Amiodarone 200mg tablets

Main information

  • Trade name:
  • Amiodarone 200mg tablets
  • Dosage:
  • 200mg
  • Pharmaceutical form:
  • Tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Amiodarone 200mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 02030200

Status

  • Source:
  • eMC
  • Last update:
  • 29-01-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

PACKAGE LEAFLET:

INFORMATION FOR THE USER

Amiodarone 100 mg Tablets

Amiodarone 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 you doctor,

pharmacist or nurse. This includes any

possible side effects not listed in this leaflet.

See section 4.

What is in this leaflet:

What Amiodarone Tablets are and what they

are used for

What you need to know before you take

Amiodarone Tablets

How to take Amiodarone Tablets

Possible side effects

How to store Amiodarone Tablets

Contents of the pack and other information

1. WHAT AMIODARONE TABLETS ARE AND

WHAT THEY ARE USED FOR

Amiodarone 100mg or 200mg Tablets (called

Amiodarone Tablets in this leaflet) contain a

medicine called amiodarone hydrochloride. 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 Tablets 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 Tablets are used only when other

medicines can not be used.

Treat fast heartbeats which may happen

suddenly and may be uneven. Amiodarone

Tablets are used only when other medicines

cannot be used.

2. What you need to know before you take

Amiodarone Tablets

Do not take Amiodarone Tablets if

you are allergic (hypersensitive) to iodine,

amiodarone hydrochloride or any of the other

ingredients of Amiodarone Tablets (see section

6). 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

applies to you.

If you are not sure, talk to your doctor or

pharmacist before taking Amiodarone Tablets.

Warnings and precautions

Talk to your doctor, pharmacist or nurse

before taking Amiodarone Tablets 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.

You have blistering or peeling of the skin around

the lips, eyes, mouth, nose and genitals, flu-like

symptoms and fever. This could be a condition

called Stevens-Johnson syndrome

You have a severe blistering rash in which

layers of the skin may peel off to leave large

areas of raw exposed skin over the body. You

may also feel generally unwell, have a fever,

chills and aching muscles (Toxic Epidermal

Necrolysis)

If you are not sure if any of the above apply to

you, talk to your doctor or pharmacist before

taking Amiodarone Tablets.

Other medicines and Amiodarone Tablets

Tell your doctor or pharmacist if you are taking,

have recently taken or might take any other

medicines. This is because Amiodarone Tablets

can affect the way some other medicines work.

Also some medicines can affect the way

Amiodarone Tablets works.

In particular, do not take this medicine and

tell your doctor, if you are taking:

Other medicines for an uneven heartbeat

(such as sotalol, quinidine, procainamide,

disopyramide or bretylium).

Medicines for infections (such as injectable

erythromycin, co-trimoxazole, moxifloxacin or

pentamidine)

Medicines for schizophrenia (such as

chlorpromazine, thioridazine, fluphenazine,

pimozide, haloperidol, amisulpiride 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)

Medicines for hepatitis C treatment (such as

sofosbuvir, daclatasvir, simeprevir or ledispasvir)

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, ciprofloxacin,

ofloxacin or levofloxacin)

Medicines for heart problems called

beta-blockers (such as propranolol)

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)

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 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

If you are not sure if any of the above apply to

you, talk to your doctor or pharmacist before

taking Amiodarone Tablets.

Amiodarone Tablets with food,drink and alcohol

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 problems with your liver.

Talk 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

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

Pregnancy, breast-feeding and fertility

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.

Amiodarone Tablets are normally not 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 pass into the mother’s 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.

Amiodarone Tablets contains Lactose and Iodine

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 ‘Tests’ below)

3. How to take Amiodarone tablets

Always take Amiodarone Tablets exactly as your

doctor has told you. Check with your doctor or

pharmacist if you are not sure.

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 (one

200 mg or two 100 mg Amiodarone Tablets)

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

Use in children and adolescents

Amiodarone tablets should not be given to

children and adolescents.

Artwork No.

Customer

Description

Market

Language

Size

Min. Font Size

Version No.

