Package Insert: Information for the Patient

Dronedarone Teva 400 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Dronedarone Tevaand for what it is used

2. What you need to know before starting to take Dronedarone Teva

3. How to take Dronedarone Teva

4. Possible adverse effects

5. Storage of Dronedarone Teva

6. Contents of the package and additional information

Dronedarona Tevacontains an active ingredient called dronedarone. It belongs to a group of medicines called antiarrhythmics that help regulate your heart rhythm.

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

Dronedarona Teva prevents the recurrence of your irregular heart rhythm problem. Dronedarona Teva is used only in adults.

Your doctor will consider all available treatment options before prescribing Dronedarona Teva.

Do not takeDronedarona Teva

• if you are allergic to dronedarona or any of the other ingredients of this medicine (listed in section 6),
• if you have a problem with the nerves in your heart (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 Teva,
• if you have a very slow heart rate (less than 50 beats per minute),
• if your ECG (electrocardiogram) shows a heart problem called (“corrected QT interval prolongation”) (this interval is more than 500 milliseconds),
• if you have a type of atrial fibrillation called permanent atrial fibrillation (PAF). In PAF, the atrial fibrillation has been present for a long time (at least for 6 months) and the decision has been made not to return your heart rhythm to the normal atrial rhythm with a treatment called cardioversion,
• if you have instability (falls) in your blood pressure that may cause inadequate blood flow to your organs,
• if you have or have had a problem where your heart cannot pump blood throughout your body as it should (a disease called heart failure). You may have swollen feet or legs, problems breathing when lying down or sleeping, or you may feel short of breath when moving,
• if the percentage of blood that leaves your heart each time it contracts is too low (a disease called left ventricular dysfunction),
• if you previously took amiodarone (another antiarrhythmic medicine) and had problems with your lungs or liver,
• if you are taking medicines for infections (including fungal or HIV infections), allergies, heart rhythm problems, depression, after a transplant (see the section “Other medicines and Dronedarona Teva”). This will give you more details on exactly which medicines you cannot take with Dronedarona Teva,
• if you have a severe liver problem,
• if you have a severe kidney problem,
• if you are taking dabigatran (see the section “Other medicines and Dronedarona Teva”).

If any of the above points apply to you, do not take Dronedarona Teva.

Warnings and precautions

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

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

• your atrial fibrillation becomes permanent while taking Dronedarona Teva. You should stop taking Dronedarona Teva,
• you have swollen feet or legs, breathing problems when lying down or sleeping, you feel short of breath when moving, or you gain weight (signs and symptoms of heart failure),
• inform your doctor immediately if you develop any of these signs and symptoms related to liver problems: abdominal pain or discomfort, loss of appetite, nausea, vomiting, yellowing of the skin or the white of the eyes (jaundice), unusual darkening of the urine, fatigue (especially in association with other symptoms listed above), itching,
• you have difficulty breathing or non-productive cough. Inform your doctor, they will check your lungs,

If this affects you (or you are unsure), inform your doctor or pharmacist before taking Dronedarona Teva.

Blood tests, cardiac and pulmonary tests

While taking Dronedarona Teva, your doctor may perform tests to check your health and how the medicine is affecting you.

• Your doctor may look at the electrical activity of your heart using an ECG (electrocardiogram)
• Your doctor may take blood tests to check the function of your liver before starting treatment with dronedarona and during treatment.
• If you are taking some medicines to prevent blood clots in the blood, 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 do other blood tests. The results of one of the blood tests to check your kidney function (creatinine levels in the blood) may be affected by Dronedarona Teva. Your doctor will take this into account when checking your blood levels and will use another reference value for the “normal” level of creatinine in the blood.
• Your doctor may check your lungs.

In some cases, treatment with Dronedarona Teva may need to be interrupted.

Inform anyone else who will be analyzing your blood that you are taking Dronedarona Teva.

Children and adolescents

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

Other medicines and Dronedarona Teva

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

Dronedarona Teva and some other medicines may interact and cause severe side effects. Your doctor may change the dose of other medicines you are taking.

You should not take any of the following medicines with Dronedarona Teva:

• other medicines used to control fast or irregular heartbeats such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone,
• some medicines for fungal infections such as ketoconazole, voriconazole, itraconazole, or posaconazole,
• some antidepressant medicines called tricyclic antidepressants,
• some tranquilizers 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 in your stomach to your mouth),
• ritonavir (a medicine for HIV infection),
• dabigatran (a medicine to prevent blood clots in the blood).

