400 mg film-coated tablets
dronedarone
1. What Dronedaron Sandoz is and what it is used for
Dronedarone Sandoz contains an active substance called dronedarone. It belongs to a group of medicines called antiarrhythmics that help regulate your heart rhythm.
Dronedaron Sandoz is used if you have problems with your heart rhythm (your heart beats irregularly – so-called atrial fibrillation ) and a treatment called conversion has restored your heart rhythm to a normal rhythm. Dronedaron Sandoz prevents your recurring heart rhythm problems from recurring.
Your doctor will consider all available treatment options before prescribing Dronedaron Sandoz.
Dronedaron contained in Dronedaron Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before you take Dronedaron Sandoz
Do not take Dronedaron Sandoz
- if you are allergic to dronedarone or any of the other ingredients of this medicine (listed in section 6)
- if you have problems with conduction disturbances in the heart (heart block), which can cause very slow heart rhythm or dizziness. If you have been given a pacemaker for such symptoms, you can use Dronedaron Sandoz.
- if you have a very slow heartbeat (less than 50 beats per minute),
- if your ECG ( electrocardiogram ) indicates that you have a heart problem called “prolonged QTc time” (this interval is over 500 milliseconds),
- if you have a type of irregular heartbeat called permanent atrial fibrillation. In the case of permanent atrial fibrillation, the flicker has been present for a long time (for at least 6 months) and a decision has been made not to restore your heart rhythm to a normal rhythm using conversion.
- if you have or have had problems where your heart can not pump around the blood in the body as well as it should ( heart failure ). You may have swollen feet or legs, difficulty breathing when lying down or sleeping, or shortness of breath when moving.
- if the amount of blood that leaves your heart each time it contracts is too small (left ventricular dysfunction),
- if you have previously used amiodarone (another antiarrhythmic ) and experienced lung or liver problems,
- if you are taking medicines for infections (including fungal infections or AIDS ), allergies, heart rhythm problems, depression or medicines given after a transplant (see the section below “Other medicines and Dronedaron Sandoz”). This section gives you more information about which medicines you can not bring Dronedaron Sandoz).
- if you have severe liver problems,
- if you have severe kidney problems,
- if you are taking dabigatran (see the section below “Other medicines and Dronedaron Sandoz”).
If any of the above apply to you, do not take Dronedaron Sandoz.
Warnings and cautions
Talk to your doctor or pharmacist before taking Dronedaron Sandoz
- if you have a problem that causes you to have low levels of potassium or magnesium in your blood. This problem should be treated before starting treatment with Dronedaron Sandoz.
- if you are older than 75 years,
- if you have a condition where your blood vessels, which supply the heart muscle with blood, become hardened and narrower (coronary heart disease).
While you are taking Dronedaron Sandoz, talk to your doctor about
- your atrial fibrillation becomes permanent while you are being treated with Dronedaron Sandoz. If this happens, stop using Dronedaron Sandoz.
- you have swollen feet or legs, difficulty breathing when you lie down or sleep, become short of breath when you move or gain weight (which are signs and symptoms of heart failure).
- Tell your doctor immediately if you develop any of these signs and symptoms of liver problems: abdominal pain or discomfort, loss of appetite, nausea, vomiting, yellowing of the skin or whites of the eyes (jaundice), abnormally dark urine, fatigue (especially in connection with other symptoms such as indicated above), itching.
- you are short of breath or have a dry cough. Talk to your doctor who will examine your lungs.
If this happens to you (or you are not sure) talk to your doctor or pharmacist before taking Dronedaron Sandoz.
Tests on heart, lungs, and blood
When you are being treated with Dronedaron Sandoz, your doctor may perform tests to check your medical condition and how the medicine is working for you.
- Your doctor can monitor your heart’s electrical activity using an ECG ( electrocardiogram ).
- Your doctor will order blood tests to check your liver function before you start taking Dronedaron Sandoz and also during treatment.
- If you are taking certain blood-thinning drugs such as warfarin, your doctor will order a blood test called PK (INR) to check how well your drug is working.
- Your doctor may also take other blood samples. The results of one of these blood tests, which check kidney function (blood creatinine levels), may be altered by Dronedaron Sandoz. Your doctor will keep this in mind when testing your blood levels and will use a different limit on the normal value of blood creatinine.
- Your doctor may examine your lungs.
In some cases, treatment with Dronedaron Sandoz may need to be stopped.
Tell other people who control your blood that you are taking Dronedaron Sandoz.
Children and young people
Dronedaron Sandoz is not recommended for use in children and adolescents below 18 years.
Other drugs and Dronedaron Sandoz
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 blood-thinning medicine as part of your treatment.
Dronedarone Sandoz and some other medicines can affect each other and lead to serious side effects. Your doctor may change the dosage of any of the other medicines you use.
You must not take any of the following with Dronedaron Sandoz:
- other drugs used to control irregular or rapid heartbeat such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone,
- certain medicines for fungal infections such as ketoconazole , voriconazole, itraconazole or posaconazole,
- certain antidepressants called tricyclic antidepressants,
- certain sedatives called phenothiazines,
- bepridil for chest pain caused by heart disease,
- telithromycin, erythromycin, or clarithromycin ( antibiotics for infections),
- terfenadine (an anti-allergy medicine),
- nefazodone (an antidepressant),
- cisapride (a medicine for reflux of food and acid reflux from the stomach to the mouth),
- ritonavir (a drug against AIDS infection s),
- dabigatran (a medicine that counteracts the formation of blood clots).
