AMIODARONE HYDROCHLORIDE 100mg/200mg

Why do you need this medication? Amiodarone Hydrochloride belongs to a group of medicines called antiarrhythmic. These work by controlling an irregular or rapid heartbeat (called arrhythmia). Taking the tablets helps your heartbeat to return to normal

ACTIVE INGREDIENT

Each tablet contains 100mg /200mg Amiodarone Hydrochloride

INDICATION

• To treat uneven heartbeats where other medicines either have not worked or cannot be used
• To treat an illness called Wolff-Parkison-White syndrome. This is where your heart beats unusually fast
• 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.
• To treat fast heartbeats which may happen suddenly and may be uneven. Amiodarone Tablets are used only when other medicines cannot be used.

CONTRAINDICATIONS

Do not take amiodarone if you:

• are allergic (hypersensitive) to iodine, amiodarone hydrochloride or any of the other ingredients of this medicine
• have a slower than usual heartbeat (called ‘sinus bradycardia’) or an illness called ‘Sino-atrial’ heart block.
• have any other problems with your heart and do not have a pacemaker fitted
• have ever had thyroid problems. Your doctor should test your thyroid before giving you this medicine
• are pregnant or breast−feeding
• are taking certain other medicines which could affect your heartbeat

DOSAGE AND ADMINISTRATION

Always take Amiodarone exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is: 

Adults 

Initially: The usual starting dose is 200mg three times a day for the first week. The dose should then be reduced to 200mg twice a day for a further week. Maintenance: After the initial period the dose should be reduced to 200mg daily or less, if appropriate. Rarely, a higher dose is required

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

Administration

These tablets are to be taken orally

These tablets should be swallowed whole with a glass of water.

ADDED INFORMATION

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.

Amiodarone contains 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.

WARNING AND PRECAUTIONS

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
• have any problems with your lungs or have asthma
• have liver problem
• are elderly (over 65 years of age).
• You have a condition called acute porphyria

POSSIBLE SIDE EFFECTS

Arrhythmias, hepatic disorders, hyperthyroidism, nausea, respiratory disorders, skin reactions, constipation, hypothyroidism, movement disorders, photosensitivity reaction, sleep disorders, taste altered, vomiting

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)

STORAGE

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