Amiodarone Hydrochloride 200 mg tablets – patient leaflet, side effects, dosage

1. What Amiodarone is and what it is used for

• Medicines that lengthen your heartbeat (the QT interval) such as medicines for infection (such as clarithromycin, ciprofloxacin, ofloxacin or levofloxacin)

The name of your medicine is Amiodarone Hydrochloride 100mg and 200mg Tablets (called Amiodarone Tablets throughout this leaflet.Amiodarone Hydrochloride belongs to a group of medicines called anti−arrhythmic. These work by controlling an irregular or rapid heartbeat (called ‘arrhythmia”). Taking the tablets helps your heartbeat to return to normal. Amiodarone Hydrochloride (referred to as Amiodarone throughout this leaflet) can be used to treat the following:

• 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
• To treat uneven heartbeats where other medicines either have not worked or cannot be used.
• Medicines for high cholesterol (statins) such as simvastatin or atorvastatin.

• To treat an illness called Wolff-Parkinson-White Syndrome. This is where your heart beats unusually fast.

  The following medicines can increase the chance of you getting side effects, when taken with Amiodarone Tablets:

• To treat other types of fast or uneven heartbeats known as ‘atrial flutter’ or ‘atrial fibrillation’. Amiodarone Tablets are used only when other medicines cannot be used.
• Amphotericin (when given directly into a vein) – used for fungal infections
• Medicines for inflammation (corticosteroids) such as hydrocortisone, betamethasone or prednisolone
• To treat fast heartbeats which may happen suddenly and may be uneven. Amiodarone Tablets are used only when other medicines cannot be used.
• Water tablets (diuretics)
• General anaesthetics or high dose oxygen – used during surgery

2. What you need to know before you take Amiodarone

• Tetracosactide - used to test some hormone problems Amiodarone Tablets may increase the effect of the following medicines:

Do not take Amiodarone if you:

• are allergic (hypersensitive) to iodine, amiodarone hydrochloride or any of the other ingredients of this medicine (see Section 6). Signs of an allergic reaction include a rash, swallowing or breathing difficulties, swelling of your lips, face, throat or tongue

  • Ciclosporin, tacrolimus and sirolimus – used to help prevent rejection of transplants
  • Medicines for impotence such as sildenafil, tadalafil or vardenafil
  • Fentanyl – used for pain relief

• have a slower than usual heartbeat (called ‘sinus bradycardia’) or an illness called ‘sino-atrial’ heart block

  • Ergotamine – used for migraines
  • Midazolam – used to relieve anxiety or to help you relax before surgery

• have any other problems with your heart beat and do not have a pacemaker fitted

  • 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
• have ever had thyroid problems. Your doctor should test your thyroid before giving you this medicine

• are pregnant or breast−feeding (see Section 2 “Pregnancy and breast− feeding”)

  • Lidocaine – used as an anaesthetic
  • Warfarin – used to stop your blood from clotting

• are taking certain other medicines which could affect your heartbeat (see “Other medicines and Amiodarone”).

  • 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 these tablets. Amiodarone Tablets with food and drink

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 Amiodarone Tablets. 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

• Do not drink Grapefruit juice while taking Amiodarone Tablets. 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 whilst taking these tablets. 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

Talk to your doctor or pharmacist before taking Amiodarone if you:

• have heart failure

• you currently take a medicine containing sofosbuvir for the treatment of hepatitis C as it may result in a life-threatening slowing of your heart beat. Your doctor may consider alternative treatments. If treatment with amiodarone and sofosbuvir is needed, you may require additional heart monitoring

  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 a high factor sun cream

• have any problems with your lungs or have asthma

  • Always wear a hat and clothes which cover your arms and legs
• have liver problems

• have any problems with your eyesight. This includes an illness called ‘optic neuritis’

  Pregnancy and breast−feeding

  Tell your doctor before using this medicine if you are pregnant, may become pregnant or think you may be pregnant. Amiodarone Tablets are not normally given during pregnancy.

• are about to have an operation
• are elderly (over 65 years of age). The doctor will need to monitor you more carefully

• 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

  Do not take Amiodarone Tablets if you are breast-feeding or plan to breast-feed. This is because small amounts of this medicine may pass into the mothers’ milk.

• 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

  Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding. Driving and using machines

• 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 may have blurred eyesight while taking Amiodarone Tablets. If this happens, do not drive or use any tools or machines.

  Amiodarone contains lactose

  If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

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

Amiodarone contains iodine

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

Iodine: Amiodarone 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).

• slow or irregular heartbeat or heart rhythm problems;
• shortness of breath or worsening of existing shortness of breath;
• chest pain;

3. How to take Amiodarone

• light-headedness;

  Always take Amiodarone exactly as your doctor has told you.

