AMIODARONE 200 mg Tablet

Зміст інструкції

1. Amiodarone Mylan 200 mg tablets
   1. What is Amiodarone and what is it used for
   2. What you need to know before taking Amiodarone
   3. How to take Amiodarone
   4. Possible side effects
   5. How to store Amiodarone
   6. Contents of the pack and other information

Amiodarone Mylan 200 mg tablets

amiodarone hydrochloride

Generic Medicine
Read this 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section
• 4.

The name of this medicine is Amiodarone Mylan 200 mg tablets; however for
simplicity it will be called Amiodarone throughout this leaflet.

Contents of this leaflet:

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

1. What is Amiodarone and what is it used for

These tablets contain amiodarone hydrochloride, which belongs to a class of
medicines known as antiarrhythmics. Amiodarone can help to inhibit and prevent an
abnormal or irregular heart rhythm and to restore the heart rhythm to
normal.
Amiodarone can be used:

• to treat irregular heartbeat when other medicines have not worked or cannot be used
• to treat a condition called Wolff-Parkinson-White syndrome, in which the heart beats unusually fast
• to treat other types of fast or irregular heartbeats known as “atrial flutter” or “atrial fibrillation”. Amiodarone is used only when other medicines cannot be used
• to treat heart conditions characterized by a rapid or accelerated heart rhythm, which can occur suddenly and be irregular. Amiodarone is used only when other medicines cannot be used.

2. What you need to know before taking Amiodarone

Do not take Amiodarone:

• if you are allergic to amiodarone, or to any of the other ingredients of this medicine (listed in section 6) or to iodine. The 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 heartbeat (called ‘sinus bradycardia’) or a condition called sinoatrial block.
• if you suffer from any other heart rhythm problem and do nothave a pacemaker fitted.
• if you have or have had problems with your thyroid gland. Your doctor will check your thyroid gland before prescribing this medicine.
• if you are taking other medicines that can affect your heartbeat or monoamine oxidase inhibitors (MAOIs) for the treatment of depression (see below “Other medicines and Amiodarone”).
• if you are pregnant or breastfeeding (see below “Pregnancy and breastfeeding”).

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

• if you have heart failure or suffer from shortness of breath and swollen ankles
• if you have problems with your liver
• if you have lung problems or asthma
• if you suffer from vision problems. These include a condition called “optic neuritis”
• if you are going to have surgery or general anaesthesia.
• if you are an elderly person (over 65 years of age). Your doctor will need to monitor you more closely.
• If you have a “pacemaker” or an “implantable cardioverter-defibrillator”. The doctor will check that the device is working correctly shortly after starting treatment or when the dose is changed
• are currently taking a medicine called sofosbuvir, or containing sofosbuvir, for the treatment of hepatitis C as it can cause a dangerous slowing of the heartbeat. Your doctor may consider alternative treatments. If treatment with amiodarone and sofosbuvir is necessary, additional cardiac monitoring may be required.

Immediately inform your doctorif 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 shortness of breath.
• chest pain.
• Mild confusion.
• palpitations.
• near fainting or fainting.

If you are on the waiting list for a heart transplant, your doctor may change your treatment.
This is because taking amiodarone before heart transplantation has shown an
increased risk of a potentially life-threatening complication (primary graft dysfunction) in which the transplanted heart stops working correctly within the
first 24 hours after surgery.

Protecting your skin from sunlight
Avoid direct exposure to sunlight while taking this medicine and for some
months after stopping it. Your skin will be more sensitive to the sun and can
burn, sting or blister severely if you do not take the following
precautions:

• Make sure you use a sunscreen with a high protection factor
• Always wear a hat and clothing that covers your arms and legs.

Other medicines and Amiodarone
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
The following medicines can cause an irregular heartbeat, highlighted by an abnormal ECG
and must notbe used at the same time as Amiodarone due to an
increased risk of irregular heartbeat or missed beats (torsade de pointes).