Date

Accord

Amiodarone 100/200 mg

English

170 x 550 mm (PIL)

8 (Page 1 of 2) (33-17-spc)

17_05_17 (Amiodarone (ACC-UK)33-17-spc-PIL)

Colours Used

Pantone Black

Elderly

The doctor may give you a lower dose of

Amiodarone Tablets . Also, the doctor should

check your blood pressure and thyroid

function regularly

If you take more Amiodarone Tablets than you

should

If you take more Amiodarone Tablets than you

should, tell a doctor or go to a hospital casualty

department straight away. Take the medicine

pack with you. This is so the doctor will know

what you have taken.

The following effects may happen: feeling dizzy,

faint or tired, confusion, slow heartbeat, damage

to the liver or being sick.

If you forget to take Amiodarone Tablets

If you forget a dose, take it as soon as you

remember it. However, if it is nearly time for the

next dose, skip the missed dose.

Do not take a double dose to make up for a

forgotten tablet.

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.

Tests

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 and while you are taking

Amiodarone Tablets.

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 Tablets can

cause side effects, although not everybody gets

them. The active ingredient in Amiodarone

Tablets 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 Tablets 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

You have blistering or peeling of the skin around

the lips, eyes, mouth, nose and genitals, flu-like

symptoms and fever. This could be a condition

called Stevens-Johnson syndrome

You have a severe blistering rash in which layers

of the skin may peel off to leave large areas of

raw exposed skin over the body. You may also

feel generally unwell, have a fever, chills and

aching muscles (Toxic Epidermal Necrolysis)

You have inflammation of the skin characterised

by fluid filled blisters (bullous dermatitis)

You have flu like symptoms and a rash on the

face followed by an extended rash with a high

temperature, increased levels of liver

enzymes seen in blood tests and an increase

in a type of white blood cell (eosinophilia) and

enlarged lymph nodes (DRESS)

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 Tablets 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 (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

Not Known (frequency cannot be estimated

from the available data):

Chest pain and shortness of breath and

irregular heartbeat. These could be signs of a

condition called “Torsade de pointes”

Some cases of bleeding in the lungs have been

reported in patients taking Amiodarone Tablets.

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’)

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)

Not known (frequency cannot be estimated

from the available data)

Severe stomach pain which may reach

through to your back. This could be a sign of

pancreatitis

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 heart beat

Nightmares

Problems sleeping

Constipation

Scaly and itchy rash (eczema)

Uncommon (may affect up to 1 in 100 people)

Dry mouth

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)

Granulomas, small red lumps on the skin or

inside the body which are seen by X-ray

Feeling less hungry

Movements that you cannot control, mainly of

the tongue, mouth, jaw, arms and legs

(Parkinsonism)

Feeling confused or seeing or hearing things

that are not there

A distorted sense of smell (parosmia)

Joint pain and muscle pain , fatigue,

inflammation of the tissues lining the heart

and lungs (Lupus like syndrome)

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 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

Do not store above 25°C. Store in the original

package.

Keep this medicine out of the sight and reach

of children.

Do not use this medicine after the expiry date

stated on the blister and carton.The expiry date

refers to the last day of that month.

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 protect the environment.

6. Contents of the pack and other

information

What Amiodarone Tablet contain

The active substance is amiodarone

hydrochloride.

The other ingredients are lactose

monohydrate , povidone K 90, pregelatinised

starch, colloidal anhydrous silica and

magnesium stearate (see section 2 for

Important information about some of the

ingredients of Amiodarone Tablets).

What Amiodarone Tablets look like and

contents of the pack

Amiodarone 100 mg Tablets are white to off

white, flat, round, bevelled edge, uncoated

tablets with inscription AY on one side and

scoreline on other side.

Amiodarone 200 mg Tablets are white to off

white, flat, round, bevelled edge, uncoated

tablets with inscription AZ on one side and

scoreline on other side.

Amiodarone 100 mg and 200 mg tablets are

available in blister pack of 28 tablets.

Marketing Authorisation Holder and

Manufacturer

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, United Kingdom

This leaflet was last revised in 05/2017.

