50 mg / ml injection solution 
amiodarone hydrochloride

What Cordarone is and what it is used for

This product is only used in hospitals. Cordarone is an antiarrhythmic, which lowers the heart’s electrical irritability while counteracting rapid and irregular heartbeat ( arrhythmias ).

Cordarone is used to treat severe heart rhythm disorders and when other medicines have not been effective or can be used.

The amiodarone contained in Cordarone may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before taking Cordarone

Do not use Cordarone

  • if you are allergic to amiodarone, iodine, or any of the other ingredients of this medicine (listed in section 6)
  • if you have a slow heartbeat (if you do not have a pacemaker)
  • if you have certain other types of heart disorders (if you do not have a pacemaker)
  • if you have disorders of thyroid function (metabolism)
  • if you have insufficient blood circulation or very low blood pressure
  • if you are breast-feeding
  • if you are being treated with certain medicines, see section “Other medicines and Cordarone”
  • Intravenous injection should not be given if the patient has low blood pressure, severe respiratory failure, heart muscle disease, or heart failure. The intravenous injection may aggravate these diseases.
  • Due to the presence of benzyl alcohol, Cordarone solution for injection should not be given to newborns, infants, or children up to 3 years of age.

The above does not apply to use in advanced cardiopulmonary resuscitation in case of cardiac arrest due to ventricular fibrillation ( ventricular fibrillation ) which does not respond to cardiac initiation therapy (defibrillation).

Warnings and cautions

Talk to your doctor or pharmacist before taking Cordarone:

  • if you have low blood pressure, severe breathing, or heart failure
  • if you are taking medicines containing sofosbuvir for the treatment of hepatitis C, as it may cause your heart rate to drop to a life-threatening level. Your doctor may consider alternative treatments. If you need treatment with amiodarone and sofosbuvir, extracardiac monitoring may be necessary.

If you are on a waiting list for a heart transplant, your doctor may change your treatment. This is because treatment with amiodarone before heart transplantation has been shown to increase the risk of a life-threatening complication where the transplanted heart stops functioning properly within the first 24 hours after transplantation (primary graft dysfunction).

Tell your doctor immediately if you are taking medicines containing sofosbuvir for the treatment of hepatitis C and you experience during treatment:

  • slow or irregular heartbeat, or problems with heart rhythm
  • shortness of breath or worsening of pre-existing shortness of breath
  • chest pain
  • dizziness 
  • palpitation
  • that you almost faint, or faint

Contact a doctor immediately if you receive Cordarone during treatment:

  • dry cough and shortness of breath may be signs of side effects from the lungs.
  • severe skin reactions
  • impaired vision.

See section 4 Possible side effects for further information.

Children

There are only limited data on the safety and efficacy in children.

Other medicines and Cordarone

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. The effect of the treatment can be affected if Cordarone and other medicines are taken at the same time.

Cordarone should not be combined with the following drugs:

  • certain medicines for heart rhythm disorders (eg quinidine, procainamide, sotalol, bepridil)
  • certain medicines used to treat mental illness ( neuroleptics, lithium, tricyclic antidepressants )
  • certain types of antibiotics (erythromycin, moxifloxacin)
  • agents against protozoa (pentamidine)
  • drugs for opioid dependence and severe pain conditions ( methadone )
  • anti-malarial drugs (mefloquine)

The effect of treatment with Cordarone may be affected or serious side effects may be exacerbated if Cordarone is taken at the same time as certain medicines, eg:

  • beta-blockers, flecainide, digoxin, verapamil, diltiazem, nisoldipine (used to treat heart diseases such as high blood pressure and heart failure )
  • cortisone tablets
  • warfarin (blood thinner)
  • phenytoin (for epilepsy )
  • ciclosporin (used in organ transplantation)
  • diuretics ( diuretics )
  • lipid-lowering drugs so-called statins e.g. simvastatin, atorvastatin, lovastatin
  • fentanyl (painkiller)
  • ergotamine, dihydroergotamine, eletriptan (anti-migraine medicine )
  • triazolam (sedatives and sleeping pills)
  • fluoroquinolone is, amphotericin B ( antibiotics )
  • intestinal irritants laxatives
  • drugs that inhibit an enzyme called CYP3A4 (eg HIV – protease inhibitors(ritonavir), ketoconazole, itraconazole, voriconazole, posaconazole, telithromycin, clarithromycin, or nefazodone)
  • dabigatran (counteracts blood clots)
  • sofosbuvir (medicine for hepatitis C)
  • grapefruit juice

Before any surgery, it is important that your anesthesiologist knows that you are using Cordarone.

