DRONEDARONA AUROVITAS 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Dronedarone Aurovitas 400 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

This medicine contains the active substance dronedarone. It belongs to a group of medicines called anti-arrhythmics that help regulate your heart rhythm.

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 coming back. Dronedarone is used only in adults.

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

2. What you need to know before you take Dronedarone Aurovitas

Do not take Dronedarone Aurovitas

• If you are allergic to dronedarone or any of the other ingredients of this medicine (listed in section 6).
• If you have a problem with the nerves in your heart (cardiac 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 heart rate (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 leaving your heart each time it contracts is too low (a condition called left ventricular dysfunction).
• If you previously took amiodarone (another anti-arrhythmic medicine) and had lung or liver problems.
• If you are taking medicines for infections (including fungal or HIV infections), allergies, heart rhythm problems, depression, or after a transplant (see section "Taking Dronedarone Aurovitas with other medicines").
• If you have severe liver problems.
• If you have severe kidney problems.
• If you are taking dabigatran (see section "Other medicines and Dronedarone Aurovitas").

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 where the blood vessels that supply blood to the heart become hardened and narrowed (coronary artery disease).

While taking dronedarone, tell your doctor if:

• Your atrial fibrillation while taking dronedarone becomes permanent. You must 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 above symptoms), itching.
• You have difficulty breathing or non-productive cough. Contact your doctor, he will review your lungs.

If any of the above situations apply to you (or you are not sure), 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 medicine.

• Your doctor may look at 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 certain medicines that prevent blood clots, such as warfarin, your doctor will request a blood test called INR to check if your medicine 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 review 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 medicines and Dronedarone Aurovitas

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

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

Do not take any of the following medicines with dronedarone:

• Other medicines used to control irregular or fast heartbeats, such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone.
• Certain medicines for fungal infections, such as ketoconazole, voriconazole, itraconazole, or posaconazole.
• Certain medicines for depression called tricyclic antidepressants.
• Certain sedative medicines called phenothiazines.
• Bepridil for chest pain caused by heart disease.
• Telithromycin, erythromycin, or clarithromycin (antibiotics for infections).
• Terfenadine (a medicine for allergies).
• Nefazodone (a medicine for depression).
• Cisapride (a medicine for food and acid reflux from the stomach to the mouth).
• Ritonavir (a medicine for HIV infection).
• Dabigatran (a medicine to prevent blood clots).

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

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

Taking Dronedarone Aurovitas with food, drinks, and alcohol

Do not drink grapefruit juice while taking this medicine. 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 are planning to have a baby, ask your doctor for advice before taking this medicine.

• If you are a woman who can become pregnant, your doctor will perform a pregnancy test before starting treatment with dronedarone.
• This medicine 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 talk to 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 dronedarone or breastfeed. Do not breastfeed during treatment with dronedarone or for 7 days after the last dose.

Driving and using machines

Dronedarone normally does not 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 contains lactose

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

3. How to take Dronedarone Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

If you need to switch from amiodarone (another medicine for irregular heart rhythm) to dronedarone, your doctor may provide special recommendations, such as pausing amiodarone before switching. Inform your doctor of all the medicines you are taking.

How much to take

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

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

If you think your medicine is too strong or too weak, consult your doctor or pharmacist.

Taking this medicine

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

If you take more Dronedarone Aurovitas than you should

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

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 medicine and the amount ingested.

If you forget to take Dronedarone Aurovitas

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

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 attention.

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

• Problems where your heart does not pump blood properly 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 those who received placebo. The 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 heart rate.

Uncommon(may affect up to 1 in 100 people)

• Inflammation of the lungs (including scarring and thickening of the lungs). The 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. The 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 above 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 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, nausea, vomiting, and stomach pain.
• Fatigue.
• Skin problems, such as rash or itching.
• Changes in the results of blood tests 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 of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dronedarone Aurovitas

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

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice any change in the appearance of the tablets.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Dronedarona Aurovitas

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

Tablet core:lactose monohydrate, corn starch, crospovidone (Type A), hypromellose 2910, anhydrous colloidal silica, poloxamer (Type 407), and magnesium stearate.

Tablet coating:hypromellose 2910, titanium dioxide, and macrogol 6000.

Appearance of the Product and Container Content

Dronedarona Aurovitas is a film-coated tablet, white to off-white in color, oblong in shape, marked with "E" on one side and "400" on the other side.

Dronedarona Aurovitas is available in blister pack containers.

Container sizes:20, 50, 60, and 100 film-coated tablets.

Only some container 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:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Dronedaron PUREN 400 mg film-coated tablets

Spain: Dronedarona Aurovitas 400 mg film-coated tablets EFG

Italy: Dronedarone Aurobindo

Portugal: Dronedarona Generis

Date of the Last Revision of this Leaflet:April 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)