Prasugrel Vivanta 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Prasugrel Vivanta 5 mg film-coated tablets EFG

prasugrel

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Prasugrel Vivanta is and what it is used for
2. What you need to know before taking Prasugrel Vivanta
3. How to take Prasugrel Vivanta
4. Possible side effects
5. How to store Prasugrel Vivanta
6. Contents of the pack and other information

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

The active substance is prasugrel, which belongs to a group of medicines called antiplatelet agents. Platelets are very small blood cells. 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 because they block blood flow, leading to heart attack (myocardial infarction), stroke (cerebrovascular accident), or death. Clots in arteries supplying blood to the heart may also reduce blood flow, causing unstable angina (severe chest pain).

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

You have been prescribed prasugrel 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 reduces the risk of future heart attacks 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 starting to take Prasugrel Vivanta

Do not take Prasugrel Vivanta

• If you are allergic (hypersensitive) to prasugrel or to any of the other components of this medicine. An allergic reaction may present as a 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 gastrointestinal bleeding.
• If you have ever had a stroke or transient ischemic attack.
• If you have severe liver disease.

Warnings and precautions

• Before taking prasugrel:

Talk to your doctor before starting prasugrel.

Consult your doctor or pharmacist before starting prasugrel 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 experienced or have a history of recurrent gastrointestinal bleeding (e.g., 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 medication (see "Use of 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 Vivanta 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 prasugrel treatment. If, after taking prasugrel, you experience an allergic reaction such as rash, itching, facial swelling, lip swelling, or difficulty breathing, contact your doctor immediately.

• While taking prasugrel:

You must contact your doctor immediately if you develop a condition called Thrombotic Thrombocytopenic Purpura (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 must not be used in children or adolescents under 18 years of age.

Other medicines and Prasugrel Vivanta

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 that you inform your doctor if you are being treated with:

• clopidogrel (an antiplatelet agent),
• warfarin (an anticoagulant),
• “non-steroidal anti-inflammatory drugs” for pain and fever (such as ibuprofen, naproxen, etoricoxib).

If 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).

Use other medicines while taking prasugrel only if your doctor has instructed you to do so.

Pregnancy and breastfeeding

Inform your doctor if you become pregnant or are trying to become pregnant while taking prasugrel. 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 might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

It is unlikely that prasugrel will affect your ability to drive or operate machinery.

Prasugrel Vivanta contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Prasugrel Vivanta contains sodium

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

3. How to take/use Prasugrel Vivanta

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

The usual dose of prasugrel is 10 mg once daily. Your treatment will start 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 will specify the exact dose you should take (usually between 75 mg and 325 mg daily).

You may take prasugrel with or without food. Take your dose at approximately the same time each day. Do not break or split the tablet.

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

If you take more Prasugrel Vivanta 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 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, stating the medication and the amount ingested.

If you forget to take Prasugrel Vivanta

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

If you stop taking Prasugrel Vivanta

Do not stop your treatment without consulting your doctor. If you stop treatment with prasugrel 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 side effects

Like all medicines, this medicine can cause side 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.

All of these may be signs of a stroke. Stroke is an uncommon side effect of prasugrel in patients who have never previously had a stroke or a transient ischaemic attack.

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

• Fever and bruising (haematomas) under the skin appearing as localized red spots, with or without unexplained extreme tiredness, confusion, or yellowing of the skin or eyes (jaundice) (see section 2 “What you need to know before you take prasugrel”).
• 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 take prasugrel”).

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.

All of these may be signs of bleeding, the most common side effect with prasugrel. Although uncommon, serious bleeding can be fatal.

Common side 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 spots on the skin (purpura)
• Blood in urine
• Haematoma (bleeding under the skin at the injection site or in 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, swelling of 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 blood
• Subcutaneous haematoma (bleeding under the skin, causing swelling)

Reporting of side effects

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

5. Storage of Prasugrel Vivanta

Keep this medicine out of the sight and reach of children.

Store below 25°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Prasugrel Vivanta

• The active substance is prasugrel.

Prasugrel Vivanta 5 mg: Each tablet contains 5.490 mg of prasugrel hydrochloride equivalent to 5 mg of prasugrel.

• The other components are:

Tablet core: microcrystalline cellulose, mannitol (E421), sodium croscarmellose, hypromellose (E464), magnesium stearate.

Tablet coating: lactose monohydrate, HPMC 2910 / hypromellose, titanium dioxide (E171), triacetin (E1518), yellow iron oxide (E172), and talc.

Appearance of the product and contents of the container

Prasugrel Vivanta 5 mg: Yellow, oval-shaped, biconvex film-coated tablets with "5" engraved on one side and "M" on the other.

Prasugrel Vivanta is available in aluminum blisters in pack sizes of 14, 28, 30, 30 (x1), 56, 84, 90 (x1) and 98 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder:

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Prague 9

Czech Republic

Manufacturing Responsible Party:

Pharmadox Healthcare Limited,

KW20A Kordin Industrial Park

Paola, PLA3000

Malta

You may request further information about this medicinal product by contacting the local representative of the marketing authorization holder:

Local Representative:

Mabo-Farma S.A.

Calle Vía de los Poblados 3, Edificio 6

28033 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands Prasugrel Vivanta 5 mg film-coated tablets

Germany Prasugrel Vivanta 5 mg film-coated tablets

Spain Prasugrel Vivanta 5 mg film-coated tablets EFG

Portugal Prasugrel Vivanta

Date of the most recent review of this summary: July 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.