.
Warnings and precautions
Talk to your doctor or pharmacist before taking AMIODARONE EG

  • if you have severe heart problems (cardiomyopathies and severe coronary artery disease) and during treatment develop productive cough (with phlegm), difficulty breathing, fever, weight loss;
  • if you have liver problems; your doctor will closely monitor your liver function, both at the beginning of therapy and during treatment. In case of severe liver function abnormalities, your doctor will discontinue the medicine and initiate appropriate treatment;
  • if you have lung problems or asthma;
  • if you have vision problems, especially reduced blood supply and inflammation of the optic nerve (optic neuropathy and optic neuritis). In this case, your doctor will discontinue the medicine;
  • if you have muscle problems;
  • if you have thyroid problems;
  • if you are scheduled for surgery under general anaesthesia;
  • if you are elderly (over 65 years of age). Your doctor will need to monitor you more closely;
  • if you have a "pacemaker" or an "implantable cardioverter defibrillator". In these cases, your doctor will check that the device is functioning correctly before and during treatment or when the amiodarone dose is changed;
  • if you are currently taking a medicine containing sofosbuvir and/or daclatasvir, sofosbuvir/ledipasvir, with or without other drugs that reduce heart rate for the treatment of hepatitis C, as this may cause life-threatening slowing of the heartbeat. Your doctor may consider alternative treatments. If treatment with amiodarone and sofosbuvir and/or daclatasvir, sofosbuvir/ledipasvir, with or without other heart rate-lowering drugs, is necessary, you may require additional cardiac monitoring;
  • if during treatment with Amiodarone EG you are taking statins to reduce cholesterol levels in the blood, your doctor will prescribe a statin suitable for use with amiodarone (see also "Other medicines and Amiodarone EG");
  • if you are taking other medicines (see "Other medicines and Amiodarone EG").

Contact your doctor immediately if:

  • you are taking a medicine containing sofosbuvir for the treatment of hepatitis C, and during treatment you experience:
  • slow or irregular heartbeat, or heart rhythm disturbances;
  • shortness of breath or worsening of existing shortness of breath;
  • chest pain;
  • dizziness;
  • palpitations;
  • near-fainting or fainting.

Use of amiodarone may cause skin disorders (cutaneous reactions), even very severe and fatal ones, due to diseases known as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (see "Possible side effects"), which manifest with flu-like symptoms followed by progressive skin redness (skin rash), often accompanied by blisters, bullae, and which may also affect mucous membranes. In such cases, stop treatment with amiodarone and contact your doctor immediately.
Amiodarone EG 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 EG, your doctor will perform an electrocardiogram (ECG), a test that allows analysis of heart activity, and will check your blood potassium levels.
During treatment with this medicine, you will undergo electrocardiograms and certain blood tests to assess liver function (transaminases).
Since the likelihood of side effects (see "Possible side effects") increases with higher doses of the medicine (dose-dependent), your doctor will administer the lowest effective dose for controlling your heart rate. If your heart rhythm disturbances worsen or new ones appear, your doctor will determine whether this is due to loss of efficacy of the medicine or worsening of the underlying disease.
If you are on a waiting list for a heart transplant, your doctor may modify your treatment, as taking amiodarone before a heart transplant has been associated with an increased risk of potentially life-threatening complications (primary graft dysfunction), in which the transplanted heart stops functioning properly within the first 24 hours after surgery.
During treatment with Amiodarone EG or even long after stopping treatment, you may develop increased thyroid function with symptoms such as weight loss, heart rhythm disturbances, and chest pain. Your doctor will perform close monitoring and, if necessary, discontinue the medicine.
Amiodarone EG may cause serious nerve and muscle problems (peripheral sensory-motor neuropathy and myopathy). In such cases, your doctor will discontinue the medicine.
If during treatment with Amiodarone EG you develop dry cough, fever, difficulty breathing associated with severe general malaise, your doctor will perform a chest X-ray and other tests to assess your lung function. This is because pulmonary toxicity may occur during treatment with Amiodarone EG, 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 (use a high-protection-factor sunscreen, wear a hat, and wear clothing covering arms and legs) during treatment with this medicine (see "Possible side effects").
Children
The use of Amiodarone EG is not recommended in children.
Other medicines and Amiodarone EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes over-the-counter medicines, including herbal remedies.
This is because they may affect how some other medicines work. In addition, some medicines may affect how amiodarone works.
The combination of Amiodarone EG with the following medicines is contraindicated:

