Amiodarone Hydrochloride 100mg Tablets
Out of date information, search anotherPATIENT INFORMATION LEAFLET Amiodarone hydrochloride 100mg and 200mg Tablets
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. 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 leaflet, please tell your doctor or pharmacist.
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 TABLET IS AND WHAT IT IS USED FOR
Amiodarone hydrochloride 100mg and 200mg Tablets are used to control severe rhythm disorders of the heart or irregular heart beats of a sudden nature when other treatments cannot be used. Treatment with amiodarone is normally initiated and monitored under hospital or specialist supervision.
2. BEFORE YOU TAKE AMIODARONE TABLETS Do not take Amiodarone tablets
• If you are allergic to amiodarone or any of the other ingredients of amiodarone tablets (see section 6)
• If you have heart block - which may cause a very slow or irregular pulse and/or dizziness
• If you have or have had thyroid problems
• If you are allergic to iodine
• If you are pregnant or breast-feeding (see ‘Pregnancy and breast-feeding’ below)
• If you are taking other medicines;
• Other anti-arrhythmic drugs used to treat irregular heartbeats (e.g. quinidine, sotalol, disopyramide, procainamide, bretylium)
• Medicines used to treat psychiatric problems (e.g. chlorpromazine, thioridazine, fluphenazine,
pimozide, haloperidol, amisulpiride and sertindole)
• Some antihistamines - used to treat allergies and hayfever (e.g. terfenadine, mizolastine, astemizole)
• Intravenous antibiotics such as erythromycin, co-trimoxazole, moxifloxacin or pentamidine used to treat infections
• Anti malarials - used to treat or prevent malaria (e.g. chloroquine, halofantrine, mefloquine and quinine)
• Medicines for other mental illnesses (such as lithium, doxepin, maprotiline or amitriptyline).
Take special care with Amiodarone tablets and talk to your doctor.
• If you have heart failure
• If you are pregnant or likely to become pregnant
• If you need to have an operation
• If you have liver problems
• If you have any problems with your lungs or have asthma
If you have any problems with your eyesight. This includes an illness called ‘optic neuritis’
• If you are elderly (over 65 years of age). The doctor will need to monitor you more carefully
• If 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 Tablets.
Taking other medicines
The effects of amiodarone can be altered by other medicines and the effects of the other medicines can be changed by amiodarone.
Please check with your doctor if you are taking any of the following medicines:
• Anticoagulants-used to thin the blood (particularly warfarin)
• Other drugs which are highly protein bound (e.g. phenytoin, tolbutamide, aspirin)
• Diuretics (water tablets)
• Digoxin - used for heart problems
• Beta blockers - used to treat high blood pressure, angina or an irregular heart beat (e.g. atenolol, propranolol)
• Some calcium channel blockers - used to treat high blood pressure and angina (e.g. verapamil, diltiazem)
• Ciclosporin - used after transplant operations
• Oral steroids, e.g. prednisolone
• Stimulant laxatives (e.g. dantron or bisacodyl) which may cause low levels of potassium in the blood
• Flecainide to regulate the rate and rhythm of the heart
• Simvastatin or other statins (used to lower cholesterol levels)
• Amphotericin - used to treat infections
• Medicines for infection (such as ciprofloxacin, ofloxacin or levofloxacin)
• General anaesthetics or high dose oxygen used during surgery
• Tetracosactide - used to test some hormone problems
• Medicines for impotence such as sildenafil, tadalafil or vardenafil
• Fentanyl - used for pain relief
• Ergotamine - used for migraines
• Midazolam - used to relieve anxiety or to help you relax before surgery
• Lidocaine - used as an anaesthetic.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Amiodarone Tablets.
Taking Amiodarone tablet with food or drink
Grapefruit juice can increase the blood level of Amiodarone hydrochloride and should be avoided during treatment with Amiodarone hydrochloride tablets.
You should limit the amount of alcohol you drink whilst taking these tablets.
Pregnancy and breast feeding
• Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or think you may be pregnant. Amiodarone Tablets are not normally given during pregnancy
• Do not take Amiodarone if you are breast feeding.
Driving and using machines
Amiodarone hydrochloride tablets may cause blurred vision in some people. Do not drive or operate machinery if you experience this side-effect.
Important information about some of the ingredients of the Amiodarone tablet
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE AMIODARONE TABLETS
Take your Amiodarone hydrochloride Tablets as prescribed by your doctor and as stated on the pharmacy label on the carton of your medicine.
Swallow the tablets whole and take with a glass of water. Amiodarone Tablets can be taken with or without food.
If you are not sure how to take your tablets or how many to take, please speak to your pharmacist or doctor.
Dosage: Adults & the elderly
• The usual dose of amiodarone is 200mg three times a day for the first week, followed by 200mg twice a day for the next week and then 200mg daily
• In some patients this may be reduced to 100mg a day
• Elderly patients may be prescribed lower doses.
Your doctor will have decided the correct dose for you. Keep taking your medicine until your doctor tells you to stop.
