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AMIODARONE HYDROCHLORIDE TABLETS 200MG

Active substance(s): AMIODARONE HYDROCHLORIDE

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e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

240810/1

Colours Used

Customer

Ennogen

Black

Description

Amiodarone Leaflet

Keyline

Market

UK

Language

English

Size

160 x 360 mm

Min. Font Size

9 pt

Page No.

1 of 2

Version No.

11

Date

22-12-15

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amiodarone Hydrochloride 200mg 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 or 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 or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section
4.
What is in this leaflet:
1. What Amiodarone Tablets are and what they
are used for
2. What you need to know before you take
Amiodarone Tablets
3. How to take Amiodarone Tablets
4. Possible side effects
5. How to store Amiodarone Tablets
6. Contents of the pack and other information
1. WHAT AMIODARONE TABLETS ARE AND
WHAT THEY ARE USED FOR
Amiodarone Tablets are from a group of medicines
called anti-arrhythmics which are used in the
treatment of severe or life threatening cardiac
arrhythmias (where the heart beats rapidly or
irregularly). In particular a fast heart beat
associated with Wolff-Parkinson-White Syndrome,
treatment of severe rhythm disorders not
responding to other drugs or used in treatment
when other drugs cannot be used. These tablets
can be used for stabilization and long term
treatment.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE AMIODARONE TABLETS
Do not take Amiodarone Tablets if you:
! Are hypersensitive (allergic) to Amiodarone or
any of the other ingredients of Amiodarone
Tablets such as iodine. One 200mg tablet
contains approximately 75mg iodine (listed in
section 6)
! Have heart block, which may cause a very
slow, rapid or irregular pulse or dizziness
! Suffer from or have a history of thyroid
problems. Your doctor may recommend regular
check-ups to monitor your condition
! Are pregnant or breastfeeding as you should
check with your doctor beforehand (see
'Pregnancy and breastfeeding below).
Amiodarone must not be given to children,
premature babies or neonates.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before
taking this medicine if you:
! Have heart failure or a heart condition such as
a slow heart rate
! Have liver problems
! Have problems with your lungs, shortness of
breath or have asthma
! Have problems with your eyesight. This
includes an illness called 'optic neuritis'
! Are about to have an operation
! Are elderly (over 65 years of age). The doctor
will need to monitor you more carefully
! Are on digitalis therapy as this may affect the
rhythm of your heart
! Are on radio-iodine uptake as this medicine
contains iodine which may affect its uptake in
the body
! Have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicine
! Have ever had thyroid problems. Your doctor
should test your thyroid before giving you this
medicine
! Tell your doctor or nurse you are taking these
tablets if you are going to have surgery,
including dental.
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.

Taking other medicines
Please tell your doctor or pharmacist if you are
taking, have recently taken or plan to take any
other medicines. In particular, do not take this
medicine and tell your doctor, if you are taking:
! Other medicines for an uneven heartbeat (such
as solatol, quinidine, procainamide,
disopyramide or bretylium)
! Medicines for infections (such as intra-venous
erythromycin, co-trimoxazole, moxifloxacin or
pentamidine)
! Medicines for schizophrenia (such as
chlorpromazine, thioridazine, fluphenazine,
pimozide, haloperidol, amisulpride or
sertindole)
! Medicines for other mental illnesses (such as
lithium, doxepin, maprotiline or amitriptyline)
! Medicines for malaria (such as quinine,
mefloquine, chloroquine or halofantrine)
! 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 that lengthen your heart beat (the
QT interval) such as medicines for infection
(such as clarithromycin)
! Medicines for heart problems called betablockers and medicines called calcium channel
blockers 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 Tablets:
! Amphotericin (when given directly into a vein) used for fungal infections
! Medicines for inflammation (corticosteroids)
! Water tablets (diuretics)
! General anaesthetics or high dose oxygen used during surgery
! Tetracosactide - used to test some hormone
problems
Amiodarone Tablets 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 migraines
! Midazolam - used to relieve anxiety or to help
you relax before surgery
! Colchicine - used for the treatment of gout
! Flecainide - another medicine used for uneven
heartbeats. Your doctor should monitor your
treatment and may half your dose of Flecainide
! Lidocaine - used as an anaesthetic
! Warfarin - used to stop your blood from clotting
! Digitalis - used for some heart conditions
! Dabigatran - used to thin the blood
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice if you are
pregnant or planning on becoming pregnant before
taking this medicine. Do not take if you are breast
feeding or plan to breastfeed. This is because
small amounts of this medicine may pass into the
mother's milk.
Driving and using machines
You may have blurred eyesight after taking this
medicine if this happens, do not drive or use any
tools or machinery.
Amiodarone Tablets with food and 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.
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 a problem with your liver. Talk to your
doctor or pharmacist about the amount of alcohol
you can drink.

e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

240810/1

Colours Used

Customer

Ennogen

Black

Description

Amiodarone Leaflet

Keyline

Market

UK

Language

English

Size

160 x 360 mm

Min. Font Size

9 pt

Page No.

2 of 2

Version No.

