Prasugrel Combix 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Prasugrel Combix 10 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. 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, and must not be given to other people, even if they have the same symptoms as you. It could 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.

Leaflet contents:

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

1. What Prasugrel Combix 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 cells that circulate in the blood. When a blood vessel is damaged, for example due to a cut, platelets clump together to help form a blood clot (thrombus). Therefore, platelets are essential for helping to stop bleeding. The formation of clots in hardened blood vessels, such as arteries, can be very dangerous because they block the passage of blood, causing 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 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 myocardial infarctions or strokes (cerebrovascular accidents) or dying from such atherothrombotic events. Your doctor will also prescribe you acetylsalicylic acid (e.g. aspirin), another antiplatelet agent.

2. What you need to know before taking Prasugrel Combix

Do not take Prasugrel Combix

• If you are allergic (hypersensitive) to prasugrel or to any of the other components of this medicine. An allergic reaction may include skin rash, itching, facial swelling, lip swelling, or difficulty breathing. If you experience any of these, contact your doctor immediately.
• If you have a condition causing active bleeding, such as bleeding from the stomach or intestines.
• If you have ever had a stroke or a transient ischemic attack (TIA).
• If you have severe liver disease.

Warnings and precautions

• Before taking prasugrel:

Talk to your doctor before starting prasugrel.

Talk to 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 aged 75 years and above 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 medicines (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 Combix due to an increased risk of bleeding.

• If you have had allergic reactions (hypersensitivity) to clopidogrel or to 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:

Contact your doctor immediately if you develop a condition called Thrombotic Thrombocytopenic Purpura (TTP). TTP is associated with fever and bruising (bleeding under the skin) appearing as small 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.

Use of Prasugrel Combix 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, or 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 (NSAIDs) for pain and fever (such as ibuprofen, naproxen, etoricoxib). When used 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 if your doctor has instructed you that it is safe 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 may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

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

3. How to take Prasugrel Combix

Follow exactly your doctor's instructions on how to take 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 Combix 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 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Prasugrel Combix

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, take your usual prasugrel dose the next day. Do not take a double dose to make up for missed doses.

If you stop taking Prasugrel Combix

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 gets them.

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

• Sudden numbness or weakness of the arm, leg, or face, especially if it only affects one side of the body.
• Sudden confusion, difficulty speaking or understanding others.
• Sudden difficulty walking, or loss of balance or coordination.
• Sudden dizziness or severe 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 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, yellowing of the skin or eyes (jaundice) (see section 2 “What you need to know before you take prasugrel”).
• A 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 lead to death.

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

• Bleeding in the stomach or intestines
• Bleeding at the site of needle injection
• Nosebleeds
• Skin rash
• Small red bruises 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 from 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 effects, talk to your doctor or pharmacist, even if they are possible side effects 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 Combix

Keep this medicine out of sight and reach of children.

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

Do not store above 30°C. Store in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Prasugrel Combix

• The active substance is prasugrel. Each film-coated tablet contains 10 mg of prasugrel.
• The other components (excipients) are:

Tablet core: microcrystalline cellulose (E460i), mannitol (E421), sodium croscarmellose, hypromellose (E464), magnesium stearate (E470b).

Tablet coating: Opadry brown 03F565009 (hypromellose (E464), titanium dioxide (E171), polyethylene glycol (E1521), yellow iron oxide (E172), talc (E553b), red iron oxide (E172), and black iron oxide (E172)).

Appearance of the product and contents of the package

Prasugrel Combix is a brown, oval-shaped, film-coated tablet with bevelled edges, marked “P10” on one side and smooth on the other.

Prasugrel Combix is available in packs containing 28 and 90 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer:

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

or

Netpharmalab Consulting Services

Crta. De Fuencarral, 22

28108 Alcobendas (Madrid)

Spain

Date of latest revision of this package leaflet: November 2019

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.