DRONEDARONE TEVA 400 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

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.

What is in this leaflet

• 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 sideeffects

• 5 How to store Dronedarone Teva

• 6. Contents of the pack and other information

1.

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

Dronedarone Teva is used if you have a problem with your heart rhythm (your heart beats out of time – atrial fibrillation) and spontaneously, or through a treatment called cardioversion has changed your heart beat back to normal rhythm. Dronedarone Teva prevents repetition of your problem of irregular heart rhythm. Dronedarone Teva is used only in adults.

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

2.

in section 6)

• if you have a problem with the nerves in your heart (heart block). Your heart might beat

very slowly or you may feel dizzy. If you have had a pacemaker fitted for this problem, you can use Dronedarone Teva

• if you have a very slow heart beat (less than 50 beats a minute)
• if your ECG (electrocardiogram) shows a heart problem called “prolonged QT corrected

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 during 6 months) and a decision has been made not to change back your heart rhythm to atrial normal rhythm

with a treatment called cardioversion

• if you have instability (drops) in your blood pressure which can lead to inadequate arterial

blood flow to your organs,

• if you have or had a problem where your heart cannot pump the blood round your body as

well as it should (condition called heart failure). You may have swollen feet or legs, trouble breathing when lying down or sleeping, or shortness of breath when moving around

• if the percentage of blood leaving your heart each time it contracts is too low (condition

called left ventricular dysfunction)

• if you took amiodarone (another antiarrhythmic medicine) previously and experienced

lung or liver problems

• if you take medicines for infection (including fungal infection or AIDS), allergies, heart

beat problems, depression, after a transplant (see section below on “Other medicines and Dronedarone Teva”. This will give you more details on exactly what medicines you cannot take with Dronedarone Teva)

• if you have a severe liver problem
• if you have a severe kidney problem
• if you take dabigatran (see section below on “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 problem that gives you a low level of potassium or magnesium in your blood.

This problem should be corrected before starting treatment with Dronedarone Teva

• you are more than 75 years old
• you have a condition when the vessel that supplies blood to heart muscle becomes hardened

and narrowed (coronary artery disease).

While taking Dronedarone Teva, tell your doctor if

• your atrial fibrillation becomes permanent while you are taking Dronedarone Teva. You

should stop taking Dronedarone Teva

• you have swollen feet or legs, trouble breathing when lying down or sleeping, shortness of

breath when moving around, or weight increase (which are signs and symptoms of heart failure)

• tell your doctor immediately if you develop any of these signs and symptoms of liver

problems: stomach (abdominal) area pain or discomfort, 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 breathlessness or non-productive cough. Tell your doctor, he/she will check your

lung.

If this applies to you (or you are not sure), please talk to your doctor or pharmacist before taking Dronedarone Teva.

Heart, lung and blood tests

While you are taking Dronedarone Teva, your doctor may perform tests to check your medical condition and how the medicine is working for you.

• Your doctor may look at your heart’s electrical activity using an ECG (electrocardiogram)

machine.

• Your doctor will order blood tests to check your liver function before you start taking

Dronedarone Teva and during treatment.

• If you are taking some medicines against blood clot formation such as warfarin, your doctor

will order a blood test called INR to check how well your medicine is working.

• Your doctor may also do other blood tests. The results of one of the blood tests to check

kidney function (blood creatinine levels) may be changed by Dronedarone Teva. Your doctor will take this into account when checking your blood levels and will use another reference of the “normal” value of blood creatinine.

• Your doctor may check your lungs.

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

Please tell any other person who checks your blood that you are taking Dronedarone Teva.

Children and adolescents

Dronedarone Teva is not recommended in children and adolescents below 18 years of age.

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 against blood clot formation according to your condition.

Dronedarone Teva and some other medicines can affect each other and cause serious side effects.

Your doctor may change the dose of any other medicines you are taking.

You must not take any of the following with Dronedarone Teva:

• other medicines used to control an irregular or fast heart beat 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 tranquilising 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 AIDS infection)
• dabigatran (a medicine for prevention of blood clot formation).

