AMIODARONE HYDROCHLORIDE 100MG TABLETS

Active substance: AMIODARONE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

Amiodarone Hydrochloride 100mg & 200mg Tablets
(Amiodarone Hydrochloride)
Please read this entire leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your pharmacist.
This medicine has been prescribed for you personally and you should 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 become serious or you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
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Phenytoin (for epilepsy)
Medicines used to treat high blood pressure, angina or
an irregular heart beat, such as atenolol and
propranolol (beta blockers)
Verapamil and diltiazem, used to treat high blood
pressure and chest pain (calcium channel inhibitors)
Stimulant laxatives, such as bisacodyl and senna
Medicines which may cause a drop in blood potassium
or magnesium levels, such as diuretics (water tablets),
steroids, tetracosactide (used to test adrenal function)
and amphotericin injection (antifungal medicine)
Cyclosporin and tacrolimus, used after transplant
operations.
Flecainide, used for irregular heart rhythms
Medicines for infections, such as ciprofloxacin,
levofloxacin, and ofloxacin
Medicines for high cholesterol (statins) such as
simvastatin, atorvastatin and lovastatin
Lidocaine, used as an anaesthetic
Sildenafil, used for impotence
Fentanyl, for pain relief
Midazolam, used to relieve anxiety or to help you relax
before surgery
Triazolam, used as a sedative for severe sleep problems
Ergotamine or dihydroergotamine, used for migraine

What this medicine is and what it is
used for

Amiodarone Hydrochloride is an anti−arrhythmic drug used
to control an irregular or rapid heart rate.

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Before you take

Do not take if:
you have heart block, which may cause a very slow,
very fast or irregular pulse or dizziness
you have any other problems with your heart and do
not have a pacemaker fitted
you have or have had thyroid problems
you are allergic to iodine, amiodarone or any of the
other ingredients (see section 6 and ’Important
information about some of the ingredients, section 2)
you are pregnant or breast−feeding (see ’Pregnancy
and breast−feeding, section 2)
you are taking the following other medicines:
− Medicines to treat irregular heart rhythms, such as
quinidine, procainamide, disopyramide, sotalol
(beta−blocker) and bretylium
− Medicines for infections such as erythromycin
injection, co−trimoxazole and moxifloxacin (antibiotics)
− Pentamidine injection (used to treat infections such
as pneumonia in AIDs patients)
− Medicines used to treat mental illnesses, such as
chlorpromazine, thiordazine, pimozide, haloperidol
fluphenazine, amisulpiride and sertindole
− Lithium and other anti−depressants, such as
doxepin, maprotiline and amitriptyline
− Some medicines used to treat allergies and hay fever
(antihistamines), such as terfenadine, astemizole
and mizolastine
− Medicines to treat or prevent malaria, such as
quinine, metfloquine, chloroquine and halofantrine
Take special care if:
you have heart failure
you are to have an operation under anaesthetic or a
high dose of oxygen. (tell your doctor that you are
taking Amiodarone Hydrochloride)
you are exposed to direct sunlight. You should avoid
exposure of your skin to direct sunlight or sunlamps.
You should take sensible precautions when you are in
the sun; wear a wide brimmed hat and keep your arms
and legs covered; apply total sun block cream to
exposed areas of the skin
you are elderly as your 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 any of the above apply to you, please contact your
doctor or pharmacist.
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines including
those obtained without prescription. Some medicines
may interact with your Amiodarone Hydrochloride Tablets.
Medicines not to be taken with Amiodarone Hydrochloride
See medicines listed in Section 2 ’Do not take if’
Other medicines which may interact with Amiodarone
Hydrochloride
Digoxin (used to increase heart muscle contraction and
in heart failure)
Warfarin (anticoagulant, used to thin the blood)

Hard to Read?

Possible side effects
How to store
Further information

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What this medicine is and what it is used for
Before you take
How to take

Taking with alcohol food and drink
Grapefruit juice should not be drunk whilst taking this
medicine.
You should limit the amount of alcohol you drink whilst
taking these tablets.
Pregnancy and breast−feeding
If you are pregnant or think you may be pregnant you
should not take Amiodarone Hydrochloride unless your
doctor decides that it is essential.
If you are breast−feeding you should not take this medicine.
Driving and using machinery
Amiodarone Hydrochloride should not affect your ability to
drive or operate machinery. However, if you do experience
blurred vision, you should not drive or operate machinery.
Lactose: Important information about some of the
ingredients
This medicine contains lactose. If you have been told by
your doctor that you have intolerance to some sugars,
contact your doctor before taking this medicine.

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How to take

You should always take this medicine as prescribed
by your doctor. Read and follow the instructions on
the pharmacist’s label. If you are not sure about
anything please ask your doctor or pharmacist.
These tablets are to be taken orally
Swallow the tablets with a drink of water.
Keep taking your medicine until your doctor tells you to stop.
Do not stop taking it because you feel better. If you stop
the tablets your condition may get worse.
Usual dosage
The doses given below are guidelines only. You should
always take this medicine as prescribed by your doctor.
Adults
Initially:

The usual starting dose is 200mg three
times a day for the first week. The dose
should then be reduced to 200mg twice a
day for a further week.

Maintenance: After the initial period the dose should be
reduced to 200mg daily or less, if appropriate.
Rarely, a higher dose is required.

Phone

continued....

0800 970 6115

for help
Till−Ver.3s

Elderly

Lower doses may be prescribed. Your doctor will
prescribe the correct dose for you. Check the
label and if you are not sure ask your doctor or
pharmacist.

