近日，赛诺菲-安万特公司产品Multaq通过了欧盟的批准，这是10年以来首个在欧盟国家获准的抗心律失常新药。
　今年9月份，Multaq得到了欧洲人用医疗产品委员会的肯定，而它最终获准上市销售表明欧盟采纳了该委员会的建议。Multaq用于有非永久性房颤史或目前正患有这种疾病，并且临床上病情稳定的成人患者，以防止疾病复发或降低心室率。
　这次Multaq获准的依据是7项相关的临床实验数据。参加这一系列实验的患者人数总共达7000人，其中的4000人接受该药治疗。其中，一项名为Athena的实验最为显著，房颤和房扑患者用药后因心血管疾病需要住院治疗或死亡的几率显著降低，达到临床受益水平。
　赛诺菲研发部主管Marc Cluzel表示，Multaq是该公司15年研发工作的成果，它在欧盟获准上市销售对房颤患者来说意义重大，这意味着他们可以选择全新的药物进行治疗。
MULTAQ 400MG. 20TABLETS
What MULTAQ is and what it is used
MULTAQ contains an active substance named dronedarone. It belongs to a group of medicines called antiarrhythmics that help regulate heart rhythm.
MULTAQ is used if you have a problem with your heart beat (your heart beat irregularly - atrial fibrillation) and your heart is back to normal rhythm with a treatment called cardioversion.
MULTAQ prevents repetition of your problem of irregular heart rhythm.
2. What you need to know before taking MULTAQ
Do not take MULTAQ if:
you are allergic to dronedarone or any of the other ingredients of this medicine (listed in section 6);
have problems with the nerves of the heart (heart block). Your heart might beat very slowly or you may feel dizzy. If you have a pacemaker fitted for this problem, you can take MULTAQ;
you have a very slow heartbeat (less than 50 beats per minute);
Your ECG (electrocardiogram), shows a heart problem called "prolonged QT corrected interval" (this interval is more than 500 milliseconds);
have a kind of atrial fibrillation called permanent atrial fibrillation (AF). In permanent AF, atrial fibrillation existed for a long time (at least 6 months) and decided your heart rate does not return to normal atrial rhythm with treatment called cardioversion;
have or have had a problem in which the heart can not pump the blood in your body as it should (a condition called heart failure). You may have swollen feet or legs, trouble breathing when lying down or sleeping, or shortness of breath when you move;
amount of blood that pushes your heart every time shortens, is too small (condition called left ventricular dysfunction);
you are taking amiodarone previously and have had lung or liver problems;
take medicines for infection (including fungal infection or AIDS), allergies, heart beat problems, depression, after a transplant (see section "Other medicines MULTAQ and below." There you will find detailed information on exactly what medicines you can not take with MULTAQ);
you have severe liver problems;
you have severe kidney problems;
dabigatran (see section "Other medicines and MULTAQ" below).
If any of the above applies to you, do not take MULTAQ.
Warnings and Precautions
Talk to your doctor or pharmacist before taking MULTAQ, if:
have a problem that leads to low levels of potassium or magnesium in your blood. This condition should be corrected before starting treatment with MULTAQ;
you are aged over 75 years;
have a condition in which the blood vessel supplying blood to the heart muscle has hardened and narrowed (coronary artery disease).
Tell your doctor while taking MULTAQ, if:
Your atrial fibrillation becomes permanent while taking MULTAQ. You should stop taking MULTAQ;
have swollen feet or legs, trouble breathing when lying down or sleeping, shortness of breath when moving around, or weight gain;
Tell your doctor immediately if you develop any of these signs and symptoms of liver problems: pain or discomfort in the stomach (abdomen), loss of appetite, nausea, vomiting, yellowing of the skin or whites of the eyes (jaundice), unusual darkening urine, fatigue (particularly in combination with other symptoms listed above), itching;
have breathlessness or non-productive cough. Tell your doctor, he / she will check the condition of your lungs.
If this applies to you (or are not sure), talk to your doctor or pharmacist before taking MULTAQ.
Heart and blood tests
While taking MULTAQ, your doctor may perform tests to check your medical condition and how the medicine affects you.
Your doctor may monitor the electrical activity of your heart using an ECG (electrocardiogram);
Your doctor will order blood tests to check your liver function before you start taking MULTAQ and during treatment. In some cases you may need treatment with MULTAQ be discontinued;
Your doctor may also do other blood tests. The results of one of the blood tests (blood creatinine levels) may be changed by MULTAQ. Your doctor will take this into account when checking your blood levels and will use another reference of the "normal" blood creatinine.
Tell any other person who checks your blood that you are taking MULTAQ.
