Patient Leaflet Updated 30-Jan-2023 | Krka UK Ltd
Prasugrel
Prasugrel 5 mg film-coated tablets
Prasugrel 10 mg film-coated tablets
prasugrel
1. What Prasugrel is and what it is used for
2. What you need to know before you take Prasugrel
3. How to take Prasugrel
4. Possible side effects
5. How to store Prasugrel
6. Contents of the pack and other information
This medicine contains the active substance prasugrel, belongs to a group of medicines called antiplatelet 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).
Prasugrel inhibits the clumping of platelets and so reduces the chance of a blood clot forming.
You have been prescribed Prasugrel 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. Prasugrel 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 antiplatelet agent.
Before you are taking Prasugrel
Talk to your doctor or pharmacist before taking Prasugrel.
You should tell your doctor before taking Prasugrel 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’).
Prasugrel 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), or “non steroidal anti inflammatory drugs” for pain and fever (such as ibuprofen, naproxen, etoricoxib). If given together with prasugrel 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 prasugrel if your doctor tells you that you can.
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.
Tell your doctor if you become pregnant or are trying to become pregnant while you are taking Prasugrel. You should use Prasugrel only after discussing with your doctor the potential benefits and any potential risks to your unborn child.
Prasugrel 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.
Prasugrel contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose 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 Prasugrel 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 Prasugrel 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 Prasugrel.
Contact your doctor or hospital straight away, as you may be at risk of excessive bleeding. You should show the doctor your pack of Prasugrel.
Do not take a double dose to make up for a forgotten dose.
If you miss your scheduled daily dose, take Prasugrel when you remember. If you forget your dose for an entire day, just resume taking Prasugrel at its usual dose the next day. Do not take two doses in one day.
Do not stop taking Prasugrel without consulting your doctor; if you stop taking Prasugrel 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:
All of the above may be signs of a stroke. Stroke is an uncommon side effect of Prasugrel 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 Prasugrel. 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)
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 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.
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 packaging after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package in order to protect from 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.
5 mg film-coated tablets are pale brownish yellow, oval, biconvex, film-coated tablets, dimensions 8.5 mm x 4.5 mm.
10 mg film-coated tablets are pink, oval, slightly biconvex, film-coated tablets, dimensions 10.5 mm x 5.5 mm.
Prasugrel 5 mg film-coated tablets:
Prasugrel is available in boxes containing 28, 30 and 84 film-coated tablets in blisters.
Prasugrel 10 mg film-coated tablets:
Prasugrel is available in boxes containing 28, 30, 84 and 90 film-coated tablets in blisters.
Not all pack sizes may be marketed.
This leaflet was last revised in 01/2019
P0947
KRKA UK Ltd, Thames House, Waterside Drive, Langley, Slough, SL3 6EZ, UK
+44 (0)7572 410 233
+44 (0)7894 980 624
www.krka.co.uk
+44 (0)207 164 6156
