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Amiodarone Hydrochloride 200mg Tablets

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PACKAGE LEAFLET

Package leaflet: Information for the patient

[Product Name] 200 mg Tablets

Amiodarone hydrochloride

Read all of 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 further questions, ask your doctor, pharmacist or nurse.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the leaflet.

The name of your medicine is Amiodarone Hydrochloride 200 mg tablets; however for simplicity it will be referred to as Amiodarone throughout the leaflet.

What is in 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 Amiodarone is and what it is used for.

Your tablet contains amiodarone hydrochloride, which belongs to a class of medicines known as

antiarrhythmics. Amiodarone can help to suppress and prevent an abnormal or irregular heart rhythm

and so return your heart rhythm to normal.

Amiodarone can be used to:

•    Treat uneven heartbeats where other medicines either have not worked or cannot be used.

•    Treat an illness called Wolff-Parkinson-White Syndrome. This is where your heart beats unusually fast.

•    Treat other types of fast or uneven heartbeats known as ‘atrial flutter’ or ‘atrial fibrillation. Amiodarone is used only when other medicines cannot be used.

•    Treat fast heartbeats which may happen suddenly and may be uneven. Amiodarone is used only when other medicines cannot be used.

2.    What you need to know before you take 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. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

•    you have a slower than usual heartbeat (called ‘sinus bradycardia’) or an illness called ‘sino-atrial’ heart block.

•    you have any other problems with your heartbeat and do not have a pacemaker fitted.

•    you have or have had thyroid problems. Your doctor should test your thyroid before giving you this medicine.

•    you are taking certain other medicines which could affect your heartbeat or monoamine-oxidase inhibitors (MAOI) to treat your depression (see section ‘Taking Other medicines and Amiodarone’ below).

•    you are pregnant or breast-feeding (see ‘Pregnancy and breast-feeding’ below).

Warnings and precautions

Talk to your doctor or pharmacist before taking Amiodarone if you:

•    have had heart failure or suffer from breathlessness and swollen ankles

•    have liver problems

• have any problems with your lungs or have asthma

• have any problems with your eyesight This includes an illness called ‘optic neuritis’

•    are about to have an operation or may be given general anaesthetic

•    are elderly (over 65 years of age). The doctor will need to monitor you more carefully

•    have a pacemaker or implantable cardioverter defibrillator (ICD). Your doctor will check that your device is working properly shortly after you start taking the tablets or if your dose is changed.

Protect your skin from sunlight

Keep out of direct sunlight while taking this medicine and for a few months after you have finished taking it. This is because your skin will become much more sensitive to the sun and may burn, tingle or severely blister if you do not take the following precautions:

•    Make sure you use high factor sun cream.

•    Always wear a hat and clothes which cover 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 may cause irregular heart rhythm, showing as an abnormal ECG and should not be used with amiodarone due to increased risk of an irregular heart rhythm or missed beats (torsades de pointes).

•    other medicines for an uneven heartbeat (such as quinidine, disopyramide, procainamide, sotalol, bretylium, flecainide or bepridil).

•    medicines to treat mental illness or depression, such as chlorpromazine, pimozide, thioridazine, haloperidol, lithium, doxepin, maprotiline, amitriptyline or sertindole.

•    medicines used to treat hayfever, rashes or other allergies (antihistamines such as terfenadine, astemizole, mizolastine).

•    antimalarial medicine (such as quinine, mefloquine, halofantrine, chloroquine).

•    medicines for infections (such as intravenous erythromycin, co-trimoxazole, moxifloxicin or pentamidine).

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

•    monoamine-oxidase inhibitor (MAOI), such as phenelzine to treat depression.

•    medicines for high cholesterol, such as simvastatin, lovastatin, atorvastatin or pravastatin.

•    medicines for infection, such as 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 high blood pressure.

The following medicines can increase the chance of you getting side effects, when taken with Amiodarone:

•    amphotericin (when given directly into a vein)-used for fungal infections.

•    medicines for inflammation (corticosteriods) such as hydrocortisone, betamethasone or prednisolone.

•    water tablets (diuretics).

•    general anaesthetics or high dose oxygen- used during surgery.

