Dronedarone Aurovitas 400 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dronedarone Aurovitas 400 mg film-coated tablets EFG

Read the entire 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

This medicine contains an active substance called dronedarone. It belongs to a group of medicines known as antiarrhythmics, which help regulate your heartbeat.

Dronedarone is used if you have a problem with your heart rhythm (atrial fibrillation: your heart beats irregularly) and have spontaneously returned, or have been returned through a treatment called cardioversion, to a normal heart rhythm. 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 to you.

2. What you need to know before taking Dronedarone Aurovitas

Do not take Dronedarone Aurovitas

• If you are allergic to dronedarone or to any of the other ingredients of this medicine (listed in section 6).
• If you have a nerve problem in your heart (heart block). Your heart may beat very slowly or you may feel dizzy. If you have had a pacemaker implanted for this condition, you may 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 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, the AF has been present for a long time (at least 6 months), and the decision has been made not to restore your heart rhythm to normal sinus rhythm with a treatment called cardioversion.
• If you have instability (drops) in your blood pressure that may cause inadequate arterial blood flow to your organs.
• If you have or have had a condition in which your heart cannot pump blood properly throughout your body (a condition called heart failure). You may have swollen feet or legs, difficulty breathing when lying down or sleeping, or shortness of breath during physical activity.
• If the percentage of blood pumped out of your heart with each beat is too low (a condition called left ventricular dysfunction).
• If you previously took amiodarone (another antiarrhythmic medicine) and experienced lung or liver problems.
• If you are taking medicines for infections (including fungal infections or AIDS), allergies, heart rhythm problems, depression, or after an organ transplant (see section “Taking Dronedarone Aurovitas with other medicines”. This will provide more details on which medicines must not be taken with dronedarone).
• If you have severe liver disease.
• If you have severe kidney disease.
• If you are taking dabigatran (see section “Other medicines and Dronedarone Aurovitas”).

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

Warnings and precautions

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

• You have a condition that causes low levels of potassium or magnesium in your 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 supplying the heart become hardened and narrowed (coronary artery disease).

While taking dronedarone, inform your doctor if:

• Your atrial fibrillation becomes permanent while you are taking dronedarone. You must stop taking dronedarone.
• You develop swollen feet or legs, difficulty breathing when lying down or sleeping, shortness of breath during activity, or weight gain (these are signs and symptoms of heart failure).
• You develop any of the following signs or symptoms related to liver problems: discomfort or pain in the stomach area (abdomen), loss of appetite, nausea, vomiting, yellowing of the skin or whites of the eyes (jaundice), unusual darkening of the urine, fatigue (especially when associated with the symptoms listed above), or itching. Inform your doctor immediately.
• You experience difficulty breathing or a dry cough. Contact your doctor, who will examine your lungs.

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

Blood tests, cardiac and pulmonary examinations

While taking dronedarone, your doctor may perform tests to monitor your health and assess the medicine’s effects.

• Your doctor may evaluate the electrical activity of your heart using an ECG (electrocardiogram).
• Your doctor will request blood tests to check your liver function before starting and during treatment with dronedarone.
• If you are taking medications that prevent blood clotting, such as warfarin, your doctor will request a blood test called INR to ensure your medication is working properly.
• Your doctor may also request other blood tests. One blood test used to assess kidney function (blood creatinine levels) may be affected by dronedarone. Your doctor will take this into account when interpreting your blood levels and will use an adjusted reference value for normal blood creatinine.
• Your doctor may examine your lungs.

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

Inform any healthcare professional performing blood tests that you are taking dronedarone.

Use in children and adolescents

Dronedarone is not recommended for use 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 need to take any other medicines. Your doctor may recommend a medicine to prevent blood clots, depending on your clinical condition.

Dronedarone may interact with other medicines and cause serious adverse effects. Your doctor may adjust the dose of other medicines you are taking.

You must not take any of the following medicines with dronedarone:

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

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 conditions such as verapamil, diltiazem, nifedipine, metoprolol, propranolol, or digoxin.
• Certain cholesterol-lowering medicines (such as simvastatin, lovastatin, atorvastatin, or rosuvastatin).
• Certain medicines that prevent blood clots such as warfarin, rivaroxaban, edoxaban, or apixaban.
• Certain antiepileptic medicines called phenobarbital, carbamazepine, or phenytoin.
• Sirolimus, tacrolimus, everolimus, and cyclosporine (used after organ transplantation).
• St. John’s wort – a herbal remedy 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 blood levels of dronedarone and increase the risk of adverse 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 medicine.

• If you are a woman of childbearing potential, your doctor will perform a pregnancy test before starting treatment with dronedarone.
• This medicine is not recommended if you are pregnant or suspect you may be pregnant.
• Do not take dronedarone if you are a woman who could become pregnant and are not using a reliable contraceptive method.
• Use an effective method of contraception during treatment and for 7 days after the last dose of dronedarone.
• Stop taking your tablets and contact your doctor immediately if you become pregnant while taking dronedarone.
• It is not known whether dronedarone passes into breast milk. You and your doctor must decide whether to take dronedarone or breastfeed. Do not breastfeed during treatment with dronedarone and for 7 days after the last dose.

Driving and using machines

Dronedarone normally does not affect the ability to drive or operate machinery. However, your ability to drive or operate machinery may be impaired by adverse effects such as fatigue.

Dronedarone Aurovitas contains lactose

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

3. How to take Dronedarone Aurovitas

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Treatment with dronedarone must be supervised by a doctor experienced in the treatment of heart disease.

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

How much to take

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

• one tablet with breakfast and
• one tablet with dinner.

If you think that your medicine may be having too strong or too weak an effect, 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 nearest emergency department or hospital immediately. Take the medicine package with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 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 missed doses. Take the next dose at the time you are normally due to take it.

If you stop taking Dronedarone Aurovitas

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported with this medicine:

Contact your doctor immediately if you notice any of the following serious adverse effects – you may require urgent medical attention.

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

• Problems in which your heart does not pump blood around your body properly as it should (congestive heart failure). In clinical studies, this adverse effect was observed at a similar frequency in patients who took dronedarone and in those who received placebo. Signs 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)

• Diarrhoea, vomiting which, if excessive, may 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 difficulties or dry 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 stomach area (abdomen), loss of appetite, nausea, vomiting, yellowing of the skin or whites of the eyes (jaundice), darkening of the urine, fatigue (especially when associated with the previously mentioned symptoms), itching.
• Allergic reactions, including swelling of the face, lips, mouth, tongue or throat.

Other adverse 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) known as 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.
• Tiredness.
• Skin problems such as rash or itching.
• Changes in blood test results used 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 becomes more sensitive to sunlight.
• Change in the taste of things.

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the blister and carton after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dronedarone Aurovitas

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

Tablet core: monohydrate lactose, 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 contents of the pack

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

Dronedarone Aurovitas is available in blister packs.

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

Only some pack 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

Tel.: 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 Filmtabletten

Spain: Dronedarona Aurovitas 400 mg film-coated tablets EFG

Italy: Dronedarone Aurobindo

Portugal: Dronedarona Generis

Date of the most recent review of this leaflet: April 2025

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