Efient 5 mg film-coated tablets

Efient 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.

Do not take Efient

• If you are allergic (hypersensitive) to prasugrel or any of the other ingredients of Efient. 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.

Take special care with 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 ?Taking other medicines? 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 are Asian - there is limited experience of Efient use in Asians
• 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.

While you are taking Efient:
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?).

Taking other medicines

Please tell your doctor if you are taking or have recently taken 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), or ?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

Only take other medicines while you are on Efient if your doctor tells you that you can.

Taking Efient with food and drink

Efient may be taken with or without food.

Pregnancy and breast-feeding

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 breast-feeding, ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

No studies on the effects of Efient on the ability to drive and use machines have been performed. Efient is unlikely to affect your ability to drive or use machines.

Important information about some of the ingredients of Efient

Efient contains lactose. If you have been told by a doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take Efient exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how many Efient tablets to take. 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. Efient should not be used in children and adolescents below 18 years of age.

If you take more Efient than you should

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 forget to take 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 two doses in one day. 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.

If you stop taking Efient

Do not stop taking Efient without consulting your doctor. It is especially important to discuss with your doctor before stopping Efient because both the risks and the benefits are based on regular use.

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

Like all medicines, Efient 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 ?BEFORE YOU TAKE EFIENT?)
• A rash, itching, or a swollen face, swollen lips/tongue, or shortness of breath. Thesemay be signs of an allergic reaction (see section 2 ?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 (affect 1 to 10 users in 100)

• 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 (affect 1 to 10 users in 1,000)

• 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 (affect 1 to 10 users in 10,000)

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell you doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Efient 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 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 no longer required. These measures will help to protect the environment.

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), 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.

What Efient looks like and contents of the pack

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, 56, 84, 90 and 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Eli Lilly Nederland BV
Grootslag 1 ? 5
NL-3991 RA, Houten
The Netherlands.

Manufacturer:

Lilly S.A.
Avda. de la Industria 30
28108 Alcobendas
Madrid
Spain.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

BelgiqueBelgiëBelgien Daiichi Sankyo Belgium N.V.-S.A TélTel 32 0 10 48 95 95 .. - . 359 2 491 41 40 eská republika ELI LILLY R, s.r.o. Tel 420 234 664 111 Danmark Eli Lilly Danmark AS Tlf 45 45 26 60 00 Deutschland Daiichi Sankyo Deutschland GmbH Tel. 49 0 69 50 98 53 41 Eesti Eli Lilly Holdings Limited Eesti filiaal Tel 372 6 817 280 - .... 30 210 629 4600 España Daiichi Sankyo España, S.A. Tel 34 0 91 539 99 11 LuxembourgLuxemburg Daiichi Sankyo Belgium N.V.-S.A TélTel 32 0 10 48 95 95 Magyarország Lilly Hungária Kft. Tel 36 1 328 5100 Malta Charles de Giorgio Ltd. Tel 356 25600 500 Nederland Daiichi Sankyo Nederland B.V. Tel 31 0 20 4 07 20 72 Norge Eli Lilly Norge A.S. Tlf 47 22 88 18 00 Österreich Daiichi Sankyo Austria GmbH Tel 43 0 1 481 06 45 Polska Eli Lilly Polska Sp. z o.o. Tel. 48 0 22 440 33 00 Portugal Daiichi Sankyo Portugal, Lda. Tel 351 21 4232010

România Eli Lilly România S.R.L. Tel 40 21 4023000 Slovenija Eli Lilly farmacevtska druba, d.o.o. Tel 386 01 580 00 10 Slovenská republika Eli Lilly Slovakia, s.r.o. Tel 421 220 663 111 SuomiFinland Oy Eli Lilly Finland Ab PuhTel 358-0 9 85 45 250 Sverige Eli Lilly Sweden AB Tel 46 0 8 7378800 United Kingdom Daiichi Sankyo UK Ltd Tel 44 0 1753 893 600 France Daiichi Sankyo France SAS Tél 33 0 1 55 62 14 60 Ireland Daiichi Sankyo UK Ltd Tel 44 0 1753 893 600 Ísland Icepharma hf. Sími 354 540 8000 Italia Daiichi Sankyo Italia S.p.A. Tel 39 0 06 85 2551 Phadisco Ltd 357 22 715000 Latvija Eli Lilly Holdings Limited prstvniecba Latvij Tel 371 67364000 Lietuva Eli Lilly Holdings Limited atstovyb Tel. 370 5 2649600

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