Package Insert: Information for the Patient

Dronedarone Aurovitas Spain 400 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Dronedarona Aurovitas Spaincontains an active ingredient called dronedarone. It belongs to a group of medications known as antiarrhythmics that help regulate your heart rhythm.

Dronedaroneis used if you have a problem with your heart rhythm (atrial fibrillation: your heart beats irregularly) and it has spontaneously returned to your normal heart rhythm, or through a treatment called cardioversion.Dronedaroneprevents your irregular heart rhythm problem from recurring. Dronedarone is used only in adults.

Your doctor will consider all possible treatment options before prescribingdronedarone.

Do not takeDronedarone Aurovitas Spain

• If you are allergic to dronedarone or any of the other ingredients in this medicine (listed in section 6).
• If you have a heart rhythm problem (heart block). Your heart may beat very slowly or you may feel dizzy. If you have had a pacemaker for this problem, you may be able to take dronedarone.
• If you have a very slow heart rate (less than 50 beats per minute).
• If your ECG (electrocardiogram) shows a heart problem called a prolonged corrected QT interval (this interval is more than 500 milliseconds).
• If you have a type of atrial fibrillation (AF) called permanent atrial fibrillation. In permanent AF, AF has been present for a long time (at least 6 months) and the decision has been made not to return your heart rhythm to normal sinus rhythm with a treatment called cardioversion.
• If you have instability (falls) in your blood pressure that may cause inadequate blood flow to your organs.
• If you have or have had a problem where your heart cannot pump blood throughout your body as it should (a condition called heart failure). You may have swollen feet or legs, problems breathing when lying down or sleeping, or shortness of breath when moving.
• If the percentage of blood that leaves your heart each time it contracts is too low (a condition called left ventricular dysfunction).
• If you previously took amiodarone (another antiarrhythmic medication) and had lung or liver problems.
• If you are taking medications for infections (including fungal or HIV infections), allergies, heart rhythm problems, depression, after a transplant (see section “Other medicines andDronedarone Aurovitas Spain”. This will give you more details on which medicines you cannot take with dronedarone).
• If you have severe liver disease.
• If you have severe kidney disease.
• If you are taking dabigatran (see section “TakingDronedarone Aurovitas Spainwith other medicines”).

If you can be attributed to any of the above situations, do not take dronedarone.

Warnings and precautions

Consult your doctor or pharmacist before starting to take dronedarone if:

• You have a condition that causes a drop in your potassium or magnesium levels in the blood. This condition must be corrected before starting treatment with dronedarone.
• You are over 75 years old.
• You have a disease in which the blood vessels that supply blood to the heart become hardened and narrowed (coronary artery disease).

While taking dronedarone, inform your doctor if:

• Your atrial fibrillation while taking dronedarone becomes permanent. You should stop taking dronedarone.
• You have swollen feet or legs, breathing problems when lying down or sleeping, shortness of breath when moving, or weight gain (are signs and symptoms of heart failure).
• Inform your doctor immediately if you develop any of these signs and symptoms related to liver problems: discomfort or pain in the abdominal area, loss of appetite, nausea, vomiting, yellowing of the skin or the white of the eyes (jaundice), dark urine, fatigue (especially associated with the above symptoms), itching.
• You have difficulty breathing or non-productive cough. Contact your doctor, they will check your lungs.

If you can be attributed to any of the above situations (or are unsure), consult your doctor or pharmacist before taking dronedarone.

Blood tests, cardiac and pulmonary tests

While taking dronedarone, your doctor may perform tests to check your health status and what effect the medication is having on you.

• Your doctor may look at the electrical activity of your heart using an ECG (electrocardiogram).
• Your doctor will ask you to have blood tests to check liver function before starting treatment with dronedarone and during treatment.
• If you are taking some medications that prevent the formation of blood clots, such as warfarin, your doctor will ask you to have a blood test called INR to check if your medication is working properly.
• Your doctor may also do other blood tests. The results of one of the blood tests to check your kidney function (creatinine levels in the blood) may be altered by dronedarone. Your doctor will take this into account when checking your blood levels and will use another reference value for the “normal” level of creatinine in the blood.
• Your doctor may check your lungs.

In some cases, it may be necessary to interrupt treatment with dronedarone.

Inform any other person who analyzes your blood that you are taking dronedarone.

Use in children and adolescents

Dronedarone is not recommended for children and adolescents under 18 years old.

Other medicines andDronedarone Aurovitas Spain

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Your doctor may recommend a medication to prevent blood clots in the blood according to your clinical condition.

Dronedarone and other medications may interact and cause severe side effects. Your doctor may change the dose of other medications you are taking.

You should not take any of the following medications with dronedarone:

• Other medications used to control irregular or rapid heartbeats such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone.
• Some medications for fungal infections such as ketoconazole, voriconazole, itraconazole, or posaconazole.
• Some antidepressant medications called tricyclic antidepressants.
• Some tranquilizers called phenothiazines.
• Bepridil for chest pain caused by heart disease.
• Telithromycin, erythromycin, or clarithromycin (antibiotics for infections).
• Terfenadine - (allergy medication).
• Nefazodone - (depression medication).
• Cisapride - (medication for food and acid reflux in your stomach to your mouth).
• Ritonavir - (medication for HIV infection).
• Dabigatran - (medication to prevent blood clots in the blood).

You should consult your doctor or pharmacist if you are taking any of the following medications:

• Other medications for high blood pressure, for chest pain caused by heart disease, or other heart problems such as verapamil, diltiazem, nifedipine, metoprolol, propranolol, or digoxin.
• Some medications that lower cholesterol in your blood (such as simvastatin, lovastatin, atorvastatin, or rosuvastatin).
• Some medications that prevent blood clots in the blood such as warfarin,rivaroxaban, edoxaban, and apixaban.
• Some medications for epilepsy called phenobarbital, carbamazepine, or phenytoin.
• Sirolimus, tacrolimus, everolimus, and cyclosporin (used after a transplant).
• St. John's Wort - a medicinal herb for depression.
• Rifampicin - for tuberculosis.

