DRONEDARONE AUROVITAS SPAIN 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Dronedarone Aurovitas Spain 400 mg film-coated tablets EFG

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

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

Contents of the Package Leaflet

1. What Dronedarone Aurovitas Spain is and what it is used for
2. What you need to know before taking Dronedarone Aurovitas Spain
3. How to take Dronedarone Aurovitas Spain
4. Possible side effects
5. Storage of Dronedarone Aurovitas Spain
6. Contents of the pack and further information

1. What Dronedarone Aurovitas Spain is and what it is used for

Dronedarone Aurovitas Spain contains the active substance dronedarone. It belongs to a group of medications called anti-arrhythmics that help regulate your heartbeat.

Dronedarone is 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. Dronedarone prevents your irregular heart rhythm problem from recurring. Dronedarone is used only in adults.

Your doctor will consider all possible treatment options before prescribing dronedarone.

2. What you need to know before taking Dronedarone Aurovitas Spain

Do not take Dronedarone Aurovitas Spain

• If you are allergic to dronedarone or any of the other components of this medication (listed in section 6).
• If you have a problem with the nerves in your heart (heart block). Your heart may beat very slowly or you may feel dizzy. If you have had a pacemaker for this problem, you can use dronedarone.
• If you have a very slow heartbeat (less than 50 beats per minute).
• If your ECG (electrocardiogram) shows a heart problem called "prolonged 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, the 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 with a treatment called cardioversion.
• If you have instability (drops) in your blood pressure that can 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, breathing problems 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 anti-arrhythmic medication) and had lung or liver problems.
• If you are taking medications for infections (including fungal or AIDS infections), allergies, heart rhythm problems, depression, or after a transplant (see section "Other medications and Dronedarone Aurovitas Spain" for more details on which medications you should not take with dronedarone).
• If you have severe liver problems.
• If you have severe kidney problems.
• If you are taking dabigatran (see section "Taking Dronedarone Aurovitas Spain with other medications").

If any of the above situations apply to you, do not take dronedarone.

Warnings and precautions

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

• You have a problem that causes your potassium or magnesium levels in the blood to drop. This problem 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 (signs and symptoms of heart failure).
• Immediately inform your doctor 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 whites of the eyes (jaundice), darkening of the urine, fatigue (especially associated with the aforementioned symptoms), itching.
• You have difficulty breathing or non-productive cough. Contact your doctor; they will check your lungs.

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

Blood tests, heart tests, and lung tests

While taking dronedarone, your doctor may perform tests to check your health and the effect of the medication.

• Your doctor may check the electrical activity of your heart with an ECG (electrocardiogram).
• Your doctor will request blood tests to check your liver function before starting treatment with dronedarone and during treatment.
• If you are taking medications that prevent blood clots, such as warfarin, your doctor will request a blood test called INR to check if your medication is working properly.
• Your doctor may also perform 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 "normal" creatinine levels 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 analyzing your blood that you are taking dronedarone.

Use in children and adolescents

Dronedarone is not recommended in children and adolescents under 18 years of age.

Other medications and Dronedarone Aurovitas Spain

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

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

Do 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.
• Certain medications for fungal infections, such as ketoconazole, voriconazole, itraconazole, or posaconazole.
• Certain medications for depression called tricyclic antidepressants.
• Certain sedative medications called phenothiazines.
• Bepridil for chest pain caused by heart disease.
• Telithromycin, erythromycin, or clarithromycin (antibiotics for infections).
• Terfenadine (medication for allergies).
• Nefazodone (medication for depression).
• Cisapride (medication for stomach problems and acid reflux).
• Ritonavir (medication for AIDS infection).
• Dabigatran (medication to prevent blood clots).

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

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

Taking Dronedarone Aurovitas Spain with food and drinks

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

Pregnancy and breastfeeding

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

• If you are a woman of childbearing age, your doctor will perform 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 reliable contraceptive method.
• Use a reliable contraceptive method during treatment and for 7 days after the last dose of dronedarone.
• Stop taking your tablets and consult your doctor immediately if you become pregnant during treatment with dronedarone.
• It is not known if dronedarone passes into breast milk. You and your doctor must decide whether to 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 does not normally affect your ability to drive or use machines. However, your ability to drive or use machines may be affected by side effects such as fatigue.

Dronedarone Aurovitas Spain contains lactose

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

3. How to take Dronedarone Aurovitas Spain

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are unsure, ask your doctor or pharmacist.

Treatment with dronedarone must be supervised by a doctor with experience in treating heart disease.

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

How much to take

The normal 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 be too strong or too weak, consult your doctor or pharmacist.

Taking this medication

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

If you take more Dronedarone Aurovitas Spain than you should

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

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

If you forget to take Dronedarone Aurovitas Spain

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

If you stop taking Dronedarone Aurovitas Spain

Do not stop taking this medication without talking to your doctor or pharmacist first.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The following side effects have been reported with this medication:

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

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

• Problems where your heart does not pump blood properly throughout your body, such as heart failure. In clinical studies, this side effect was observed with a similar frequency in patients who took dronedarone and those who received a placebo. Signs include swollen feet or legs, breathing problems 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 can lead to kidney problems.
• Slow heartbeats.

Uncommon(may affect up to 1 in 100 people)

• Inflammation of the lungs (including scarring and thickening of the lungs). Signs include breathing problems or non-productive cough.

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

• Liver problems, including potentially life-threatening liver failure. Signs include discomfort or pain in the abdominal area, loss of appetite, nausea, vomiting, yellowing of the skin or whites of the eyes (jaundice), darkening of the urine, fatigue (especially associated with the aforementioned 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 blood test results: your creatinine level in the blood.
• 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.
• Skin problems, such as rash or itching.
• Changes in blood test results 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 the blood vessels (vasculitis, including leucocytoclastic vasculitis).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Dronedarone Aurovitas Spain

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

Do not use this medication after the expiration date stated on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and medication you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

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 corn starch, crospovidone, lactose monohydrate, anhydrous colloidal silica, magnesium stearate.

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

Appearance of the Product and Package Contents

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 are presented in packages of 20, 20x1, 30, 30x1, 50, 50x1, 60, 60x1, 70, 70x1, 100 and 100x1 tablets in opaque PVC-aluminum, opaque PVC/PE/PVdC-aluminum or in unit-dose perforated blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

Rontis Hellas Medical and Pharmaceutical Products S.A.

P.O. Box 3012 Larissa Industrial Area

Larissa - 41500

Greece

Date of the Last Revision of this Leaflet: 03/2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)