Side Effects

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. Stop taking Amiodarone Tablets and see a doctor or go to a hospital straight away if you notice any of the following serious side effects – you may need urgent medical treatment: ! You have an allergic reaction or severe allergic reaction (anaphylactic reaction, anaphylactic shock). 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 ! 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 can be very dangerous and can happen at any time after starting treatment ! Your heartbeat becomes even more uneven or erratic. This can lead to a heart attack, so you should go to hospital straight away ! Feeling numb or weak, tingling or burning feelings in any part of your body ! 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), 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 ! 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) ! Sudden inflammation of the pancreas (pancreatitis (acute)) ! Chest pain and shortness of breath and irregular heartbeat. These could be signs of a condition called “Torsade de pointes”. ! Primary graft dysfunction post cardiac transplant 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 (may affect more than 1 in 10 people) ! Blurred eyesight or seeing a coloured halo in dazzling light. Common (may affect up to 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 ‘hyperthyroidism’ ! 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 ‘hypothyroidism’ ! Trembling when you move your arms or legs ! Blue or grey marks on parts of your skin exposed to sunlight, especially the face. ! Decrease in sex drive Uncommon (may affect up to 1 in 100 people) ! Muscle cramps, stiffness or spasm. Very rare (may affect up to 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 antidiuretic hormone secretion’ (SIADH) ! Increased creatinine levels which is a sign of impaired kidney function. This can be seen in blood tests. 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 get serious or lasts longer than a few days: Very common (may affect 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. Common (may affect up to 1 in 10 people) ! Slightly slower heartbeat ! Nightmares ! Problems sleeping ! Constipation ! Scaly and itchy rash (eczema). Uncommon (may affect up to 1 in 100 people) ! Dry mouth. Very rare (may affect up to 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, 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 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