Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - efient

Document Subject

Generated Narrative: MedicinalProductDefinition mp2776bfb7e1f074708f890100ca32d64b

identifier: http://ema.europa.eu/identifier/EU/1/08/503/001 – 007, 015

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Efient 10 mg film-coated tablets.

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-2776bfb7e1f074708f890100ca32d64b

identifier: http://ema.europa.eu/identifier/EU/1/08/503/001 – 007, 015

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - efient

Attesters

What is in this leaflet

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 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.

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 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.

Warnings and precautions

• Before you are taking Efient:

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.

• 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 ).

Children and adolescents Efient should not be used in children and adolescents below 18 years of age.

Other medicines and Efient 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.

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 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 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.

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 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.

If you stop taking Efient 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)

Reporting of side effects 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.

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, 30 (x1), 56, 84, 90 (x1) and 98 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder SUBSTIPHARM 24 rue Erlanger 75016 Paris France

Manufacturer: 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:

Belgi /Belgique/ Belgien SUBSTIPHARM T l/Tel: 080077Lietuva SUBSTIPHARM Tel: +33 1 43 18 13
Zentiva, k.s .: +359 24417Luxembourg/Luxemburg SUBSTIPHARM T l/Tel: 80024 esk republika Zentiva, k.s. Tel: +420 267 241 Magyarorsz g Zentiva Pharma Kft. Tel: +36 1 299 1Danmark Kurantis ApS Tlf: +45 33 60 89 Malta SUBSTIPHARM Tel: +33 1 43 18 13 Deutschland SUBSTIPHARM Tel: 08001801Nederland SUBSTIPHARM Tel: 08000228Eesti SUBSTIPHARM Tel: +33 1 43 18 13 Norge Kurantis ApS Tlf: +45 33 60 89

: +30 210 620 8 sterreich SUBSTIPHARM Tel: 0800298Espa a SUBSTIPHARM Tel: 900993Polska Berlin-Chemie/Menarini Polska Sp. z o.o. Tel: +48 22 566 21 France SUBSTIPHARM T l: +33 1 43 18 13 Portugal SUBSTIPHARM Tel: 800833Hrvatska SUBSTIPHARM Tel: +33 1 43 18 13 Rom nia SUBSTIPHARM Tel: +33 1 43 18 13 Ireland SUBSTIPHARM Tel: 1800300Slovenija Zentiva, k.s. Tel: +386 360 00 sland Kurantis ApS Simi: +45 33 60 89 Slovensk republika Zentiva, a.s. Tel: +421 2 3918 3Italia SUBSTIPHARM Tel: 800780Suomi/Finland Kurantis ApS Puh./Tel: +45 33 60 89
SUBSTIPHARM : +33 1 43 18 13 Sverige Kurantis ApS Tel: +45 33 60 89 Latvija SUBSTIPHARM Tel.: +33 1 43 18 13 United Kingdom (Northern Ireland) SUBSTIPHARM Tel: 1800300This leaflet was last revised in {MM/YYYY}.

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: