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Efient 10 mg film-coated tablets Prasugrel,Hydrochloride
2014-08-18 12:20:43 来源: 作者: 【 】 浏览:364次 评论:0

For doctors

 

What is it and how is it used?

Efient belongs to a group of medicines called anti-platelet agents. Platelets are very small cell particles that circulate in the blood. When a blood vessel is damaged, for example if it is cut, platelets clump together to help form a blood clot (thrombus). Therefore, platelets are essential to help stop bleeding. If clots form within a hardened blood vessel such as an artery they can be very dangerous as they can cut off the blood supply, causing a heart attack (myocardial infarction), stroke or death. Clots in arteries supplying blood to the heart may also reduce the blood supply, causing unstable angina (a severe chest pain).

Efient inhibits the clumping of platelets and so reduces the chance of a blood clot forming.

You have been prescribed Efient because you have already had a heart attack or unstable angina and you have been treated with a procedure to open blocked arteries in the heart. You may also have had one or more stents placed to keep open a blocked or narrowed artery supplying blood to the heart. Efient reduces the chances of you having a further heart attack or stroke or of dying from one of these atherothrombotic events. Your doctor will also give you acetylsalicylic acid (e.g. aspirin), another anti-platelet agent.

What do you have to consider before using it?

Do not take Efient

Take special care with Efient
You should tell your doctor before taking Efient if any of the situations mentioned below apply to you:

While you are taking Efient:
You should tell your doctor immediately if you develop a medical condition called Thrombotic Thrombocytopaenic Purpura (or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘POSSIBLE SIDE EFFECTS’).

Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, dietary supplements and herbal remedies. It is particularly important to tell your doctor if you are being treated with clopidogrel (an anti-platelet agent), warfarin (an anti-coagulant), or “non steroidal anti inflammatory drugs” for pain and fever (such as ibuprofen, naproxen, etoricoxib). If given together with Efient these medicines may increase the risk of bleeding

Only take other medicines while you are on Efient if your doctor tells you that you can.

Taking Efient with food and drink
Efient may be taken with or without food.

Pregnancy and breast-feeding
Tell your doctor if you become pregnant or are trying to become pregnant while you are taking Efient. You should use Efient only after discussing with your doctor the potential benefits and any potential risks to your unborn child.
If you are breast-feeding, ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
No studies on the effects of Efient on the ability to drive and use machines have been performed. Efient is unlikely to affect your ability to drive or use machines.

Important information about some of the ingredients of Efient
Efient contains lactose. If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How is it used?

Always take Efient exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how many Efient tablets to take. The usual dose of Efient is 10 mg per day. You will start the treatment with a single dose of 60 mg.
If you weigh less than 60 kg or are more than 75 years of age, the dose is 5 mg Efient per day. Your doctor will also tell you to take acetylsalicylic acid- (s)he will tell you the exact dose to take (usually between 75 mg and 325 mg daily).

You may take Efient with or without food. Take your dose at around the same time every day. Do not break or crush the tablet.

It is important that you tell your doctor, dentist and pharmacist, that you are taking Efient. Efient should not be used in children and adolescents below 18 years of age.

If you take more Efient than you should
Contact your doctor or hospital straight away, as you may be at risk of excessive bleeding. You should show the doctor your pack of Efient.

If you forget to take Efient
If you miss your scheduled daily dose, take Efient when you remember. If you forget your dose for an entire day, just resume taking Efient at its usual dose the next day. Do not take two doses in one day. For the 14, 28, 56 84 and 98 tablet pack sizes, you can check the day on which you last took a tablet of Efient by referring to the calendar printed on the blister.

If you stop taking Efient
Do not stop taking Efient without consulting your doctor. It is especially important to discuss with your doctor before stopping Efient because both the risks and the benefits are based on regular use.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, Efient can cause side effects, although not everybody gets them.

Contact your doctor immediately if you notice any of the following:

Also contact your doctor immediately if you notice any of the following:

Tell your doctor promptly if you notice any of the following:

All of the above may be signs of bleeding, the most common side effect with Efient. Although uncommon, severe bleeding can be life-threatening.

Common side effects (affect 1 to 10 users in 100)

Uncommon side effects (affect 1 to 10 users in 1,000)

Rare side effects (affect 1 to 10 users in 10,000)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell you doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Efient 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.

