Multaq Tablets (Dronedarone Hydrochloride (Uncoated))

Adult dose

The recommended dose of this medicine is 1 tablet (400 milligrams of dronedarone) twice daily for adults only, taken with the morning and evening meals. Before starting this medicine, treatment with Class I or III antiarrhythmic agents (e.g., amiodarone, flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol) or potent CYP3A inhibitors (e.g., ketoconazole) should be discontinued. Patients with renal impairment No dose adjustment is necessary in patients with renal impairment. (Renal excretion of dronedarone is very low.) Patients with hepatic impairment No dose adjustment is necessary in patients with mild or moderate hepatic impairment; however, clinical experience in patients with moderate hepatic impairment is limited. This medicine should not be administered to patients with severe hepatic impairment because there is no experience of use in this group. (Dronedarone is extensively metabolized in the liver.) Older adults No dose adjustment is necessary.

Child dose

Use of this medicine is not recommended in pediatric and adolescent patients under 19 years of age because its safety and efficacy have not been established.

This medicine is used to control the heart rhythm, but it may be risky for patients with permanent atrial fibrillation, hence regular ECG tests must be conducted during treatment. It should not be used in patients with heart failure or decreased left ventricular function, and if symptoms worsen, consultation with a physician should be made immediately. It may affect liver function, thus regular liver function tests are needed before and during treatment, and if liver damage is suspected, the medication should be discontinued. If blood potassium and magnesium levels are low, the risk of arrhythmias may increase, so electrolyte levels should be kept normal before starting this medication. If respiratory illnesses are present or symptoms such as cough or shortness of breath occur, there may be a risk of pulmonary toxicity, requiring immediate examination; if problems are confirmed, the medication should be stopped. Individuals with allergic reactions, certain heart diseases, severe liver disorders, or women who are pregnant or breastfeeding should not take this medication. While taking this medication, gastrointestinal side effects such as diarrhea, nausea, abdominal pain, and lethargy, as well as adverse reactions such as skin rash and bradycardia may occur. If symptoms are severe, consultation with a physician is advised. There are various medications that may interact with this drug, so if taking other medications, it is essential to inform healthcare professionals, particularly avoiding grapefruit juice. Women who are pregnant or may become pregnant should confirm their pregnancy status before taking this medication and should use effective contraception while taking it. The safety and efficacy in children and adolescents have not been established, so its use in these populations is not recommended. In case of overdose, heart rhythm and blood pressure must be closely monitored and necessary treatment administered, as there is no antidote for this medication. This medication should be kept out of reach of children and must not be transferred to other containers.

• Cardiovascular death
• increased stroke
• increased cardiovascular hospitalization
• congestive heart failure
• onset or worsening of heart failure
• left ventricular systolic dysfunction
• hepatocellular liver injury
• loss of appetite
• nausea
• vomiting

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. Also, avoid excessively hot or cold places, and it is advisable to store it at room temperature between 1°C and 30°C.

Appearance

White, film-coated rectangular tablet imprinted with the number '4142' on one side and a double wave pattern on the other side.

Package unit

60 tablets [10 tablets/blister x 6] / box