Amiodarone

Package leaflet: Information for the patient

Amiodarone Sandoz 200 mg tablets

Equivalent 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 other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Amiodarone is an antiarrhythmic medicine, capable of correcting certain specific disturbances
in your heart rhythm, that is, irregularities in heartbeat such as missed beats, irregular heartbeat, or heartbeat at the wrong rate.
Amiodarone Sandoz may be used in the treatment of:

• heart conditions characterized by a fast or accelerated heart rate, when other medicines have not worked
• other types of irregular heartbeat, known as "atrial flutter" or "atrial fibrillation", when other medicines have not worked
• a condition called Wolff-Parkinson-White syndrome, in which the heartbeat is very rapid
• heart conditions characterized by a fast or accelerated heart rate that may occur suddenly and be irregular
• prevention of chest pain caused by heart problems (angina pectoris)

2. What you should know before taking Amiodarone Sandoz

Do not take Amiodarone Sandoz
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 (sinus bradycardia)
if you have sinoatrial block (characterized by delayed formation of heartbeats)
if you suffer from any other heart rhythm disorders and do not have a pacemaker
(electrostimulator) implanted
if you are taking certain medicines that may cause a serious heart arrhythmia
(torsades de pointes) (see "Other medicines and Amiodarone Sandoz")
if you have or have had thyroid problems. Your doctor may perform a thyroid examination
before prescribing this medicine
if you are pregnant (except when, in the doctor’s judgment, the benefit outweighs the risk)
if you are breastfeeding

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

• if you have severe heart problems (cardiomyopathies, severe coronary artery disease, severe bradycardia)
• if you have liver problems. Your doctor will closely monitor your liver function, both at the beginning of treatment and during therapy. If severe liver function abnormalities occur, your doctor will stop administering the medicine and initiate appropriate treatment
• if you have lung problems or suffer from asthma and during treatment develop productive cough (with phlegm), difficulty breathing, fever, or weight loss
• if you have vision problems (including optic neuritis, inflammation of the optic nerve). In this case, your doctor will stop administration of the medicine
• if you are elderly
• if you have an implanted pacemaker or implantable cardioverter defibrillator (ICD). Your doctor will check that the device is functioning properly shortly after you start taking Amiodarone Sandoz or if the dose has been changed
• if you are scheduled for surgery or general anesthesia
• if you have or have had thyroid problems
• if you have muscle problems
• if 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 heart rate. Your doctor may consider alternative treatments. If treatment with amiodarone and sofosbuvir cannot be avoided, additional cardiac monitoring may be required

Amiodarone Sandoz will only be administered after your doctor has carefully evaluated your
health condition. Your doctor will closely monitor you during treatment.
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 problems
• shortness of breath or worsening of existing breathlessness
• chest pain
• lightheadedness (dizziness)
• palpitations
• near-fainting or fainting

Before starting treatment with Amiodarone Sandoz, 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 blood tests for liver function (transaminases) and ECGs.
Since the likelihood of adverse effects (see “Possible side effects”) increases with higher
doses (dose-dependent), your doctor will prescribe the lowest effective dose to control your
heart rate. If your heart rhythm disturbances worsen or new disturbances appear, your doctor
will determine whether this is due to loss of effectiveness 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.
This is because taking amiodarone before 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.
During treatment with Amiodarone Sandoz, or even long after stopping treatment, you may
develop increased thyroid function with symptoms such as weight loss, changes in heart
rhythm, and chest pain. Your doctor will closely monitor you and, if necessary, stop the
medicine.
Amiodarone Sandoz may cause serious muscle problems (sensory-motor peripheral
neuropathy and myopathy). In such cases, your doctor will stop administration of the
medicine.
Skin disorders (skin reactions) may occur, including very severe and life-threatening
conditions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (see: Possible
side effects), which present as 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 Sandoz may cause lung problems. For example, it may cause a type of lung
inflammation called interstitial pneumonia. If you develop breathing difficulties, alone or
associated with worsening general condition (dry cough, difficulty breathing, weight loss,
fever), your doctor will perform a chest X-ray and, if necessary, reduce the dose or stop the
medicine.
Protect your skin from sunlight. During treatment with Amiodarone Sandoz and for several
months after stopping treatment, avoid direct sunlight and tanning lamps. Your skin will be
more sensitive to sunlight and may suffer severe burns if you do not take the following
precautions:
always wear a hat and clothing covering arms and legs
always use sunscreen with high protection factor