  • medicines that may cause a specific type of heart rhythm disorder (torsades de pointes), such as medicines used to prevent and control heart rhythm disturbances
    (antiarrhythmics of Class IA, e.g.: quinidine, procainamide, disopyramide; antiarrhythmics of Class II, e.g: sotalol, bepridil, bretylium), non-antiarrhythmic medicines such as vincamine, medicines for treating certain mental illnesses (such as sultopride, lithium, doxepine, maprotiline or amitriptyline),
    cisapride (a medicine used for treating gastric reflux, i.e. backflow of stomach contents into the oesophagus), erythromycin and co-trimoxazole for intravenous use (antibiotics);
    intravenous pentamidine (used for certain types of pneumonia);

  • moxifloxacin (an antibiotic belonging to the fluoroquinolone class);

  • medicines for treating depression (MAO inhibitors);

  • medicines for schizophrenia (such as chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpride or sertindole);

  • antimalarial medicines (such as quinine, mefloquine, chloroquine or halofantrine);

  • medicines used for hay fever, skin rashes or other allergies called antihistamines (such as terfenadine, astemizole or mizolastine). Heart activity checks are necessary to prevent low potassium levels in the blood (hypokalaemia) (see section 2 "Do not take Amiodarone EG").

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

  • medicines that slow the heartbeat (beta-blockers and calcium channel blockers) such as propranolol, verapamil and diltiazem;
  • medicines that may cause reduced potassium levels in the blood (hypokalaemia), such as medicines that increase intestinal motility and evacuation (stimulant laxatives such as bisacodyl or senna);
  • sofosbuvir, a medicine used in combination with other medicines for the treatment of chronic hepatitis C, sofosbuvir and/or daclatasvir, sofosbuvir/ledipasvir;
  • certain antibiotics belonging to the fluoroquinolone class (including ciprofloxacin, ofloxacin or levofloxacin).

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

  • medicines that may cause a specific type of heart rhythm alteration known as QT prolongation, including certain medicines for treating infections (such as clarithromycin);
  • medicines that promote urine production (diuretics), alone or in combination;
  • medicines for controlling inflammation and allergies (systemic glucocorticoids and mineralocorticoids such as hydrocortisone, betamethasone or prednisolone);
  • tetracosactide, used to study certain hormonal problems;
  • intravenous amphotericin B, used to treat fungal infections.

The effects of Amiodarone EG may be influenced by or may influence the following

  • medicines: general anaesthesia and high doses of oxygen during surgical procedures;
  • digoxin, used to increase the force of heart contraction;
  • phenytoin, a medicine for treating epilepsy;
  • statins, used to reduce cholesterol levels in the blood, such as simvastatin, atorvastatin and lovastatin, whose combination increases the risk of muscle disorders (e.g.: rhabdomyolysis). Your doctor will prescribe a statin suitable for use with amiodarone;
  • cyclosporine, tacrolimus and sirolimus – used to suppress the immune system and help prevent transplant rejection;
  • medicines used for erectile dysfunction, such as sildenafil, tadalafil or vardenafil;
  • fentanyl – used for pain relief;
  • dihydroergotamine and ergotamine – used to treat certain types of headache (migraine);
  • midazolam and triazolam – used to treat anxiety or to help you relax before surgery;
  • colchicine – used to treat joint inflammation causing pain and swelling (gout);
  • flecainide – another medicine used for irregular heartbeat. Your doctor must monitor treatment and may halve the flecainide dose;
  • lidocaine – used as an anaesthetic;
  • coumarin – used to prevent blood from clotting;
  • dabigatran and warfarin, anticoagulants used to make blood less prone to clotting.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking
Amiodarone EG.
Amiodarone EG with food, drinks and alcohol
Do not drink grapefruit juice while taking this medicine, as it may increase the likelihood of side effects.
You should limit your alcohol intake during treatment with this medicine. This is because drinking alcohol while taking this medicine increases the risk of liver problems. Talk to your doctor or pharmacist about how much alcohol you can drink.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Amiodarone EG during pregnancy unless your doctor considers it necessary, as it may harm the unborn child.
Breastfeeding
Do not take Amiodarone EG if you are breastfeeding. Amiodarone EG passes into breast milk and may harm your baby.
Driving and using machines
After taking this medicine, you may experience blurred vision. If this occurs, do not drive or operate machinery.
Amiodarone EG contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Amiodarone EG

