PRASUGREL COMBIX 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Prasugrel Combix 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:

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

1. What is Prasugrel Combix and what is it 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 if you cut yourself, platelets clump together to form a blood clot. This helps to stop bleeding. The formation of blood clots in hardened blood vessels, such as arteries, can be very dangerous because it can stop blood flowing, causing a heart attack (myocardial infarction), stroke or death. Blood clots in arteries that supply blood to the heart can also reduce blood flow, causing unstable angina (severe chest pain).

Prasugrel inhibits platelet clumping, which reduces the chance of blood clots forming.

You have been prescribed prasugrel 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 inserted in the blocked or narrowed artery to restore blood flow to the heart. Prasugrel reduces the chance of you having another heart attack or stroke, or dying from one of these events. Your doctor will also prescribe acetylsalicylic acid (e.g. aspirin), another antiplatelet agent, for you to take.

2. What you need to know before you take Prasugrel Combix

Do not take Prasugrel Combix

• If you are allergic (hypersensitive) to prasugrel or any of the other ingredients of this medicine. You can recognize an allergic reaction by a skin 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 stomach or intestinal bleeding.
• If you have ever had a stroke or a transient ischaemic attack.
• If you have severe liver disease.

Warnings and precautions

• Before taking prasugrel:

Talk to your doctor before starting to take prasugrel.

Tell your doctor or pharmacist before starting to take prasugrel 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 because 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 ulcers 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 "Using other medicines")
  • you are scheduled to have surgery (including some dental procedures) in the next 7 days. Your doctor may advise you to temporarily stop taking Prasugrel Combix 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 you experience an allergic reaction after taking prasugrel, 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:

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

Children and adolescents

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

Using Prasugrel Combix and other medicines

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 only if your doctor tells you to.

Pregnancy and breast-feeding

Tell your doctor if you become pregnant or are planning to become pregnant while taking prasugrel. You should take prasugrel only after talking to your doctor about the potential benefits and any potential risk to the fetus.

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.

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 (1mmol) per dose unit, which is essentially "sodium-free".

3. How to take Prasugrel Combix

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The usual dose of prasugrel is 10 mg once a day. Your treatment will start with a one-time dose of 60 mg. If you weigh less than 60 kg or are over 75 years old, the dose is 5 mg of prasugrel once a day. 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 a day).

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

It is important that you tell your doctor, dentist or pharmacist that you are taking prasugrel.

If you take more Prasugrel Combix than you should

Contact your doctor or hospital directly as you may be at risk of excessive bleeding. You should show your doctor the pack of prasugrel.

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

If you forget to take Prasugrel Combix

If you forget to take your daily dose, take prasugrel as soon as 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 Combix

Do not stop your treatment without talking to your doctor, if you stop taking prasugrel too soon, the risk of you having a heart attack may increase.

If you have any further questions on 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 everybody gets them.

Contact your doctor immediatelyif you experience any of the following signs:

• Numbness or weakness suddenly affecting one side of the body, face, arm or leg.
• Sudden confusion, difficulty speaking or understanding others.
• Sudden difficulty walking or loss of balance or coordination.
• Sudden severe headache or dizziness without a known cause.

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 transient ischaemic attack.

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

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

Tell your doctor promptlyif you experience any of the following signs:

• Blood in your urine.
• Rectal bleeding, blood in your stools or black stools.
• Uncontrolled bleeding, for example after a cut.

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
• Skin rash
• Small red spots on the skin (ecchymosis)
• Blood in your 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 the lips/tongue, or difficulty breathing)
• Spontaneous bleeding in the eye, rectum, gums or in the abdomen around the internal organs
• Bleeding after surgery
• Bleeding when coughing
• Blood in your stools

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

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

Reporting of side effects

If you get 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 Monitoring System for Human Use: 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 the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month shown.

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

What Prasugrel Combix contains

• The active substance is prasugrel. Each film-coated tablet contains 10 mg of prasugrel.
• The other ingredients are:

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

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

Appearance and packaging

Prasugrel Combix is a film-coated tablet, brown, oval, engraved with "P10" on one side and plain on the other.

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

Marketing authorisation holder and manufacturer

Marketing authorisation 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 last revision of this leaflet: November 2019

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