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Amiodarone 100mg Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Amiodarone 100mg and 200mg Tablets

Amiodarone

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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

2. Before you take Amiodarone Tablets.

3. How to take Amiodarone Tablets.

4. Possible side effects.

5. How to store Amiodarone Tablets.

6. Further information.

1. WHAT AMIODARONE TABLETS ARE AND WHAT THEY ARE USED FOR.

Amiodarone Tablets belong to a group of medicines called anti-arrhythmics. They are used when the heartbeat is very irregular or very fast.

They are only used for serious conditions which do not respond to other treatments or when other treatments cannot be used. Treatment with amiodarone is normally under hospital or specialist supervision.

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.

Swallow the tablets whole with a glass of water.

Amiodarone Tablets can be taken with or without food.

Adults:

The usual dose is one 200mg tablet taken three times a day for the first week, followed by one 200mg tablet taken twice a day for the next week and then one 200mg taken daily.

In some patients this may be reduced to one I00mg tablet taken each day.

Elderly:

Elderly patients may be prescribed lower doses. Your doctor will decide the correct dose for you. Children and adolescents:

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

Keep taking your medicine until your doctor tells you to stop. Do not stop taking it because you feel better. If you take more Amiodarone Tablets than you should

If you have taken too many tablets tell your doctor or go to the nearest hospital casualty department IMMEDIATELY. Take this leaflet and any remaining tablets with you so the doctor knows what you have taken.

If you forget to take Amiodarone Tablets

If you forget a dose take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.

2.BEFORE YOU TAKE AMIODARONE TABLETS

Do not take Amiodarone Tablets

• If you are allergic (hypersensitive) to amiodarone or any of the other ingredients of Amiodarone tablets.

• if you have heart block - which may cause a very slow, very fast or irregular pulse or dizziness

• if you are allergic to iodine

• if you have thyroid problems or have not yet had your thyroid function tested

• If you are taking certain medicines (see "Taking other medicines”)

• if you are pregnant or breast feeding.

4.POSSIBLE SIDE EFFECTS_

Like all medicines, Amiodarone Tablets can cause side effects, although not everybody gets them.

You should contact your doctor as soon as possible if you experience any of the following symptoms, as you may have to stop taking the tablets:

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Take special care with Amiodarone Tablets

Tell your doctor before taking these tablets if any

• if you are elderly

• if you are exposed to sunlight for long periods (see section 4, Possible Side Effects)

• if you are going to have an operation

• if you have heart failure

• if you have a pacemaker or implantable cardioverter defibrillator

• if you take high doses of amiodarone or are elderly and suffer from a very slow heart rate

of the following apply to you:

• if you have been taking amiodarone for long periods, as your doctor may need to monitor you to avoid delayed side effects

• if you suffer from blurred or decreased vision

• if you have liver problems

• if you suffer from nerve or muscular disorders

• if you have sudden shortness of breath or a dry cough.

Your doctor may want to arrange tests such as blood tests, chest x-rays and eye examinations before and during treatment with these tablets.

Taking other medicines

The effects of amiodarone can be altered by other medicines and the effects of the other medicines can be changed by amiodarone. Please check with your doctor if you are taking any of the

following medicines:

• certain antibiotics called fluoroquinolones (e.g. moxifloxacin)

• medicines used to thin the blood (particularly warfarin)

• phenytoin (for epilepsy)

• tolbutamide (for diabetes)

• aspirin

• fentanyl (a strong painkiller)

• diuretics (water tablets)

• digoxin (used for heart problems).

• Beta blockers (used to treat high blood pressure, angina or an irregular heart beat) e.g. atenolol and propranolol - you must NOT take amiodarone if you are taking sotalol

• certain medicines to treat high blood pressure and angina (chest pain) e.g. verapamil and diltiazem

• medicines used to treat irregular heartbeats (e.g. quinidine, disopyramide, procainamide, and bretylium)

• medicines used to treat psychiatric problems (e.g. chlorpromazine, thioridazine, fluphenazine, amisulpiride, pimozide and haloperidol)

• lithium and tricyclic antidepressants (e.g. doxepin, maprotiline and amitriptyline)

• some antihistamines (used to treat allergies and hayfever) e.g. terfenadine and astemizole

• intravenous erythromycin, co-trimoxazole, amphotericin or pentamidine (used to treat infections)

• anti malarials (used to treat or prevent malaria) e.g. chloroquine, halofantrine, mefloquine and quinine

• ciclosporine and tacrolimus (used after transplant operations)

• oral steroids, e.g. prednisolone

• stimulant laxatives (e.g. dantron or bisacodyl) which may cause low levels of potassium in the blood

• flecainide (used to regulate the rate and rhythm of the heart).

