Patient leaflet - Amiodarone 100 mg tablets BP

1. WHAT AMIODARONE TABLET IS AND WHAT IT IS USED

FOR

The name of your medicine is Amiodarone Hydrochloride 100mg and 200mg Tablets (called Amiodarone Tablets throughout this leaflet). 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 this medicine (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
If you have a slower than usual heartbeat (called ‘sinus bradycardia’) or an illness called ‘sino-atrial’ heart block
If you have any other problems with your heartbeat and do not have a pacemaker fitted
If you are taking certain other medicines which could affect your heart-beat (see ‘Other medicines and Amiodarone Tablets’ below)
If you are pregnant or breast-feeding (see ‘Pregnancy and breast-feeding’ below)
If you have ever had thyroid problems. Your doctor should test your thyroid before giving you this medicine

Talk to your doctor, pharmacist or nurse before you are given this medicine: If you are on a heart transplant waiting list, your doctor may change your treatment. This is because taking amiodarone before heart transplantation has shown an increased risk of a life-threatening complication (primary graft dysfunction) in which the transplanted heart stops working properly within the first 24 hours after surgery.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Amiodarone Tablets.

If you have nervous system disorders
If you have heart failure
If you have liver problems
If you have any problems with your lungs or have asthma
If you have any problems with your eyesight. This includes an illness called ‘optic neuritis’
If you are about to have an operation
If you are elderly (over 65 years of age). The doctor will need to monitor you more carefully
If you have a pacemaker or implantable cardioverter defibrillator (ICD). Your doctor will check that your device is working properly shortly after you start taking the tablets or if your dose is changed
If you 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 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
If you are currently taking a medicine containing sofosbuvir for the treatment of hepatitis C as it may result in a life-threatening slowing of your heartbeat. Your doctor may consider alternative treatments. If treatment with amiodarone and sofosbuvir is needed, you may require additional heart monitoring.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Amiodarone Tablets.

Tell your doctor immediately if you are taking a medicine containing sofosbuvir for the treatment of hepatitis C and during treatment you experience:

slow or irregular heartbeat or heart rhythm problems
shortness of breath or worsening of existing shortness of breath
chest pain
light-headedness
palpitations
near-fainting or fainting.
Other medicines and Amiodarone Tablets
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Amiodarone Tablets can affect the way some other medicines work. Also some medicines can affect the way Amiodarone Tablets works.
Do not take Amiodarone Tablets if you are taking any of the following medicines:
- Other medicines for an uneven heartbeat (such as flecainide, quinidine, procainamide, disopyramide, sotalol 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
Medicines for treatment of hepatitis C such as Sofosbuvir. The following medicines can increase the chance of you getting side effects, when taken with Amiodarone Tablets:
Medicines for fungal infections (such as amphotericin when given directly into a vein)
Medicines for inflammation (corticosteroids) such as hydrocortisone, betamethasone or prednisolone
Water tablets (diuretics) such as furosemide
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
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 - to stop blood from clotting
Phenytoin - to treat epilepsy
Digoxin - to slow fast heart rate
Colchicine - used for the treatment of gout
Dabigatran - used to thin the blood
Digitalis – used for some heart conditions

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 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 problems with your liver. Talk to your doctor or pharmacist about the amount of alcohol you can drink.

Pregnancy and breast-feeding

Amiodarone is 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 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.

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 contain:

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 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 Section 3 - ‘Tests’ below)

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

3. HOW TO TAKE AMIODARONE TABLETS

Always take this medicine exactly as your doctor or pharmacist 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

Product: Amiodarone Hydrochloride Tablets 100mg & 200mg

Process Black

Size: 180 x 330mm

Amendment Date

If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

The recommended dose is Adults

The usual starting dose is 200mg (one 200mg or two 100mg Amiodarone 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 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

There are only limited data on the efficacy and safety in children. Your doctor will decide on an appropriate dose.

