If you suffer from severe heart failure, you shouldn’t use dronedarone. In those with severe heart failure, dronedarone may raise the chance of death. If you experience shortness of breath after light exercise, after engaging in any physical activity, or when at rest, let your doctor know if you have heart failure that is severe enough to cause these symptoms. Even if you feel better, let your doctor know if you have recently been hospitalised for heart failure. Dronedarone won’t be prescribed to you by your doctor.

If your atrial fibrillation (a heart rhythm issue that can result in a fast, irregular heartbeat) is not or cannot be converted back to a normal heart rhythm, you shouldn’t use dronedarone. In patients with persistent atrial fibrillation, dronedarone may raise the risk of death, stroke, and the requirement for hospitalisation. When you are on dronedarone, your doctor will monitor your heart rhythm at least every three months. If while taking dronedarone your heartbeat becomes rapid or irregular, call your doctor right away.

The patient information sheet (Medication Guide) from the manufacturer will be sent to you by your doctor or pharmacist when you start dronedarone medication and each time you get a prescription refill. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).

Dronedarone is used to treat patients who currently have a normal cardiac rhythm but previously experienced atrial fibrillation. Dronedarone reduces the likelihood that someone with atrial fibrillation will need to be hospitalised for treatment. Antiarrhythmics, which include dronedarone, are a group of drugs. It helps by promoting regular heartbeat.

Tablets of dronedarone are available for oral consumption. It is typically consumed with the morning meal and the evening meal twice a day. Take dronedarone every day at roughly the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Dronedarone should be taken as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

While you are using dronedarone, your doctor may advise you to take specific drugs to lower your risk of stroke. Throughout your treatment, take this drug precisely as prescribed.

Just as long as you keep taking dronedarone will it help you regulate your heart rate. Even if you feel good and have felt good for a while, keep taking dronedarone. Without consulting your doctor, do not discontinue taking dronedarone.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

Before taking dronedarone,

• If you have any allergies, including to dronedarone, other drugs, or any of the substances in dronedarone tablets, notify your doctor right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
• If you are taking any of the following medications, let your doctor know: Amoxapine, clomipramine (Anafranil), desipramine (Norpramin), amitriptyline (Limbitrol), doxepin (Sinequan), and imipramine are a few examples of antidepressants (Tofranil), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend); clarithromycin (Biaxin); cyclosporine (Gengraf, Neoral, Sandimmune); nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); medication for irregular heartbeats such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), flecainide (Tambocor), propafenone (Rythmol), quinidine, and sotalol (Betapace); erythromycin (E.E.S., E-Mycin, Erythrocin); nefazodone, ritonavir (Norvir), telithromycin, or phenothiazine drugs for nausea or mental illness (Ketek). If you are taking any of these drugs, your doctor might advise against using dronedarone.
• Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, and dietary supplements you are currently taking or intend to take. Incorporate any of the following: beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); anticoagulants (blood thinners) such as dabigatran (Pradaxa) and warfarin (Coumadin); calcium channel blockers such nifedipine (Adalat, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and diltiazem (Cardizem, Dilacor, Tiazac); carbamazepine (Epitol, Equetro, Tegretol); statins, which decrease cholesterol, include atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor); digoxin (Lanoxicaps, Lanoxin); diuretics (water pills); phenobarbital; SSRIs such citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); sirolimus (Rapamune); and tacrolimus; phenytoin (Dilantin); rifampin (Rifadin, Rimactane (Prograf). Your doctor might need to adjust your medication doses or keep a close eye out for any negative side effects.
• Please let your doctor know if you are taking any herbal supplements, especially St. John’s wort.
• Inform your physician if you suffer from liver disease, a fast or slow heartbeat, a long QT interval (a cardiac condition that can result in irregular heartbeat, fainting, or sudden death), or if you have ever experienced liver or lung issues following the use of amiodarone (Pacerone). You could be advised by your doctor not to take dronedarone.
• If you have or have ever had any additional medical conditions, let your doctor know.
• If you are pregnant or plan to become pregnant, let your doctor know. Throughout your dronedarone treatment, you must practise effective birth control. Discuss effective birth control options with your doctor. Call your doctor right away if you find yourself pregnant while taking dronedarone. The foetus can suffer from dronedarone.
• While receiving therapy with dronedarone, breastfeeding is not advised.
• If you are 65 years of age or older, discuss the advantages and disadvantages of taking dronedarone with your doctor. Dronedarone is not as safe or as successful for treating the same problem in certain older persons as other drugs, therefore they shouldn’t take it.

While using this medication, avoid grapefruit and grapefruit juice.

Keep eating normally unless your doctor instructs you otherwise.

Ignore the missed dose and carry on with my normal dosing routine. Never attempt to make up a missing dose or take two doses to make up for one.

Side effects from dronedarone are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:

• Diarrhea
• Heartburn
• Weakness
• Rash
• Redness

Certain adverse effects can be very harmful. You should stop taking dronedarone and contact your doctor right away, or seek emergency medical attention, if you have any of the following symptoms or any of those in the IMPORTANT WARNING section:

• Breathing difficulty
• Breathing or swallowing challenges
• Wheezing
• Chest constriction
• Wet cough
• Spitting up foaming mucus
• Breathing issues preventing you from falling asleep
• Need to use additional pillows to raise yourself so you can breathe at night
• Weight growth of five pounds or more in a short amount of time
• Swelling of the hands, feet, legs, lips, neck, eyes, and/or face.
• Reduced heart rate
• Fainting
• Fever
• Flu-like signs
• Eyes or skin that have a yellow tint
• Itching
• Significant bruising or bleeding
• Nausea
• Vomiting
• Reduced appetite
• Stomach ache in the top right corner
• Fatigue or little energy
• Unexpected urine darkening
• Stool with a light colour
• Acutely painful headache
• Unexpected total or partial vision loss
• An arm or leg that is weak or numb
• Having trouble remembering, concentrating, or picking up new information

Further negative effects of dronedarone are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

Keep this medication tightly closed in the original container and out of the reach of children. Keep it away from excessive heat and moisture at room temperature (not in the bathroom).

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Keep all of your appointments with your physician and the lab. To monitor how your body is responding to dronedarone, your doctor may request specific lab tests.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.