Prepared By

Regulatory Affairs

Checked By

Regulatory Affairs

Approved By

Quality Assurance

PACKAGE LEAFLET:

INFORMATION FOR THE USER

Amiodarone 100 mg Tablets

Amiodarone 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 you doctor,

pharmacist or nurse. This includes any

possible side effects not listed in this leaflet.

See section 4.

What is in this leaflet:

What Amiodarone Tablets are and what they

are used for

What you need to know before you take

Amiodarone Tablets

How to take Amiodarone Tablets

Possible side effects

How to store Amiodarone Tablets

Contents of the pack and other information

1. WHAT AMIODARONE TABLETS ARE AND

WHAT THEY ARE USED FOR

Amiodarone 100mg or 200mg Tablets (called

Amiodarone Tablets in this leaflet) contain a

medicine called amiodarone hydrochloride. 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 Tablets 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 Tablets are used only when other

medicines can not be used.

Treat fast heartbeats which may happen

suddenly and may be uneven. Amiodarone

Tablets are used only when other medicines

cannot be used.

2. What you need to know before you take

Amiodarone Tablets

Do not take Amiodarone Tablets if

you are allergic (hypersensitive) to iodine,

amiodarone hydrochloride or any of the other

ingredients of Amiodarone Tablets (see section

6). 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

applies to you.

If you are not sure, talk to your doctor or

pharmacist before taking Amiodarone Tablets.

Warnings and precautions

Talk to your doctor, pharmacist or nurse

before taking Amiodarone Tablets 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.

You have blistering or peeling of the skin around

the lips, eyes, mouth, nose and genitals, flu-like

symptoms and fever. This could be a condition

called Stevens-Johnson syndrome

You have a severe blistering rash in which

layers of the skin may peel off to leave large

areas of raw exposed skin over the body. You

may also feel generally unwell, have a fever,

chills and aching muscles (Toxic Epidermal

Necrolysis)

If you are not sure if any of the above apply to

you, talk to your doctor or pharmacist before

taking Amiodarone Tablets.

Other medicines and Amiodarone Tablets

Tell your doctor or pharmacist if you are taking,

have recently taken or might take any other

medicines. This is because Amiodarone Tablets

can affect the way some other medicines work.

Also some medicines can affect the way

Amiodarone Tablets works.

In particular, do not take this medicine and

tell your doctor, if you are taking:

Other medicines for an uneven heartbeat

(such as sotalol, quinidine, procainamide,

disopyramide or bretylium).

Medicines for infections (such as injectable

erythromycin, co-trimoxazole, moxifloxacin or

pentamidine)

Medicines for schizophrenia (such as

chlorpromazine, thioridazine, fluphenazine,

pimozide, haloperidol, amisulpiride 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)

Medicines for hepatitis C treatment (such as

sofosbuvir, daclatasvir, simeprevir or ledispasvir)

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, ciprofloxacin,

ofloxacin or levofloxacin)

Medicines for heart problems called

beta-blockers (such as propranolol)

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)

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 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

If you are not sure if any of the above apply to

you, talk to your doctor or pharmacist before

taking Amiodarone Tablets.

Amiodarone Tablets with food,drink and alcohol

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 problems with your liver.

Talk 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

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

Pregnancy, breast-feeding and fertility

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.

Amiodarone Tablets are normally not 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 pass into the mother’s 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.

Amiodarone Tablets contains Lactose and Iodine

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 ‘Tests’ below)

3. How to take Amiodarone tablets

Always take Amiodarone Tablets exactly as your

doctor has told you. Check with your doctor or

pharmacist if you are not sure.

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 (one

200 mg or two 100 mg Amiodarone Tablets)

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

Use in children and adolescents

Amiodarone tablets should not be given to

children and adolescents.

Elderly

The doctor may give you a lower dose of

Amiodarone Tablets . Also, the doctor should

check your blood pressure and thyroid

function regularly

If you take more Amiodarone Tablets than you

should

If you take more Amiodarone Tablets than you

should, tell a doctor or go to a hospital casualty

department straight away. Take the medicine

pack with you. This is so the doctor will know

what you have taken.