Store in the original package to protect from air and moisture.

Medicines 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.

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For doctors

What is it?

Efient is a medicine that contains the active substance prasugrel. It is available as double-arrow-shaped tablets (yellow: 5 mg; beige: 10 mg).

What is it used for?

Efient is taken together with aspirin to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) in patients with acute coronary syndrome who are undergoing percutaneous coronary intervention. Acute coronary syndrome is a group of conditions that includes unstable angina (a severe type of chest pain) and heart attack. Percutaneous coronary intervention is an operation used to unblock narrowed coronary arteries (blood vessels in the heart).
The medicine can only be obtained with a prescription.

How is it used?

Efient treatment starts with one 60-mg dose. This is then followed by 10 mg taken once a day, except in patients weighing less than 60 kg, who should take 5 mg once a day. The medicine can be taken with or without food. Patients taking Efient should also take aspirin at a dose prescribed by their doctors. It is recommended that treatment with Efient and aspirin continue for up to a year. The use of Efient in patients below 18 years of age is not recommended because of a lack of information on safety and effectiveness in this age group. Its use is also not recommended in patients over 75 years of age, unless the doctor has carefully considered its benefits and risks, and regards treatment with Efient as necessary. In this case, the 5-mg daily dose should be used following a 60-mg starting dose.

How does it work?

The active substance in Efient, prasugrel, is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming. When the blood clots, this is due to special cells in the blood, the platelets, sticking together (aggregating). Prasugrel stops the platelets aggregating by blocking a substance called ADP from binding to a receptor on their surface. This stops the platelets becoming ‘sticky’, reducing the risk of a blood clot forming and helping to prevent a heart attack or a stroke.

How has it been studied?

The effects of Efient were first tested in experimental models before being studied in humans. In one main study Efient, given as a 60-mg starting dose followed by 10-mg ‘maintenance’ doses, was compared with clopidogrel (another inhibitor of platelet aggregation), both medicines taken in combination with aspirin. The study involved almost 14,000 adults with acute coronary syndrome who were about to undergo percutaneous coronary intervention. The main measure of effectiveness was the reduction in the total number of cardiovascular deaths (deaths due to problems in the heart or blood vessels), heart attacks or strokes. The patients were followed up for an average of 14.5 months.

What benefits has it shown during the studies?

Efient was more effective than clopidogrel at reducing the total number of cardiovascular deaths, heart attacks or strokes. At the end of the study, 9% of the patients taking Efient had died from cardiovascular causes or had a heart attack or stroke (643 out of 6,813) compared with 11% of the patients taking clopidogrel (781 out of 6,795).

What is the risk associated?

The most common side effects with Efient (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), haematoma (a collection of blood under the skin or in a muscle), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), rash, haematuria (blood in the urine), bleeding from needle puncture sites, haematoma at puncture sites and bruising. For the full list of all side effects reported with Efient, see the Package Leaflet.
Efient should not be used in people who may be hypersensitive (allergic) to prasugrel or any of the other ingredients. It must not be used in patients who have a condition that causes excessive bleeding, who have had a stroke or transient ischaemic attack (a temporary reduction in the blood supply to part of the brain), or with severe liver problems.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Efient’s benefits are greater than its risks, when co-administered with aspirin, for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing primary or delayed percutaneous coronary intervention. The Committee recommended that Efient be given marketing authorisation.

How has it been studied?

The company that makes Efient will make sure that educational materials are available in all Member States for doctors who will treat patients with the medicine. The materials will include information on how to prescribe the medicine safely and to remind doctors that the medicine is not recommended for patients over the age of 75 years.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Efient to Eli Lilly Nederland BV on 25 February 2009.

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Name

 

Efient 10 mg film-coated tablets

 

Composition

 

Each tablet contains 10 mg prasugrel (as hydrochloride).
Excipient: Each tablet contains 2.1 mg lactose.

For a full list of excipients, see section 6.1.

 

Pharmaceutical Form

 

Film-coated tablet (tablet).

Beige and double-arrow shaped tablets, debossed with “10 MG” on one side and “4759” on the other.

 

Are you an Healthcare Professional? Access professional drug leaflets on Diagnosia.com!

 

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