Patient leaflet - Prasugrel Accord 10 mg film-coated tablets
1 What Prasugrel Tablets are and what they are used for
Prasugrel Tablets contain the active substance prasugrel and belong 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 Tablets inhibit the clumping of platelets and so reduces the chance of a blood clot forming.
You have been prescribed Prasugrel Tablets 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 Tablets reduce 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 Prasugrel Tablets
Do not take Prasugrel Tablets:
- 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 take Prasugrel Tablets
Talk to your doctor before taking Prasugrel Tablets.
You should tell your doctor before taking Prasugrel Tablets if any of the situations mentioned below apply to you:
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If you have an increased risk of bleeding such as:
- age of 75 years or older. Your doctor should prescribe a daily dose of 5mg 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 60kg. Your doctor should prescribe a daily dose of 5mg of Prasugrel Tablets if you weigh less than 60kg
- renal (kidney) disease or moderate liver problems
- taking certain types of medicines (see ‘Other medicines and Prasugrel Tablets’ below)
- planned surgery (including some dental procedures) in the next seven days. Your doctor may wish you to stop taking Prasugrel Tablets 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 Prasugrel Tablets. If you then take Prasugrel Tablets 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 Prasugrel Tablets:
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
Prasugrel Tablets should not be used in children and adolescents below 18 years of age.
Other medicines and Prasugrel Tablets
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 Prasugrel Tablets 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 Tablets 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 Prasugrel Tablets. You should use Prasugrel Tablets 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
Prasugrel Tablets are unlikely to affect your ability to drive or use machines.
Prasugrel Tablets contain lactose and sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Information on sodium content
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3 How to take Prasugrel Tablets
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 Tablets is 10mg per day. You will start the treatment with a single dose of 60mg. If you weigh less than 60kg or are more than 75 years of age, the dose is 5mg Prasugrel Tablets per day. Continued top of next column Continued over page
Your doctor will also tell you to take acetylsalicylic acid- they will tell you the exact dose to take (usually between 75mg and 325mg daily).
You may take Prasugrel Tablets 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 Tablets.
If you take more Prasugrel Tablets 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 Prasugrel Tablets.
If you forget to take Prasugrel Tablets
If you miss your scheduled daily dose, take Prasugrel Tablets when you remember. If you forget your dose for an entire day, just resume taking Prasugrel Tablets at its usual dose the next day. Do not take a double dose to make up for a forgotten dose.
If you stop taking Prasugrel Tablets
Do not stop taking Prasugrel Tablets without consulting your doctor; if you stop taking Prasugrel Tablets 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:
- 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 Prasugrel Tablets 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 Prasugrel Tablets’)
- 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 Prasugrel Tablets’).
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 Prasugrel Tablets. 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). BBBB9193
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Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Prasugrel Tablets
Keep this medicine out of the sight and reach of children.
Do not take 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.
This medicinal product does not require any special temperature storage conditions. Store in the original package.
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 Prasugrel Tablets contain
The active substance is prasugrel. Prasugrel 5mg film-coated tablets: Each tablet contains 5mg of prasugrel. Prasugrel 10mg film-coated tablets: Each tablet contains 10mg of prasugrel.
The other ingredients are crospovidone, lactose monohydrate, croscarmellose sodium, cellulose microcrystalline, sucrose fatty acid ester, hypromellose (E464), titanium dioxide (E171), triacetin (E1518), talc, iron oxide yellow (E172) and Iron oxide red (E172) (10mg tablets only).
What Prasugrel Tablets look like and contents of the pack
Prasugrel 5mg film-coated tablets: The tablets are yellow, oblong, biconvex film-coated tablets with ‘F1’ debossed on one side.
Dimensions: Length 10.3 - 10.8 mm, width 5.1 - 5.6 mm.
Prasugrel 10mg film-coated tablets: The tablets are orange, oblong, biconvex film-coated tablets with ‘F2’ debossed on one side.
Dimensions: Length 13.0 - 13.5 mm, width 6.5 - 7.0 mm.
Prasugrel Tablets are available in aluminium-aluminium blister packs of 14, 28, 30, 30 (x1), 56, 84, 90 (x1) and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom
Manufacturer
Neuraxpharm Pharmaceuticals, S.L. Avda. Barcelona, 69
Sant Joan Despí - Barcelona
08970
Spain
This leaflet was last revised in February 2024.
If you would like a leaflet with larger text, please contact
01271 385257.