AMIODARONE 200 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - AMIODARONE 200 MG TABLETS

5. how to store amiodarone tablets

Keep out of the reach and sight and children.
Do not take the tablets after the expiry date stated on the pack; the expiry date refers to last day of the month.
Do not store above 25 °C.
Store in the original packaging.

Medicines should not be disposed with the help of wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. contents of the pack and other informationwhat amiodarone tablets containeach 100 mg tablet contains: amiodarone hydrochloride (active ingredient) 100 mg.

Each 200 mg tablet contains: Amiodarone Hydrochloride (active ingredient) 200 mg.

The other ingredients are: lactose monohydrate, maize starch, povidone, colloidal anhydrous silica, pre-gelatinised starch and magnesium stearate.

What Amiodarone Tablets look like and contents of the pack

Pack sizes: The tablets are available in packs of 28 tablets.

The 100 mg tablets are round, white tablets with a break line on one side and embossed ‘100‘on the reverse side.

The 200 mg tablets are round, white tablets with a break line on one side and embossed ‘200’ on the reverse side.

PL 21880/0095

PL 21880/0096

This leaflet was last revised in July 2017

POM

Marketing Authorization Holder and Manufacturer: MMEDREICH PLC

Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK

E-mail:

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amiodarone 100 mg Tablets

if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. see section 4.

What is in this leaflet:

1. What Amiodarone Tablets are and what they are used for
2. What you need to know before you take Amiodarone Tablets
3. How to take Amiodarone Tablets
4. Possible side effects
5. How to store Amiodarone Tablets
6. Contents of the pack and other information

1. What Amiodarone Tablets are and what they are used for

Amiodarone Tablets 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 help 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 cannot 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 and tell your doctor if:

You are allergic/sensitive 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 or had any problems with your thyroid. 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 breastfeeding (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 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 suffer from heart failure as you may need to take these tablets in conjunction with other therapies which will be advised by your doctor
You have the rare hereditary condition porphyria (where urine and faeces exposed to light turn purple)
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 applies to you, talk to your doctor or pharmacist before taking Amiodarone Tablets.

Other medicine and Amiodarone Tablets: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines 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.

Do not take Amiodarone tablets if you are taking any of the following medicines:

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 used for hay fever, rashes or other allergies called antihistamines (such as terfenadine, astemizole or mizolastine)
Medicines for malaria (such as quinine, mefloquine, chloroquine or halofantrine)
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
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 follow ing 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
Dabigatran – used to thin the blood
Phenytoin – used to treat epilepsy
Digitalis – used for some heart conditions

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

Taking Amiodarone Tablets with food and drink: Amiodarone tablets do not have to be taken with food. 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 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 bum, 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 Amiodarone 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 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: This product may cause vertigo or blurred vision, so do not drive or operate machinery.

Important information about some of the ingredients in Amiodarone 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: 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. 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 200 mg 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
Amiodarone Tablets should not be given to children and adolescents.

Elderly

The doctor may give you a lower dose of amiodarone. Also, the doctor should check your blood pressure and thyroid function regularly.

If you take more Amiodarone Tablets than you should: If you take too many tablets or someone else takes your tablets, consult your nearest hospital casualty department or your doctor for advice. Take this leaflet, and any tablets that you still have to show the doctor. The following effects may happen:

Feeling dizzy, faint or tired, confusion, slow heartbeat, damage to the liver or being sick.

If you forgot to take Amiodarone Tablets: If you forget to take a dose at the right time, take it as soon as you remember. 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: It can be dangerous to stop taking your tablets without your doctor’s advice first.

If you have any further questions on the use of this product, 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 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 aw ay 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).

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.
Your heartbeat becomes even more uneven or erratic. This can lead to a heart attack, so you

should go to hospital straight away.

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’.

Stop taking Amiodarone Tablets and see a doctor straight aw ay if you notice any of the follow ing serious side effects – you may need urgent medical treatment:

Feeling numb or weak, tingling or burning feelings in any part of your body
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
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 follow ing side effects:

Very common (affects more than 1 in 10 people)

Blurred eyesight or seeing a coloured halo in dazzling light