DRONEDARONA ARISTO 400 mg FILM-COATED TABLETS

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

Do not take Dronedarone Aristo:

• 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 Aristo,
• if you have a very slow heart beat (less than 50 beats per minute),
• if your ECG (electrocardiogram) shows a heart problem called “prolonged QTc 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 beat to the normal rhythm with a treatment called cardioversion,
• if you have or have had a problem where your heart cannot pump blood around your body properly (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 with each beat 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 beat problems, depression, after a transplant (see section “Taking Dronedarone Aristo with other medicines”. This will give you more details on which medicines you cannot take with Dronedarone Aristo),
• if you have severe liver problems,
• if you have severe kidney problems.
• if you are taking dabigatran (see section “Taking Dronedarone Aristo with other medicines”).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dronedarone Aristo 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 Aristo,
• 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 Aristo, tell your doctor if:

• your atrial fibrillation while taking Dronedarone Aristo becomes permanent. You must stop taking Dronedarone 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),
• report immediately to your doctor if you develop any of these signs and symptoms related to liver problems: discomfort or pain in the stomach area (abdomen), loss of appetite, nausea, vomiting, yellowing of the skin or the whites of the eyes (jaundice), darkening of the urine, fatigue (especially associated with the above-mentioned symptoms), itching,
• you have difficulty breathing or non-productive cough. Contact your doctor, he will check your lungs.

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking Dronedarone Aristo.

Blood tests, heart and lung tests

While taking Dronedarone Aristo, your doctor may perform tests to check your state of health and the effect the medicine is having.

• Your doctor may look at the electrical activity of your heart with an ECG (electrocardiogram).
• Your doctor will ask for blood tests to check your liver function before starting treatment with Dronedarone Aristo and during treatment.
• If you are taking some medicines that prevent blood clots such as warfarin, your doctor will ask for 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 with Dronedarone Aristo. 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 check your lungs.

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

Use in children and adolescents

Dronedarone Aristo is not recommended in children and adolescents under 18 years.

Taking Dronedarone Aristo with other medicines

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 according to your clinical condition.

Dronedarone Aristo and other medicines may 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 Aristo:

• other medicines used to control fast or irregular heart beats such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone,
• some medicines for fungal infections such as ketoconazole, voriconazole, itraconazole or posaconazole,
• some medicines for depression called tricyclic antidepressants,
• some 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 your stomach to your 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, for chest pain caused by heart disease or other heart problems such as verapamil, diltiazem, nifedipine, metoprolol, propranolol or digoxin,
• some medicines that lower cholesterol levels in your blood (such as simvastatin, lovastatin, atorvastatin or rosuvastatin),
• some medicines that prevent blood clots such as warfarin, rivaroxaban, edoxaban and apixaban,
• some medicines for epilepsy called 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 Aristo with food and drinks

Do not drink grapefruit juice while taking Dronedarone Aristo. It may increase the levels of dronedarone in your blood and increase the risk of side effects.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

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 can become pregnant and are not using a reliable contraceptive method.

Stop taking your tablets and talk to your doctor immediately if you become pregnant during treatment with Dronedarone Aristo.

If you are breast-feeding, you should consult your doctor before taking Dronedarone Aristo.

Driving and using machines

Dronedarone Aristo 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 (if it occurs).

Dronedarone Aristo contains lactose

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

3. How to take Dronedarone Aristo

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

Follow exactly the administration instructions of this medicine given by your doctor. If you are not sure, ask your doctor or pharmacist.

If you need to change from amiodarone (another medicine for irregular heart beat) to Dronedarone Aristo, your doctor will do this change with caution.

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 that your medicine is too strong or too weak, talk to 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 Aristo than you should

Contact your doctor or the nearest emergency department or hospital immediately. Bring the package of this medicine with you. 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 medicine and the amount taken.

If you forget to take Dronedarone Aristo

Do not take a double dose to make up for forgotten doses. Take the next dose when you normally would.

If you stop taking Dronedarone Aristo

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:

Tell your doctor immediately if you notice any of the following serious side effects – because 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 around 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 in patients 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 beats.

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 stomach area (abdomen), loss of appetite, nausea, vomiting, yellowing of the skin or the whites of the eyes (jaundice), darkening of the urine, fatigue (especially associated with the above-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 creatinine level in the blood,
• changes in your ECG (electrocardiogram) called QTc Bazett prolongation.

Common(may affect up to 1 in 10 people)

• digestive problems 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 the blood vessels (vasculitis including leucocytoclastic vasculitis).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects 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 Aristo

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 carton and on the blister after “EXP”. The expiry date refers to 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 visible signs of deterioration (see section 6).

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

• 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 corn starch, 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).

Product Appearance and Container Content

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

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

Dronedarone 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 some 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

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

You can request more information about this medicinal product 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 medicinal product is authorized in the Member States of the European Economic Area 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: Dronedarone Aristo 400 mg film-coated tablets

Spain: Dronedarona Aristo 400 mg film-coated tablets EFG

Date of the last revision of this leaflet: September 2020

Detailed and updated 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/