You must tell 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 for reducing the cholesterol in your blood (such as simvastatin, lovastatin,

atorvastatin, or rosuvastatin)

• some medicines against blood clot formation such as warfarin, rivaroxaban, edoxaban and

apixaban

• some medicines for epilepsy called phenobarbital, carbamazepine or phenytoin
• sirolimus, tacrolimus, everolimus and cyclosporine (used after a transplant)
• St John’s Wort – a herbal medicine for depression
• rifampicin – for tuberculosis.

Dronedarone Teva with food and drink

Do not drink grapefruit juice while taking Dronedarone Teva. It can increase the blood levels of dronedarone and may increase your chance of getting 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 Teva is not recommended if you are pregnant or you think you may be

pregnant.

• Do not take Dronedarone Teva if you are a woman able to have children and you are not

using a reliable contraceptive method.

• Stop taking your tablets and talk to your doctor straight away if you get pregnant while

taking Dronedarone Teva.

• It is not known if Dronedarone Teva passes into your breast milk. You and your doctor

should decide if you will take Dronedarone Teva or breastfeed. You should not do both.

Driving and using machines

Dronedarone Teva does not usually affect your ability to drive or use machine. However, your ability to drive and use machines may be affected by side effects such as tiredness.

Dronedarone Teva contains lactose

If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicine.

3.    

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Treatment with Dronedarone Teva will be overseen by a doctor who is experienced in the treatment of heart disease.

If you need to change from amiodarone (another medicine for irregular heart beat) to Dronedarone Teva, your doctor can provide special recommendations, for example pausing amiodarone before switching. Tell your doctor about all the medicines you take.

How much to take

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

• one tablet during your morning meal and
• one tablet during your evening meal.

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

Taking this medicine

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

If you take more Dronedarone Teva than you should

Contact immediately your doctor or the nearest emergency department or hospital. Take the medicine pack with you.

If you forget to take Dronedarone Teva

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

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 on the use of this medicine, ask your doctor or pharmacist.

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:

Talk to your doctor straight away, 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)

• problem where your heart does not adequately pump the blood round your body as well as

it should (congestive heart failure). In clinical studies, this side effect was observed at a similar rate in patients receiving dronedarone and in patients receiving placebo. Signs include swollen feet or legs, trouble breathing when lying down or sleeping, shortness of breath when moving around, or weight increase.

Common (may affect up to 1 in 10 people)

• diarrhoea, vomiting when excessive as it can lead to kidney problems
• slow heart beat.

Uncommon (may affect up to 1 in 100 people)

• inflammation of the lungs (including scarring and thickening of the lungs). Signs include

breathlessness or non-productive cough.

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

• liver problems including life threatening liver failure. Signs include stomach (abdominal)

area pain or discomfort, 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:

• changes in your ECG (electrocardiogram) called QTc Bazett prolonged.

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 rash or itching
• change in the results of blood tests used 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

blistering)

• your skin being more sensitive to the sun
• change in how things taste.

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

• losing your sense of taste
• inflammation of blood vessels (vasculitis including leukocytoclastic vasculitis).

Reporting of side effects

If you get 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 via the Yellow Card Scheme Website:or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5.

Do not use this medicine after the expiry date, which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not use this medicine if you notice any visible sign of deterioration (see section 6).

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.

dronedarone (as hydrochloride).

• The other ingredients in the tablet core are hypromellose, maize starch pregelatinized,

crospovidone, lactose monohydrate, silica colloidal anhydrous, magnesium stearate.

• The other ingredients in the tablet coat are hypromellose (E464), macrogol (E1521),

What Dronedarone Teva looks like and content of the pack

Dronedarone Teva is a white, oblong shaped tablet with dimensions of 17.6 × 8.1 mm.

Dronedarone Teva film-coated tablets are supplied in packs of 20, 50, 60 and 100 in opaque PVC-Aluminium or opaque PVC/PE/PVDC-Aluminium blisters and in perforated unit dose opaque PVC-Aluminium or opaque PVC/PE/PVDC-Aluminium blisters in packs of 100×1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne, BN22 9AG, United Kingdom

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A, P.O Box 3012 Larisa Industrial Area, Larisa, 41004, Greece

This leaflet was last revised in 07/2020.

PL 00289/2246