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 to reduce cholesterol in your blood (such as simvastatin, lovastatin, atorvastatin, or rosuvastatin),
• some medicines to prevent blood clots in the blood, 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 medicinal herb for depression,
• rifampicin – for tuberculosis.

Dronedarona Teva with food and drinks

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

Pregnancy and breastfeeding

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

• Dronedarona Teva is not recommended if you are pregnant or think you may be pregnant.
• Do not take Dronedarona Teva 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 Teva.
• If you are breastfeeding, you should consult with your doctor before taking Dronedarona Teva.
• We do not know if Dronedarona Teva passes into breast milk. You and your doctor must decide whether to take Dronedarona Teva or breastfeed. You should not do both.

Driving and using machines

Dronedarona Teva usually does not affect your ability to drive and use machines. However, your ability to drive and use machines may be affected by side effects such as fatigue.

Dronedarona Teva contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The treatment with Dronedarona Teva will be supervised by a doctor experienced in the treatment of heart disease.

If you need to switch from amiodarone (another medication for irregular heartbeat) to Dronedarona Teva, your doctor may provide special recommendations, such as stopping the amiodarone before switching. Inform your doctor of all the medications you take.

How much to take

The recommended dose is one 400 mg tablet twice a day. Take:

• one tablet during breakfast and
• one tablet during dinner

If you think this medication is too strong or too weak, talk to your doctor or pharmacist.

Taking this medication

Swallow the tablet whole with a glass of water during a meal. The tablet cannot be divided into equal doses.

If you take more Dronedarona Teva than you should

In case of overdose or accidental ingestion, contact your doctor, the nearest emergency service, hospital, orconsult the Toxicological Information Service, phone 91562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to takeDronedarona Teva

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

If you interrupt treatment with Dronedarona Teva

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:

Inform your doctor immediately if you notice any of the following serious side effects – 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 receiving dronedarone as in patients receiving a placebo. Symptoms include swelling of 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 heartbeats.

Uncommon(may affect up to 1 in 100 people)

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

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

• liver problems including potentially fatal liver failure. Symptoms include pain or discomfort in the abdominal area, loss of appetite, nausea, vomiting, yellowing of the skin or white of the eyes (jaundice), unusual darkening of urine, fatigue (especially associated with the symptoms listed above), itching,
• allergic reactions, including swelling of the face, lips, mouth, tongue, or throat.

Other side effects include:

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

• changes in the results of a test in your blood test: your blood creatinine levels,
• changes in your ECG (electrocardiogram) called QTc Bazett prolongation

Common(may affect up to 1 in 10 people)

• problems with your digestive system such as indigestion, diarrhea, nausea, vomiting, and stomach pain,
• feeling tired, weakness
• skin problems such as itching or rash,
• change 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 may become more sensitive to the sun,
• changes in how things taste.

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 blister pack and on the packaging 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 packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofDronedarona Tevafilm-coated tablets

• The active ingredient is dronedarone. Each film-coated tablet contains 400 mg of dronedarone (as hydrochloride).
• The other ingredients in the tablet core are hypromellose, pregelatinized maize starch, crospovidone, lactose monohydrate, anhydrous colloidal silica, magnesium stearate.
• The other ingredients in the coating are hypromellose (E464), macrogol (E1521), titanium dioxide (E171).

Appearance of the product and contents of the packaging

Dronedarona Teva 400 mg film-coated tablets are white, oblong tablets with dimensions of 17.6 x 8.1 mm.

Dronedarona Teva is available in blister packs containing 20, 50, 60, and 100 film-coated tablets in opaque PVC-aluminium blisters, or opaque PVC/PE/PVDC-aluminium blisters, and in perforated unit-dose blisters of opaque PVC-aluminium or opaque PVC/PE/PVDC-aluminium in packs of 100 x 1 film-coated tablets.

Only some sizes of packaging may be commercially available

Marketing authorization holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Responsible for manufacturing

Rontis Hellas Medical and Pharmaceutical Products S.A.

Larissa Industrial Area, P.O Box 3012

Larissa, 41500

Greece

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

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

28108, Alcobendas, Madrid (Spain)

Date of the last review of this leaflet:August 2020

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

You can access detailed and updated information about this medicine by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/84026/P_84026.html

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