Dronedarone Stada
Dronedarone Stada is a medication that helps regulate your heart rhythm and prevents irregular heartbeats (atrial fibrillation) from returning after a procedure to restore normal rhythm.
Form
tabletti, kalvopäällysteinen
Strength
400 mg
Active Ingredient
Dronedarone hydrochloride
Manufacturer
STADA Arzneimittel AG
How to Use
Dosage
One 400 mg tablet.
Method
Take one tablet with breakfast and one tablet with the evening meal, swallowing them whole with water.
Important
The usual maximum daily dose is two 400 mg tablets, totaling 800 mg.
Possible Side Effects
COMMON
- •Swelling of legs or ankles, difficulty breathing (especially when lying down or sleeping), shortness of breath during activity, weight gain.
- •Changes in blood creatinine levels (a test for kidney function).
- •Prolonged QTc interval on ECG (heart tracing).
- •Diarrhea, nausea, vomiting, stomach pain.
- •Slow heart rate.
- •Fatigue.
- •Rash or itching.
- •Changes in liver function blood test results.
RARE
- •Lung inflammation (scarring or thickening of the lungs), with symptoms like shortness of breath or irritating cough.
- •Redness, eczema (redness, itching, burning sensation, or blisters), increased sensitivity to sunlight.
- •Severe liver problems, including life-threatening liver failure, with symptoms such as abdominal pain, loss of appetite, nausea, vomiting, yellowing of skin or eyes (jaundice), unusually dark urine, tiredness, or itching.
- •Allergic reactions, including swelling of the face, lips, mouth, tongue, or throat.
- •Changes in taste, or loss of taste.
- •Blood vessel inflammation (vasculitis).
Important Warnings
- Do not take if you are allergic to dronedarone or any other ingredients in this medicine.
- Do not take if you have severe heart rhythm problems, very slow heart rate (less than 50 beats per minute), or a prolonged QTc interval on your ECG.
- Do not take if you have permanent atrial fibrillation where a decision has been made not to try to restore normal heart rhythm.
- Do not take if you have heart failure (your heart cannot pump enough blood) or left ventricular dysfunction.
- Do not take if you previously used amiodarone and had lung or liver problems.
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- Do not take if you have severe liver or kidney disease.
- Do not take with other medicines for irregular or fast heart rhythms (e.g., flecainide, amiodarone, sotalol).
- Do not take with certain antifungal medicines (e.g., ketoconazole, voriconazole).
- Do not take with tricyclic antidepressants or phenothiazine antipsychotics.
- Do not take with bepridil, certain antibiotics (telithromycin, erythromycin, clarithromycin), terfenadine, nefazodone, cisapride, or ritonavir.
- Do not take with dabigatran (a blood clot prevention medicine).
- Do not drink grapefruit juice while taking this medicine.
- Do not take if you are pregnant, think you might be pregnant, or are a woman who can become pregnant and are not using reliable birth control.
- Stop taking immediately and contact your doctor if you become pregnant during treatment.