Patient Leaflet Updated 15-Jul-2024 | MSN Laboratories Europe Ltd
Prasugrel film-coated tablets
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
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).
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 anti- platelet agent.
Talk to your doctor 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:
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.
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.
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.
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.
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 Prasugrel 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.
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 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 Prasugrel by referring to the calendar printed on the blister.
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 the Yellow Card Scheme at 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 blister and carton after EXP. The expiry date refers to the last day of that month.
Store below 25ºC.
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.
Prasugrel 5 mg: Each tablet contains 5 mg of prasugrel (as hydrochloride).
Prasugrel 10 mg: Each tablet contains 10 mg of prasugrel (as hydrochloride).
The other ingredients are:
Tablet core: microcrystalline cellulose, mannitol (E421), croscarmellose sodium, hypromellose (E464), magnesium stearate.
Tablet-coat: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518), iron oxide red (10 mg tablets only) (E172), iron oxide yellow (E172) and talc.
Prasugrel 5 mg: yellow coloured, oval shaped, (approximately 7 mm length & 4 mm width) biconvex film coated tablets debossed with "5" on one side and "M" on other side.
Prasugrel 10 mg: beige coloured, oval shaped, (approximately 11 mm length & 5 mm width) biconvex film coated tablets debossed with "10" on one side and "M" on other side.
Prasugrel is available in blisters in packs of 14, 28, 30, 30(x1), 56, 84, 90(x1) and 98 tablets. Not all pack sizes may be marketed.
This leaflet was last revised in June 2023.
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