Amiodarone Sandoz may increase the effect of the following medicines:
Cyclosporine, tacrolimus, and sirolimus – used to help prevent transplant rejection

Children and adolescents
The use of Amiodarone Sandoz is not recommended in children.

Other medicines and Amiodarone Sandoz
Tell your doctor if you are taking, have recently taken, or might take any other medicine.
The following medicines may cause an irregular heart rhythm, shown by an abnormal
electrocardiogram, and must not be used together with Amiodarone Sandoz due to an
increased risk of heart rhythm disturbances or missed heartbeats (torsades de pointes):
any other antiarrhythmic medicine to control heart rhythm, including quinidine,
disopyramide, procainamide, sotalol, or bepridil
vincamine (a medicine for cerebral decline)
neuroleptics (antipsychotics) such as sultopride
cisapride (a medicine used to treat gastric reflux)
pentamidine (for treatment of certain types of pneumonia) when given parenterally
erythromycin (for treatment of infections) when given intravenously
antibiotics called fluoroquinolones (for treatment of infections)
monoamine oxidase inhibitors (MAOIs), used to treat depression
sofosbuvir, a medicine used in combination with other medicines to treat chronic hepatitis C

Tell your doctor before taking any of the following medicines in combination with
Amiodarone Sandoz:
beta-blockers and calcium antagonists that reduce heart rate (verapamil, diltiazem)
laxatives (which increase intestinal motility), diuretics (to increase urine production)
amphotericin B (when administered directly into a vein) used to treat fungal infections
phenytoin for the treatment of epilepsy
medicines to treat inflammation (corticosteroids) such as hydrocortisone, betamethasone,
or prednisolone
tetracosactide, used to investigate certain hormonal problems
dabigatran and warfarin, used to thin the blood
flecainide, another medicine used for irregular heartbeat
digoxin, used to treat heart problems
cholesterol-lowering medicines, e.g. simvastatin, atorvastatin, and lovastatin; their
combination increases the risk of muscle problems (e.g. rhabdomyolysis)
cyclosporine, sirolimus, and tacrolimus, used to prevent rejection after transplantation
fentanyl, ergotamine, and dihydroergotamine, used as painkillers
lidocaine, used as an anesthetic
medicines used for erectile dysfunction, such as sildenafil
midazolam, used to treat anxiety or help you relax
colchicine, used to treat gout
triazolam, used for sleep disorders
general anesthesia and high doses of oxygen during surgical procedures
sofosbuvir, a medicine used in combination with other medicines to treat chronic hepatitis C

If you have any doubts, consult your doctor or pharmacist before taking Amiodarone Sandoz.

Amiodarone Sandoz with food and drink
Do not eat grapefruit or drink grapefruit juice during treatment with Amiodarone
Sandoz, as it may increase the risk of side effects.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor for advice before taking this medicine.

Pregnancy
Do not take Amiodarone Sandoz if you are pregnant, unless your doctor considers it necessary,
as it may cause harm to the unborn baby.

Breastfeeding
Do not take Amiodarone Sandoz if you are breastfeeding. Amiodarone Sandoz passes into
breast milk in significant amounts and may harm your baby.

Driving and using machines
Amiodarone Sandoz does not impair the ability to drive or use machines.

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

3. How to take Amiodarone Sandoz

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the most appropriate route of administration, initial dose, and maintenance dose for you.
If you think the effect of the medicine is too weak or too strong, do not change the dose on your own; consult your doctor instead.