• cholesterol reducing drugs (statins)

• lidocaine (a local anaesthetic)

• sildenafil (also known as Viagra)

• midazolam (a sedative)

• ergotamine (for migraine headaches).

Please tell you doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Amiodarone Tablets with food and drink

You should AVOID drinking grapefruit juice whilst on treatment with Amiodarone Tablets. Grapefruit juice contains some substances that can change the way these tablets work.

You should limit the amount of alcohol you drink whilst taking these tablets.

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant, likely to become pregnant, or are breast feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Amiodarone can cause eye disorders and blurred vision. If you are affected do not drive or operate machinery.

Important Information about some of the ingredients of Amiodarone Tablets

This medicine contains lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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• jaundice (yellowing of the skin or whites of the eyes)

• extreme restlessness and / or loss of weight

• extreme tiredness and / or weight increase

• persistent cough and / or shortness of breath or fever

• pins and needles, weakness of hands or legs, cramps and loss of balance

• problems with your eyesight

• problems with the rhythm of the heart including palpitations (heart flutter) or chest pain.

Exposure to sunlight: Amiodarone can cause some patients to become sensitive to the sun or may cause a discolouration of the skin or a rash. You should avoid exposure of your skin to direct sunlight or sunlamps. You should take sensible precautions when you are in the sun such as wearing a wide brimmed hat and keeping arms and legs covered. Use a total sun block cream for exposed areas of skin. Occasionally, amiodarone may cause a grey or blue discolouration of skin exposed to light. If you are sensitive to the sun, then this may persist for some time after treatment stops.

The following side effects have also been reported. Tell your doctor or pharmacist if you get any troublesome symptoms which you think might be side effects.

Very common side effects (probably affecting more than 1 in 10 people):

• blurred vision • vomiting • sensitivity to light.

• feeling sick • a metallic taste

Common side effects (probably affecting fewer than 1 in 10 people)

• slow pulse • disturbed sleep patterns • coughing,

• liver problems (enlarged • shortness of breath • shakiness.

liver, jaundice, liver failure) • thyroid problems

Uncommon side effects (probably affecting fewer than 1 in 100 people)

• difficulty balancing and • muscle pain and weakness

walking • irregular pulse / dizziness.

Very rare side effects (probably affecting fewer than 1 in 10,000 people)

anaemia

very slow pulse

chronic liver disease

progressive blindness

impotence

headache

painful swelling of the testicles

vertigo (dizziness) skin rashes hair loss

scaly and flaking skin

inflammation of the veins and problems with the blood (you may notice bruising or nose bleeds).

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.HOW TO STORE AMIODARONE TABLETS_

Keep out of the reach and sight of children.

Do not use Amiodarone Tablets after the expiry date which is stated on the carton after EXP;. The expiry date refers to the last day of that month.

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

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 Amiodarone Tablets contain

• The active substance is amiodarone hydrochloride. The tablets are available in two strengths containing 100mg and 200mg amiodarone.

• The other ingredients are lactose monohydrate, maize starch, povidone K90, silica, colloidal anhydrous, pregelatinised starch and magnesium stearate.

What Amiodarone Tablets look like and contents of the pack

Amiodarone 100mg Tablets are round, white, flat with a central division line on one face and embossed "100” on the reverse.

Amiodarone 200mg Tablets are round, white, flat with a central division line on one face and embossed "200” on the reverse.

Amiodarone 100mg and 200mg Tablets are supplied in cartons of 28 tablets.

Marketing Authorisation Holder

Arrow Generics Limited, Whiddon Valley, Barnstaple, Devon, EX32 8NS, United Kingdom Manufacturer

Arrow Pharm (Malta), HF 62, Hal Far Industrial Estate, Hal Far, Malta This leaflet was last revised in January 2014.