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 carton and any Amiodarone Tablets left with you so the doctor knows what you have taken. Symptoms of an overdose are 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, unless it is time for your next 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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Tests

Your doctor will take regular tests to check how your liver is working. Amiodarone 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 Amiodarone Tablets contains iodine which can cause problems with 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, this medicine can cause side effects, although not everybody gets them. Amiodarone Tablets may stay in your blood for up to a month after stopping treatment. You may still get side effects in this time. If you suffer from any of the following at any time while you are taking these tablets, STOP TAKING them and seek IMMEDIATE medical help:

If you have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swollen eyelids, face, lips, throat or tongue (frequency not known).
If 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 Steven-Johnsons syndrome (frequency not known).
If 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, chills and aching muscles (Toxic Epidermal Necrolysis) (frequency not known).
If you have inflammation of the skin characterised by fluid filled blister (bullous dermatitis) (frequency not known).
If 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) (frequency not known)' 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).

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)
Blurred eyesight or seeing a coloured halo in dazzling light Common (affects less than 1 in 10 people)
Slightly slower heart beat
Nightmares
Problems sleeping
Scaly and itchy rash (eczema)
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 (which may progressively worse), coughing which will not go away, wheezing, weight loss. This could be due to inflammation of your lungs which can be very dangerous and can happen anytime after starting treatment.
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.
Decreased sex drive
Constipation
Product: Amiodarone Hydrochloride Tablets 100mg & 200mg
Size: 180 x 330mm
Amendment Date
Uncommon (affects less than 1 in 100 people)
- Feeling numb or weak, tingling or burning feelings in any part of your body.
- Your heartbeat becomes even more uneven or erratic. This can lead to a heart attack, so you should go to hospital straight away.
- Muscle cramps, stiffness or spasm
- Dry mouth

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
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), 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, 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
Headache
Balance problems, feeling dizzy (vertigo)
Difficulty in getting or maintaining an erection or in ejaculating
Hair loss, balding
Skin redness during radio-therapy
Chronic liver disease which can sometimes be fatal
Increase in blood creatinine
Swelling of the testicles
Red, scaly patches of skin, loss of hair or loosening of nails (called ‘exfoliative dermatitis’)
Feeling 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 irritable. This could be an illness called ‘syndrome of inappropriate anti-diuretic hormone secretion’ (SIADH)
Skin rash

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.

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”
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 (hallucination)
A distorted sense of smell (parosmia)
Severe stomach pain which may reach through to your back. This could be a sign of pancreatitis.
You may get more infections than usual. This could be caused by a decrease in the number of white blood cells (neutropenia)
You may get infections more easily than usual. This could be because of a blood disorder (agranulocytosis)'
Life-threatening complication after heart transplantation (primary graft dysfunction) in which the transplanted heart stops working properly (see section 2, Warnings and precautions)
Lupus-Like syndrome (a disease where the immune system attacks various parts of the body and leading to pain, stiffness and swelling in joints and red skin, sometimes in the shape of butterfly wings on the face Tests

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

Keep this medicine out of the sight and reach of children.
Do not store above 25ºC.
Do not use this medicine after the expiry date which is stated on the carton. 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 use this medicine if you notice your tablets are crumbling, broken or discoloured.
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 Tablets contains

Each tablet contains 100mg or 200mg of Amiodarone Hydrochloride as the active substance.

The other ingredients are lactose monohydrate, maize starch, povidone, colloidal anhydrous silica, pregelatinised starch and magnesium stearate. What Amiodarone Tablets looks like and contents of the pack

The 100mg tablets are white to off white coloured, round shaped, flat uncoated Tablet with a score line on one face & embossed 100 on reverse. The 200mg tablets are White to off white coloured, round shaped, Flat, uncoated tablets, one side plain and other side break line. The tablets are available in the packs of 28 and 30 tablets. Marketing Authorisation Holder and Manufacturer

Crescent Pharma Ltd., Key House, Sarum Hill, Basingstoke, RG21 8SR, UK. Product License Number

PL 20416/0955 & PL 20416/0956

This leaflet was last revised in: June 2025.

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