Amiodarone Aurobindo

Package leaflet: Information for the user

Amiodarone Aurobindo 200 mg tablets

Generic medicine
Please read this leaflet carefully before you start 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 pass it on to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Amiodarone Aurobindo contains a medicine called amiodarone hydrochloride, which belongs to a group of medicines known as antiarrhythmics.
It works by controlling irregular heartbeat (called "arrhythmia"). Taking the tablets may help restore the heart rhythm to normal.
Amiodarone can be used to

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

2. What you need to know before taking Amiodarone Aurobindo

Do not take Amiodarone Aurobindo

• 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".
• if you have any other heart rhythm problems and do not have a pacemaker implanted.
• if you have ever had thyroid problems. Your doctor will examine your thyroid before giving you this medicine.
• if you are already taking certain medicines that may affect your heart rhythm (see section "Taking Amiodarone Aurobindo with other medicines" below).
• if you are breastfeeding (see section "Pregnancy and breastfeeding" below).

Do not take this medicine if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Amiodarone Aurobindo.
Warnings and precautions

• if you have heart failure
• if you have liver problems
• if you have lung problems or asthma
• if you have vision problems. These include a condition called "optic neuritis"
• if you are scheduled for surgery
• 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". Your doctor will check that the device is functioning properly shortly after starting treatment or when the dose is changed.
• Very rare cases of potentially life-threatening skin reactions (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis) have been reported with the use of amiodarone. Symptoms may include: flu-like symptoms followed by a widespread painful red or reddish rash and blisters.
• When Amiodarone Aurobindo is taken with hepatitis C medications such as sofosbuvir, daclatasvir, simeprevir, or ledipasvir, cases of severe, potentially life-threatening bradycardia (slow heart rate) have been reported. Symptoms of bradycardia include dizziness, fainting, shortness of breath, confusion. If you develop any of these symptoms, inform your doctor immediately.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking
Amiodarone Aurobindo.
Other medicines and Amiodarone Aurobindo
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. These may affect how some other medicines work. Also, some medicines may affect how amiodarone works.
In particular, do not take this medicine and inform your doctor if you are taking:

• Other medicines for irregular heartbeat (such as sotalol, quinidine, procainamide, disopyramide, or bretylium)
• Medicines for infections (such as erythromycin, co-trimoxazole, moxifloxacin, or intravenous pentamidine)
• Medicines for schizophrenia (such as chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpride, or sertindole)
• Medicines for other mental disorders (such as lithium, doxepin, maprotiline, or amitriptyline)
• 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)

Inform your doctor if you are taking any of the following medicines:

• Medicines that prolong the heart rhythm (QT interval), such as medicines used to treat infections (such as clarithromycin, ciprofloxacin, ofloxacin, or levofloxacin)
• Medicines for heart conditions called beta-blockers (such as propranolol)
• Medicines for treating hepatitis C, a liver disease, such as sofosbuvir, daclatasvir, simeprevir, ledipasvir
• Medicines called "calcium antagonists" – for chest pain (angina) or high blood pressure (such as verapamil or diltiazem)
• Laxatives for constipation, such as bisacodyl or senna
• Medicines for high cholesterol (statins), such as simvastatin or atorvastatin

The following medicines may increase the likelihood of side effects when taken together with Amiodarone Aurobindo:

• Amphotericin (when administered intravenously) – used to treat fungal infections
• Medicines for inflammation (corticosteroids) such as hydrocortisone, betamethasone, or prednisolone
• Diuretics
• General anaesthetics or high doses of oxygen – used during surgery
• Tetracosactide – used to investigate certain hormonal problems

Amiodarone Aurobindo may increase the effect of the following medicines:

• Cyclosporine and tacrolimus – used to prevent transplant rejection
• Medicines used for erectile dysfunction, such as sildenafil, tadalafil, or vardenafil
• Fentanyl – used for pain relief
• Ergotamine – used for migraine
• Midazolam – used to treat anxiety or to help you relax before surgery
• Colchicine – used to treat gout
• Flecainide – another medicine used for irregular heartbeat. Your doctor must monitor your treatment and may halve the dose of flecainide
• Lidocaine – used as an anaesthetic
• Coumarins – used to prevent blood from clotting
• Digitalis – used for certain heart conditions
• Dabigatran – used to thin the blood

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking
Amiodarone Aurobindo.
Amiodarone Aurobindo with food, drinks, and alcohol
Do not drink grapefruit juice while taking this medicine, as drinking grapefruit juice with Amiodarone Aurobindo may increase the risk of side effects.
You should limit your alcohol intake during treatment with this medicine. Drinking alcohol while taking this medicine may increase the risk of liver problems. Speak with your doctor or pharmacist about how much alcohol you can safely drink.
Protect your skin from sunlight
Avoid direct sunlight while taking this medicine and for several months after stopping it. Your skin will be more sensitive to sunlight and may burn, tingle, or blister severely if you do not follow these precautions:

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

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

• Amiodarone Aurobindo is generally not given during pregnancy.
• Do not take Amiodarone Aurobindo if you are breastfeeding or plan to breastfeed, as small amounts of this medicine may pass into breast milk.

Driving and using machines
After taking this medicine, you may experience blurred vision. If this occurs, do not drive or operate machinery.
Amiodarone Aurobindo contains lactose: If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Amiodarone Aurobindo

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
This will help you achieve the best results and reduce the risk of unwanted side effects.

Initial dose
The recommended dose is 200 mg of amiodarone three times a day (for a total of 600 mg per day) for 8–10 days.

Maintenance dose
Once the desired effect has been achieved, the dose may be reduced to 100–400 mg (½ to 2 tablets of amiodarone 200 mg) per day.
Amiodarone 200 mg may be administered once every 2 days when considered appropriate (200 mg every 2 days corresponds to 100 mg per day).

Amiodarone 200 mg tablets should be taken during or immediately after a meal with water (e.g. a glass of water).

Use in children and adolescents
Available data on efficacy and safety in children are limited. Your doctor will determine the appropriate dose.
The tablet may be divided into two equal doses.

If you take more Amiodarone Aurobindo than you should
If you take more Amiodarone Aurobindo than prescribed, contact your doctor or go immediately to the nearest emergency department.
Take the medicine pack with you so that the doctor knows what you have taken.
The following effects may occur: dizziness, weakness or fatigue, confusion, slow heartbeat, liver damage, and general malaise.

If you forget to take Amiodarone Aurobindo
If you forget a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for the forgotten tablet.

If you stop taking Amiodarone Aurobindo
Continue taking Amiodarone Aurobindo until your doctor tells you to stop. Do not stop taking Amiodarone Aurobindo just because you feel better.
If you stop taking this medicine, irregular heartbeats may return, which could be dangerous.

Monitoring
Your doctor may carry out regular checks to monitor liver function. Amiodarone Aurobindo may affect how the liver works.
If this occurs, your doctor will decide whether you should continue taking these tablets.

During treatment with this medicine, your doctor may also perform regular checks of your thyroid gland.
Amiodarone Aurobindo contains iodine, which may cause thyroid problems.

Your doctor may also carry out other regular checks such as blood tests, chest X-rays, ECGs (electrical tests of heart rhythm), and eye examinations before and during treatment with Amiodarone Aurobindo.

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 Aurobindo can remain in the blood for up to one month after stopping treatment.
Side effects may still occur during this period.

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

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

Common side effects (affect less than 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, breathlessness, 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 (affect less than 1 in 100 people)

• Heartbeat becomes increasingly irregular and unstable. This may lead to a heart attack, so you must go to hospital immediately.
• Dry mouth

Very rare side effects (affect less than 1 in 10,000 people)

• Loss of vision in one eye or blurred vision with loss of colour vision. You may have eye pain and feel pain when moving your eyes. This could be a condition called "optic neuropathy" or "neuritis".
• Heart rate 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, blistering, 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.

