Cordarone X 200 tablets

Main information

  • Trade name:
  • Cordarone X 200 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:
  • Cordarone X 200 tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 02030200; GTIN: 5013417102095

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 17780/0587
  • Last update:
  • 29-01-2019

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

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PACKAGE LEAFLET:

INFORMATION FOR THE USER

Cordarone ® X 100mg and 200mg

Tablets

Amiodarone hydrochloride

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 Cordarone X Tablets are and what they are used for

2. Before you take Cordarone X Tablets

3. How to take Cordarone X Tablets

4. Possible side effects

5. How to store Cordarone X Tablets

6. Further information

1. What Cordarone X Tablets are and

what they are used for

Cordarone X 100mg or 200mg Tablets (called Cordarone

X 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.

Cordarone X 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’. Cordarone X Tablets

are used only when other medicines cannot be used.

Treat fast heartbeats which may happen suddenly

and may be uneven. Cordarone X Tablets are used

only when other medicines cannot be used.

2. Before you take Cordarone X Tablets

Do not take this medicine and tell your doctor if:

×

You are allergic (hypersensitive) to:

iodine

amiodarone

any of the other ingredients of Cordarone X Tablets

(listed in Section 6 below)

Signs of an allergic reaction include: a rash,

swallowing or breathing difficulties, 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 Cordarone X Tablets.

Take special care with Cordarone X Tablets.

Check with your doctor or pharmacist before taking

your medicine 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 Cordarone

X Tablets.

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 prescription, including herbal

medicines. This is because Cordarone X Tablets can

affect the way some other medicines work. Also, some

medicines can affect the way Cordarone X Tablets work.

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)

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 Cordarone

X 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

Cordarone X Tablets may increase the effect of the

following medicines:

Ciclsporin 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 Cordarone

X Tablets.

Taking Cordarone X Tablets with food and drink

Do not drink grapefruit juice while taking this medicine.

This is because drinking grapefruit juice while taking

Cordarone X Tablets can increase your chance of getting

side effects.

Limit the amount of alcohol you drink whilst 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 and breast-feeding

Tell your doctor before taking this medicine if you are

pregnant, might become pregnant or think you may

be pregnant. Cordarone X Tablets are 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 pass into the 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 Cordarone X Tablets

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: Cordarone X Tablets contain 37.5mg of iodine

in a 100mg tablet and 75mg 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 Cordarone X Tablets

Always take Cordarone X Tablets exactly as your doctor

has told you. You should 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 200mg (one 200mg or two

100mg Cordarone X Tablets) three times each day for

one week

The dose will then be lowered to 200mg twice each

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 then decide to either

increase or lower the amount you take each day. This

will depend on how to react to this medicine

Children and adolescents

Cordarone X Tablets should not be given to children

and adolescents.

Elderly

The doctor may give you a lower dose of Cordarone

X Tablets. Also, the doctor should check

your blood pressure and thyroid function

regularly

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If you take more Cordarone X Tablets than you

should

If you take more Cordarone X 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 knows 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 Cordarone X 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 Cordarone X Tablets

Keep taking Cordarone X Tablets until your doctor tells

you to stop. Do not stop taking Cordarone X 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 will take regular tests to check how your

liver is working. Cordarone X Tablets can affect how

your liver works. If this happens, your doctor will

decide whether you should keep taking these tablets.

Your doctor may do regular thyroid tests while you

are taking this medicine. This is because Cordarone X

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 Cordarone X 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, Cordarone X Tablets can cause side

effects, although not everybody gets them. Cordarone X

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 Cordarone X 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 (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 Cordarone X 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 (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), 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 Cordarone X 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 (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)

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 (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 heartbeat

Nightmares

Problems sleeping

Constipation

Scaly and itchy rash (eczema)

Uncommon (affects less than 1 in 100 people)

Dry mouth

Very rare (affects less than 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)

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 Cordarone X Tablets

Keep this medicine in a safe place where children

cannot see or reach it.

Do not use Cordarone X Tablets 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 store above 25°C.

Do not use Cordarone X Tablets 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 Cordarone X Tablets contain

Each Cordarone X 100mg Tablet contains 100mg of

the active substance, amiodarone hydrochloride

Each Cordarone X 200mg Tablet contains 200mg of

the active substance, amiodarone hydrochloride

The other ingredients are lactose monohydrate,

maize starch, povidone, colloidal anhydrous silica

and magnesium stearate

What Cordarone X Tablets look like and contents of

the pack

100mg Tablets: The tablets are round and white in

colour. One side has a break-line and the other side is

imprinted with ‘100’.

200mg Tablets: The tablets are round and white in

colour. One side has a break-line and the other side is

imprinted with ‘200’.

The tablets are available in blister-packs of 28 and 30

tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS,

Manufacturer

S.C. Zentiva S.A.

50, Theodor Pallady Blvd., 032266, Bucharest, Romania.

This leaflet does not contain all the information about

your medicine. If you have any questions or are not

sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in September 2016

‘Zentiva’ is a registered trademark © 2016 Zentiva.

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