11

Date

22-12-15

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Amiodarone Tablets contain lactose
If you have been told by your doctor that you have
an intolerance to some sugars talk to your doctor
before taking this medicine.
Amiodarone Tablets contain iodine
These tablets also contain 75mg of iodine in a
200mg tablet and can cause problems to your
thyroid.
3. HOW TO TAKE AMIODARONE TABLETS
Always take Amiodarone Tablets exactly as your
doctor has instructed you. You should check with
your doctor or pharmacist if you are unsure.
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
! The usual dosage is 200mg, three times a day
for one week
! The dose will then be lowered to 200mg, twice
a day for one week
! The dose will then be lowered to 200mg once
each day until you are told otherwise.
In some cases your doctor may decide to either
increase or lower the amount you take each day.
This will depend on how you react to this medicine.
Elderly:
The prescribed dose may be lower than the usual
dose.
Children and adolescents:
There are only limited data on the efficacy and
safety in children. Your doctor will decide on the
appropriate dose.
If you take more Amiodarone Tablets than you
should
This medicine is to be taken at regular intervals, as
determined by the physician. If you take too many
tablets by mistake contact your nearest hospital
casualty department or tell your doctor
immediately. Take your tablet pack with you.
If you stop taking Amiodarone Tablets
Keep taking Amiodarone Tablets until your doctor
tells you to stop. Do not stop taking Amiodarone
Tablets just because you feel better. If you stop
taking this medicine the uneven heartbeats may
come back, this could be dangerous.
If you forget to take Amiodarone Tablets
If you have forgotten to take a dose, leave out that
dose completely. Take your next dose at the
normal time. If you have trouble remembering to
take the tablets, tell your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Amiodarone Tablets can cause
side effects, although not everyone gets them.
If you experience any of the following then
STOP taking the medicine and contact a doctor
immediately
! You get a pain in your chest that feels like
pressure, squeezing or fullness. It may feel
similar to heartburn or indigestion. Other
symptoms may include discomfort in one or
both arms, neck , jaw or stomach, shortness of
breath, with feeling or being sick, feeling lightheaded and breaking out in a cold sweat. YOU
SHOULD GO TO HOSPITAL IMMEDIATELY.
! Your heart beat becomes even more uneven or
erratic. This can lead to a heart attack, so you
should go to the hospital straightaway.
! Allergic reactions may occur rarely, with
symptoms such as rash, itching, swelling of the
face, wheeziness, shortness of breath,
tightness in the chest, fever, low blood
pressure and feeling dizzy particularly when
standing up
! 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.
Common (may affect up to 1 in 10 people)
! Constipation
! Itchy, red rash (eczema).
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.
! Dry mouth.
Not known (frequency cannot be estimated
from the available data)
! Severe allergic reaction (anaphylactic reaction,
anaphylactic shock); sudden inflammation of
the pancreas (pancreattis (acute)); decreased
appetite; unusual muscle movements; stiffness;
shaking and restlessness (parkinsonism);
abnormal sense of smell (parosmia); confusion

Quality Control (QC)

Production

(delirium); life-threatening skin
reactions characterised by rash,
blisters, peeling skin and pain (toxic
epidermal necrolysis (TEN), StevensJohnson sundrome (SJS), bullous
dermatitis, Drug reaction with
eosinophilia and systemic symptoms
(DRESS)).
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 heart beat becomes very slow or stops
beating.
Not known (frequency cannot be estimated
from the available data)
! Severe allergic reaction (anaphylactic reaction,
anaphylactic shock); sudden inflammation of
the pancreas (pancreattis (acute)); decreased
appetite; unusual muscle movements;
stiffness; shaking and restlessness
(parkinsonism); abnormal sense of smell
(parosmia); confusion (delirium); lifethreatening skin reactions characterised by
rash, blisters, peeling skin and pain (toxic
epidermal necrolysis (TEN), Stevens-Johnson
sundrome (SJS), bullous dermatitis, Drug
reaction with eosinophilia and systemic
symptoms (DRESS)).
!
Amiodarone may cause some patients to become
sensitive to the sun or may cause a discolouration
to the skin or a rash. You should avoid exposure of
your skin to direct sunlight or sunlamps. Sunlight
sensitivity may persist for some time after
treatment stops and therefore sensible precautions
should be taken to minimize the amount of sun
exposure to the skin.
Other side effects include:
Headaches, disturbed sleep patterns, nausea,
vomiting, a metallic taste, painful swelling of the
testicles, impotence, a slow pulse, shakiness, hair
loss, muscle pain and weakness, difficulty in
walking or balancing, inflammation of the veins
and problems with the blood (you may notice
bruising or nose bleeds).
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE AMIODARONE TABLETS
Check the expiry date printed on the label or side
of the box. Do not use after the expiry date stated
on the label.
Do not store above 25°C. Store in the original
package.
In case of any visible signs of deterioration, you
should discard the package.
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures help to protect the environment.
Keep out of the sight and reach of children
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Amiodarone Tablets contain:
Amiodarone Tablets contain 200mg of the active
substance amiodarone hydrochloride in each
tablet.
The other ingredients are: maize starch, lactose
monohydrate, povidone (K90) magnesium
stearate, silica, colloidal anhydrous and
pregelatinised starch.
What Amiodarone Tablets look like and
contents of the pack
Each tablet is a white flat tablet marked with '200'
on one side and a break line on the other side.
Amiodarone Tablets are supplied in packs of 28.
Marketing Authorisation Holder
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
Manufacturer:
NivoPharma SA
PO BOX 40, Via Cantonale
Manno-Lugano, 6928, Switzerland.
This leaflet was last revised in December 2015

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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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