Efient
prasugrel
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.
What Efient is and what it is used for
What you need to know before you take Efient
How to take Efient
Possible side effects
How to store Efient
Contents of the pack and other information
Efient, which contains the active substance prasugrel, 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.
If you are allergic to prasugrel or any of the other ingredients of this medicine (listed in
section 6). An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath. If this has happened to you, tell your doctor immediately.
If you have a medical condition that is currently causing bleeding, such as bleeding from your
stomach or intestines.
If you have ever had a stroke or a transient ischaemic attack (TIA).
If you have severe liver disease.
Talk to your doctor before taking Efient.
You should tell your doctor before taking Efient if any of the situations mentioned below apply to you:
If you have an increased risk of bleeding such as:
age of 75 years or older. Your doctor should prescribe a daily dose of 5 mg as there is a greater risk of bleeding in patients older than 75 years
a recent serious injury
recent surgery (including some dental procedures)
recent or recurrent bleeding from the stomach or intestines (e.g. a stomach ulcer or colon polyps)
body weight of less than 60 kg. Your doctor should prescribe a daily dose of 5 mg of Efient
if you weigh less than 60 kg
renal (kidney) disease or moderate liver problems
taking certain types of medicines (see ‘Other medicines and Efient’ below)
planned surgery (including some dental procedures) in the next seven days. Your doctor may wish you to stop taking Efient temporarily due to the increased risk of bleeding
If you have had allergic reactions (hypersensitivity) to clopidogrel or any other anti-platelet agent please tell your doctor before starting treatment with Efient. If you then take Efient and experience allergic reactions that may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath you need to tell your doctor immediately.
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’).
Efient should not be used in children and adolescents below 18 years of age.
Tell your doctor if you are taking, have recently taken or might take 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),
“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.
Tell your doctor if you are taking morphine or other opioids (used to treat severe pain). Only take other medicines while you are on Efient if your doctor tells you that you can.
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 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.
Efient is unlikely to affect your ability to drive or use machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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.
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 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 a double dose to make
up for a forgotten dose. 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.
Do not stop taking Efient without consulting your doctor; if you stop taking Efient too soon, your risk of a heart attack may be higher.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 of the arm, leg or face, especially if only on one side of the
body.
Sudden confusion, difficulty speaking or understanding others.
Sudden difficulty in walking or loss of balance or co-ordination.
Sudden dizziness or sudden severe headache with no known cause.
All of the above may be signs of a stroke. Stroke is an uncommon side effect of Efient in patients who have never had a stroke or transient ischaemic attack (TIA).
Also contact your doctor immediately if you notice any of the following:
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 2 ‘What you need to know before you take Efient’).
A rash, itching, or a swollen face, swollen lips/tongue, or shortness of breath. These may be signs of a severe allergic reaction (see section 2 ‘What you need to know before you take Efient’).
Tell your doctor promptly if you notice any of the following:
Blood in your urine.
Bleeding from your rectum, blood in your stools or black stools.
Uncontrollable bleeding, for example from a cut.
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 (may affect up to 1 in 10 people)
Bleeding in the stomach or bowels
Bleeding from a needle puncture site
Nose bleeds
Skin rash
Small red bruises on the skin (ecchymoses)
Blood in urine
Haematoma (bleeding under the skin at the site of an injection, or into 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, swollen lips/tongue, or shortness of breath)
Spontaneous bleeding from the eye, rectum, gums or in the abdomen around the internal organs
Bleeding after surgery
Coughing up blood
Blood in stools
Rare side effects (may affect up to 1 in 1,000 people)
Low blood platelet count
Subcutaneous haematoma (bleeding under the skin causing a swelling)
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.
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 carton after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from air and moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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), croscarmellose sodium, hypromellose (E464) magnesium stearate, lactose monohydrate, titanium dioxide (E171), triacetin (E1518), iron oxide red (10 mg tablets only) (E172), iron oxide yellow (E172) and talc.
Efient 10 mg: The tablets are beige and double-arrow-shaped, with “10 MG” debossed on one side and “4759” on the other.
Efient 5 mg: The tablets are yellow and double-arrow-shaped, with “5 MG” debossed 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.
81379 Munich Germany
Daiichi Sankyo Europe GmbH Luitpoldstrasse 1
85276 Pfaffenhofen Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Daiichi Sankyo Belgium N.V.-S.A Tél/Tel: +32-(0) 2 227 18 80
Алвоген Фарма България ЕООД тел. +359 24417136
Zentiva, k.s.
Tel: +420 267 241 111
Daiichi Sankyo Nordics ApS Tlf: +45 (0) 88 44 45 45
Daiichi Sankyo Deutschland GmbH Tel. +49 (0) 89 7808 0
Daiichi Sankyo Europe GmbH Tel: +49 (0) 89 7808 0
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Τηλ: +30 210 629 4600
Daiichi Sankyo España, S.A. Tel: +34 91 539 99 11
Daiichi Sankyo France SAS Tél: +33 (0) 1 55 62 14 60
Daiichi Sankyo Europe GmbH Tel: +49 (0) 89 7808 0
Daiichi Sankyo Ireland Ltd Tel: +353-(0) 1 489 3000
Daiichi Sankyo Nordics ApS Sími: +354 5357000
Daiichi Sankyo Italia S.p.A. Tel: +39-06 85 2551
Daiichi Sankyo Europe GmbH
Τηλ: +49 (0) 89 7808 0
Daiichi Sankyo Europe GmbH Tel: +49 (0) 89 7808 0
Daiichi Sankyo Europe GmbH Tel. +49 (0) 89 7808 0
Daiichi Sankyo Belgium N.V.-S.A Tél/Tel: +32-(0) 2 227 18 80
Aramis Pharma Kft Tel: +36 1 299 1058
Daiichi Sankyo Europe GmbH Tel: +49 (0) 89 7808 0
Daiichi Sankyo Nederland B.V. Tel: +31 (0) 20 4 07 20 72
Daiichi Sankyo Nordics ApS Tlf: +47 (0) 21 09 38 29
Daiichi Sankyo Austria GmbH Tel: +43 (0) 1 485 86 42 0
Berlin-Chemie/Menarini Polska Sp. z o.o. Tel.: +48 22 566 21 00
Daiichi Sankyo Portugal, Unip. LDA Tel: +351 21 4232010
Daiichi Sankyo Europe GmbH Tel: +49 (0) 89 7808 0
Apta Medica Internacional d.o.o. Tel: +386 41 301 360
Zentiva, a.s.
Tel: +421 2 3918 3010
Daiichi Sankyo Nordics ApS Puh/Tel: +358 (0) 9 3540 7081
Daiichi Sankyo Nordics ApS Tel: +46 (0) 40 699 2524
Daiichi Sankyo Europe GmbH Tel: +49 (0) 89 7808 0