5 mg and 10 mg film-coated tablets
prasugrel
What Prasugrel Krka is and what it is used for
Prasugrel Krka, which contains the active substance prasugrel, belongs to a group of medicines called platelet inhibitors. Platelets are very small cells in the blood. When a blood vessel is damaged, for example in cuts, the platelets clump together to form a blood clot ( clot ). Therefore, platelets are necessary to stop bleeding. If blood clots form in an atherosclerotic blood vessel, such as an artery, they can become very dangerous because they can shut off the blood supply and cause a heart attack (heart attack), stroke, or death. Blood clots in the arteries (blood vessels) that supply the heart with blood can also reduce blood supply and cause unstable angina(angina).
Prasugrel Krka prevents platelets from clumping together, reducing the risk of blood clots forming.
You have been given Prasugrel Krka because you have already had a heart attack or have unstable angina and have been treated with a method that opens clogged arteries in your heart. You may also have one or more stents inserted to keep open a blocked or narrowed artery that supplies blood to the heart. Prasugrel Krka reduces the risk of having a new heart attack or stroke or dying from a blood clot in the blood vessels. Your doctor has also prescribed you take acetylsalicylic acid, which is another antiplatelet agent.
Prasugrel contained in Prasugrel Krka may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Prasugrel Krka
Do not use Prasugrel Krka
- if you are allergic to prasugrel or any of the other ingredients of this medicine (listed in section 6). An allergic reaction manifests itself as a rash on the skin, itching, swelling of the face or lips, or shortness of breath. If this has happened to you, contact your doctor immediately.
- if you have any disease that causes bleeding such as bleeding from the stomach or intestines.
- if you have ever had a stroke or transient ischemic attack ( TIA ).
- if you have severe liver disease.
Warnings and cautions
Before taking Prasugrel Krka
Talk to your doctor or pharmacist before taking Prasugrel Krka.
Tell your doctor before taking Prasugrel Krka if any of the following apply to you:
- If you have an increased risk of bleeding, for example:
- is 75 years or older. Your doctor should prescribe a daily dose of 5 mg as the risk of bleeding is greater in patients over 75 years of age.
- a recent, serious injury.
- recently undergone surgery (including some dental procedures).
- recent or recurrent bleeding from the stomach or intestines (eg gastric ulcer, polyps in the colon).
- body weight below 60 kg. Your doctor should prescribe a daily dose of 5 mg if you weigh less than 60 kg.
- kidney disease or liver problems that are not considered serious.
- taking certain types of medicines (see “Taking other medicines” below).
- planned surgery (including certain dental procedures) within the next seven days. Your doctor may want you to stop taking Prasugrel Krka temporarily due to the risk of bleeding.
- If you have had allergic reactions (hypersensitivity) to clopidogrel or any other antiplatelet agent, you should tell your doctor before starting treatment with Prasugrel Krka. If you take Prasugrel Krka and experience allergic reactions such as rash, itching, swollen face, swollen lips, or difficulty breathing, you should inform your doctor immediately.
When you take Prasugrel Krka
You should inform your doctor immediately if you get a disease called thrombotic thrombocytopenic purpura (or TTP) which causes fever and bleeding under the skin that manifests as red pin-sized dots, with or without unexplained extreme fatigue, confusion, yellowing of the skin, or eyes ( jaundice) (see section 4 “Possible side effects”).
Children and young people
Prasugrel Krka should not be used by children or adolescents under 18 years of age.
Other medicines and Prasugrel Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, dietary supplements, and herbal medicines. It is especially important to tell your doctor if you are being treated with clopidogrel (an antiplatelet agent), warfarin ( an anticoagulant ), or non-steroidal anti-inflammatory drugs for pain fever (such as ibuprofen, naproxen, etoricoxib). Taking these medicines together with prasugrel may increase the risk of bleeding.
Tell your doctor if you are taking morphine or other opioids (to treat severe pain).
Only take such medicines together with prasugrel, which your doctor has told you to use.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, 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 use Prasugrel Krka only after discussing with your doctor the possible benefits for you and any risks to the fetus.
Driving and using machines
Prasugrel Krka is unlikely to affect your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Prasugrel Krka 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 medicine.
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Prasugrel Krka
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 10 mg once daily. You will start treatment with a single dose of 60 mg. If you weigh less than 60 kg or are older than 75 years, the dose is one 5 mg Prasugrel Krka per day.