• Other medicines for irregular heartbeat (such as quinidine, disopyramide, procainamide, sotalol, bretylium, flecainide or bepridil).
• Medicines for the treatment of mental illness or depression, such as chlorpromazine, pimozide, thioridazine, fluphenazine, haloperidol, amisulpride, lithium, doxepin, maprotiline, amitriptyline or sertindole.
• Medicines used to treat hay fever, skin rashes or other allergies (antihistamines such as terfenadine, astemizole, mizolastine).
• Antimalarial medicines, such as quinine, mefloquine, halofantrine, chloroquine.
• Medicines used to treat infections such as erythromycin intravenously, co-trimoxazole, moxifloxacin or pentamidine.
• Medicines for the treatment of hepatitis C (sofosbuvir, daclatasvir, simeprevir or ledipasvir).

Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including those available without a prescription or the
following:

• monoamine oxidase inhibitors (MAOIs), such as phenelzine for the treatment of depression
• medicines to lower cholesterol (statins), such as simvastatin, lovastatin, atorvastatin or pravastatin
• medicines to treat infections, such as clarithromycin, ciprofloxacin, ofloxacin or levofloxacin
• medicines for constipation (laxatives), such as senna or bisacodyl
• medicines for heart problems (beta-blockers) such as propranolol
• medicines called “calcium channel blockers” (such as diltiazem or verapamil) for chest pain (angina) or to treat high blood pressure.

The following medicines can increase the possibility of having side effects,
when taken together with Amiodarone:

• amphotericin B (when administered directly into a vein) used to treat fungal infections
• medicines to treat inflammation (corticosteroids (gluco-, mineral-)) such as hydrocortisone, betamethasone or prednisolone
• diuretics (tablets that promote diuresis)
• general anaesthetics or high doses of oxygen, used during surgery
• tetracosactide, used to investigate some hormonal problems.

Amiodarone can increase the effect of the following medicines:

• cyclosporine, tacrolimus and sirolimus, used to help prevent rejection after a transplant
• medicines for impotence, such as sildenafil, tadalafil or vardenafil
• fentanyl, used as a painkiller
• ergotamine, used for migraine
• midazolam, used to treat anxiety or to help you relax before surgery
• flecainide, another medicine used for irregular heartbeat. The doctor must monitor the treatment and may halve the dose of flecainide.
• lidocaine, used as an anaesthetic
• dabigatran, used to thin the blood
• warfarin, used to stop blood clots from forming
• digoxin, used for some heart conditions
• colchicine, used in the treatment of gout
• phenytoin, used in the treatment of epilepsy.

Amiodarone with food, drinks and alcohol
Limit the amount of alcohol you drink while taking this medicine. This is because drinking
alcohol while taking this medicine increases the chance of having liver problems.
Talk to your doctor or pharmacist about how much alcohol you can drink.
Do not drink grapefruit juice while taking this medicine because drinking grapefruit juice while taking Amiodarone tablets can increase the chance of having side
effects.

Pregnancy and breastfeeding
Do nottake Amiodarone if you are pregnant or planning a pregnancy.

Do notbreastfeed your baby if you are taking Amiodarone. Small amounts of this
medicine can pass into breast milk and harm your baby.
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.

Driving and using machines
After taking this medicine, your vision may be blurred. If this happens, do not drive
vehicles or use machines until your vision has returned to normal.

Amiodarone contains lactose(a type of sugar)
If you have been diagnosed with intolerance to some sugars, contact your doctor before
taking this medicine.

Amiodarone contains iodine
One 200 mg tablet contains 75 mg of iodine. Iodine is present in amiodarone
hydrochloride, the medicine contained in your tablets. Iodine can cause problems with the
thyroid gland (see “Checks” below).

3. How to take Amiodarone

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Swallow the tablets whole or divide them into two equal parts if necessary. The tablet can be divided into two equal doses. Do not crush or chew the tablets. If you feel that your condition is not improving while taking this medicine, contact your doctor.
Do not stop taking this medicine without first consulting your doctor.

Adults
The recommended dose is 200 mg threetimes a day for the first week, then 200 mg

twotimes a day for the second week. Afterwards, your doctor will reduce the dose of
Amiodarone further, generally to 200 mg once a day, unless you are told otherwise.
In some cases, your doctor may decide to increase or decrease the dose you need to
take each day. This will depend on how you respond to the medicine.

