Amiodarone 100mg Tablets Bp
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AMIODARONE 100 mg and 200 mg Tablets
Amiodarone hydrochloride
Read all of this leafl et carefully before you start taking this medicine
• Keep this leafl et. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
• If any of the side effects gets serious, or if you notice any side effects not listed in this leafl et, please tell your doctor or pharmacist
• Your doctor may have given you this medicine before from another company. It may have looked slightly different. However, either brand will have the same effect.
In this leaflet:
1. What amiodarone is and what it is used for
2. Before you take amiodarone
3. How to take amiodarone
4. Possible side effects
5. How to store amiodarone
6. Further information
1. WHAT AMIODARONE IS AND WHAT IT IS USED FOR
The name of your medicine is Amiodarone Hydrochloride 100mg and 200mg Tablets (called amiodarone throughout this leafl et). This belongs to a group of medicines called anti-arrhythmics. It works by controlling the uneven beating of your heart (called 'arrhythmias'). Taking the tablets helps your heartbeat to return 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 fl utter' or 'atrial fi brillation. Amiodarone is used only when other medicines can not be used
• Treat fast heartbeats which may happen suddenly and may be uneven. Amiodarone is used only when other medicines cannot be used
2. BEFORE YOU TAKE AMIODARONE Do not take amiodarone and tell your doctor if:
• You are allergic (hypersensitive) to iodine, amiodarone or any of the other ingredients of this medicine (listed in Section 6 below)
• 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 ever 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 (see 'Taking other medicines' below)
• You are pregnant or breast-feeding (see 'Pregnancy and breast-feeding' below)
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking amiodarone.
Take special care and check with your doctor or pharmacist before taking amiodarone if:
• You have heart failure
• You have liver problems
• You have any problems with your lungs or have asthma
• You have any problems with your eyesight. This includes an illness called 'optic neuritis'
• You are about to have an operation
• You are elderly (over 65 years of age). The doctor will need to monitor you more carefully
• You 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.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking amiodarone.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because amiodarone can affect the way some other medicines work. Also some medicines can affect the way amiodarone works.
In particular, do not take this medicine and tell your doctor, if you are taking:
• Other medicines for an uneven heartbeat (such as fl ecainide, quinidine, procainamide, disopyramide, sotalol or bretylium)
• Medicines for infections (such as intra-venous erythromycin, co-trimoxazole, moxifloxacin or pentamidine)
• Medicines for schizophrenia (such as chlorpromazine, thioridazine, fluphenazine, pimozide, haliperidol, amisulpiride or sertindole)
• Medicines for other mental illnesses (such as lithium, doxepin, maprotiline or amitriptyline)
• Medicines for malaria (such as quinine, mefl oquine, chloroquine or haloantrine)
• Medicines used for hay fever, rashes or other allergies called antihistamines (such as terfenadine, astemizole or mizolastine)
Tell your doctor if you are taking any of the following medicines:
• Medicines for infection (such as ciprofl oxacin, ofl oxacin or levofl oxacin)
• Medicines for heart problems called beta-blockers (such as propranolol)
• Medicines for chest pain (angina) or high blood pressure (such as diltiazem or verapamil)
• Medicines for constipation (laxatives) such as bisacodyl or senna
• Medicines for high cholesterol (statins) such as simvastatin or atorvastatin
The following medicines can increase the chance of you getting side effects, when taken with amiodarone:
• Medicines for fungal infections (such as amphotericin when given directly into a vein)
• Medicines for infl ammation (corticosteroids) such as hydrocortisone, betamethasone or prednisolone
• Water tablets (diuretics) such as furosemide
• 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 sildenafi l, tadalafi l or vardenafi l
• Fentanyl - used for pain relief
• Ergotamine - used for migraines
• Midazolam - used to relieve anxiety or to help you relax before surgery
• Flecainide - another medicine used for uneven heartbeats
• Lidocaine - used as an anaesthetic
• Warfarin - to stop blood from clotting
• Phenytoin - to treat epilepsy
• Digoxin - to slow fast heart rate
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking amiodarone.
Taking amiodarone with food and drink
Do not drink grapefruit juice while taking this medicine.
This is because drinking grapefruit juice while taking amiodarone can increase your chance of getting side effects.
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. T alk to your doctor or pharmacist about the amount of alcohol you can drink.
