Dronedarone Aristo 400 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dronedarone Aristo 400 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• 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, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Dronedarona Aristo 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 either spontaneously returned, or 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 starting Dronedarone Aristo

Do not take Dronedarone:

• 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 Aristo,
• if you have a very slow heart rate (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 could cause inadequate 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, breathing difficulties when lying down or sleeping, or shortness of breath on exertion,
• if the percentage of blood pumped out of your heart with each contraction 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 disorders, depression, or after transplantation (see section “Taking Dronedarone Aristo with other medicines”. This will provide more details on which medicines must not be taken with Dronedarone Aristo),
• if you have severe liver disease,
• if you have severe kidney disease,
• if you are taking dabigatran (see section “Taking Dronedarone Aristo with other medicines”).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Dronedarone Aristo 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 Aristo,
• 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 Aristo, inform your doctor if:

• your atrial fibrillation becomes permanent while you are taking Dronedarone Aristo. You must stop taking Dronedarone Aristo,
• you develop swollen feet or legs, breathing difficulties when lying down or sleeping, shortness of breath on exertion, or weight gain (signs and symptoms of heart failure),
• immediately inform your doctor if 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,
• 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 Aristo.

Blood tests, cardiac and pulmonary tests

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

• Your doctor may assess 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 Aristo.
• If you are taking blood-thinning medicines such as warfarin, your doctor will request a blood test called INR to check whether your medicine is working properly.
• Your doctor may also perform other blood tests. One of the blood tests used to assess kidney function (blood creatinine levels) may be affected by Dronedarone Aristo. Your doctor will take this into account when interpreting your blood results and will use an alternative reference value for the “normal” blood creatinine level.
• Your doctor may monitor your lungs.

In some cases, treatment with Dronedarone Aristo may need to be interrupted. Inform any healthcare professional performing blood tests that you are taking Dronedarone Aristo.

Use in children and adolescents

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

Taking Dronedarone Aristo with other medicines

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 Aristo 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 Aristo:

• other medicines used to control fast or irregular heartbeats such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone,
• certain antifungal medicines such as ketoconazole, voriconazole, itraconazole, or posaconazole,
• certain antidepressants called tricyclic antidepressants,
• certain tranquilizers called phenothiazines,
• bepridil for chest pain caused by heart disease,
• telithromycin, erythromycin, or clarithromycin (antibiotics for infections),
• terfenadine (an allergy medicine),
• nefazodone (a medicine for depression),
• cisapride (a medicine for stomach food and acid reflux into 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 cholesterol-lowering medicines (such as simvastatin, lovastatin, atorvastatin, or rosuvastatin),
• certain medicines that prevent blood clots such as warfarin, rivaroxaban, edoxaban, and apixaban,
• certain antiepileptic medicines called phenobarbital, carbamazepine, or phenytoin,
• sirolimus, tacrolimus, everolimus, and cyclosporine (used after transplantation),
• St. John’s wort – a herbal remedy for depression,
• rifampicin – for tuberculosis.

Taking Dronedarone Aristo with food and drink

Do not drink grapefruit juice while taking Dronedarone Aristo. 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 Aristo.
• Dronedarone Aristo is not recommended if you are pregnant or think you may be pregnant.
• Do not take Dronedarone Aristo 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 Aristo.
• Stop taking the tablets and contact your doctor immediately if you become pregnant during treatment with Dronedarone Aristo.
• It is not known whether Dronedarone Aristo passes into breast milk: You and your doctor must decide whether to take Dronedarone Aristo or breastfeed. Do not breastfeed during treatment with Dronedarone Aristo or for 7 days after the last dose.

Driving and using machines

Dronedarone Aristo 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 Aristo contains lactose

Lactose is a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Dronedarona Aristo

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

Treatment with dronedarone will be supervised by a physician 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 special recommendations, such as stopping amiodarone before switching. Inform your doctor about all the medicines you are taking.

How much to take

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

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

If you think that your medicine is 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 Dronedarona Aristo than you should

Contact your doctor, nearest emergency service, or hospital immediately. Take the medicine package with you. You may also consult your pharmacist or call the Toxicology Information Service at phone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dronedarona Aristo

Do not take a double dose to make up for missed doses. Take the next dose at the usual time.

If you stop taking Dronedarona Aristo

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 – because 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 properly throughout your body 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, breathing difficulties 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 symptoms listed above), 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 Bazett QTc prolongation.

Common (may affect up to 1 in 10 people)

• Digestive problems such as diarrhoea, 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 or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via 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 Aristo

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

Do not use this medicine after the expiry date stated on the carton and blister 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 visible signs of deterioration (see section 6.).

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

• The active substance is dronedarone. Each tablet contains 400 mg of dronedarone (as hydrochloride).
• The other components of the tablet core are hypromellose (E464), pregelatinized corn starch, crospovidone (E1202), lactose monohydrate, colloidal anhydrous silica, and magnesium stearate (E572).
• The other components of the coating are hypromellose (E464), macrogol (E1521), and titanium dioxide (E171).

Nature of the product and pack contents

Dronedarona Aristo is a white, oval, film-coated tablet measuring 17.6 mm x 8.1 mm.

Opaque PVC/aluminum or PVC/PE/PVDC-aluminum blisters.

Dronedarona Aristo is available in packs of 20, 20x1, 40, 40x1, 50, 50x1, 60, 60x1, 100, and 100x1 film-coated tablets in blisters and in perforated unit-dose blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larissa Industrial Area,
41500 Larissa,
Greece

Manufacturer responsible for production

Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.
C/ Solana, 26
28850 Torrejón de Ardoz
Madrid, Spain

This medicinal product is authorized in the European Economic Area (EEA) Member States and the United Kingdom (Northern Ireland) under the following names:

Germany: Dronedaron Aristo 400 mg Filmtabletten
Austria: Dronedaron Aristo 400 mg Filmtabletten
Denmark: Dronedaron Aristo
Norway: Dronedaron Aristo
Sweden: Dronedaron Aristo
Italy: Dronedarone Aristo
Hungary: Dronedaron Aristo 400 mg filmtabletta
United Kingdom (Northern Ireland): Dronedarone Aristo 400 mg film-coated tablets
Spain: Dronedarona Aristo 400 mg comprimidos recubiertos con película EFG

Date of the most recent review of this leaflet: August 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/)