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. This will help you achieve the best results and reduce the risk of
unwanted side effects.
Your doctor will determine the route of administration, initial dose, and maintenance dose based on the severity
of your condition and your response to treatment.
Recommended doses are:
Initial dose
The initial dose is 600 mg (3 tablets) to be divided into three daily doses for at least two
weeks.
Maintenance dose
Once the desired effect has been achieved, your doctor will reduce the dose and establish a
maintenance dose of 100–400 mg per day (½ to 2 tablets) or may establish an intermittent treatment regimen
(for example, taking Amiodarone EG for 2 or 3 weeks per month or for 5 days per week).
Amiodarone 200 mg tablets should be taken during or immediately after a meal with water (e.g. a glass).
Use in children
The use of Amiodarone is not recommended in children.
The tablet may be divided into two equal doses.
If you take more Amiodarone EG than you should
If you take more Amiodarone EG than you should, contact your doctor or go immediately to the nearest
emergency department. Take the medicine package with you so that the doctor knows what you have taken.
There are no available data regarding overdose with Amiodarone EG. 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 problems (circulatory failure), liver damage (hepatic damage), dizziness, weakness or fatigue, confusion, and malaise.
If you forget to take Amiodarone EG
If you forget a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Amiodarone EG
Continue taking Amiodarone EG until your doctor tells you to stop. Do not stop taking Amiodarone EG just because you feel better. If you stop taking this medicine, heart rhythm irregularities may return. This could be dangerous.
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 everybody gets them.
Amiodarone EG can remain in the blood for up to one month after stopping treatment. During this period, side effects may still occur.

Stop taking Amiodarone EG and contact your doctor or go to hospital immediately if:

  • you have an allergic reaction. Signs may include: a rash, difficulty swallowing or breathing, swelling of the eyelids, face, lips, throat or tongue.

Common side effects (may affect up to 1 in 10 people)

  • Yellowing of the skin or eyes (jaundice), feeling tired or unwell, loss of appetite, stomach ache or high temperature. These may be signs of liver problems or liver damage, which can be very dangerous.
  • Difficulty breathing or tightness in the chest, persistent cough, shortness of breath, weight loss and fever. These symptoms may be due to inflammation of the lungs, which can be very dangerous.
  • Red, itchy skin rash (eczema).

Uncommon side effects (may affect up to 1 in 100 people)

  • Increasingly irregular and unstable heartbeat, up to cardiac arrest.
  • Dry mouth.

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

  • Loss of vision in one eye or blurred vision with loss of colour perception. You may experience eye pain and feel pain when moving your eyes. This could be a condition called “optic neuropathy” or “neuritis”.
  • Heartbeat becomes very slow or stops. If this happens, go to hospital immediately.
  • Inflammation of the lungs which can become very dangerous.

Frequency not known (frequency cannot be estimated from the available data)
Severe allergic reaction (anaphylactic reaction, anaphylactic shock); sudden inflammation of the pancreas (acute pancreatitis); reduced appetite; unusual muscle movements, stiffness, tremor and restlessness (parkinsonism); abnormal sense of smell (parosmia); confusion (delirium); 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)), acute bleeding from the lungs, swelling of the face, hands and feet, lips, tongue or throat (Quincke's oedema), lupus-like syndrome (a disease in which the immune system attacks various parts of the body, leading to joint pain, stiffness and swelling, and skin redness, sometimes in a butterfly-shaped pattern on the face), potentially fatal complication after heart transplant (primary graft dysfunction) in which the transplanted heart stops functioning properly (see section 2, Warnings and precautions).

Stop taking Amiodarone EG and go to the doctor immediately if you notice any of the following side effects – you may need urgent medical treatment:
Uncommon side effects (may affect up to 1 in 100 people)

  • Numbness or weakness in hands and feet, tingling or burning sensation anywhere in the body, reduced ability to feel pain (peripheral sensory-motor neuropathy).

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

  • Skin rash caused by narrowing or blockage of blood vessels (vasculitis).
  • Headache (usually worse in the morning or occurring after coughing or straining), feeling unwell (nausea), seizures, fainting, vision problems or confusion. These could be signs of brain problems (benign intracranial hypertension).
  • Unsteady or staggering gait (cerebellar ataxia), slow and slurred speech.
  • Feeling faint, dizzy, unusually tired and short of breath due to a slow or irregular heartbeat (particularly in people over 65 years of age). Cases of bleeding in the lungs have been reported in patients taking Amiodarone EG. You must inform your doctor immediately if you cough up blood.