Protect your skin from sunlight
Keep out of direct sunlight while taking this medicine and for a few months after you have fi nished 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
Pregnancy and breast-feeding
be pregnant. pass into the
• Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or think you may Amiodarone is not normally given during pregnancy
• Do not take if you are breast-feeding or plan to breast-feed. This is because small amounts of this medicine may mothers' milk
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
You may have blurred eyesight after taking this medicine.
If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of amiodarone
This medicine contains:
• Lactose (a type of sugar): If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine
• Iodine: amiodarone tablets contain 37.5mg of iodine in a 100 mg tablet and 75 mg of iodine in a 200mg tablet. Iodine is present in amiodarone hydrochloride, the medicine your tablets contain. Iodine can cause problems to your thyroid (see Section 3 -'Tests' below)
Always take amiodarone exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
3. HOW TO TAKE AMIODARONE Taking this medicine
• Take this medicine by mouth
• Swallow the tablets whole. Do not crush or chew your tablets
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
How much to take Adults
• The usual starting dose is 200 mg three times each day for one week
• The dose will then be lowered to 200 mg twice each day for one week
• The dose will then be lowered to 200 mg once each 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 react to this medicine
Children and adolescents
• There are only limited data on the efficacy and safety in children. Your doctor will decide on an appropriate dose.
Elderly
• The doctor may give you a lower dose of amiodarone. Also, the doctor should check your blood pressure and thyroid function regularly
If you take more amiodarone than you should
If you take more amiodarone than you should, tell a doctor or go to a hospital casualty department straight away. Take the carton and any amiodarone tablets left with you so the doctor knows what you have taken.
Symptoms of an overdose are feeling dizzy, faint or tired, confusion, slow heartbeat, damage to the liver or being sick.
If you forget to take amiodarone
If you forget a dose, take it as soon as you remember it, unless it is time for your next dose.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking amiodarone
Keep taking amiodarone until your doctor tells you to stop. Do not stop taking amiodarone just because you feel better. If you stop taking this medicine the uneven heartbeats may come back. This could be dangerous.
Tests
Your doctor may do regular thyroid tests while you are taking this medicine.
This is because amiodarone contains iodine which can cause problems with 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 and while you are taking amiodarone.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, amiodarone 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 amiodarone 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 (affects less than 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 (affects less than 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 (affects less than 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 (affects less than 1 in 100 people)
• Feeling numb or weak, tingling or burning feelings in any part of your body
Very rare (affects less than 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) fi ts, 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 (affects more than 1 in 10 people)
• Blurred eyesight or seeing a coloured halo in dazzling light
Common (affects less than 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 (affects less than 1 in 100 people)
• Muscle cramps, stiffness or spasm
Very rare (affects less than 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')
• 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)
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
Very common (affects 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 (affects less than 1 in 10 people)
• Slightly slower heart beat
• Nightmares
• Problems sleeping
Very rare (affects less than 1 in 10,000 people)
• Headache
• Balance problems, feeling dizzy (vertigo)
• Diffi culty 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)
Tests
Your doctor will take regular tests to check how your liver is working. Amiodarone can affect how your liver works. If this happens, your doctor will decide whether you should keep taking these tablets. Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days or if you notice any side effects not listed in this leaflet.
5. HOW TO STORE AMIODARONE
• Keep this medicine in a safe place where children cannot see or reach it.
• Do not store above 25C.
• Do not use amiodarone after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• Keep the blister strip in the outer carton in order to protect from light.
• Do not use amiodarone if you notice your tablets are crumbling, broken or discoloured.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION What amiodarone contains
Each tablet contains 100mg or 200mg of amiodarone hydrochloride as the active substance.
The other ingredients are lactose monohydrate, maize starch, povidone, colloidal anhydrous silica, pregelatinised starch and magnesium stearate.
What amiodarone looks like and contents of the pack
The 100 mg tablets are round, white tablets with a break line on one side and are embossed '100' on the reverse side. The 200 mg tablets are round, white tablets with a break line on one side and are embossed '200' on the reverse side.
The tablets are available in the packs of 28 and 30 tablets.
Marketing Authorisation Holder
Activase Pharmaceuticals Limited 11 Boumpoulinas, 3rd Floor P.C. 1060 Nicosia, Cyprus
Manufacturer & Batch Release Site:
Rivopharm SA, PO Box 40, via Cantonale Manno-Lugano 6928,
Switzerland