Children and adolescents
MULTAQ is not recommended in children and adolescents under 18 years of age.
Other medicines and MULTAQ
Your doctor may advise you to use a drug that prevents blood clots, depending on your condition.
MULTAQ 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 should not take any of the following with MULTAQ:
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 infections called macrolides;
some medicines for depression called tricyclic antidepressants;
some sedative drugs called phenothiazines;
bepridil - for chest pain caused by heart disease;
telithromycin, erythromycin or clarithromycin (antibiotics for infections);
terfenadine - for allergies;
nefazodone - for depression;
cisapride - for gastric reflux;
ritonavir - for AIDS infection;
dabigatran - to prevent the formation of blood clots.
Tell your doctor or pharmacist if you are taking any of these medicines:
other medicines for high blood pressure, chest pain caused by heart disease or other heart problems, such as verapamil, diltiazem, nifedipine, metoprolol, propranolol or digoxin;
some medicines for reducing blood cholesterol (eg simvastatin, lovastatin, atorvastatin, rosuvastatin or pravastatin);
Certain medicines against blood clots such as warfarin;
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.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
MULTAQ with food and drink
Take one tablet during your morning meal and one tablet with dinner. Do not drink grapefruit juice while taking MULTAQ. It can interfere with the usual effect of your medicine.
Pregnancy, lactation and fertility
MULTAQ is not recommended if you are pregnant or suspect that you are pregnant.
Do not take MULTAQ, if you are a woman of childbearing age and not using a reliable contraceptive method.
Stop taking your tablets and tell your doctor immediately if you become pregnant while taking MULTAQ.
If you are a mother breast-feed should discuss this with your doctor before taking MULTAQ.
Driving and using machines
No studies on the effects on the ability to drive and use machines.
MULTAQ contains lactose
MULTAQ contains lactose, which is a type of sugar. If you are told by your doctor that you have an intolerance to some sugars, contact your doctor before taking MULTAQ.
3. How to take MULTAQ
Always take this medicine exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
If you need to switch from amiodarone (another medicine to treat irregular heartbeat) of MULTAQ, your doctor will perform this change with caution.
How much to take
The usual dose is one tablet of 400 mg twice daily.
take:
one tablet with the morning meal and
one tablet with dinner.
If you think your medicine is too strong or too weak, talk to your doctor or pharmacist.
Taking the medicine
Swallow the tablets with water during meals.
If you take more MULTAQ than
Contact your doctor or the nearest emergency department or hospital. Take the medicine pack with you.
If you forget to take MULTAQ
Do not take a double dose to make up for a forgotten tablet. Take your next dose at its regular time.
If you stop taking MULTAQ
Do not stop taking this medication 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following adverse reactions have been reported with the use of this medicine:
Very common (may affect more than 1 in 10 people):
changes in the results of the following blood tests: the level of creatinine in the blood;
changes in your ECG (electrocardiogram);
problem in which the heart does not pump enough blood in your body (congestive heart failure), which can cause shortness of breath or swelling of the ankles. In clinical trials, this side effect has been observed with similar frequency in patients receiving MULTAQ and patients receiving placebo.
Common (may affect up to 1 in 10 people):
digestive problems such as diarrhea, nausea, vomiting and stomach pain;
tiredness;
slow heartbeat;
skin problems such as rash or itching;
change in the results of blood tests used for checking 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);
the sensitivity of your skin to the sun;
changes in taste;
inflammation of the lungs (including scarring and thickening of the lungs).
Rare (may affect up to 1 in 1000 people):
loss of taste;
liver problems, including life-threatening liver failure;
allergic reactions including swelling of the face, lips, mouth, tongue or throat.
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store MULTAQ
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the 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 in section 6 "What MULTAQ looks like and contents of the pack").
Do not dispose of medications in 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 pack and other information
What MULTAQ
The active substance is dronedarone.
Each tablet contains 400 mg of dronedarone (as hydrochloride).
The other ingredients in the core of the film-coated tablet are hypromellose, maize starch, crospovidone, poloxamer 407, lactose monohydrate, colloidal anhydrous silica, magnesium stearate.
The other ingredients in the coating of the film-coated tablets are hypromellose, macrogol 6000, titanium dioxide (E171), carnauba wax.
MULTAQ looks like and contents of the pack
MULTAQ is a white, oval, film-coated tablet (tablet) with a double wave marking on one side and "4142" on the other.
MULTAQ film-coated tablets are available in packs of 20, 50, 60 tablets in blisters of opaque PVC and aluminum, and 100x1 tablets in unit dose blister packs of opaque PVC and aluminum.
Not all pack sizes may be marketed.
https://www.medicines.org.uk/emc/product/497/pil