Elderly
Your doctor may give you a lower dose of amiodarone. Also, your doctor should check your
blood pressure and thyroid function regularly.

Use in children and adolescents
The data available regarding efficacy and safety in children are limited,
therefore this medicine is not recommended in children.

If you take more Amiodarone than you should
If you have taken too many tablets, contact your doctor immediately or go to the nearest
emergency room. Take the medicine packaging with you. The following effects may occur:
dizziness, weakness or fatigue, confusion, slow heartbeat, feeling unwell and liver damage.

If you forget to take Amiodarone
Take the tablets as soon as you remember. If it is almost time for the next dose,
skip the missed dose and take the next one at the scheduled time. Do not take
a double dose to make up for a missed dose.

If you stop taking Amiodarone
Continue to take this medicine until your doctor tells you to stop. Do not stop
taking this medicine just because you feel better. If you stop taking this
medicine, irregular heartbeats may return. This can be dangerous.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

Checks
Your doctor will prescribe regular tests to check your liver function during
treatment and for several months after stopping this medicine. Amiodarone
can affect liver function.
If this happens, your doctor will decide whether you should continue to take these tablets.
Your doctor may prescribe regular thyroid tests while you are taking this medicine.
This is because Amiodarone tablets contain iodine, which can cause thyroid problems.
Your doctor may prescribe you other regular checks, such as blood tests, chest X-rays,
ECG (electrical test of the heartbeat) and eye examinations, both before, during and
a few months after stopping Amiodarone.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Amiodarone can remain in the blood for up to a month after stopping treatment.
During this period, side effects may still occur.

Stop takingthis medicine and consult a doctor or go to hospital
immediatelyif you notice any of the following side effects.

Common(may affect up to 1 in 10 people)

• Yellowing of the skin or eyes (jaundice), feeling tired or unwell, loss of appetite, stomach pain or high fever. These can be signs of damage or problems with the liver which can be very dangerous.
• Difficulty breathing or a feeling of 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.
• Decreased sexual desire

Uncommon(may affect up to 1 in 100 people)

• Irregular heartbeat or missed heartbeats. This can cause a heart attack, you should see a doctor immediately.

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

• Loss of vision in one eye or visual disturbances and inability to perceive colors. Your eyes may be painful or weak and you may experience pain when moving them. These can be signs of a disease called “optic neuropathy or neuritis”.
• Your heartbeat becomes very slow or stops. If this happens, you should go to hospital immediately.
• Shortness of breath and difficulty breathing caused by excessive and prolonged contraction of the muscles of the airways (bronchospasm).
• Weakness, fatigue, loss of appetite, weight loss, stomach pain and swelling, nausea, vomiting, swelling of the ankles and yellowing of the skin and/or eyes. These may be signs of chronic liver disease.

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

• Severe and sudden allergic reaction with symptoms such as swelling of the face, lips, mouth, tongue or throat, which can cause difficulty swallowing or breathing (angioedema).
• Severe allergic reaction (anaphylactic reaction, anaphylactic shock).
• Sudden onset inflammation of the pancreas (pancreatitis (acute)).
• You may contract more infections than usual. This may be caused by a decrease in the number of white blood cells (neutropenia).
• Severe reduction in the number of white blood cells that makes infections more likely (agranulocytosis).
• Abnormal muscle movements, stiffness, tremor and restlessness (parkinsonism).
• Confusion (delirium), hallucinations.
• Seeing, hearing or perceiving things that are not there (hallucinations).
• Potentially life-threatening skin reactions characterized by rash, blisters, peeling of the skin and pain (toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), bullous dermatitis, drug reaction with eosinophilia and systemic symptoms (DRESS)).
• Potentially life-threatening complication (primary graft dysfunction) following a heart transplant, in which the transplanted heart stops working properly (see section 2, Warnings and precautions).

Stop taking Amiodarone and see your doctor immediately if you notice
any of the following serious side effects - urgent medical treatment may be
needed:
Uncommon(may affect up to 1 in 100 people)

• Feeling of numbness or weakness, tingling or burning sensation in any part of the body.