•    tetracosactide- used to test some hormone problems.

Amiodarone may increase the effect of the following medicines:

•    ciclosporin and tacrolimus, used to help prevent rejection of transplants.

•    medicines for impotence, such as sildenafil, tadalafil or vardenafil.

•    fentanyl, used for pain relief.

•    ergotamine, used for migraine.

•    midazolam, used to relieve anxiety or to help you relax before surgery.

•    flecainide, another medicine used for uneven heartbeats. Your doctor should monior your treatment and may half your dose of flecainide.

•    lidocaine, used as an anaesthetic.

Amiodarone with food, drink and alcohol

Limit the amount of alcohol you drink while taking this medicine. This is because drinking alcohol while taking this medicine will increase the chance of you having problems with your liver. Talk to your doctor or pharmacist about the amount of alcohol you can drink.

Do not drink grapefruit juice while taking this medicine. This is because drinking grapefruit juice while taking amiodarone tablets can increase your chance of getting side effects.

Pregnancy and breast-feeding

Do not take amiodarone if you are pregnant or intend to become pregnant.

Do not breast-feed 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 or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You may have blurred eyesight after taking this medicine. If this happens to you, you should not drive or operate machinery until your eyesight is clear.

Amiodarone contains lactose (a type of sugar).

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Amiodarone contains iodine

Your tablets contain 75 mg of iodine in a 200 mg tablet. Iodine is present in amiodarone hydrochloride, the medicine your tablets contain. Iodine can cause problems to your thyroid (see ‘Tests’ below).

3. How to take Amiodarone

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the tablets whole or divide them into equal halves if necessary. The tablet can be divided into equal doses. Do not crush or chew your tablets. If you feel your condition is not improving while taking your medicine, tell your doctor.

Do not stop taking your medicine without consulting your doctor.

Adults

The recommended dose is 200 mg three times a day for the first week, then 200 mg twice a day for the second week. After this your doctor will reduce the dose of amiodarone again, usually to 200 mg once a day, until you are told otherwise.

In some cases, your doctor may then decide to either increase or lower the amount you take each day. This will depend on how you respond to the medicine.

Elderly

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

Use in children and adolescents

There are only limited data on the efficacy and safety in children, therefore this medicine is not recommended for children.

If you take more Amiodarone than you should

If you have taken too many tablets, immediately consult with your doctor or the nearest emergency department. Take the medicine pack with you. You may notice the following effects of overdose: feeling dizzy, faint or tiredness, confusion, slow heartbeat, being sick and damage to your liver.

If you forget to take Amiodarone

Take your tablets as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose, take the next dose on time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Amiodarone

Keep taking 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 the uneven heartbeats may come back. This could be dangerous.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Tests

Your doctor will take regular tests to check how your liver is working during the treatment and for several months after you stop taking this medicine. Amiodarone can affect how your liver works.

If this happens, your doctor will decide whether you should keep taking these tablets.

Your doctor may do regular thyroid tests while you are taking this medicine. This is because Amiodarone tablets contain iodine which can cause problems to your thyroid.

Your doctor may also do other regular tests such as blood tests, chest X-rays, ECG (electrical test of your heartbeat) and eye tests both before, while you are taking and a few months after you stop taking Amiodarone.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Amiodarone may stay in your blood for up to a month after stopping treatment. You may still get side effects in this time.

Stop taking this medicine and see a doctor or go to a hospital straight away if you have an allergic reaction. The signs may include a rash, swallowing or breathing problems, swollen eyelids, face, lips, throat or tongue.

Common (may affect up to 1 in 10 people)

•    You get yellowing of the skin or eyes (jaundice) feel tired or sick, loss of appetite, stomach pain or high temperature. These can be signs of liver problems or damage which can be very dangerous.

•    Difficulty breathing or tightness in the chest, coughing which will not go away, wheezing, weight loss and fever. This could be due to inflammation of your lungs which can be very dangerous.

Uncommon (may affect up to 1 in 100 people)

•    Your heartbeat becomes even more uneven or erratic. This can lead to a heart attack, so you should go to hospital straight away.