The following effects may happen: feeling dizzy,

faint or tired, confusion, slow heartbeat, damage

to the liver or being sick.

If you forget to take Amiodarone Tablets

If you forget a dose, take it as soon as you

remember it. However, if it is nearly time for the

next dose, skip the missed dose.

Do not take a double dose to make up for a

forgotten tablet.

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.

Tests

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 and while you are taking

Amiodarone Tablets.

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 Tablets can

cause side effects, although not everybody gets

them. The active ingredient in Amiodarone

Tablets 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 Tablets 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

You have blistering or peeling of the skin around

the lips, eyes, mouth, nose and genitals, flu-like

symptoms and fever. This could be a condition

called Stevens-Johnson syndrome

You have a severe blistering rash in which layers

of the skin may peel off to leave large areas of

raw exposed skin over the body. You may also

feel generally unwell, have a fever, chills and

aching muscles (Toxic Epidermal Necrolysis)

You have inflammation of the skin characterised

by fluid filled blisters (bullous dermatitis)

You have flu like symptoms and a rash on the

face followed by an extended rash with a high

temperature, increased levels of liver

enzymes seen in blood tests and an increase

in a type of white blood cell (eosinophilia) and

enlarged lymph nodes (DRESS)

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 Tablets 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 (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

Not Known (frequency cannot be estimated

from the available data):

Chest pain and shortness of breath and

irregular heartbeat. These could be signs of a

condition called “Torsade de pointes”

Some cases of bleeding in the lungs have been

reported in patients taking Amiodarone Tablets.

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’)

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)

Not known (frequency cannot be estimated

from the available data)

Severe stomach pain which may reach

through to your back. This could be a sign of

pancreatitis

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 heart beat

Nightmares

Problems sleeping

Constipation

Scaly and itchy rash (eczema)

Uncommon (may affect up to 1 in 100 people)

Dry mouth

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)

Granulomas, small red lumps on the skin or

inside the body which are seen by X-ray

Feeling less hungry

Movements that you cannot control, mainly of

the tongue, mouth, jaw, arms and legs

(Parkinsonism)

Feeling confused or seeing or hearing things

that are not there

A distorted sense of smell (parosmia)

Joint pain and muscle pain , fatigue,

inflammation of the tissues lining the heart

and lungs (Lupus like syndrome)

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 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

Do not store above 25°C. Store in the original

package.

Keep this medicine out of the sight and reach

of children.

Do not use this medicine after the expiry date

stated on the blister and carton.The expiry date

refers to the last day of that month.

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 protect the environment.

6. Contents of the pack and other

information

What Amiodarone Tablet contain

The active substance is amiodarone

hydrochloride.

The other ingredients are lactose

monohydrate , povidone K 90, pregelatinised

starch, colloidal anhydrous silica and

magnesium stearate (see section 2 for

Important information about some of the

ingredients of Amiodarone Tablets).

What Amiodarone Tablets look like and

contents of the pack

Amiodarone 100 mg Tablets are white to off

white, flat, round, bevelled edge, uncoated

tablets with inscription AY on one side and

scoreline on other side.

Amiodarone 200 mg Tablets are white to off

white, flat, round, bevelled edge, uncoated

tablets with inscription AZ on one side and

scoreline on other side.

Amiodarone 100 mg and 200 mg tablets are

available in blister pack of 28 tablets.

Marketing Authorisation Holder and

Manufacturer

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, United Kingdom

This leaflet was last revised in 05/2017.

Artwork No.

Customer

Description

Market

Language

Size

Min. Font Size

Version No.

Date

Accord

Amiodarone 100/200 mg

English

170 x 550 mm (PIL)

7 (Page 2 of 2) (30-15-spc)

13_01_17 (Amiodarone (ACC-UK)30-15-spc-PIL)

Colours Used

Pantone Black

Prepared By

Regulatory Affairs

Checked By

Regulatory Affairs

Approved By

Quality Assurance

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