Prasugrel Qualigen 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Prasugrel Qualigen 10 mg film-coated tablets EFG

Prasugrel Qualigen 5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Prasugrel Qualigen is and what it is used for

2. What you need to know before taking Prasugrel Qualigen

3. How to take Prasugrel Qualigen

4. Possible side effects

5. How to store Prasugrel Qualigen

6. Contents of the pack and other information

1. What Prasugrel Qualigen is and what it is used for

Prasugrel Qualigen 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 by a cut, platelets clump together to help form a blood clot (thrombus). Thus, platelets are essential for helping to stop bleeding. However, the formation of clots in hardened blood vessels, such as arteries, can be very dangerous, as they block the flow of blood, leading to a heart attack (myocardial infarction), stroke (cerebrovascular accident), or death. Clots in arteries supplying blood to the heart can also reduce blood flow, causing unstable angina (severe chest pain).

Prasugrel Qualigen inhibits platelet aggregation, thereby reducing the likelihood of blood clot formation.

You have been prescribed Prasugrel Qualigen because you have had a myocardial infarction or unstable angina and have been treated with a procedure to open 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 Qualigen reduces the risk of future myocardial infarctions or strokes (cerebrovascular accidents), or of dying from such atherothrombotic events. Your doctor will also prescribe acetylsalicylic acid (e.g., aspirin), another antiplatelet agent.

2. What you need to know before taking Prasugrel Qualigen

Do not take Prasugrel Qualigen:

• If you are allergic (hypersensitive) to prasugrel or to any of the other ingredients of Prasugrel Qualigen. An allergic reaction may include skin rash, itching, facial swelling, lip swelling, or difficulty breathing. If this has happened to you, consult your doctor immediately.
• If you have a condition causing bleeding, such as stomach or intestinal bleeding.
• If you have ever had a stroke or transient ischemic attack.
• If you have severe liver disease.

Warnings and precautions

• Before taking Prasugrel Qualigen:

Talk to your doctor or pharmacist before starting Prasugrel Qualigen if any of the following apply to you:

• If you are at high risk of bleeding because:

  • you are 75 years of age or older. Your doctor should prescribe a daily dose of 5 mg, as patients over 75 years have an increased risk of bleeding
  • you have recently suffered a serious injury
  • you have recently undergone surgery (including certain dental procedures)
  • you have recently or repeatedly experienced stomach or intestinal bleeding (e.g., a stomach ulcer or colon polyps)
  • you weigh less than 60 kg. In this case, your doctor should prescribe a daily dose of 5 mg of prasugrel
  • you have kidney disease or moderate liver problems
  • you are taking other types of medicines (see "Use with other medicines")
  • you are scheduled to undergo surgery (including certain dental procedures) within the next seven days. Your doctor may instruct you to temporarily stop treatment with prasugrel due to an increased risk of bleeding.

• If you have had allergic reactions (hypersensitivity) to clopidogrel or any other antiplatelet agent, please inform your doctor before starting treatment with prasugrel. If, after taking Prasugrel Qualigen, you experience an allergic reaction such as rash, itching, facial swelling, lip swelling, or difficulty breathing, contact your doctor immediately.

• While taking Prasugrel Qualigen:

You should contact your doctor immediately if you develop a condition called Thrombotic Thrombocytopenic Purpura (or TTP). TTP is associated with fever and bruising (hematomas) under the skin appearing as localized red spots, with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").

Children and adolescents

Prasugrel Qualigen must not be used in children or adolescents under 18 years of age.

Use of Prasugrel Qualigen with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, dietary supplements, and herbal products. It is especially important to inform your doctor if you are being treated with clopidogrel (an antiplatelet agent), warfarin (an anticoagulant), or "non-steroidal anti-inflammatory drugs" for pain and fever (such as ibuprofen, naproxen, etoricoxib). When administered together with prasugrel, these medicines may increase the risk of bleeding.

Inform your doctor if you are taking morphine or other opioids (used to treat acute pain).

Only take other medicines while taking Prasugrel Qualigen if your doctor has instructed you to do so.

Pregnancy and breastfeeding

If you are pregnant or planning to become pregnant, consult your doctor before using this medicine. You should take prasugrel only after discussing with your doctor the potential benefits and any potential risks to the fetus.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

It is unlikely that Prasugrel Qualigen will affect your ability to drive or use machines.