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

•    You get loss of eyesight in one eye or your eyesight becomes dim and colourless. Your eyes may feel sore or tender and feel painful to move. This could be an illness called ‘optic neuropathy or neuritis’.

•    Your heartbeat becomes very slow or stops beating. If this happens, go to hospital straight away.

Stop taking Amiodarone and see a doctor straight away if you notice any of the following serious

side effects - you may need urgent medical treatment:

Uncommon (may affect up to 1 in 100 people)

•    Feeling numb or weak, tingling or burning feelings in any part of your body.

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

•    Skin rash caused by narrow or blocked blood vessels (called ‘vasculitis’).

•    Headache (which is usually worse in the morning or happens after coughing or straining), feeling sick (nausea) fits, fainting, eyesight problems or confusion can occur. These could be signs of problems with your brain.

•    Moving unsteadily or staggering, slurred or slow speech.

•    Feeling faint, dizzy, unusually tired and short of breath. These could be signs of a very slow heartbeat (especially in people over 65 years old) or other problems with your heart’s natural beat.

Some cases of bleeding in the lungs have been reported in patients taking Amiodarone. You should

tell your doctor straight away if you cough up any blood.

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

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

•    Blurred eyesight or seeing a coloured halo in dazzling light.

Common (may affect up to 1 in 10 people)

•    Feeling extremely restless or agitated, weight loss, increased sweating and being unable to stand the heat.

•    These could be signs of an illness called ‘hyper-thyroidism’.

•    Feeling extremely tired, weak or ‘run-down’, weight gain, being unable to stand the cold, constipation and aching muscles. These could be signs of an illness called ‘hypo-thyroidism’.

•    Trembling when you move your arms or legs.

•    Blue or grey marks on parts of your skin exposed to sunlight, especially the face.

Uncommon (May affect up to 1 in 100 people)

•    Muscle cramps, stiffness or spasm.

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

•    Swelling of the testicles.

•    Red, scaly patches of skin, loss of hair or loosening of nails (called ‘exfoliative dermatitis’).

•    Feeling tired, faint, dizzy or having pale skin. These could be signs of anaemia.

•    You may bleed or bruise more easily than usual. This could be because of a blood disorder (called ‘thrombocytopenia’).

•    You may get infections frequently with symptoms such as fever, severe chills and sore throat or mouth ulcers (called ‘leucopoenia’).

•    Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable. This could be an illness called ‘syndrome of inappropriate anti-diuretic hormone secretion’ (SIADH).

•    Fever, night sweats and fatigue.

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

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

•    Feeling sick (nausea) or being sick (vomiting).

•    Change in the way things taste.

•    Changes in the amount of liver enzymes at the beginning of treatment. This can be seen in blood tests.

•    Burning more easily in the sun (see ‘Protect your skin from sunlight’ in Section 2).

Common (may affect up to 1 in 10 people)

•    Slightly slower heartbeat.

•    Nightmares.

•    Problems sleeping.

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

•    Headache.

•    Balance problems, feeling dizzy (vertigo).

•    Difficulty in getting or maintaining an erection or in ejaculating.

•    Hair loss, balding.

•    Skin rash.

•    Skin redness during radio-therapy.

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

•    Hives (itchy, lumpy rash).

•    Metallic taste

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via [to be completed nationally with national reporting system].

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 carton, blister and bottle after EXP. The expiry date refers to the last day of that month.

Storage conditions for blister packs:

Do not store above 25°C. Store in the original package in order to protect from light and moisture. Storage conditions for polypropylene containers:

Do not store above 25°C. Keep the container tightly closed in order to protect from light and moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of pack and other information What Amiodarone Tablets contain

The active substance 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.

What Amiodarone looks like and contents of the pack

This medicine comes as round white uncoated with break line, marked ‘AM 200’ on one side and ‘G’ on the other.

Amiodarone is available in containers or blister packs of 10, 20, 28, 30, 50, 60 or 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

McDermott Laboratories Ltd (t/a Gerard Laboratories)

35/36 Baldoyle Industrial Estate Grange Road Dublin 13 Ireland

Generics [UK] Ltd Station Close Potters Bar Hertfordshire EN6 1TL United Kingdom

This leaflet was last revised in: 04/2014 [To be completed nationally]