Efient 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Efient 10 mg film-coated tablets

Efient 5 mg film-coated tablets

prasugrel

Read the entire leaflet carefully before you start taking this medicine, as 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; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Efient is and what it is used for

2. What you need to know before taking Efient

3. How to take Efient

4. Possible adverse effects

5. How to store Efient

6. Contents of the pack and other information

1. What Efient is and what it is 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 by a cut, platelets clump together to help form a blood clot (thrombus). Therefore, platelets are essential for helping to stop bleeding. The formation of clots in hardened blood vessels, such as arteries, can be very dangerous because they block blood flow, causing a heart attack (myocardial infarction), stroke (cerebrovascular accident), or death. Clots in arteries supplying blood to the heart may also reduce blood flow, causing unstable angina (severe chest pain).

Efient inhibits platelet aggregation, thereby reducing the likelihood of blood clot formation.

Efient has been prescribed for you because you have had a myocardial infarction or unstable angina and have been treated with 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 risk of future myocardial infarctions or strokes (cerebrovascular accidents) or the risk of dying from such atherothrombotic events. Your doctor will also prescribe acetylsalicylic acid (e.g., aspirin), another antiplatelet agent.

2. What you need to know before starting to take Efient

Do not take Efient

• If you are allergic to prasugrel or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction may include skin rash, itching, facial swelling, swelling of the lips, or difficulty breathing. If this happens to you, consult your doctor immediately.
• If you have a medical condition causing bleeding, such as bleeding in the stomach or intestines.
• If you have ever had a stroke or a transient ischemic attack (TIA).
• If you suffer from severe liver disease.

Warnings and precautions

• Before taking Efient:

Talk to your doctor before starting to take Efient.

Talk to your doctor or pharmacist before starting Efient if any of the following apply to you:

• If you are at high risk of bleeding because:

  • you are 75 years of age or older. Your doctor should prescribe a daily dose of 5 mg, as patients over 75 have an increased risk of bleeding
  • you have recently suffered a serious injury
  • you have recently undergone surgery (including certain dental procedures)
  • you have recently or repeatedly experienced stomach or intestinal bleeding (e.g. a 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 problems
  • you are taking other medicines (see “Other medicines and Efient”)
  • you are planning to undergo surgery (including certain dental procedures) within the next seven days. Your doctor may instruct you to temporarily stop treatment with Efient due to an increased risk of bleeding.

• If you have previously 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 such as rash, itching, facial swelling, lip swelling, or difficulty breathing, contact your doctor immediately.

• While taking Efient:

You must contact your doctor immediately if you develop a condition called Thrombotic Thrombocytopenic Purpura (TTP). TTP is associated with fever and bruising (ecchymoses) under the skin appearing as small red spots, with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 “Possible side effects”).

Children and adolescents

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

Other medicines and Efient

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, dietary supplements, or 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 drugs" for pain and fever (such as ibuprofen, naproxen, etoricoxib).

When taken together with Efient, these medicines may increase the risk of bleeding.

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

Only take other medicines while taking Efient if your doctor has instructed you that it is safe to 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 discussing with your doctor the potential benefits and any potential risks to the fetus.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using 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 informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Efient

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

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

You may take Efient with or without food. Take your dose every day at approximately 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 immediately, as you may be at risk of excessive bleeding. You should show your doctor the Efient packaging.

If you forget to take Efient

If you forget to take your scheduled daily dose, take Efient as soon as you remember. If you forget to take your dose for an entire day, resume your usual daily dose of Efient the next day. Do not take a double dose to make up for a missed dose. 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 stop taking Efient

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you experience any of the following signs:

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

These may all be signs of a stroke. Stroke is an uncommon adverse effect of Efient in patients who have never previously had a stroke or transient ischemic attack.

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

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

Inform your doctor promptly if 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.

These may all be signs of bleeding, the most common adverse effect with Efient. Although infrequent, serious bleeding can be fatal.

Common adverse 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 bruises on the skin (ecchymosis)
• Blood in urine
• Bruising (bleeding under the skin at the injection site, or in a muscle, causing swelling)
• Low hemoglobin or red blood cell count (anemia)
• Bruising

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

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

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

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Efient

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store in the original container 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 and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Efient

• 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 components are:

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

Appearance of the product and contents of the pack

Efient 10 mg: The tablets are beige in colour and shaped as a double arrow, with “10 MG” engraved on one side and “4759” on the other.

Efient 5 mg: The tablets are yellow in colour and shaped as a double arrow, 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.

Only certain 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet: {MM/YYYY}.

Other sources of information

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