Dronedarone Aurovitas Spain 400 mg film-coated tablets EFG

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Dronedarone Aurovitas Spain 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 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. How to store Dronedarone Aurovitas Spain
6. Contents of the pack and other information

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

Dronedarona Aurovitas Spain 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 it has either spontaneously returned to normal or has been restored to normal rhythm through a treatment called cardioversion. Dronedarone prevents the recurrence of your irregular heart rhythm problem. 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 Spain

Do not take Dronedarone Aurovitas Spain

• 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 due to this condition, you may use dronedarone.
• If you have a very slow heart rate (less than 50 beats per minute).
• If your ECG (electrocardiogram) shows a heart condition 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 rhythm using a treatment called cardioversion.
• If you have instability (drops) in your blood pressure that could cause inadequate arterial blood flow to your organs.
• If you have or have had a condition where your heart cannot pump blood properly throughout your body (a disease called heart failure). You may have swollen feet or legs, breathing difficulties when lying down or sleeping, or shortness of breath during physical activity.
• 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 an organ transplant (see section "Other medicines and Dronedarone Aurovitas Spain". This section provides more details about 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 "Taking Dronedarone Aurovitas Spain with other medicines").

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

Warnings and precautions

Talk to your doctor or pharmacist before starting 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 taking dronedarone. You must stop taking dronedarone.
• You develop swollen feet or legs, breathing difficulties when lying down or sleeping, shortness of breath during activity, or sudden 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 previously mentioned symptoms), 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 situations apply to you (or if you 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 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.
• If you are taking certain 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 results and will use an adjusted reference value for "normal" blood creatinine levels.
• Your doctor may examine your lungs.

In some cases, treatment with dronedarone may need to be discontinued.

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

Use in children and adolescents

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

Other medicines and Dronedarone Aurovitas Spain

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

Dronedarone can 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 acid reflux).
• Ritonavir (a medicine for HIV 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 Spain with food and drinks

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 are planning 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 think you may be pregnant.
• Do not take dronedarone if you are a woman of childbearing potential and are not using a reliable method of contraception.
• Use an effective method of contraception during treatment and for 7 days after the last dose of dronedarone.
• Stop taking the 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 this medicine or breastfeed. Do not breastfeed during treatment with dronedarone or for 7 days after the last dose.

Driving and using machines

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

Dronedarone Aurovitas Spain 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 Spain

Follow exactly the instructions for administration of this medicine given by your doctor. If in doubt, ask your doctor or pharmacist.

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 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 may have too strong or too weak an effect, consult your doctor or pharmacist.

How to take 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 Spain than you should

Contact your doctor or nearest emergency department or hospital immediately. Bring the medicine packaging with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine 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 at the time you would normally take it.

If you stop taking Dronedarone Aurovitas Spain

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 will experience 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 need 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 during activity, or weight gain.

Common (may affect up to 1 in 10 people)

• Diarrhoea, vomiting which in excess may 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). 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), unusual darkening of the urine, fatigue (especially associated with the symptoms mentioned 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) called Bazett QTc prolongation.

Common (may affect up to 1 in 10 people)

• Problems with your digestive system such as indigestion, 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 sensation 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 type of adverse effect, consult 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 Aurovitas Spain

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

Do not use this medicine after the expiry date stated on the blister pack 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 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 collection point at your pharmacy. If you are in doubt, 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

Composition of Dronedarone Aurovitas Spain

• The active substance 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, colloidal anhydrous silica, magnesium stearate.

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

Appearance of the product and contents of the pack

Dronedarone Aurovitas Spain is a white, film-coated, oblong tablet measuring 17.6 x 8.1 mm.

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

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:

Rontis Hellas Medical and Pharmaceutical Products S.A.

P.O. Box 3012 Larissa Industrial Area

Larissa - 41500

Greece

Date of latest review of this leaflet: 03/2025

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