Stop taking Amiodarone Aurobindo and go to the doctor immediately if you notice any of the following side effects – you may need urgent medical treatment:

Uncommon side effects (affect less than 1 in 100 people)

• Numbness or weakness, tingling or burning sensation in any part of the body

Very rare side effects (affect less than 1 in 10,000 people)

• Skin rash caused by narrowing or blockage of blood vessels (called "vasculitis")
• Headaches (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.
• Unsteady or staggering gait, slow and slurred speech
• Feeling faint, dizzy, unusually tired and short of breath. These could be signs of a slow heartbeat (particularly in people over 65 years of age) or other problems with the heart's natural rhythm. Cases of lung bleeding have been reported in patients taking Amiodarone Aurobindo. Inform your doctor immediately if you cough up blood.

Not known

• Chest pain, shortness of breath and irregular heartbeat. These could be signs of a condition called "Torsades de pointes".

Tell your doctor as soon as possible if you get any of the following side effects:

Very common side effects (affect more than 1 in 10 people)

• Blurred vision or seeing coloured halos in bright light

Common side effects (affect less than 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"
• Trembling of the arms or legs
• Bluish or greyish skin discolouration in sun-exposed areas, especially on the face

Uncommon side effects (affect less than 1 in 100 people)

• Muscle cramps, stiffness or spasms

Very rare side effects (affect less than 1 in 10,000 people)

• Swelling of the testicles
• Red, scaly skin patches, hair loss or weakened nails (called "exfoliative dermatitis")
• Feeling tired, faint, dizzy or pale. These could be signs of anaemia.
• You may bleed or bruise more easily than usual. This could be due to a blood disorder called "thrombocytopenia"
• Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be a condition called "syndrome of inappropriate antidiuretic hormone secretion" (SIADH)

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

• Reduced number of white blood cells

Tell your doctor or pharmacist if any of the following side effects worsen or last for more than a few days:

Very common side effects (affect more than 1 in 10 people)

• Feeling sick (nausea) or being sick (vomiting)
• Altered taste
• Changes in liver enzyme levels at the start of treatment, visible in blood tests
• Becoming sunburnt more easily (see "Protect your skin from sunlight" in section 2)

Common side effects (affect less than 1 in 10 people)

• Slightly slowed heartbeat
• Nightmares
• Difficulty sleeping

Very rare side effects (affect less than 1 in 10,000 people)

• Headache
• Balance problems, feeling dizzy (vertigo)
• Difficulty achieving or maintaining an erection or problems with ejaculation
• Hair loss, baldness
• Skin rash
• Skin redness during radiotherapy
• Increased creatinine in the blood, shown by blood tests. This may indicate impaired kidney function.

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

• Hives (itchy rash with lumps)
• Granulomas, small red nodules on the skin or inside the body, visible on X-rays
• Pancreatitis / acute pancreatitis
• Dry mouth
• Anaphylactic reactions
• Reduced appetite
• Parkinsonism
• Parosmia (a disorder of the sense of smell)
• Confusional state, hallucinations
• Reduced libido
• Bullous dermatitis

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.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amiodarone Aurobindo

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 medicines 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 Aurobindo contains

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

Description of the appearance of Amiodarone Aurobindo and package contents
Tablets.
Tablets from white to off-white, round, biconvex, uncoated, marked with '8' and '4' separated by a score line on one side and 'A' on the other side.
Amiodarone Aurobindo 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 Authorization Holder
Aurobindo Pharma (Italia) s.r.l. – Via San Giuseppe, 102 – 21047 Saronno (Varese)

Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000. Malta
Milpharm Limited Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD. United Kingdom

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Amiodarone Aurobindo
Portugal: Amiodarona Aurovitas
Spain: Amiodarona Aurovitas 200 mg comprimidos EFG