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,
- certain blood cholesterol-lowering medicines (such as simvastatin, lovastatin, atorvastatin, or rosuvastatin),
- certain drugs that counteract the formation of blood clots such as warfarin, rivaroxaban, edoxaban, and apixaban,
- certain medicines for epilepsy called phenobarbital, carbamazepine or phenytoin,
- sirolimus, tacrolimus, everolimus and ciclosporin (used after transplantation),
- St. John’s wort (herbal remedy for mild depression),
- rifampicin (for tuberculosis).
Dronedaron Sandoz with food and drink
Do not drink grapefruit juice while taking Dronedaron Sandoz, as it may raise the blood levels of dronedarone and thus increase the risk of side effects.
Pregnancy and breastfeeding
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 using this medicine.
- Dronedaron Sandoz is not recommended if you are pregnant or think you may be pregnant.
- Do not take Dronedaron Sandoz if you can have children and do not use a reliable method of contraception.
- Stop taking your tablets and contact your doctor immediately if you become pregnant while taking Dronedaron Sandoz.
- If you are breast-feeding, you should consult your doctor before taking Dronedaron Sandoz.
Driving and using machines
Dronedaron Sandoz does not usually affect your ability to drive and use machines. However, the ability to drive and use machines may be affected by side effects such as fatigue (if experienced).
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist
Dronedarone Sandoz 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. How to take Dronedaron Sandoz
Treatment with Dronedaron Sandoz will be supervised by a doctor who has experience in the treatment of heart disease. Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
If you need to change treatment from amiodarone (another medicine used to treat atrial fibrillation ) to Dronedaron Sandoz, your doctor will closely monitor such a change.
Dosage
The usual dose is one 400 mg tablet twice a day. Take:
- a tablet with breakfast and
- one tablet with the evening meal.
If you have the impression that the medicine is too strong or too weak, talk to your doctor or pharmacist.
Taking this medicine
Swallow the tablet whole with water along with a meal. The tablet cannot be divided into equal doses.
If you take more Dronedaron Sandoz then you should
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Take the medicine pack with you.
If you forget to take Dronedaron Sandoz
Do not take a double dose to make up for a forgotten tablet. Take the next dose as you normally would.
If you stop taking Dronedaron Sandoz
Do not stop treatment without first consulting a doctor or pharmacist.
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:
Talk to a 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 user in 10)
- Problems where your heart is not pumping around enough blood in the body, as good as it should be ( heart failure ). In clinical trials, these adverse reactions were observed at similar frequencies in patients receiving dronedarone and in patients receiving placebo. Symptoms of this include swollen feet or legs, difficulty breathing when lying down or sleeping, shortness of breath when moving, or weight gain.
Common (may affect up to 1 in 10 people)
- Diarrhea, persistent vomiting, can lead to kidney problems.
- Slow heartbeat.
Uncommon (may affect up to 1 in 100 people)
- Pneumonia (with scarring and thickening of the lungs). Symptoms of this include shortness of breath and dry cough.
Rare (may affect up to 1 in 1,000 people)
- Liver problems including life-threatening liver failure. Symptoms of this include abdominal pain or discomfort, loss of appetite, nausea, vomiting, yellowing of the skin or whites of the eyes (jaundice), abnormally dark urine, fatigue (especially in connection with other symptoms listed above), itching.
- Allergic reactions including swelling of the face, lips, tongue, or throat.
Other side effects include:
Very common (may affect more than 1 user in 10)
- changes in the results of a blood test (your blood creatinine level),
- changes in your ECG ( electrocardiogram ) called QTc (Bazett) extension.
Common (may affect up to 1 in 10 people)
- problems with your digestion such as diarrhea, nausea, vomiting, and stomach pain,
- fatigue and weakness,
- skin problems such as rash or itching,
- changes 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 or eczema ( redness, itching, burning sensation, or blisters),
- increased sensitivity to sunlight,
- taste disorders.
Rare (may affect up to 1 in 1,000 people)
- lost taste,
- inflammation of a blood vessel ( vasculitis including leukocytoclastic vasculitis ).
5. How to store Dronedaron Sandoz
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 carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Do not use this medicine if you notice any visible signs of deterioration (see section 6 “What the medicine looks like and contents of the pack”).
The medicine 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 to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is dronedarone. Each film-coated tablet contains 400 mg 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 tablet coating are hypromellose (E464), macrogol (E1521), titanium dioxide (E171).
What the medicine looks like and the contents of the pack
Dronedaron Sandoz is a white, oblong tablet measuring 17.6 x 8.1 mm.
Dronedaron Sandoz film-coated tablets are packaged in a carton of blisters or perforated unit dose blisters of opaque PVC aluminum or opaque PVC / PE / PVDC aluminum.
Pack sizes:
20, 20 × 1, 50, 50 × 1, 60, 60 × 1, 100 and 100 × 1 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Rontis Hellas Medical and Pharmaceutical Products SA, PO Box 3012 Larisa Industrial Area, Larisa 41004, Greece
or
LEK Pharmaceuticals dd, Verovskovaulica 57, 1526 Ljubijana, Slovenia