The recommended dose is:

Treatment of rhythm disorders:
The initial dose is 1 tablet three times a day (600 mg) until an adequate therapeutic response is achieved, usually within two weeks.
Subsequently, your doctor will gradually reduce the dose until establishing the maintenance dose, typically between 100–400 mg per day.
In some cases, your doctor may prescribe an intermittent treatment regimen (e.g., taking Amiodarone Sandoz for 2 or 3 weeks per month or 5 days per week). This will depend on your response to the medicine.

Preventive treatment of angina pectoris attacks (chest pain):
Loading dose: 1 tablet three times a day (600 mg) for approximately 7 days.
Maintenance dose: 100–400 mg per day or intermittent therapy, as prescribed by the doctor (5 days per week or 2–3 weeks per month).

Use in children and adolescents
The safety and efficacy of Amiodarone Sandoz in children and adolescents have not been established.
Therefore, the use of Amiodarone Sandoz in children and adolescents is not recommended.

Elderly patients
Your doctor may prescribe a lower dose of Amiodarone Sandoz. Additionally, your doctor will frequently monitor your blood pressure and thyroid function.

If you take more Amiodarone Sandoz than you should
Contact your doctor immediately or go to the nearest hospital. Take the packaging with you so the doctor can see what you have taken.
There are no available data regarding overdose with Amiodarone Sandoz. In case of overdose, possible effects may include sinus bradycardia (slow heart rate), cardiac arrest, ventricular tachycardia (faster than normal heart rate), torsades de pointes (a serious heart arrhythmia), circulatory failure, and liver damage.

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

If you stop taking Amiodarone Sandoz
If you have any questions about using this medicine, consult your doctor.
Take Amiodarone Sandoz for the entire duration prescribed by your doctor. Do not stop taking the medicine even if you feel better.

Examinations
Your doctor will regularly perform tests to monitor your liver function.
Amiodarone Sandoz may affect liver function, and if this occurs, your doctor will decide whether treatment should be discontinued.
During treatment, your doctor will regularly perform thyroid function tests because Amiodarone Sandoz contains iodine, which may cause thyroid problems. Furthermore, before and during treatment with Amiodarone Sandoz, your doctor may also regularly perform other tests such as blood tests, chest X-ray, ECG (electrocardiogram), and vision check-ups.

If you have any doubts, consult your doctor or pharmacist.

4. Possible side effects

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

Stop taking Amiodarone Sandoz immediately and contact a doctor or go to hospital if you experience an allergic reaction. Signs may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.

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

• Microdeposits in the cornea, usually limited to the area below the pupil, possibly causing coloured halos around lights or blurred vision
• Photosensitivity (skin problems after exposure to sunlight or sunbeds)
• Nausea, vomiting, altered taste (dysgeusia), which generally occur with the initial recommended dose and resolve with dose reduction
• Isolated increase in serum transaminases (specific blood tests for monitoring liver function). Test results return to normal with dose reduction or spontaneously, i.e. without specific intervention

Common (may affect up to 1 in 10 people)

• Skin discolouration appearing grey or bluish, especially with prolonged treatment and high daily doses; such discolouration slowly fades after stopping treatment
• Slow heart rate (bradycardia), generally moderate and dose-dependent
• Thyroid disorders (hypothyroidism and hyperthyroidism, sometimes fatal)
• Acute liver disease (hepatopathy) with elevated serum transaminases and/or jaundice, including liver failure, sometimes fatal
• Lung problems (alveolar/interstitial pneumonitis or fibrosis)
• Inflammation of the pleura (pleuritis), inflammation of the bronchioles (obliterative bronchiolitis with organised pneumonia), sometimes fatal
• Rhythmic, slow tremor (extrapyramidal tremor)
• Nightmares
• Sleep disturbances
• Constipation (stipsis)
• Itching, red skin rash (eczema)
• Decreased sexual desire

Uncommon (may affect up to 1 in 100 people)