• palpitations;

• near-fainting or fainting.

  Check with your doctor or pharmacist if you are not sure.

Other medicines and Amiodarone

• These tablets are to be taken orally

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained 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 work.

• These tablets should be swallowed whole with a glass of water. Do not crush or chew your tablets
• The score line on the tablet is only to facilitate breaking for ease of swallowing and not to divide the tablet into equal doses.
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

In particular, do not take this medicine and tell your doctor if you are taking:

• Other medicines for an uneven heartbeat (such as quinidine, procainamide, disopyramide, sotalol (beta−blocker) and bretylium)

  The recommended dose is:

  Adults

  Initially: The usual starting dose is 200mg (one 200mg or two 100mg amiodarone Tablets) three times a day for the first week. The dose should then be reduced to 200mg twice a day for a further week.

• Medicines for infections (such as intravenous erythromycin, co−trimoxazole, moxifloxacin or pentamidine)

• Medicines for schizophrenia (such as chlorpromazine, thioridazine, pimozide, haloperidol, fluphenazine, amisulpride or sertindole)

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

• Medicines for other mental illnesses (such as lithium, doxepin, maprotiline or amitriptyline)
• Medicines for malaria (such as quinine, mefloquine, chloroquine and or halofantrine)

Elderly

Lower doses may be prescribed. Your doctor will prescribe the correct dose for you. Also, the doctor should check your blood pressure and thyroid function regularly.

Use in children and adolescents

Amiodarone should not be given to children and adolescents.

If you take more Amiodarone than you should

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.

Symptoms of an overdose may include; feeling dizzy, faint or tired, confusion, slow heartbeat, damage to the liver or being sick.

If you forget to take Amiodarone

If you forget to take a dose, take it as soon as you remember it, unless it is nearly time for your next dose. Do not take a double dose to make up for the forgotten dose.

If you stop taking Amiodarone

It is important that you keep taking Amiodarone for as long as your doctor has told you to. Do not stop taking Amiodarone 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. 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 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 medicine, 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 stream 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 (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
• Shortness of breath or difficulty breathing (which may get progressively worse), 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 is very dangerous and can happen at any time after starting treatment.

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.
• Severe lung inflammation causing respiratory failure (respiratory distress syndrome), most often seen in the period after surgery.

Not known (frequency cannot be estimated from the available data)

• 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. 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 (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 or short of breath. These could be signs of a very slow heartbeat (especially in people over 65 years old) or other problems with your hearts 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’.
• Life-threatening complication after heart transplantation (primary graft dysfunction) in which the transplanted heart stops workingproperly (see section 2, Warnings and precautions) 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 (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 gets serious or lasts longer than a few days:

Very common (affects more than 1 in 10 people)

• Feeling sick (nausea) or being sick (vomiting)
• Changes 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)
• Decrease in sex drive

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)
• Seeing, hearing or feeling things that are not there (hallucinations)
• You may get more infections than usual. This could be caused by a decrease in the number of white blood cells (neutropenia).
• Severe reduction in the number of white blood cells which makes infections more likely (agranulocytosis). Reporting of side effects

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. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Amiodarone

• Keep this medicine out of the sight and reach of children.
• Store in the original package in order to protect from light.
• Do not store above 30°C.
• Do not use this medicine after the expiry date which is stated on the carton/blister after EXP. The expiry date refers to the last day of that month.
• 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 to protect the environment.

6. Contents of the pack and other information

What Amiodarone contains:

Each 100mg tablet contains 100mg of Amiodarone Hydrochloride.

Each 200mg tablet contains 200mg of Amiodarone Hydrochloride.

The other ingredients are: lactose, maize starch, polyvidone, colloidal silicon dioxide and magnesium stearate.

What Amiodarone looks like and contents of the pack:

Amiodarone Hydrochloride 100mg tablets are white, round tablets of diameter 7.8-8.2mm and height of 3.0-3.4mm, convex on one side with a score notch on other side.

Amiodarone Hydrochloride 200mg tablets are white, round, biconvex tablets of diameter 9.8-10.2mm and height of 4.0-4.4mm with a score notch on one side. Amiodarone is available in:

Amiodarone tablets are available in packs of 28 or 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder & Manufacturer:

Crescent Pharma Ltd., Key House,

Sarum Hill, Basingstoke, RG21 8SR, UK.

Product Licence Numbers:

Amiodarone Hydrochloride 100mg Tablets PL 20416/0841

Amiodarone Hydrochloride 200mg Tablets PL 20416/0842

Date of revision April 2025.

P3380T