Skin rashes, including flaking of the skin or redness
during radiotherapy
Hair loss
Reduction in red blood cells which can make the skin
pale yellow and cause weakness or breathlessness
Severe reduction in blood cells which can cause
weakness, bruising or make infections more likely
Reduction in blood platelets, which increases risk of
bleeding or bruising
Difficulty in breathing or wheezing, especially if
asthmatic
Feeling unwell, confused or weak, feeling sick, loss of
appetite or feeling irritable (symptoms of syndrome of
inappropriate anti−diuretic hormone secretion (SAIDH)
Increase in blood creatinine levels (detected through
blood test)
Reduced sexual potency
Swollen testicles

Children and adolescents There is only limited data on
the efficacy and safety in children. Your doctor
will decide on an appropriate dose.
If you forget to take Amiodarone Hydrochloride
Take your missed dose as soon as you remember. Do not
take a double dose to make up for the forgotten individual
dose. If you miss several doses, tell your doctor.
If you take more Amiodarone Hydrochloride than you
should
As with all medicines an overdose could be dangerous. If
you, or someone else, swallow more tablets than you
should, tell your doctor or go to the nearest hospital
casualty department immediately.

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Possible side effects

Like all medicines, Amiodarone Hydrochloride can cause
unwanted side effects in some patients.
Serious side effects
If you experience any of the following you should see
your doctor as soon as possible as you may have to
stop taking the tablets:
Yellowing of the skin or white of the eyes (symptoms of
jaundice), feeling tired or sick, loss of appetite, stomach
pain or high temperature (symptoms of other liver
problems)
Weight loss, weakness or loss of strength,
restlessness, increased heart rate or change in heart
rhythm, chest pain or heart failure (symptoms of over
active thyroid)
Persistent cough, breathlessness, tiredness, weight
loss or fever (symptoms of inflammation of the lungs)
Short or rapid breathing and confusion (symptoms of
adult respiratory distress syndrome). More likely to
happen after surgery
Coughing up blood (symptom of pulmonary
haemorrhage)
Dizziness, weakness, confusion or a very slow heart
beat (a pacemaker may need to be fitted)
Problems with the rhythm of the heart, including
palpitations or chest pains (especially the elderly) or the
heart stops beating
Moving unsteadily or staggering, slurred or slow speech
(symptoms of a brain problem)
Headache (usually worse in the morning or occurs after
coughing or straining), feeling or being sick (symptoms
of a brain problem)
Sore or tender eyes which are painful to move or loss
of vision. This could progress to blindness (symptoms
of optic neuropathy or neuritis)
Swelling of the face or throat or inflammation of the
blood vessel, often with a skin rash (symptoms of an
allergic reaction)
Very common side effects (affect more than 1 in 10 people)
Stomach problems such as feeling or being sick,
metallic or unusual taste in the mouth
Increased sensitivity to sunlight (symptoms include
tingling, burning, redness or blistering of the skin (see
section 2, ’Take special care’ for precautions)
Micro deposits in the cornea (usually only detected by
eye examination) but may cause blurred vision or
seeing halos around objects or lights
Changes in the amount of liver enzymes at the
beginning of treatment (detected through blood test)
Common side effects (affect less than 1 in 10 people)
Slower heart beat
Nightmares
Difficulty sleeping and/or sleep disorders
Involuntary movements
Slate grey or bluish discolouration of light exposed skin,
particularly on the face
Under active thyroid gland which can cause tiredness
or weight gain
Uncommon side effects (affect less than 1 in 100 people)
Decreased ability to move or feel (sensation) due to
nerve damage
Muscle pain or weakness
Very rare side effects (affect less than 1 in 10,000 people)
A feeling of dizziness or "spinning"
Headaches

Hard to Read?

Other side effects (frequency not known)
Tiredness
Tingling or numbness in the hands or feet
High fever and feeling unwell (possible symptoms of
bone marrow granulomas)
Itchy rash
Your doctor may want to arrange tests such as blood tests,
chest x−rays and eye examinations before and during
treatment to monitor your medical condition.
If any of the side effects become serious or you notice
any not listed, please tell your doctor or pharmacist.

5

How to store

Store out of reach and sight of children.
These tablets should be stored away from light.
Do not store above 30°C.
Keep your Amiodarone Hydrochloride tablets in the original
container in which they were given to you.
Do not take after the expiry date, which is stated on the
carton after EXP. The expiry date refers to the last day of
that month.
If there are any tablets left after your doctor has told you to
stop taking them, return them to the pharmacist.

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Further information

What Amiodarone Hydrochloride tablets contain:
Active ingredient:
Each tablet contains either 100mg or 200mg of
Amiodarone Hydrochloride Ph. Eur.
Other ingredients:
lactose, maize starch, polyvidone, colloidal silicon dioxide
and magnesium stearate.
This medicine contains lactose (see ’Important
information about some of the ingredients’, section 2)
What Amiodarone Hydrochloride tablets look like and
the contents of the pack:
Amiodarone Hydrochloride Tablets are white, round,
biconvex tablets with a score notch on one side.
They are supplied in cartons of 28 or 30 tablets.
Marketing Authorisation Holder:
Tillomed Laboratories Ltd
3 Howard Road, Eaton Socon, St. Neots,
Cambridgeshire, PE19 8ET,
UK
Manufacturer:
Salutas Pharma GmbH
39179 Barleben,
Otto−von−Guericke Allee 1
Germany
Product Licence Numbers:
Amiodarone Hydrochloride 100mg Tablets PL 11311/0170
Amiodarone Hydrochloride 200mg Tablets PL 11311/0171

Date of last revision: December 2011

Phone

0800 970 6115

for help
Till−Ver.3s

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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