Cordarone is broken down slowly and therefore remains in the body long after the end of treatment (individually, but up to several months). This is especially true when long-term treatment with Cordarone tablets, but also with Cordarone injection. It can therefore affect other medicines even after your Cordarone treatment has stopped. Consult a physician in case of uncertainty.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is a risk that the fetus is affected. Therefore, do not use Cordarone during pregnancy unless you have been prescribed by a doctor.

It is possible that a breastfed baby may be affected. Therefore, do not use Cordarone while breast-feeding.

Driving and using machines

Cordarone is unlikely to impair your ability to drive or use machines.

Cordarone contains benzyl alcohol

Cordarone contains benzyl alcohol as a preservative (20 mg/ml). May cause poisoning or allergic reactions in infants and children under 3 years of age.

3. How to use Cordarone

Cordarone solution for injection is used in hospitals as an intravenous infusion or injection. Dosage one is determined and adjusted individually by the doctor.

The usual dose is 5 mg/kg body weight. For further information on dosing, see section: “The following information is intended for healthcare professionals only” at the end of this leaflet.

If you use more Cordarone than you should 

Your doctor or healthcare professional will give you Cordarone and it is unlikely that you will receive too much of the medicine. If you suspect you have been given too much, tell your healthcare provider immediately.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact a doctor immediately if you get any of the following symptoms:

  • Skin rash, fever, difficulty breathing, and drop in blood pressure. This may be a sign of anaphylactic reaction ( hypersensitivity reaction ) including shock occurring in up to 1 in 10,000 users.
  • Swelling of the face, tongue, or throat; difficulty swallowing; hives, and difficulty breathing. This may be a sign of angioedema occurring in an unknown number of users.
  • An infection with symptoms such as fever with severe general deterioration or fever with local symptoms of infection such as sore throat/pharynx/mouth or difficulty urinating. This may indicate a lack of white blood cells ( agranulocytosis ) which has been reported in an unknown number of users.
  • Severe skin reactions with widespread skin damage (skin detachment of the epidermis and superficial mucous membranes) or skin rash usually in the form of blisters or sores in the mucous membranes such as the oral cavity and eyes. This may be a sign of toxic epidermal necrolysis, Stevens-Johnson syndrome, bullous dermatitis, or drug reaction with eosinophilia and systemic symptoms (DRESS) occurring in an unknown number of users.
  • Dry cough and shortness of breath. It can be a sign of side effects from the lungs that can be serious, which occurs in up to 1 in 10,000 users.
  • Impaired vision. It can be a sign of severe optic nerve damage that can lead to blindness, which occurs in up to 1 in 10,000 users.

The following side effects have also been reported with Cordarone:

Common (may affect up to 1 in 10 people): Slow heartbeat ( bradycardia ). Injection site reactions such as pain, redness of the skin, swelling due to fluid retention, tissue death, hemorrhage, inflammation, hardening of the tissue, infection, and pigment changes. Low blood pressure, usually moderate and transient. . Itchy, red rash ( eczema ).

Very rare (may affect up to 1 in 10,000 people): Disorders of the heart rhythm. Nausea. Disorder of liver function, changes in liver values. Elevated pressure in the brain, headache. Respiratory disorders (eg pneumonia including connective tissue formation). Sweating, hot flashes. Feeling sick, feeling confused or weak, nausea, decreased appetite, irritation. This can be a disease called inadequate ADH – secretion (SIADH, “Syndrome of Inappropriate anti-diuretic hormone secretion”).

Has been reported (occurs in an unknown number of users):

Overproduction of hormone in the thyroid gland that regulates metabolism ( hyperthyroidism ). Back hurts.

A special form of elevated heart rhythm ( torsade de points ). Blood effects. Confusion ( delirium ), hallucination. Sudden inflammation of the pancreas ( acute pancreatitis ). Hives. Decreased sex drive. Life-threatening complication after heart transplantation where the transplanted heart stops functioning properly (primary graft dysfunction) (see section 2, Warnings and Precautions).

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Cordarone

Keep this medicine out of the sight and reach of children.

Store below 25 ° C. Store in the original package. Sensitive to light.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Cordarone will be discarded by your doctor or nurse once the infusion/injection has been completed.

6. Contents of the packaging and other information

Content declaration

  • The active substance is amiodarone hydrochloride. 1 ml solution for injection contains 50 mg of amiodarone hydrochloride.
  • The other ingredients are benzyl alcohol, polysorbate 80, and water for injections.

What the medicine looks like and the contents of the pack

The clear, pale yellow solution in a 3 ml ampoule.

Pack size: 6×3 ml, 10×3 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sanofi AB, Box 30052, 104 25 Stockholm

Muhammad Nadeem

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