Active ingredient
- prasugrel hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/08/503/012, EU/1/08/503/002, EU/1/08/503/015, EU/1/08/503/005, EU/1/08/503/006, EU/1/08/503/007, EU/1/08/503/010, EU/1/08/503/004, EU/1/08/503/014, EU/1/08/503/011, EU/1/08/503/016, EU/1/08/503/001, EU/1/08/503/013, EU/1/08/503/009, EU/1/08/503/008, EU/1/08/503/003.
Efient 5mg & 10mg film-coated tablets (Eli Lilly and Company Ltd Daiichi Sankyo UK Limited)
Package Leaflet: Information for the user
Efient 10 mg film-coated tablets
Efient 5 mg film-coated tablets
prasugrel
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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
1. What Efient is and what it is used for
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.
2. What you need to know before you take Efient
Do not take Efient
Warnings and precautions
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:
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:
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’.
3. How to take Efient
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.
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:
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:
Tell your doctor promptly if you notice any of the following:
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)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 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.
6. Contents of the pack and other information
What Efient contains
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
Manufacturer:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in October 2020.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
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