DRONEDARONE PACKAGE INSERT PDF

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. MULTAQ contains an active substance named dronedarone. It belongs. Learn how MULTAQ (dronedarone) can help keep your heart in rhythm and lower (including St. John’s wort) you take to help avoid serious drug interactions. Package Insert – Dronedarone (Multaq®). Jan 2. Assessment Report for dronedarone (Multaq). European Medicines Agency. EMEA/H/C/

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It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged. Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above. The product code s for this leaflet are: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Contents of the pack and other information. It belongs to a group of medicines called anti-arrhythmics that help regulate your heart beat. MULTAQ is used if you have a problem with your heart beat your heart beats out of time – atrial fibrillation and a treatment called cardioversion has changed your heartbeat back to normal rhythm.

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

Your doctor may change the dose of any other medicines you are taking. It can increase the blood levels of dronedarone and may increase your chance of getting side effects.

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. However, your ability to drive and use machines may be affected by side effects such as fatigue if present. Lactose is a type of sugar. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. If you need to change from amiodarone another medicine for irregular heart beat to MULTAQ, your doctor will handle such change with caution.

Swallow the tablet whole with a drink of water drinedarone a meal. The tablet cannot be divided into equal doses. Contact immediately your doctor or the nearest emergency department or hospital. Take the medicine pack with you. 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. Talk to your doctor straight away, if you notice any of the following serious side effects — you may need urgent medical assistance.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: You can also report lackage effects directly via ADR Reporting www. Do not throw away any medicines via wastewater or household waste.

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Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. Detailed information on this medicine is available on the European Medicines Agency web site: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder. This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies.

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Continue typing to refine. Active ingredient dronedarone hydrochloride.

Last updated on eMC: What is a Patient Information Cronedarone and why is it packaage Multaq mg tablets Package 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 dronerarone them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. What is in this leaflet 1. Your heart might beat very slowly or you may feel dizzy.

In permanent AF, the AF has been present for a long time at least during 6 months and a drronedarone has been made not to change back your heart rhythm to atrial normal rhythm with a treatment called cardioversion, 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.

Warnings and precautions Talk to your doctor or pharmacist before taking MULTAQ 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 MULTAQ, 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. You should stop taking MULTAQ, 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 failuretell lnsert doctor immediately if you develop iinsert of these signs and symptoms of liver problems: Heart, lung and blood tests While you are taking MULTAQ, your pxckage may perform tests to check your medical condition and how the medicine is working for you.

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.

Multaq mg tablets – Patient Information Leaflet (PIL) – (eMC)

Your doctor may also do other blood tests. Your doctor may check your lungs. You must tell your doctor or pharmacist if you are taking any of the following medicines: 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.

How much to take The usual dose is one mg tablet twice a day. 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. 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 inserh your heart does not adequately pump dronedaronee 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 MULTAQ and in patients receiving placebo.

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Signs include swollen feet or legs, trouble breathing when lying down or sleeping, shortness of breath when moving around, or weight increase.

Multaq 400mg tablets

Common may affect up to 1 in 10 people Diarrhoea, vomiting when excessive as dronedsrone can lead to kidney problems. Uncommon may affect up to 1 in 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, 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 jaundiceunusual darkening of the urine, fatigue especially in association with other symptoms listed aboveitching. 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 one blood test: Common may affect up to 1 in 10 people problems with your digestion such as diarrhoea, nausea, vomiting and stomach pain, feeling tired, 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 people other skin problems such as redness of the insett or eczema redness, itching, burning or blisteringyour skin being more sensitive to the sun, change in how things taste. Rare may affect up to 1 in paclage, 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, pharmacist or nurse. 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. Each film-coated tablet contains mg of dronedarone as hydrochloride. The other ingredients in the tablet core are hypromellose Emaize starch, crospovidone Epoloxamer dtonedarone, lactose monohydrate, colloidal anhydrous silica, magnesium stearate E The other ingredients in the tablet coat are hypromellose Emacrogoltitanium dioxide Ecarnauba wax E Not all pack size may be marketed.

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