Your doctor will also tell you to take acetylsalicylic acid and how much to take (usually between 75 mg and 325 mg daily).
You can take Prasugrel Krka regardless of the meal. Take dose one at about the same time each day. Do not break or crush the tablets.
It is important to tell your doctor, dentist, and pharmacist that you are taking Prasugrel Krka.
If you use more Prasugrel Krka than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.
Contact your doctor or hospital immediately, as there is a risk of severe bleeding. Show your doctor your pack of Prasugrel Krka.
If you forget to use Prasugrel Krka
Do not take a double dose to make up for a forgotten dose.
If you forget to take your daily dose, take Prasugrel Krka when you can. If you have not remembered to take Prasugrel Krka for the whole day, then just take the usual dose the next day. Do not take two doses in one day.
If you stop using Prasugrel Krka
Do not stop taking Prasugrel Krka without consulting your doctor, if you stop taking Prasugrel Krka too soon, the risk of having a heart attack may be greater.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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 in the 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 keeping balance or coordination difficulties.
- Sudden dizziness or sudden severe headache for no known reason.
All of the above reactions may be signs of a stroke. Stroke is a less common side effect of Prasugrel Krka in patients who have never had a stroke or transient ischemic attack ( TIA ).
Also, contact your doctor immediately if you notice any of the following:
- Fever and bleeding under the skin that appears as red pin-sized dots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 2 “What you need to know before taking Prasugrel Krka”).
- Rash, itching or swollen face, swollen lips/tongue, or difficulty breathing. This may be a sign of a severe allergic reaction (see section 2 “What you need to know before you take Prasugrel Krka”).
Tell your doctor as soon as possible if you notice any of the following:
- Blood in the urine.
- Bleeding from the rectum, blood in the stool, or black stools.
- Bleeding can not be stopped, for example from a cut.
All of the above reactions may be signs of bleeding which is the most common side effect of Prasugrel Krka. Severe bleeding can be life-threatening but is less common.
Common side effects (may affect up to 1 in 10 people)
- Bleeding from the stomach or intestines
- Bleeding from the insertion site of the needle
- Nosebleed
- Rash
- Small red bruises on the skin ( ecchymosis )
- Blood in the urine
- Bleeding under the skin at an injection site, or in a muscle that causes swelling (hematoma)
- Low hemoglobin or red blood cell count ( anemia )
- Bruises
Uncommon side effects (may affect up to 1 in 100 people)
- Allergic reactions (rash, itching, swollen lips/tongue or difficulty breathing)
- Spontaneous bleeding from the eye, rectum, gums, or abdomen around the internal organs
- Bleeding after surgery
- Bloody cough
- Blood in stool
Rare side effects (may affect up to 1 in 1,000 people)
- Low red blood cell count
- Bleeding under the skin that causes swelling ( subcutaneous hematoma)
How to store 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 expiration date is the last day of the specified month.
Do not store above 30 ° C.
Store in the original package. Moisture sensitive.
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 to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is prasugrel. Each film-coated tablet contains 5 mg and 10 mg prasugrel, respectively.
- The other ingredients are microcrystalline cellulose, macrogol 4000, poloxamer 188, fumaric acid (for pH adjustment), croscarmellose sodium, hydrophobic colloidal silica, mannitol, and magnesium stearate in the tablet core, and hypromellose, lactose monohydrate, titanium dioxide (E171) (e171) in 5 mg film-coated tablets) and red iron oxide (E172) (only in 10 mg film-coated tablets) in the tablet coating. See section 2 “Prasugrel Krka contains lactose and sodium”.
What the medicine looks like and the contents of the pack
5 mg film-coated tablets (tablets) are pale brown-yellow, oval, biconvex, film-coated tablets measuring 8.5 mm x 4.5 mm.
10 mg film-coated tablets (tablets) are pink, oval, slightly biconvex, film-coated tablets measuring 10.5 mm x 5.5 mm.
Prasugrel Krka 5 mg film-coated tablets:
Prasugrel Krka is available in cartons of 28, 30, and 84 film-coated tablets in blisters.
Prasugrel Krka 10 mg film-coated tablets:
Prasugrel Krka is available in cartons of 28, 30, 84, and 90 film-coated tablets in blisters.
Not all packaging may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia