Leaflet: information for the user

Efient 10 mg film-coated tablets

Efient 5 mg film-coated tablets

prasugrel

Read this leaflet carefully before you start taking the medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What you need to know before you start taking Efient

1. How to take Efient

1. Possible side effects

1. Storage of Efient

1. Contents of the pack and additional information

Efient contains the active ingredient prasugrel, which belongs to a group of medications called antiplatelet agents. Platelets are very small cells that circulate in the blood. When a blood vessel is damaged, for example when it is cut, platelets aggregate to help form a blood clot (thrombus). Therefore, platelets are essential in helping to stop bleeding. The formation of clots in hardened blood vessels, such as arteries, can be very dangerous as it blocks blood flow, causing a heart attack (myocardial infarction), stroke (cerebrovascular accident) 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 aggregation, thereby reducing the likelihood of blood clots forming.

You have been prescribed Efient because you have suffered a myocardial infarction or unstable angina and have undergone a procedure to open blocked heart arteries. You may have had one or more stents placed in the blocked or narrowed artery to restore blood flow to the heart. Efient reduces the likelihood of future myocardial infarctions, stroke (cerebrovascular accident) or death due to one of these atherothrombotic events. Your doctor will also prescribe acetylsalicylic acid (e.g. aspirin), another antiplatelet agent.

Do not take Efient

• If you are allergic to prasugrel or any of the other components of this medication (listed in section 6). A reaction to an allergen can be recognized as a skin rash, itching, swelling of the face, swelling of the lips or difficulty breathing. If this has happened to you, consult your doctorimmediately.
• If you have a disease that is causing bleeding, such as stomach or intestinal bleeding.
• If you have ever had a stroke or a transient ischemic attack.
• If you suffer from a 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 have a high risk of bleeding because:
• • You are 75 years of age or older. Your doctor should prescribe a daily dose of 5 mg since patients over 75 years of age have a higher risk of bleeding
  • You have recently suffered a serious injury
  • You have recently undergone a surgical procedure (including some dental procedures)
  • You have recently or recurrently suffered stomach or intestinal bleeding (e.g. stomach ulcer or colon polyps)
  • You weigh less than 60 kg. In this case, your doctor should prescribe a daily dose of 5 mg of Efient
  • You have kidney disease or moderate liver disease
  • You are using another type of medication (see “Other medications and Efient”)
  • You are planning to undergo a surgical procedure (including some dental procedures) in the next seven days. Your doctor may indicate that you temporarily suspend the treatment with Efient due to an increased risk of bleeding.
• If you have had allergic reactions (hypersensitivity) to clopidogrel or to any other antiplatelet agent, please inform your doctor before starting the treatment with Efient. If after taking Efient, you experience an allergic reaction that can be recognized by a rash, itching, swelling of the face, swelling of the lips or difficulty breathing, contactimmediatelyyour doctor.

• While taking Efient:

You must contact your doctor immediately if you develop a disease called Thrombotic Thrombocytopenic Purpura (or TTP). TTP is associated with fever and bruises (hematomas) under the skin that appear as localized red spots, with or without extreme fatigue, confusion, yellow discoloration of the skin or eyes (jaundice) (see section 4 “Possible side effects”)

Children and adolescents

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

Other medications and Efient

Inform your doctor if you are taking, have taken recently or may have to take any other medication, even those acquired without a prescription, dietary supplements and herbal products.

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

• Clopidogrel (an antiplatelet agent),
• Warfarin (an anticoagulant),
• “non-steroidal anti-inflammatory drugs” for pain and fever (such as ibuprofen, naproxen, etoricoxib).

If administered together with Efient, these medications may increase the risk of bleeding.

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

Use other medications while taking Efient, only if your doctor indicates that you can do so.

Pregnancy and breastfeeding

Inform your doctor if you become pregnant or are trying 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 breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Efient is unlikely to affect your ability to drive and operate machinery.

Efient contains lactose and sodium

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The usual dose of Efient is 10 mg per day. Your treatment will begin with a single dose of 60 mg. If your weight is less than 60 kg or you are over 75 years old, the dose is 5 mg of Efient per day. Your doctor will also instruct 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 approximately the same time.

Do not break or crush the tablet.

It is essential 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 must show your doctor the Efient packaging.

If you forget to take Efient

If you forget to take your daily scheduled dose, take Efient when you remember. If you forget to take your dose for an entire day, take your usual dose of Efient the next day. Do not take a double dose to compensate for the missed doses. In the 14, 28, 56, 84, and 98 tablet packs, you can check the last day you took an Efient tablet by looking at the calendar printed on the blister pack.

If you interrupt treatment with Efient

Do not stop your treatment without consulting your doctor. If you stop treatment with Efient too soon, the risk of having a myocardial infarction may increase.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Contact your doctorimmediatelyif you experience any of the following symptoms:

• Sudden numbness or weakness of the arm, leg, or face, especially if it only affects one side of the body.
• Sudden confusion, difficulty speaking, or understanding other people.
• Sudden difficulty walking or loss of balance or coordination.
• Sudden severe dizziness or severe headache without a known cause.

They may be signs of a stroke. A stroke is a rare side effect of Efient in patients who have never had a stroke or a transient ischemic attack.

You must also contact your doctorimmediatelyif you notice any of the following symptoms:

• Fever and bruising (hematomas) under the skin that appear as localized red spots, with or without extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 2 “What you need to know before starting Efient”).
• A rash, itching, or swelling of the face, lips/lips, or difficulty breathing. They may be signs of a severe allergic reaction (see section 2 “What you need to know before starting Efient”).

Inform your doctorquicklyif you experience any of the following symptoms:

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

They may be signs of bleeding, the most common side effect of Efient. Although rare, severe bleeding can cause death.

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

• Gastrointestinal bleeding
• Bleeding at the injection site
• Nasal bleeding
• Skin rash
• Small red spots on the skin (petechiae)
• Blood in urine
• Hematoma (bleeding under the skin at the injection site, or in a muscle, causing swelling)
• Low hemoglobin or red blood cell count (anemia)
• Bruising

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

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

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from air and moisture.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Efient

• The active ingredient 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 components are:

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

Appearance of the product and contents of the package

Efient 10 mg: The tablets are beige in color 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 in color and have a double arrow shape, with "5 MG" engraved on one side and "4760" on the other.

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

SUBSTIPHARM

24 rue Erlanger

75016 Paris

France

Responsible manufacturer:

Daiichi Sankyo Europe GmbH

Luitpoldstrasse 1

85276 Pfaffenhofen

Germany

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last revision date of this leaflet: {MM/AAAA}.

Other sources of information

More detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu.