EFIENT 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Efient 10 mg film-coated tablets

Efient 5 mg film-coated tablets

prasugrel

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.

Contents of the pack

1. What is Efient and what is it used for

1. What you need to know before you take Efient

1. How to take Efient

1. Possible side effects

1. Storage of Efient

1. Contents of the pack and other information

1. What is Efient and what is it used for

Efient contains the active substance prasugrel, which belongs to a group of medicines called antiplatelet agents. Platelets are very small cells that circulate in the blood. When a blood vessel is damaged, for example cut, platelets clump together to help form a blood clot. Therefore, platelets are essential to help stop bleeding. The formation of clots in hardened blood vessels, such as arteries, can be very dangerous as they can block the flow of blood, causing a heart attack (myocardial infarction), stroke or death. Clots in arteries that supply blood to the heart can also reduce blood flow, causing unstable angina (severe chest pain).

Efient inhibits platelet clumping, which reduces the chance of forming blood clots.

You have been prescribed Efient because you have had a heart attack or unstable angina and have been treated with a procedure to open up blocked heart arteries. You may have had one or more stents inserted into the blocked or narrowed artery to restore blood flow to the heart. Efient reduces the chance of having another heart attack or stroke, or dying from one of these events. Your doctor will also prescribe you acetylsalicylic acid (e.g. aspirin), another antiplatelet agent.

2. What you need to know before you take Efient

Do not take Efient

• If you are allergic to prasugrel or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can be recognized as a skin rash, itching, swelling of the face, lips or difficulty breathing. If this has happened to you, contact your doctor immediately.
• If you have a condition that is causing bleeding, such as stomach or intestinal bleeding.
• If you have ever had a stroke or a transient ischaemic attack.
• If you have severe liver disease.

Warnings and precautions

• Before taking Efient:

Consult your doctor before starting to take Efient.

Consult your doctor or pharmacist before starting to take Efient if you are in any of the following situations:

• If you are at high risk of bleeding because:
• • you are 75 years or older. Your doctor should prescribe you a daily dose of 5 mg as patients over 75 years have a higher risk of bleeding
  • you have recently had a serious injury
  • you have recently had surgery (including some dental procedures)
  • you have recently had or recurrent stomach or intestinal bleeding (e.g. stomach ulcer or colon polyps)
  • you weigh less than 60 kg. In this case, your doctor should prescribe you a daily dose of 5 mg of Efient
  • you have kidney disease or moderate liver problems
  • you are taking other medicines (see "Other medicines and Efient")
  • you are scheduled to have surgery (including some dental procedures) in the next 7 days. Your doctor may advise you to temporarily stop treatment with Efient due to an increased risk of bleeding.
• If you have had allergic reactions (hypersensitivity) to clopidogrel or any other antiplatelet agent, please inform your doctor before starting treatment with Efient. If after taking Efient, you experience an allergic reaction that you can recognize by rash, itching, swelling of the face, swelling of the lips or difficulty breathing, contact your doctor immediately.

• While taking Efient:

You should contact your doctor immediately if you develop a condition called Thrombotic Thrombocytopenic Purpura (or TTP). TTP is associated with fever and bruising (haematoma) under the skin that appear as red dots, with or without extreme unexplained tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").

Children and adolescents

Efient should not be used in children and adolescents under 18 years of age.

Other medicines and Efient

Tell your doctor if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription, dietary supplements and herbal products.

It is especially important that you inform your doctor if you are being treated with:

• clopidogrel (an antiplatelet agent),
• warfarin (an anticoagulant),
• "non-steroidal anti-inflammatory medicines" for pain and fever (such as ibuprofen, naproxen, etoricoxib).

If these medicines are administered with Efient, they may increase the risk of bleeding.

Tell your doctor if you are taking morphine or other opioids (used to treat acute pain).

Use other medicines while taking Efient only if your doctor tells you to.

Pregnancy and breast-feeding

Tell your doctor if you become pregnant or are planning to become pregnant while taking Efient. You should take Efient only after talking to your doctor about the potential benefits and any potential risk to the fetus.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Efient is unlikely to affect your ability to drive or use machines.

Efient contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Efient

Take this medicine exactly as your doctor has told you. If you are not sure, contact your doctor or pharmacist.

The usual dose of Efient is 10 mg per day. Your treatment will start with a single dose of 60 mg. If your weight is less than 60 kg or you are over 75 years, the dose is 5 mg of Efient per day. Your doctor will also tell you to take acetylsalicylic acid and the exact dose you should take (usually between 75 mg and 325 mg per day).

You can take Efient with or without food. Take your dose every day at about the same time.

Do not break or split the tablet.

It is important that you inform your doctor, dentist and pharmacist that you are taking Efient.

If you take more Efient than you should

Contact your doctor or hospital directly as you may be at risk of excessive bleeding. You should show your doctor the pack of Efient.

If you forget to take Efient

If you forget to take your daily dose, take Efient when you remember. If you forget to take your dose for a whole day, take your normal dose of Efient the next day. Do not take a double dose to make up for forgotten doses. In packs of 14, 28, 56, 84 and 98 tablets, you can check the last day you took a tablet of Efient by looking at the calendar printed on the blister.

If you stop taking Efient

Do not stop your treatment without consulting your doctor, if you stop taking Efient too soon, the risk of having a heart attack may increase.

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.

Contact your doctor immediatelyif you experience any of the following signs:

• Numbness or weakness suddenly affecting one side of the body, arm, leg or face.
• Sudden confusion, difficulty speaking or understanding others.
• Sudden difficulty walking or loss of balance or coordination.
• Sudden severe headache or dizziness without known cause.

All these can be signs of a stroke. A stroke is an uncommon side effect of Efient in patients who have never had a stroke or a transient ischaemic attack.

You should also contact your doctor immediatelyif you notice any of the following signs:

• Fever and bruising (haematoma) under the skin that appear as red dots, with or without extreme unexplained tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 2 "What you need to know before you take Efient").
• A rash, itching, swelling of the face, swelling of the lips/tongue, or difficulty breathing. These can be signs of a severe allergic reaction (see section 2 "What you need to know before you take Efient").

Tell your doctor promptlyif you experience any of the following signs:

• Blood in urine.
• Rectal bleeding, blood in stools or black stools.
• Uncontrolled bleeding, for example after a cut.

All these can be signs of bleeding, the most common side effect with Efient. Although rare, severe bleeding can cause death.

Common side effects (may affect up to 1 in 10 people)

• Bleeding in the stomach or intestine
• Bleeding at the injection site
• Nosebleeds
• Skin rash
• Small red spots on the skin (ecchymosis)
• Blood in urine
• Haematoma (bleeding under the skin at the injection site, or in a muscle, causing swelling)
• Low haemoglobin or red blood cell count (anaemia)
• Bruising

Uncommon side effects (may affect up to 1 in 100 people)

• Allergic reaction (rash, itching, swelling of the lips/tongue, or difficulty breathing)
• Spontaneous bleeding in the eye, rectum, gums or in the abdomen around the internal organs
• Bleeding after surgery
• Bleeding when coughing
• Blood in stools

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

• Low platelet count in the blood
• Subcutaneous haematoma (bleeding under the skin, causing swelling)

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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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5. Storage of Efient

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 carton after EXP. The expiry date refers to the last day of the month shown.

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

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 protect the environment.

6. Contents of the pack and other information

What Efient contains

• The active substance is prasugrel.

Efient 10 mg: Each tablet contains 10 mg of prasugrel (as hydrochloride).

Efient 5 mg: Each tablet contains 5 mg of prasugrel (as hydrochloride).

• The other ingredients are:

Microcrystalline cellulose, mannitol (E421), sodium croscarmellose, hypromellose (E464), magnesium stearate, lactose monohydrate, titanium dioxide (E171), triacetin (E1518), red iron oxide (only 10 mg tablets) (E172), yellow iron oxide (E172) and talc.

Appearance and packaging

Efient 10 mg: The tablets are beige and have a double arrow shape, with "10 MG" engraved on one side and "4759" on the other.

Efient 5 mg: The tablets are yellow and have a double arrow shape, with "5 MG" engraved on one side and "4760" on the other.

Efient is available in packs of 14, 28, 30, 30 (x1), 56, 84, 90 (x1) and 98 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

SUBSTIPHARM

24 rue Erlanger

75016 Paris

France

Manufacturer:

Daiichi Sankyo Europe GmbH

Luitpoldstrasse 1

85276 Pfaffenhofen

Germany

You can request more information about this medicine from the representative of the marketing authorisation holder:

Date of last revision of this leaflet: {MM/AAAA}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.