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

• Skin rash caused by narrowing or blockage of blood vessels (called “vasculitis”).
• Headache (usually worse in the morning or after coughing or exertion), feeling unwell (nausea), seizures, fainting, visual problems or confusion. These may be signs of problems with the brain.
• Unsteady gait or stumbling, slurred or slowed speech.
• Feeling faint, dizziness, unusual fatigue and shortness of breath. These may be signs of a very slow heartbeat (especially in people over 65 years of age) or other problems with your heart's natural rhythm.

Not known

• Chest pain and shortness of breath and irregular heartbeat. These may be signs of a condition called “torsades de pointes”
• Some cases of bleeding in the lungs have been reported in patients treated with amiodarone. You should tell your doctor immediately if you notice blood in your sputum.
• Lupus-like syndrome (including skin rashes, joint disorders and effects on blood cells)

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

• Blurred vision or perception of colored halos in bright light.

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

• Feeling extremely restless or agitated, weight loss, increased sweating and intolerance to heat. These may be signs of a disease called “hyperthyroidism”.
• Feeling extremely tired, weak or exhausted, weight gain, intolerance to cold, constipation and muscle pain. These may be signs of a disease called “hypothyroidism”.
• Tremors while moving arms or legs.
• Gray or bluish discoloration of the skin exposed to the sun, especially on the face.

Uncommon(may affect up to 1 in 100 people)

• Muscle cramps, stiffness or spasms.

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

• Swelling of the testicles.
• Red, scaly skin, hair loss or loss of nails (called “exfoliative dermatitis”).
• Feeling tired, weak, dizzy or pale. These may be signs of anemia.
• Bruising and bleeding more frequently than usual. This may be caused by a blood disease (called “thrombocytopenia”).
• Increased incidence of infections compared to usual, often with symptoms such as fever, severe chills and sore throat or mouth ulcers (called “leukopenia”).
• Feeling unwell, confusion or weakness, nausea, loss of appetite, irritability. This may be a disease called “syndrome of inappropriate antidiuretic hormone secretion” (SIADH).
• You may experience symptoms such as fever, night sweats and fatigue. This may be due to a vascular disorder (called “vasculitis”).
• Increased creatinine in the blood.

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

• Feeling sick (nausea) or feeling unwell (vomiting).
• Altered sense of taste.
• Increased liver enzymes in the blood at the beginning of treatment (confirmed by blood test).
• Increased sensitivity to sunlight (see “Protecting skin from sunlight” in section 2).

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

• Slightly slower heartbeat.
• Nightmares.
• Sleep disorders.
• Constipation.
• Itchy, red rash (eczema).

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

• Dry mouth.

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

• Headache.
• Balance problems, feeling dizzy (vertigo).
• Difficulty achieving or maintaining an erection or ejaculating.
• Hair loss, baldness.
• Skin rash.
• Redness of the skin during radiotherapy.

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

• Hives (itchy, papular rash).
• Metallic taste.
• Granulomas, small red spots on the skin or inside the body visible on X-rays
• Loss of appetite.
• Abnormal perception of smells (parosmia).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through 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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package, blister and
bottle after Exp. The expiry date refers to the last day of that month.
Storage conditions for blister packs:
Do not store at a temperature above 25°C. Store in the original packaging
to protect the medicine from light and moisture.
Storage conditions for polypropylene containers:
Do not store at a temperature above 25°C. Keep the container tightly closed to
protect the medicine from light and moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Amiodarone Tablets contains
The active ingredient is amiodarone hydrochloride. Each tablet contains 200 mg of amiodarone
hydrochloride.
The other ingredients are lactose monohydrate (see section 2, “This medicine
contains lactose”), microcrystalline cellulose, crospovidone, povidone, colloidal anhydrous
silica, talc and magnesium stearate.

Description of the appearance of Amiodarone and contents of the pack
The medicine is presented as round, white, uncoated tablets, with a score line,
marked with ‘AM 200’ on one side and ‘G’ on the other.
Amiodarone is available in containers or in blisters of 10, 20, 28, 30, 50, 60 or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano

Manufacturer
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Hungary Ltd
2900 Komárom
Mylan utca 1
Hungary
Logiters, Logistica Portugal S.A.,
Estrada dos Ameiros, 4, Azambuja, 2050-544,
Portugal