DRONEDARONA TEVA 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Dronedarone Teva 400 mg film-coated tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Dronedarone Teva is and what it is used for

Dronedarone Teva contains the active substance dronedarone. It belongs to a group of medicines called anti-arrhythmics which help to regulate your heart beat.

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

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

Your doctor will consider all the available treatment options before prescribing you Dronedarone Teva.

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

Do not take Dronedarone Teva

• 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 (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 Dronedarone Teva,
• if you have a very slow heart rate (less than 50 beats per minute),
• if your ECG (electrocardiogram) shows a heart problem called (“prolonged QT interval”) (this interval is more than 500 milliseconds),
• if you have a type of atrial fibrillation called permanent atrial fibrillation (AF). 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 rhythm to normal with a treatment called cardioversion,
• if you have instability (drops) 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 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 coming out of your heart each time it contracts 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 rhythm problems, depression, after a transplant (see the section “Other medicines and Dronedarone Teva”). This will give you more details about exactly which medicines you cannot take with Dronedarone Teva,
• if you have severe liver problems,
• if you have severe kidney problems,
• if you are taking dabigatran (see the section “Other medicines and Dronedarone Teva”).

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

Warnings and precautions

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

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

• your atrial fibrillation becomes permanent while taking Dronedarone Teva. You should stop taking Dronedarone Teva,
• 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 to your doctor immediately if you develop any of these signs and symptoms related to liver problems: pain or discomfort in the stomach area (abdomen), loss of appetite, nausea, vomiting, yellowing of the skin or the whites 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. Report to your doctor, he/she will check your lungs.

If this affects you (or you are not sure), tell your doctor or pharmacist before taking Dronedarone Teva.

Blood tests, heart tests, and lung tests

While taking Dronedarone Teva 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 using an ECG (electrocardiogram)
• Your doctor may perform blood tests to check the function of your liver before starting treatment with dronedarone and during treatment.
• If you are taking some medicines to 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 Teva. Your doctor will take this into account when checking your blood levels and will use another reference value for “normal” creatinine blood levels.
• Your doctor may also check your lungs.

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

Tell any other person analyzing your blood that you are taking Dronedarone Teva.

Children and adolescents

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

Other medicines and Dronedarone Teva

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

Dronedarone Teva and some 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 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 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 to 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.

Dronedarone Teva with food and drinks

Do not drink grapefruit juice while taking Dronedarone Teva. 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.

• If you are a woman who can become pregnant, your doctor will perform a pregnancy test before starting treatment with dronedarone.
• Dronedarone Teva is not recommended if you are pregnant or think you may be pregnant.
• Do not take Dronedarone Teva if you are a woman who can become pregnant and are not using a reliable contraceptive method.
• Use a reliable contraceptive method during treatment and for 7 days after the last dose of dronedarone.
• Stop taking your tablets and talk to your doctor immediately if you become pregnant while taking Dronedarone Teva.
• It is not known if Dronedarone Teva passes into breast milk. You and your doctor must decide whether to take Dronedarone Teva or breast-feed. You must not do both. Do not breast-feed during treatment with dronedarone and for 7 days after the last dose.

Driving and using machines

Dronedarone Teva normally 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 tiredness.

Dronedarone Teva 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 Teva

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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

If you need to change from amiodarone (another medicine for irregular heart rhythm) to Dronedarone Teva, your doctor may provide you with special recommendations, such as stopping amiodarone before switching. Tell your doctor about all the medicines you are taking.

How much to take

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

• one tablet during breakfast and
• one tablet during your dinner

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

How to take this medicine

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

If you take more Dronedarone Teva than you should

In case of overdose or accidental ingestion, contact your doctor, the nearest emergency service or hospital or the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Dronedarone Teva

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

If you stop taking Dronedarone Teva

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 product, 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 – 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 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 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 rate.

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 pain or discomfort in the stomach area (abdomen), loss of appetite, nausea, vomiting, yellowing of the skin or the whites of the eyes (jaundice), unusual darkening of the urine, fatigue (especially in association with other 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 blood test: your creatinine levels in the blood,
• 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,
• changes in the results of blood tests performed to check the function of your liver.

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 the way things taste.

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 Agency: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dronedarone Teva

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 blister and on the carton 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. Packaging Contents and Additional Information

Composition ofDronedarone Tevafilm-coated tablets EFG

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

Appearance and Packaging of the Product

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.

Larissa Industrial Area, P.O Box 3012

Larissa, 41500

Greece

Further information about this medicinal product can be obtained from the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

28108, Alcobendas, Madrid (Spain)

Date of the last revision of this leaflet:June 2025

Detailed and up-to-date 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

You can access detailed and up-to-date information about this medicinal product by scanning the QR code included in the packaging with your mobile phone (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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