5 mg film-coated tablets / 10 mg film-coated tablets 
prasugrel

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Efient is and what it is used for 
2. What you need to know before you take Efient 
3. How to take Efient 
4. Possible side effects 
5. How to store Efient 6. Contents of the pack 
and other ingredients information

1. What Efient is and what it is used for

Efient, which contains the active substance prasugrel, belongs to a group of medicines called platelet inhibitors. Platelets are very small cells in the blood. When a blood vessel is damaged, for example in cuts, the platelets clump together to form a blood clot ( clot ). Therefore, platelets are necessary to stop bleeding. If blood clots form in an atherosclerotic blood vessel, such as an artery, they can become very dangerous because they can shut off the blood supply and cause a heart attack (heart attack), stroke, or death. Blood clots in the arteries (blood vessels) that supply the heart with blood can also reduce blood supply and cause unstable angina(angina).

Efient prevents platelets from clumping together, reducing the risk of blood clots forming.

You have been given Efient because you have already had a heart attack or have unstable angina and have been treated with a method that opens clogged arteries in your heart. You may also have one or more stents inserted to keep open a blocked or narrowed artery that supplies blood to the heart. Efient reduces the risk of you having a new heart attack or stroke or dying from a blood clot in your blood vessels. Your doctor has also prescribed you to take acetylsalicylic acid, which is another antiplatelet agent.

2. What you need to know before taking 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 manifests itself as a rash on the skin, itching, swelling of the face or lips, or shortness of breath. If this has happened to you, contact your doctor immediately.
  • if you have any disease that causes bleeding such as bleeding from the stomach or intestines.
  • if you have ever had a stroke or transient ischemic attack ( TIA ).
  • if you have severe liver disease.

Warnings and cautions

  • Before you take Efient:

Talk to your doctor before taking Efient.

Tell your doctor before taking Efient if any of the following apply to you:

  • if you have an increased risk of bleeding for example:
    • is 75 years or older. Your doctor should prescribe a daily dose of 5 mg as the risk of bleeding is greater in patients over 75 years of age.
    • a recent, serious injury.
    • recently undergone surgery (including some dental procedures).
    • recent or recurrent bleeding from the stomach or intestines (eg gastric ulcer, polyps in the colon).
    • body weight below 60 kg. Your doctor should prescribe a daily dose of 5 mg if you weigh less than 60 kg.
    • kidney disease or liver problems that are not considered serious.
    • taking certain types of medicines (see “Other medicines and Efient” below).
    • planned surgery (including certain dental procedures) within the next seven days. Your doctor may want you to stop taking Efient temporarily due to the risk of bleeding.
  • if you have had allergic reactions (hypersensitivity) to clopidogrel or any of the other antiplatelet agents, you should tell your doctor before starting treatment with Efient. If you take Efient and experience allergic reactions such as rash, itching, swollen face, swollen lips, or difficulty breathing, you should inform your doctor immediately.
  • When you take Efient:

You should inform your doctor immediately if you get a disease called thrombotic thrombocytopenic purpura (or TTP) which causes fever and bleeding under the skin that manifests as red pin-sized dots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes ( jaundice) (see section 4 Possible side effects).

Children and young people

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

Other medicines and Efient

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

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

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

Taking these medicines with Efient may increase the risk of bleeding.

Tell your doctor if you are taking morphine or other opioids (for the treatment of severe pain).

Only take medicines with Efient that your doctor has told you to use.

Pregnancy and breastfeeding

Tell your doctor if you become pregnant or are trying to become pregnant while taking Efient. You should use Efient only after discussing with your doctor the possible benefits for you and any risks 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 you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

How to take Efient

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The usual dose is 10 mg once a day. You will start treatment with a single dose of 60 mg. If you weigh less than 60 kg or are older than 75 years, the dose is 5 mg Efient per day.

Your doctor will also tell you to take aspirin and what dose to take (usually between 75 mg and 325 mg daily).

You can take Efient regardless of the meal. Take dose one at about the same time each day. Do not break or crush the tablets.

It is important to tell 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 there is a risk of severe bleeding. Show your doctor your package of Efient.

If you forget to take Efient

If you forget to take your daily dose, take Efient when you can. If you have not remembered to take Efient for the whole day, then just take the usual dose the next day. Do not take a double dose to make up for a forgotten dose. You can check which day you last took a tablet on the blister pack (applies to pack sizes 14, 28, 56, 84, and 98) where the days of the week are marked.

If you stop taking Efient

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

If you have any further questions on the use of this product, 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 immediately if you notice any of the following:

  • Sudden numbness or weakness in the arm, leg, or face, especially if only one side of the body is affected
  • Sudden confusion, difficulty speaking or understanding others
  • Sudden difficulty walking or keeping balance or coordination difficulties
  • Sudden dizziness or sudden severe headache for no known reason.

All of the above reactions may be signs of a stroke ( stroke ). Stroke is a less common side effect of Efient in patients who have never had a stroke or transient ischemic attack ( TIA ).

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

  • Fever and bleeding under the skin that appears as red pin-sized dots, 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”).
  • Rash, itching or swollen face, swollen lips, swollen tongue, or difficulty breathing. This may be a sign of a severe allergic reaction (see section 2 “What you need to know before taking Efient”).

Tell your doctor as soon as possible if you notice any of the following:

  • Blood in the urine
  • Bleeding from the rectum, blood in the stool, or black stools
  • Bleeding that can not be stopped, for example, from a cut

All of the above reactions may be signs of bleeding which is the most common side effect of Efient. Severe bleeding can be life-threatening but is less common.

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

  • Bleeding from the stomach or intestines
  • Bleeding from the insertion site of the needle
  • Nosebleed
  • Rash
  • Small red bruises on the skin ( ecchymosis )
  • Blood in the urine
  • Bleeding under the skin at an injection site, or in a muscle that causes swelling (hematoma)
  • Low hemoglobin or red blood cell count ( anemia )
  • Bruises.

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

  • Allergic reactions (rash, itching, swollen lips/tongue, or difficulty breathing)
  • Spontaneous bleeding from the eye, rectum, gums, or abdomen around the internal organs
  • Bleeding after surgery
  • Bloody cough
  • Blood in stool.

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

  • Low red blood cell count
  • Bleeding under the skin causes swelling ( subcutaneous hematoma).

5. How to store 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 blister and the outer carton after EXP. The expiration date is the last day of the specified month.

Store in the original package. Sensitive to 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.

6. Contents of the packaging and other information

Content declaration

The active substance is prasugrel.

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

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

The other ingredients are microcrystalline cellulose, mannitol (E421), croscarmellose sodium, hypromellose (E464), magnesium stearate, lactose monohydrate, titanium dioxide (E171), triacetin (E1518), red iron oxide (only 10 mg tablet) (E172), yellow j172 (yellow172) talc.

What the medicine looks like and the contents of the pack

Efient 10 mg: the tablet is beige and hexagonal with “10 mg” debossed on one side and “4759” on the other.

Efient 5 mg: the tablet is yellow and hexagonal with “5 mg” debossed on one side and “4760” on the other.

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

Not all packaging may be marketed.

Marketing Authorisation Holder

Daiichi Sankyo Europe GmbH

Zielstattstrasse 48

81379 Munich

Germany

Manufacturer

Daiichi Sankyo Europe GmbH

Luitpoldstrasse 1

85276 Pfaffenhofen

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

En Eden

Daiichi Sankyo Nordics ApS

Tel: +46 (0) 40 699 2524


Muhammad Nadeem

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