Package Leaflet: Information for the Patient

Dronedarone Aristo 400 mg Film-Coated Tablets

dronedarone

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

• Keep this package 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. Do not give it to others even if they have similar symptoms to yours, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Dronedarona Aristo contains an active ingredient called dronedarone. It belongs to a group of medications known as antiarrhythmics that help regulate your heart rhythm.

Dronedarona Aristo is used if you have a problem with your heart rhythm (atrial fibrillation: your heart beats irregularly) and a treatment called cardioversion has returned your heart rhythm to normal. Dronedarona Aristo prevents your irregular heart rhythm problem from recurring.

Your doctor will consider all possible treatment options before prescribing Dronedarona Aristo.

Do not take Dronedarona:

• if you are allergic to dronedarona or any of the other ingredients of this medication (listed in section 6),
• if you have a heart conduction problem (heart block). Your heart may beat very slowly or you may feel dizzy. If you have had a pacemaker for this problem, you may use Dronedarona 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, 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 sinus rhythm with a treatment called cardioversion,
• if you have or have had a condition 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 with each contraction is too low (a condition called left ventricular dysfunction),
• if you previously took amiodarone (another antiarrhythmic medication) and had lung or liver problems,
• if you are taking medications for infections (including fungal or HIV infections), allergies, heart rhythm problems, depression, after a transplant (see section "Taking Dronedarona Aristo with other medications". This will give you more details on which medications you cannot take with Dronedarona Aristo),
• if you have severe liver disease,
• if you have severe kidney disease.
• if you are taking dabigatran (see section "Taking Dronedarona Aristo with other medications").

If you can be attributed to any of the above situations, do not take Dronedarona Aristo.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dronedarona Aristo if

• you have a condition that causes a decrease in your potassium or magnesium levels in the blood. This condition must be corrected before starting treatment with Dronedarona Aristo,
• 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 Dronedarona Aristo, inform your doctor if:

• your atrial fibrillation while taking Dronedarona Aristo becomes permanent. You must stop taking Dronedarona Aristo,
• 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),
• inform your doctor immediately 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 white of the eyes (jaundice), dark urine, fatigue (especially associated with the above symptoms), itching,
• you have difficulty breathing or non-productive cough. Contact your doctor, they will review your lungs.

If you can be attributed to any of the above situations (or are unsure), consult your doctor or pharmacist before taking Dronedarona Aristo.

Blood tests, cardiac and pulmonary tests

While taking Dronedarona Aristo, your doctor may perform tests to check your health status and the effect the medication is having on you.

• Your doctor may look at the electrical activity of your heart using an ECG (electrocardiogram).
• Your doctor will request that you have blood tests to check liver function before starting treatment with Dronedarona Aristo and during treatment.
• If you are taking some medications that act against the formation of 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 with Dronedarona Aristo. Your doctor will take this into account when checking your blood levels and will use another reference value for the "normal" creatinine level in the blood.
• Your doctor may check your lungs.

In some cases, it may be necessary to interrupt treatment with Dronedarona Aristo. Inform any other person who analyzes your blood that you are taking Dronedarona Aristo.

Use in children and adolescents

Dronedarona Aristo is not recommended for children and adolescents under 18 years old.

Taking Dronedarona Aristo with other medications

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

Dronedarona Aristo and other medications may interact and cause severe adverse effects. Your doctor may change the dose of other medications you are taking.

You should not take any of the following medications with Dronedarona Aristo:

• other medications used to control rapid or irregular heartbeats such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone,
• some medications for fungal infections such as ketoconazole, voriconazole, itraconazole, or posaconazole,
• some antidepressant medications called tricyclic antidepressants,
• some tranquilizers called phenothiazines,
• bepridil for chest pain caused by heart disease,
• telithromycin, erythromycin, or clarithromycin (antibiotics for infections),
• terfenadine (an allergy medication),
• nefazodone (a depression medication),
• cisapride (a medication for food and acid reflux in your stomach to your mouth),
• ritonavir (a medication for HIV infection).
• dabigatran (a medication to prevent blood clots in the blood).

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

• other medications for high blood pressure, for chest pain caused by heart disease, or other heart problems such as verapamil, diltiazem, nifedipine, metoprolol, propranolol, or digoxin,
• some medications that reduce cholesterol in your blood (such as simvastatin, lovastatin, atorvastatin, or rosuvastatin),
• some medications that prevent blood clots in the blood such as warfarin, rivaroxaban, edoxaban, and apixaban,
• some medications for epilepsy called phenobarbital, carbamazepine, or phenytoin,
• sirolimus, tacrolimus, everolimus, and cyclosporine (used after a transplant),
• St. John's Wort - a medicinal herb for depression,
• rifampicin - for tuberculosis.

Taking Dronedarona Aristo with food and drinks

Do not drink grapefruit juice while taking Dronedarona Aristo. It may increase the levels of dronedarona in the blood and increase the risk of adverse effects.

Pregnancy and breastfeeding

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

Dronedarona Aristo is not recommended if you are pregnant or think you may be pregnant.

Do not take Dronedarona Aristo if you are a woman who may become pregnant and are not using a safe contraceptive method.

Stop taking your tablets and talk to your doctor immediately if you become pregnant while taking Dronedarona Aristo.

If you are breastfeeding, you should consult your doctor before taking Dronedarona Aristo.

Driving and using machines

Dronedarona Aristo usually does not affect your ability to drive and use machines. However, your ability to drive and use machines may be affected by adverse effects such as fatigue (if it appears).

Dronedarona Aristo contains lactose

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

The treatment with Dronedarona Aristo must be supervised by a doctor with experience in the treatment of heart disease.

Follow exactly the administration instructions of this medication indicated by your doctor. If in doubt, ask your doctor or pharmacist.

If you need to change from amiodarone (another medication for irregular heartbeat) to Dronedarona Aristo, your doctor will make this change with caution.

How much to take

The usual 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 medication may have too strong or too weak an effect, consult with your doctor or pharmacist.

How to take this medication

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 immediately, or the nearest emergency service or hospital. Bring the packaging of this medication. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Dronedarona Aristo

Do not take a double dose to compensate for the missed doses. Take the next dose when you normally do.

If you interrupt treatment with Dronedarona Aristo

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 – as you may need urgent medical assistance.

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

• Problems where your heart does not pump blood 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 a placebo. Symptoms 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)

• Diarrhea, vomiting that may lead to kidney problems.
• Slow heartbeats.

Uncommon(may affect up to 1 in 100 people)

• Pneumonia (including scarring and thickening of the lungs). Symptoms include respiratory problems or non-productive cough.

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

• Liver problems including potentially fatal hepatic insufficiency. Symptoms include discomfort or pain in the abdominal area, loss of appetite, nausea, vomiting, yellowing of the skin or white of the eyes (jaundice), dark urine, fatigue (especially associated with the previously mentioned 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 blood creatinine level,
• Changes in your ECG (electrocardiogram) called QTc Bazett prolongation.

Common(may affect up to 1 in 10 people)

• Problems with your digestion such as diarrhea, nausea, vomiting, and stomach pain,
• Fatigue,
• Skin problems such as rash or itching,
• Changes in the results of blood tests performed 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 blood vessels (vasculitis including leucocytoclastic vasculitis).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the blister pack after “CAD”. 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 any visible signs of deterioration (see section 6).

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need atthe SIGRE Collection Pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

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

Appearance of the product and contents of the package

Dronedarone Aristo is a white-coated, oval-shaped tablet with dimensions of 17.6 mm x 8.1 mm.

Blister packs of PVC/Aluminum or opaque PVC / PE / PVDC-Aluminum in packages of 20, 40, 50, 60, and 100 coated tablets.

Dronedarone Aristo is available in packages of 20, 20x1, 40, 40x1, 50, 50x1, 60, 60x1, 100, and 100x1 coated tablets in blisters and perforated single-dose blisters.

Only some package sizes may be commercially available.

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

Responsible manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

This medication is authorized in the member states of the European Economic Area with 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:Dronedarone Aristo 400 mg film-coated tablets

Spain:Dronedarona Aristo 400 mg comprimidos recubiertos con película EFG

Last review date of this leaflet: September 2020

More detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/