• Severe disturbances in the heart's electrical activity (conduction blocks along the electrical impulse pathways)
• Onset or worsening of heart rhythm disorders (arrhythmia), sometimes followed by cardiac arrest
• Reduced movement or sensation (peripheral sensorimotor neuropathy) and/or muscle tissue disease (myopathy), generally reversible upon discontinuation of the medicine
• Dry mouth

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

• Destruction of red blood cells (haemolytic anaemia)
• Inadequate production of blood cells by the bone marrow (aplastic anaemia)
• Reduced platelet count (thrombocytopenia)
• Very slow heart rate (marked bradycardia)
• Degenerative disease of the optic nerve (neuropathy)
• Optic neuritis, which may progress to blindness
• Skin redness (erythema) during radiotherapy
• Generally non-specific skin rashes
• Skin inflammation with peeling (exfoliative dermatitis)
• Hair loss (alopecia)
• Excessive secretion of antidiuretic hormone (syndrome of inappropriate antidiuretic hormone secretion (SIADH))
• Chronic liver diseases (hepatopathies) (pseudo-alcoholic hepatitis, cirrhosis), sometimes fatal
• Increased creatinine in the blood
• Contraction of airway muscles (bronchospasm) in patients with severe respiratory insufficiency, especially in asthmatic patients
• Impaired respiratory mechanics (adult acute respiratory distress syndrome), sometimes fatal, usually immediately after surgery (possible interaction with high oxygen concentration)
• Cerebellar damage (cerebellar ataxia)
• Increased pressure inside the skull (benign intracranial hypertension)
• Headache (cephalalgia)
• Inflammation of the testicles (epididymitis), impotence
• Inflammation of blood vessels (vasculitis)

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

• Formation of nodules due to inflammation (granuloma) of the bone marrow
• Severe cardiac arrhythmia (torsades de pointes)
• Severe allergic reaction (anaphylactic reaction/anaphylactic shock)
• Red, itchy skin patches (urticaria)
• Formation of nodules in the liver due to inflammation (hepatic granuloma)
• Pulmonary haemorrhage
• Angioedema (Quincke's oedema) (localized swelling in subcutaneous tissues and mucosa)
• Severe allergic reaction (anaphylactic reaction, anaphylactic shock)
• Sudden inflammation of the pancreas (acute pancreatitis)
• Decreased appetite
• Unusual muscle movements, stiffness, agitation and restlessness (Parkinsonism)
• Altered sense of smell (parosmia)
• Confusion (delirium), hallucinations
• 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))
• Lupus-like syndrome, a disease in which the immune system attacks various parts of the body, causing pain, stiffness and swelling of the joints and skin redness, sometimes in a butterfly-shaped pattern on the face
• Seeing, hearing or sensing things that are not there (hallucinations)
• You may get more infections than usual. This could be caused by a decrease in white blood cells (neutropenia)
• Severe reduction in white blood cell count, increasing the likelihood of infections (agranulocytosis)
• Potentially life-threatening complication after heart transplantation (primary graft dysfunction), in which the transplanted heart fails to function properly (see section “Warnings and precautions”). Cases of pulmonary haemorrhage have been reported in patients taking Amiodarone Sandoz. If you cough up blood, contact your doctor immediately.

Reporting of side effects
If you experience any side effects, 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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. 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 Sandoz contains

• The active substance is: amiodarone (as hydrochloride). Each tablet contains 200 mg of amiodarone.
• The other components are: maize starch, microcrystalline cellulose, lactose, magnesium stearate.

Description of the appearance of Amiodarone Sandoz and the contents of the pack
Carton pack containing a 20-tablet blister pack of 200 mg tablets.
Marketing Authorization Holder
Sandoz S.p.A.
Largo U. Boccioni, 1
21040 Origgio (VA)
Italy
Manufacturers
Ebewe Pharma Ges.M.B.H Nfg KG
Mondseestrasse, 11
A-4866 Unterach
Austria
Salutas Pharma GmbH
Otto-von-Guericke-Allee, 1
39179 Barleben
Germany
Lek Pharmaceuticals d.d.
Verovškova, 57
1526 Ljubljana
Slovenia