Frequency not known (frequency cannot be estimated from the available data)

  • Chest pain, shortness of breath and irregular heartbeat. These could be signs of an arrhythmia called “Torsade de pointes”.

Tell your doctor as soon as possible if you experience any of the following side effects:
Very common side effects (may affect more than 1 in 10 people)

  • Blurred vision or seeing coloured halos in bright light.

Common side effects (may affect up to 1 in 10 people)

  • Feeling extremely restless or agitated, weight loss, increased sweating and inability to tolerate heat. These could be signs of a condition called “hyper-thyroidism”.
  • Feeling extremely tired, weak or debilitated, weight gain, inability to tolerate cold, constipation and muscle pain. These could be signs of a condition called “hypo-thyroidism”.
  • Tremor in arms or legs.
  • Bluish or greyish discolouration on sun-exposed areas of skin, especially on the face.

Uncommon side effects (may affect up to 1 in 100 people)

  • Muscle cramps, stiffness or spasms (myopathy).

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

  • Swelling of the testicles (epididymo-orchitis).
  • Presence of red, scaly patches on the skin (exfoliative dermatitis), hair loss (alopecia) or weakened nails.
  • Feeling tired, fainting, dizziness or pale skin. Signs of anaemia due to breakdown of red blood cells (haemolytic) or reduced production of red blood cells (aplastic).
  • Bruising and bleeding due to low platelet count in the blood.
  • Feeling unwell, confused or weak, nausea, loss of appetite, irritability due to a condition called “syndrome of inappropriate antidiuretic hormone secretion” (SIADH).

Frequency not known (frequency cannot be estimated from the available data)

  • Recurrent infections due to a decrease in white blood cell count (neutropenia).
  • Severe reduction in white blood cell count, increasing the risk of infections (agranulocytosis).
  • Muscle weakness.
  • Transient decrease in kidney function.

Tell your doctor or pharmacist if any of the following side effects worsen or last longer than a few days:
Very common side effects (may affect more than 1 in 10 people)

  • Feeling unwell with nausea and/or vomiting.
  • Change in taste (dysgeusia).
  • Changes in liver enzyme levels (transaminases) at the start of treatment, detectable by blood tests.
  • Increased sensitivity to sunlight with a tendency to sunburn more easily (see “Protect your skin from the sun” in section 2).

Common side effects (may affect up to 1 in 10 people)

  • Slightly slowed heartbeat (bradycardia).
  • Sleep disturbances, nightmares.
  • Decreased sexual desire.

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

  • Headache.
  • Balance problems, dizziness (vertigo).
  • Difficulty achieving or maintaining an erection or ejaculating (impotence).
  • Skin redness during radiotherapy.
  • Increased creatinine in the blood, shown by blood tests. This may be a sign of impaired kidney function.

Frequency not known (frequency cannot be estimated from the available data)

  • Hives (itchy rash with raised lumps).
  • Red granulomas (small nodules) on the skin or granulomas in the liver and bone marrow inside the body, visible on X-ray or ultrasound.
  • Dry mouth.
  • Reduced appetite.
  • Disturbance of smell (parosmia).
  • Confusional state (delirium).
  • Bullous dermatitis.
  • Hallucinations (seeing, hearing or sensing things that are not there).
  • Abdominal pain.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://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 EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister after EXP. The expiry date refers to the last day of that month.
Store below 30°C.
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 EG contains

  • The active substance is amiodarone hydrochloride. Each tablet contains 200 mg of amiodarone hydrochloride.
  • The other components are: monohydrate lactose, anhydrous colloidal silicon dioxide, sodium carboxymethyl starch (type A), povidone (K-30) and magnesium stearate.

Description of the appearance of Amiodarone EG and contents of the pack
Tablets.
White to off-white, round, biconvex, uncoated tablets, marked with ‘8’ and ‘4’ separated by a score line on one side and ‘A’ on the other side.
Amiodarone EG tablets are available in blister packs made of opaque white PVC – aluminium foil.
Pack sizes:
Blister packs: 10, 20, 30 and 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia 6, 20136 Milano, Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta