PRASUGREL KRKA 10 mg FILM-COATED TABLETS
How to use PRASUGREL KRKA 10 mg FILM-COATED TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Prasugrel Krka 10 mg film-coated tablets EFG
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.
Contents of the pack
- What is Prasugrel Krka and what is it used for
- What you need to know before you take Prasugrel Krka
- How to take Prasugrel Krka
- Possible side effects
- Storage of Prasugrel Krka
- Contents of the pack and other information
1. What is Prasugrel Krka and what is it used for
Prasugrel Krka contains the active substance prasugrel, which belongs to a group of medicines called antiplatelet agents. Platelets are very small cells that circulate in the blood. When a blood vessel is damaged, for example if you cut yourself, platelets clump together to help form a blood clot.
Therefore, platelets are essential to help stop bleeding. The formation of blood clots in hardened blood vessels, such as arteries, can be very dangerous because they prevent blood from flowing, causing a heart attack (myocardial infarction), stroke, or death. Blood clots in arteries that supply blood to the heart can also reduce blood supply, causing unstable angina (severe chest pain).
Prasugrel Krka inhibits platelet clumping, which reduces the chance of forming blood clots.
You have been prescribed Prasugrel Krka because you have had a heart attack or unstable angina and have been treated with a procedure to open up blocked heart arteries. You may have had one or more stents placed in the blocked or narrowed artery to restore blood flow to the heart. Prasugrel Krka reduces the chance of having another heart attack or stroke, or of dying from one of these events. Your doctor will also prescribe acetylsalicylic acid (e.g. acetylsalicylic acid), another antiplatelet agent.
2. What you need to know before you take Prasugrel Krka
Do not take Prasugrel Krka
- 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, swelling of the face, swelling of the lips or difficulty breathing. If this has happened to you, contact your doctor immediately.
- if you have a condition that is causing bleeding, such as a stomach or intestinal bleeding.
- if you have ever had a stroke or a mini-stroke (TIA).
- if you have severe liver disease.
Warnings and precautions
Before taking Prasugrel Krka
Consult your doctor or pharmacist before starting treatment with Prasugrel Krka.
Consult your doctor or pharmacist before starting treatment with Prasugrel Krka if you are in any of the following situations:
- If you are at high risk of bleeding because:
- you are 75 years old or older. Your doctor should prescribe a daily dose of 5 mg as patients over 75 years old have a higher risk of bleeding.
- you have recently had a serious injury.
- you have recently had surgery (including some dental procedures).
- you have recently had or frequently have stomach or intestinal bleeding (e.g. stomach ulcer or colon polyps).
- you weigh less than 60 kg. If you weigh less than 60 kg, your doctor should prescribe a daily dose of 5 mg of prasugrel.
- you have kidney disease or moderate liver problems.
- you are taking other medicines (see "Other medicines").
- if you are scheduled to have surgery (including some dental procedures) in the next 7 days. Your doctor may instruct you to temporarily stop treatment with prasugrel due to an increased risk of bleeding.
- If you have had an allergic reaction (hypersensitivity) to clopidogrel or any other antiplatelet agent, please inform your doctor before starting treatment with Prasugrel Krka. If you experience an allergic reaction after taking Prasugrel Krka, which you can recognize by a rash, itching, swelling of the face, swelling of the lips or difficulty breathing, contact your doctor immediately.
While taking Prasugrel Krka:
You should contact your doctor immediately if you develop a condition called Thrombotic Thrombocytopenic Purpura (or TTP) which is associated with fever and bruising under the skin that can appear as red pinpoint dots, with or without extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").
Children and adolescents
Prasugrel Krka should not be used in children and adolescents under 18 years of age.
Other medicines and Prasugrel Krka
Tell your doctor if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription, dietary supplements, and herbal products. It is especially important that you inform your doctor if you are being treated with clopidogrel (an antiplatelet agent), warfarin (an anticoagulant), or "non-steroidal anti-inflammatory medicines" for pain and fever (such as ibuprofen, naproxen, etoricoxib). If these medicines are given with prasugrel, they may increase the risk of bleeding.
Tell your doctor if you are taking morphine or other opioids (used to treat acute pain).
Use other medicines while taking Prasugrel Krka only if your doctor tells you to.
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 taking Prasugrel Krka.
You should take Prasugrel Krka only after talking to your doctor about the potential benefits and any potential risk to the fetus.
Driving and using machines
Prasugrel Krka is unlikely to affect your ability to drive or use machines.
Prasugrel Krka contains lactose and sodium
If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially "sodium-free".
3. How to take Prasugrel Krka
Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
The recommended dose of prasugrel is 10 mg once daily. Your treatment will start with a one-time dose of 60 mg.
If your weight is less than 60 kg or you are over 75 years old, the dose is 5 mg of Prasugrel Krka once daily.
Your doctor will also tell you to take acetylsalicylic acid and the exact dose you should take (usually between 75 mg and 325 mg once daily).
You can take prasugrel with or without food. Take your dose every day at about the same time. Swallow the tablet whole, do not break or crush the tablet.
It is important that you tell your doctor, dentist, and pharmacist that you are taking Prasugrel Krka.
If you take more Prasugrel Krka than you should
Contact your doctor or hospital immediately as you may be at risk of excessive bleeding. You should show your doctor the pack of Prasugrel Krka.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.
If you forget to take Prasugrel Krka
If you forget to take your daily dose, take prasugrel when you remember.
If you forget to take your dose for a whole day, take your normal dose of prasugrel the next day. Do not take a double dose to make up for forgotten doses.
If you stop taking Prasugrel Krka
Do not stop your treatment without consulting your doctor, if you stop treatment with prasugrel too soon, the risk of having a heart attack may increase.
If you have any further questions on the use of this product, 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 immediatelyif you experience any of the following signs:
- Numbness or weakness sudden onset of arm, leg, or face, especially if only one side of the body is affected.
- Sudden confusion, difficulty speaking or understanding others.
- Sudden difficulty walking or loss of balance or coordination.
- Sudden severe headache or dizziness without known cause.
All of these can be signs of a stroke. A stroke is a rare side effect of prasugrel in patients who have never had a stroke or a mini-stroke (TIA).
You should also contact your doctor immediatelyif you notice any of the following signs:
- Fever and bruising under the skin that appear as red pinpoint dots, with or without extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 2 "What you need to know before you take Prasugrel Krka").
- A rash, itching, swelling of the face, swelling of the lips or difficulty breathing. These can be signs of a severe allergic reaction (see section 2 "What you need to know before you take Prasugrel Krka").
Tell your doctor promptlyif you experience any of the following signs:
- Blood in urine.
- Rectal bleeding, blood in stools, or black stools.
- Uncontrolled bleeding, for example after a cut.
All of these can be signs of bleeding, the most common side effect with prasugrel. Although rare, severe bleeding can be life-threatening.
Common side effects (may affect up to 1 in 10 people)
- Bleeding in the stomach or intestines
- Bleeding at the injection site
- Nosebleeds
- Rash
- Small red bruises on the skin (ecchymosis)
- Blood in urine
- Hematoma (bleeding under the skin at the injection site, or in a muscle, causing swelling)
- Low hemoglobin or red blood cell count (anemia)
- Bruising
Uncommon side effects (may affect up to 1 in 100 people)
- Allergic reaction (rash, itching, swelling of the lips/tongue, or difficulty breathing)
- Spontaneous bleeding in the eye, rectum, gums, or in the abdomen around internal organs
- Bleeding after surgery
- Bleeding when coughing
- Blood in stools
Rare side effects (may affect up to 1 in 1,000 people)
- Low platelet count in the blood
- Subcutaneous hematoma (bleeding under the skin, causing swelling)
Reporting of side effects
If you experience 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 Spanish Medicines and Health Products Agency website: http://www.aemps.gob.es/. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Prasugrel Krka
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 carton after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and other information
Composition of Prasugrel Krka
The active substance is prasugrel. Each film-coated tablet contains 10 mg of prasugrel.
The other ingredients are:
- Core: Microcrystalline cellulose, macrogol 4000, poloxamer 188, fumaric acid to adjust pH, sodium croscarmellose, hydrophobic colloidal silica, mannitol, magnesium stearate.
Coating: Hypromellose, lactose monohydrate, titanium dioxide (E171), triacetin, and red iron oxide (E172)
Appearance of the product and pack contents
The tablets are pink, oval, slightly biconvex, film-coated, with a length of approximately 10.5 mm and a width of approximately 5.5 mm.
They are available in packs of 28, 30, 84, and 90 tablets in blisters.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder
KRKA d.d. Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA d.d. Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia
You can obtain further information on this medicine from the representative of the marketing authorisation holder:
KRKA Farmacéutica, S.L.,
C/ Anabel Segura 10, 28108 Alcobendas, Madrid, Spain
This medicine is authorised in the Member States of the European Economic Area under the following names:
Member State | Marketing authorisation holder |
Hungary | Prasugrel Krka 10 mg film-coated tablets |
Austria | Prasugrel HCS 10 mg film-coated tablets |
Belgium | Prasugrel Krka 10 mg film-coated tablets |
Denmark | Prasugrel Krka 10 mg film-coated tablets |
Spain | Prasugrel Krka 10 mg film-coated tablets EFG |
France | Prasugrel Krka 10 mg, film-coated tablets |
Ireland | Prasugrel Krka 10 mg film-coated tablets |
Iceland | Prasugrel Krka 10 mg film-coated tablets |
Italy | Prasugrel Krka |
Norway | Prasugrel Krka |
Sweden | Prasugrel Krka 10 mg film-coated tablets |
United Kingdom | Prasugrel Krka 10 mg film-coated tablets |
Date of last revision of this leaflet:December 2022
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
- Country of registration
- Average pharmacy price33.41 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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