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Prasugrel Krka 10 mg film-coated tablets

Active Ingredient:
prasugrel
Company:  
Krka UK Ltd See contact details
ATC code: 
B01AC22
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 01 Feb 2023
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 01656/0278.

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Prasugrel Krka 10 mg film-coated tablets

Package leaflet: Information for the patient

Prasugrel 5 mg film-coated tablets

Prasugrel 10 mg film-coated tablets

prasugrel

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. WHAT PRASUGREL IS AND WHAT IT IS USED FOR

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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRASUGREL
Do not take Prasugrel:
  • 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 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:

  • 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 Prasugrel if you weigh less than 60 kg
    • renal (kidney) disease or moderate liver problems
    • taking certain types of medicines (see ‘Taking other medicines’ below)
    • planned surgery (including some dental procedures) in the next seven days. Your doctor may wish you to stop taking Prasugrel 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. If you then take Prasugrel 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

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

Other medicines and Prasugrel

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.

Pregnancy and breast-feeding

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.

Driving and using machines

Prasugrel is unlikely to affect your ability to drive or use machines.

Prasugrel 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.

Prasugrel contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.

3. HOW TO TAKE PRASUGREL

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.

If you take more Prasugrel 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.

If you forget to take 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.

If you stop taking Prasugrel

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.

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 coordination
  • 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 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’)
  • 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’).

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. 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 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

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Prasugrel contains
  • The active substance is prasugrel.
    Each film-coated tablet contains 5 mg or 10 mg prasugrel.
  • The other ingredients are microcrystalline cellulose, macrogol 4000, poloxamer 188, fumaric acid
    • for pH-adjustment, croscarmellose sodium; hydrophobic colloidal silica; mannitol, magnesium stearate in the tablet core and hypromellose, lactose monohydrate, titanium dioxide (E171), triacetin, yellow iron oxide (E172)
    • only for 5 mg film-coated tablets, red iron oxide (E172)
    • only for 10 mg film-coated tablets, in film coating. See section 2 “Prasugrel contains lactose and sodium”.

What Prasugrel looks like and contents of the pack

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.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d.
Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Distributed by:
Consilient Health (UK) Limited.
No.1 Church Road
Richmond upon Thames
Surrey
TW9 2QE

This leaflet was last revised in 01/2019

P0947

Krka UK Ltd
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Address
KRKA UK Ltd, Thames House, Waterside Drive, Langley, Slough, SL3 6EZ, UK
WWW
www.krka.co.uk
Telephone
+44 (0)207 164 6156
Medical Information Direct Line
+44 (0)7572 410 233
Medical Information e-mail
[email protected]
Customer Care direct line
+44 (0)7894 980 624
Stock Availability
[email protected]