Children and adolescents
The safety and efficacy of amiodarone in children has not been established.
Do not stop taking it because you feel better. If you stop the tablets your condition may get worse.
If you take more Amiodarone tablets than you should
As with all medicines an overdose could be dangerous. If you, or someone else, has taken an overdose tell your doctor or go to the nearest hospital casualty department IMMEDIATELY. If you go to the doctor/hospital remember to take this leaflet and any remaining Amiodarone Tablets with you so the doctor knows what you have taken.
If you forget to take Amiodarone tablets
If you forget a dose take it as soon as you remember providing it is within 2 hours. If not, wait until your next dose is due and continue as normal. Do not take two doses at once.
Do not take a double dose to make up for a forgotten dose.
If you have any further question on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Amiodarone hydrochloride Tablets can cause side effects, although not everybody gets them.
Stop taking amiodarone immediately and call your doctor if you experience signs of allergic reaction.
Signs of an allergic reaction include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
Amiodarone may cause side effects listed as below:
Very common side effects (could affect more than 10 in 100 people)
• difficulties with your vision
• nausea (feeling sick) which subsides on dose reduction
• vomiting (being sick) which subsides on dose reduction
• a metallic taste which subsides on dose reduction
• increase in the amount of liver enzymes. This can be seen in blood tests and usually returns to normal with dose reduction
• Amiodarone can cause some patients to become sensitive to the sun. You should avoid exposure of your skin to direct sunlight or sunlamps. If you are sensitive then this may persist for some time after treatment stops. You should take sensible precautions when you are in the sun such as wearing a wide brimmed hat and keeping arms and legs covered. Use a total sun block cream for exposed areas of skin.
Common side effects (could affect more than 1 in 100 people)
• a slow pulse
• problems with your thyroid gland (you may notice extreme restlessness and/ or loss of weight, extreme tiredness and/ or gain of a lot of weight
• diseases of the liver with jaundice including liver failure
• shakiness which improves on dose reduction or drug withdrawal
• nightmares, disturbed sleep patterns
• diseases of the lungs, increased risk of infection
• slate grey or bluish discolouration of the skin exposed to light, particularly the face which disappears following treatment discontinuation.
Uncommon side effects (could affect less than 1 in 100 people)
• worsening of irregular heart beats sometimes leading to heart failure or other diseases of the heart
• pins and needles, weakness of hands or legs, cramps which subsides on drug withdrawal
• muscle pain and weakness which subsides on drug withdrawal.
Very rare side effects (could affect less than 1 in 10,000 people)
• paleness of your skin
• problems with the blood (you may notice bruising or nose bleeds)
• a slow pulse or irregular heart rate in elderly patients
• diseases of the eye that may progress to blindness
• difficulty in walking or balancing which improves on dose reduction or drug withdrawal
• headache
• vertigo (a feeling of dizziness or 'spinning')
• painful swelling of the testicles
• failure of erection
• difficulty in breathing in patients with severe respiratory failure and especially in asthmatic patients
• redness of the skin if you have radiotherapy
• skin rashes
• hair loss
• problems with the pituitary gland (a gland at the base of your brain) leading to low sodium content in blood (shown on blood tests) and water retention
• inflammation of the veins
• liver disease
• sudden, uncoordinated muscle movement.
Frequency not known (Cannot be estimated from the available data)
• rapid swelling of the skin, mucosa and submucosal tissues, especially the mouth and throat
• bleeding from the lungs
• pale red, raised, itchy bumps
• Bone marrow disease.
Anything else that is unusual or unexpected. Your doctor may want to arrange tests such as blood tests, chest x-rays, ECG (electrical tracing of your heart) and eye examinations before and during treatment to monitor your medical condition.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE AMIODARONE TABLETS
Keep out of reach and sight of children.
Expiry date (abbreviation for expiry date).
Do not take this medicine after the expiry date shown on the pack. The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original package.
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 tablet contains
Each tablet contains the active ingredient Amiodarone hydrochloride. The tablets are available in two strengths containing 100mg and 200mg amiodarone.
Each Amiodarone hydrochloride Tablet also contains: lactose monohydrate, maize starch, povidone K90, colloidal anhydrous, silica, pregelatinised starch and magnesium stearate (E470b).
What Amiodarone tablet looks like and contents of the pack
Amiodarone hydrochloride 100mg Tablets are round, white, flat with a central division line on one face and embossed“100” on the reverse.
Amiodarone hydrochloride 200mg Tablets are round, white, flat with a central division line on one face and embossed “200” on the reverse.
Amiodarone hydrochloride 100mg and 200mg Tablets are supplied in cartons of 28 tablets. Marketing Authorisation Holder and Manufacturer:
Mercury Pharmaceuticals Ltd, No. 1 Croydon, 12-16 Addiscombe Road, Croydon, CR0 0XT, UK
E-mail : medicalinformation@mercurypharma.com This leaflet was revised in March 2012