TakingDronedarone Aurovitas Spainwith food and drinks

Do not drink grapefruit juice while taking this medication. It may increase the levels of dronedarone in the blood and increase the risk of side effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before taking this medication.

• If you are a woman of childbearing age, your doctor will do a pregnancy test before starting treatment with dronedarone.
• This medication is not recommended if you are pregnant or think you may be pregnant.
• Do not take dronedarone if you are a woman who can become pregnant and are not using a safe contraceptive method.
• Use a safe and effective contraceptive method during treatment and for 7 days after the last dose of dronedarone.
• Stop taking your tablets and talk to your doctor immediately if you become pregnant during treatment with dronedarone.
• We do not know if dronedarone passes into breast milk. You and your doctor must decide if you take this medication or breastfeed. Do not breastfeed during treatment with dronedarone or for 7 days after the last dose.

Driving and using machines

Dronedarone usually does not affect your ability to drive and use machines. However, your ability to drive and use machines may be affected by side effects such as fatigue.

Dronedarone Aurovitas Spaincontains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, ask your doctor or pharmacist.

The treatment with dronedarona must be supervised by a doctor with experience in the treatment of heart disease.

If you need to switch from amiodarone (another medication for irregular heartbeat) to dronedarona, your doctor may provide special recommendations, such as pausing amiodarone before switching. Inform your doctor of all medications you take.

How much to take

The usual dose is one 400 mg tablet twice a day. Take:

• one tablet during breakfast and
• one tablet during dinner.

If you think your medication may have too strong or too weak an effect, consult with your doctor or pharmacist.

How to take this medication

Swallow the tablet whole with water during a meal. The tablet cannot be divided into equal doses.

If you take moreDronedarona Aurovitas Spainthan you should

Contact your doctor or the nearest emergency service or hospital immediately. Bring the packaging of this medication.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeDronedarona Aurovitas Spain

Do not take a double dose to make up for the missed doses. Take the next dose when you normally should take it.

If you interrupt treatment withDronedarona Aurovitas Spain

Do not stop taking this medication without first speaking with your doctor or pharmacist.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects have been reported with this medicine:

Contact your doctor immediately if you notice any of the following serious side effects – you may need urgent medical assistance.

Very common(may affect more than 1 in 10 people)

• Problems where your heart does not pump blood throughout your body as it should (congestive heart failure). In clinical studies, this side effect was observed with a similar frequency in patients who took dronedarone and patients who received a placebo. Symptoms include swollen feet or legs, difficulty breathing when lying down or sleeping, shortness of breath when moving, or weight gain.

Common(may affect up to 1 in 10 people)

• Diarrhea, vomiting that may lead to kidney problems.
• Slow heartbeats.

Uncommon(may affect up to 1 in 100 people)

• Pneumonia (including scarring and thickening of the lungs). Symptoms include respiratory problems or non-productive cough.

Rare(may affect up to 1 in 1,000 people)

• Liver problems including potentially fatal liver failure. Symptoms include discomfort or pain in the abdominal area, loss of appetite, nausea, vomiting, yellowing of the skin or white of the eyes (jaundice), dark urine, fatigue (especially associated with the previously mentioned symptoms), itching.
• Allergic reactions, including swelling of the face, lips, mouth, tongue, or throat.

Other side effects

Very common(may affect more than 1 in 10 people)

• Changes in the results of a blood test: your blood creatinine level.
• Changes in your ECG (electrocardiogram) called QTc Bazett prolongation.

Common(may affect up to 1 in 10 people)

• Problems with your digestive system such as indigestion, diarrhea, nausea, vomiting, and stomach pain.
• Fatigue.
• Problems with your skin such as rash or itching.
• Changes in the results of blood tests performed to check your liver function.

Uncommon(may affect up to 1 in 100 people)

• Other skin problems such as redness of the skin or eczema (redness, itching, burning, or blisters).
• Your skin is more sensitive to the sun.
• Change in the taste of things.

Rare(may affect up to 1 in 1,000 people)

• Loss of taste.
• Inflammation of blood vessels (vasculitis including leucocytoclastic vasculitis).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister and carton after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Do not use this medication if you observe visible signs of deterioration (see section 6).

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Dronedarona Aurovitas Spain

• The active ingredient is dronedarone. Each film-coated tablet contains 400 mg of dronedarone (as hydrochloride).
• The other components are:

Tablet core:hypromellose, pregelatinized maize starch, crospovidone, lactose monohydrate, anhydrous colloidal silica, magnesium stearate.

Tablet coating:hypromellose (E464), macrogol (E1521), titanium dioxide (E171).

Appearance of the product and contents of the packaging

Dronedarona Aurovitas Spain is a film-coated tablet, white, oblong in shape, with a size of 17.6 x 8.1 mm.

Dronedarona Aurovitas Spain 400 mg film-coated tablets arepresented in packs of 20, 20x1, 30, 30x1, 50, 50x1, 60, 60x1, 70, 70x1, 100, and 100x1 tablets in PVC opaque – aluminium blisters, PVC opaque/PE/PVdC-Aluminium blisters, or in perforated unit-dose blisters.

Only some sizes of packaging may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible manufacturer:

Rontis Hellas Medical and Pharmaceutical Products S.A.

P.O. Box 3012 Larisa Industrial Area

Larisa - 41004

Greece

Last review date of this leaflet: 03/2025

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)