Prasugrel Qualigen contains lactose and sucrose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per dose; hence, it is essentially "sodium-free".

3. How to take Prasugrel Qualigen

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg daily. Your treatment will begin with a single 60 mg dose.

If your body weight is less than 60 kg or you are over 75 years of age, the dose is 5 mg of prasugrel daily. Your doctor will also instruct you to take acetylsalicylic acid and the exact dose you should take (usually between 75 mg and 325 mg daily).

You may take Prasugrel Qualigen with or without food. Take your dose every day at approximately the same time. Do not break or divide the tablet.

It is important that you inform your doctor, dentist, and pharmacist that you are taking Prasugrel Qualigen.

If you take more Prasugrel Qualigen than you should

Contact your doctor or hospital immediately, as you may be at risk of excessive bleeding. You should show your doctor the Prasugrel Qualigen packaging.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Prasugrel Qualigen

If you forget to take your scheduled daily dose, take Prasugrel Qualigen as soon as you remember. If you forget to take your dose for a whole day, resume your usual dose of Prasugrel Qualigen the next day. Do not take a double dose to make up for missed doses.

If you stop taking Prasugrel Qualigen

Do not stop your treatment without consulting your doctor. If you stop treatment with Prasugrel Qualigen too early, your risk of having a myocardial infarction may increase.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you experience any of the following signs:

• • Sudden numbness or weakness in the arm, leg, or face, especially if it affects only one side of the body.
• Sudden confusion, difficulty speaking or understanding others.
• Sudden difficulty walking or loss of balance or coordination.
• Sudden severe dizziness or headache without a known cause.

These may all be signs of a stroke. Stroke is an uncommon adverse effect of prasugrel in patients who have never previously had a stroke or transient ischemic attack.

You should also contact your doctor immediately if you notice any of the following signs:

• Fever and bruising (hematomas) under the skin appearing as localized red spots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 2 “What you need to know before you start taking Prasugrel Qualigen”).
• Rash, itching, or swelling of the face, swelling of lips/tongue, or difficulty breathing. These may be signs of a serious allergic reaction (see section 2 “What you need to know before you start taking Prasugrel Qualigen”).

Inform your doctor promptly if 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.

These may all be signs of bleeding, the most common adverse effect with prasugrel. Although uncommon, serious bleeding can be fatal.

Common adverse effects (may affect up to 1 in 10 people)

• Bleeding in the stomach or intestine
• Bleeding at the site of needle injection
• Nosebleeds
• Skin rash
• Small red bruises on the skin (ecchymosis)
• Blood in urine
• Bruising (bleeding under the skin at the injection site, or in a muscle, causing swelling)
• Low hemoglobin or red blood cell count (anemia)
• Bruises

Uncommon adverse effects (may affect up to 1 in 100 people)

• Allergic reaction (rash, itching, swelling of lips/tongue, or difficulty breathing)
• Spontaneous bleeding from the eye, rectum, gums, or in the abdomen around internal organs
• Bleeding after surgery
• Bleeding when coughing
• Blood in stools

Rare adverse effects (may affect up to 1 in 1,000 people)

• Low platelet count in blood
• Subcutaneous hematoma (bleeding under the skin, causing swelling)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Conservation of Prasugrel Qualigen

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 on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Prasugrel Qualigen

• The active substance is prasugrel.
• Prasugrel Qualigen 5 mg: each film-coated tablet contains 5 mg of prasugrel.
• Prasugrel Qualigen 10 mg: each film-coated tablet contains 10 mg of prasugrel.
• The other components are: crospovidone, monohydrate lactose, sodium croscarmellose (E468), microcrystalline cellulose (E460), sucrose stearate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518), red iron oxide (E172) (10 mg strength only), yellow iron oxide (E172), and talc (E553b).

Nature of the product and pack sizes

Prasugrel Qualigen 5 mg are yellow, oblong, biconvex, film-coated tablets, marked with “F1” on one side.

Prasugrel Qualigen 10 mg are orange, oblong, biconvex, film-coated tablets, marked with “F2” on one side.

Prasugrel Qualigen is available in aluminium/aluminium blister packs containing 28 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí – Barcelona

Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí – Barcelona

Spain

Date of the most recent review of this product information: August 2021

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)