Dronedarone Teva 400 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dronedarone Teva 400 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because 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 others, 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 effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Dronedarone Teva contains an active substance called dronedarone. It belongs to a group of medicines known as antiarrhythmics, which help regulate your heartbeat.

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

2. What you need to know before taking 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 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 for this condition, 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 corrected QT interval” (this interval is longer than 500 milliseconds),
• if you have a type of atrial fibrillation called permanent atrial fibrillation (AF). In permanent AF, 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 sinus rhythm with a treatment called cardioversion,
• if you have instability (drops) in your blood pressure that could cause inadequate 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, shortness of breath when lying down or sleeping, or breathlessness 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 had lung or liver problems,
• if you are taking medicines for infections (including fungal infections or AIDS), allergies, heart rhythm problems, depression, or after an organ transplant (see section “Other medicines and Dronedarone Teva”). This section provides more details on exactly which medicines you must not take with Dronedarone Teva,
• if you have severe liver disease,
• if you have severe kidney disease,
• if you are taking dabigatran (see section “Other medicines and Dronedarone Teva”).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Dronedarone Teva if

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

• your atrial fibrillation becomes permanent while you are taking Dronedarone Teva. You must stop taking Dronedarone Teva,
• you develop swollen feet or legs, shortness of breath when lying down or sleeping, breathlessness during physical activity, or weight gain (signs and symptoms of heart failure),
• inform your doctor immediately if you develop any of the following signs or symptoms related to liver problems: pain or discomfort in the stomach area (abdomen), loss of appetite, nausea, vomiting, yellowing of the skin or whites of the eyes (jaundice), unusually dark urine, fatigue (especially in combination with other symptoms listed above), itching,
• you experience difficulty breathing or a dry cough. Inform your doctor, who will check your lungs.

If any of these affect you (or if you are unsure), inform your doctor or pharmacist before taking Dronedarone Teva.

Blood tests, cardiac and pulmonary tests

While taking Dronedarone Teva, your doctor may perform tests to monitor your health and the effects of the medicine.

• Your doctor may assess the electrical activity of your heart using an ECG (electrocardiogram).
• Your doctor may perform blood tests to check your liver function before starting treatment with dronedarone and during treatment.
• If you are taking certain blood-thinning medicines such as warfarin, your doctor will request a blood test called INR to check whether your medicine is working properly.
• Your doctor may also perform other blood tests. Results of one blood test used to assess kidney function (blood creatinine levels) may be altered by Dronedarone Teva. Your doctor will take this into account when interpreting your blood levels and will use an adjusted reference value for normal blood creatinine.
• Your doctor may monitor your lungs.

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

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

Children and adolescents

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

Other medicines and Dronedarone Teva

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

Dronedarone Teva and certain other medicines may interact 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 Teva:

• other medicines used to control fast or irregular heartbeats such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone,
• certain antifungal medicines such as ketoconazole, voriconazole, itraconazole, or posaconazole,
• certain antidepressants called tricyclic antidepressants,
• certain 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 stomach food and acid reflux into the 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, 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, and 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.

Dronedarone Teva with food and drink

Do not drink grapefruit juice while taking Dronedarone Teva. 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 plan 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.
• 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 an effective method of contraception during treatment and for 7 days after the last dose of dronedarone.
• Stop taking your tablets and contact your doctor immediately if you become pregnant while taking Dronedarone Teva.
• It is not known whether Dronedarone Teva passes into breast milk. You and your doctor must decide whether to take Dronedarone Teva or breastfeed. You should not do both. Do not breastfeed 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 or operate machinery. However, your ability to drive and use machines may be impaired by adverse effects such as fatigue.

Dronedarone Teva contains lactose

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

3. How to take Dronedarone Teva

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Treatment with Dronedarone Teva will 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 Teva, your doctor may provide you with special recommendations, such as stopping amiodarone before switching. Inform your doctor about all the medicines you are taking.

How much to take

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

• one tablet with breakfast and
• one tablet with dinner

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

Taking 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, nearest emergency service, hospital, or the Toxicology Information Service immediately at telephone number 91 562 04 20, stating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet 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 at the usual time.

If you stop taking Dronedarone Teva

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:

Tell 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 where 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 receiving dronedarone and in patients receiving placebo. Signs include swelling of feet or legs, breathing difficulties when lying down or sleeping, shortness of breath when moving, or weight gain.

Common (may affect up to 1 in 10 people)

• diarrhoea, vomiting which in excess may 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). 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 pain or discomfort in the stomach area (abdomen), loss of appetite, nausea, vomiting, yellowing of the skin or whites of the eyes (jaundice), unusually dark urine, fatigue (especially when associated with the symptoms listed above), itching,
• allergic reactions, including swelling of the face, lips, mouth, tongue or throat.

Other adverse effects include:

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

• changes in the results of a blood test: your blood creatinine levels,
• 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,
• feeling tired, weakness,
• skin problems such as itching or rash,
• 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 may become more sensitive to sunlight,
• changes in how things taste.

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 adverse effect, talk to 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 Medicinal Products: https://www.notificaram.es. By reporting adverse 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 stated on the blister and outer packaging following "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. Return any unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dronedarone Teva film-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, monohydrate lactose, colloidal anhydrous 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 pack

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 blisters, or opaque PVC/PE/PVDC-aluminum blisters, and in single-dose perforated opaque PVC-aluminum blisters or opaque PVC/PE/PVDC-aluminum blisters in packs of 100 x 1 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

The Netherlands

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.

Larissa Industrial Area, P.O Box 3012

Larissa, 41500

Greece

For further information about this medicinal product, please contact 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 most recent 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 of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

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