Cordarone X Intravenous, concentrated Solution

CORDARONE X INTRAVENOUS is an antidysrhythmic medicine and is used to control an irregular or rapid heart rate where other similar medicines do not have the expected effect.

CORDARONE X INTRAVENOUS should not be administered to you:

• if you are hypersensitive (allergic) to amiodarone hydrochloride, iodine or to any of the other ingredients of CORDARONE X INTRAVENOUS (see section 6)
• if you have heart block - which may cause a very slow, very fast or irregular pulse, or dizziness
• if you have a slower than usual heartbeat
• if you have any other problems with your heartbeat and do not have a pacemaker fitted
• if you have or have had thyroid problems
• if you have severe respiratory failure or very low blood pressure
• if you are being given as a single injection and you have low blood pressure, heart failure or cardiomyopathy (weakness of the heart muscle).
• if you have blood circulation problems
• if you are pregnant or likely to become pregnant. Tell your doctor about this. (see Pregnancy and Breastfeeding)
• if you are breastfeeding (see Pregnancy and Breastfeeding)
• if you are taking or have taken certain other prescription medicines: including other heart medicines (e.g. sotalol, disopyramide, quinidine, procainamide, bepridil), antibiotics (e.g. intravenous erythromycin, pentamidine injection, co-trimoxazole, ciprofloxacin or moxifloxacin), antipsychotics, antidepressants (including lithium), antihistamines, antimalarials. Tell your doctor if you are taking or have recently taken any prescription medications. (see Other medicines and CORDARONE X INTRAVENOUS)
• if you are taking or have taken certain other non-prescription medicines including herbal supplements like St John’s Wort or other nutritional supplements. Tell your doctor if you are taking or have recently taken any other non-prescription medications (see Other medicines and CORDARONE X INTRAVENOUS).

CORDARONE X INTRAVENOUS is not recommended for use in paediatric patients. The ampoules of CORDARONE X INTRAVENOUS contain benzyl alcohol (see Warnings and special precautions). Do not receive CORDARONE X INTRAVENOUS if any of the above apply to you. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before receiving CORDARONE X INTRAVENOUS.

Warnings and precautions:

Tell your doctor or other healthcare provider immediately if you notice any of the following during treatment, since you may require urgent medical care:

• difficulty breathing or lung (respiratory) problems
• unexplained weight loss or gain, cold intolerance, restlessness or slow or fast heartbeat. These could be signs of thyroid abnormalities (see Do not take CORDARONE X INTRAVENOUS and POSSIBLE SIDE EFFECTS)
• problems with your eyesight such as blurred or decreased vision
• worsening skin rash often with blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever (see section 4).

Tell your doctor or healthcare professional before being given the injection:

• if you have heart failure
• if you are going to have an anaesthetic, any kind of surgery (including dental) or high dose oxygen therapy
• if you are porphyric
• if you have or have had liver or kidney problems
• if you are a heart transplant patient
• if you are taking or have taken certain other prescription medicines including anti-infectives, statin medicines used to lower cholesterol, HIV-protease inhibitors, stimulant laxatives or hepatitis C treatment (see Other medicines and CORDARONE X INTRAVENOUS for a complete list).

Before and during treatment your doctor may perform tests to assess your medical condition such as blood tests, chest X-Rays and ECG (electrical tracing of your heart) examinations.

Do not share medicines prescribed for you with any other person. The correct dose and dilution for you will have been decided by the doctor and will depend upon your condition. You will not be expected to give yourself you CORDARONE X INTRAVENOUS. Your doctor or nurse will give you CORDARONE X INTRAVENOUS. This is because it needs to be given as a bolus injection or infusion into your vein in the hospital where the doctor can monitor your progress. If you have the impression that the effect of CORDARONE X INTRAVENOUS is too strong or too weak, tell your doctor, pharmacist or other healthcare professional.

If you receive more CORDARONE X INTRAVENOUS than you should:

Since a healthcare professional will administer this CORDARONE X INTRAVENOUS, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you missed a dose of CORDARONE X INTRAVENOUS:

Since a health care provider will administer CORDARONE X INTRAVENOUS, it is unlikely that the dose will be missed.

Effects when treatment with CORDARONE X is stopped:

Your doctor will determine if you need to continue treatment with another dosage form of CORDARONE X when you are discharged from the hospital and for how long. Do not stop taking CORDARONE X just because you feel better. If you stop taking CORDARONE X the uneven heartbeats may come back and this could be dangerous. If you are sensitive to the sun, the sensitivity may persist for some time after treatment stops and the necessary precautions need to be taken. CORDARONE X is very slowly eliminated from the body and adverse events may only disappear several months after treatment is stopped.

CORDARONE X INTRAVENOUS can have side effects. Not all side effects reported for CORDARONE X INTRAVENOUS are included in this leaflet Should your general health worsen or if you experience any untoward effects while taking CORDARONE X INTRAVENOUS, please consult your doctor, pharmacist or other healthcare provider for advice.

If any of the following happens, tell your doctor immediately:

• you have an allergic reaction. The signs may include: swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing, rash or itching and fainting
• liver disorders
• 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). These are all very serious side effects. You may need immediate medical attention.

Tell your doctor immediately if you notice any of the following:

• chest pain
• angina
• changes in the way your heart beats, for example, if you notice it beating faster
• breathing difficulties (with or without fever)
• signs of recurrent infections such as fever or sore throat
• pain in the eye.

These are all serious side effects. You may need urgent medical attention.

Frequent side effects:

• a slow pulse
• local injection site reactions including swelling, pain, redness, infection and pigmentation changes
• a decrease in blood pressure
• problem with your thyroid (see Do not take CORDARONE X and Warning and precautions):
• 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 (increased thyroid function)
• 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 (decreased thyroid function).

Less frequent side effects:

• nausea (feeling sick), vomiting (being sick), taste disturbance
• headaches
• disturbed sleep patterns, nightmares and dizziness
• hot flushes, sweating
• back pain
• urticaria (hives - itchy, lumpy rash)
• increased liver enzymes
• blood disorders (you may have nose bleeds, bruising, tiredness, paleness of skin)
• confusion
• feeling unwell, confused and/or weak, feeling sick (nausea), loss of appetite and feeling irritable. This could be something called ‘syndrome of inappropriate anti-diuretic hormone secretion (SIADH)’
• libido decreased.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can report side effects directly to Sanofi’s Pharmacovigilance Unit at Email: [email protected] or Tel: 011 256 3700 or You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form” found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of CORDARONE X INTRAVENOUS.

Protect from light and store in a cool place (at or below 25 °C). Keep the ampoule in the carton until required for use.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

Do not use after the expiry date stated on the label.