Package Insert: Information for the User

Prasugrel Combix 10 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

-Keep this package insert, 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 others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

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

3. How to take Prasugrel Combix

4. Possible side effects

5. Storage of Prasugrel Combix

6. Contents of the pack and additional information

Theactive ingredientisprasugrel, which belongs to a group of medications called antiplatelet agents. Platelets are very small cells that circulate in the blood. When a blood vessel is damaged, for example, when it is cut, platelets aggregate to help form a blood clot (thrombus). Therefore, platelets are essential in helping to stop bleeding. The formation of clots in hardened blood vessels, such as arteries, can be very dangerous as it prevents blood flow, causing a heart attack (myocardial infarction), stroke (cerebrovascular accident) or death. Clots in arteries that supply blood to the heart can also reduce blood flow, causing unstable angina (severe chest pain).

Prasugrelinhibits platelet aggregation, thereby reducing the likelihood of blood clots forming.

It has been prescribedprasugrelbecause you have suffered a myocardial infarction or unstable angina and have undergone 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.Prasugrelreduces the likelihood of future myocardial infarctions, stroke (cerebrovascular accident) or the likelihood of dying from one of these atherothrombotic events. Your doctor will also prescribe acetylsalicylic acid (e.g. aspirin), another antiplatelet agent.

Do not take Prasugrel Combix

- If you are allergic (hypersensitive) to prasugrel or to any of the other components of this medication. A reaction to an allergen can be recognized as a skin rash, itching, swelling of the face, swelling of the lips, or difficulty breathing. If this has occurred, consult your doctorimmediately.

- If you have a disease that is causing bleeding, such as a stomach or intestinal hemorrhage.

- If you have ever had a stroke or a transient ischemic attack.

- If you have a severe liver disease.

Warnings and precautions

•Before taking prasugrel:

Consult your doctor before starting to take prasugrel.

Consult your doctor or pharmacist before starting to take prasugrel if you are in any of the following situations:

• If you have a high risk of bleeding because:

- You are 75 years of age or older. Your doctor should prescribe a daily dose of 5 mg since patients over 75 years of age have a higher risk of bleeding

- You have recently suffered a serious injury

- You have recently undergone a surgical intervention (including some dental procedures)

- You have recently or recurrently suffered stomach or intestinal hemorrhages (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 disease

- You are using another type of medication (see “Use of other medications”)

- You are planning to undergo a surgical intervention (including some dental procedures) in the next seven days. Your doctor may indicate that you temporarily suspend the 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 the treatment with prasugrel. If after taking prasugrel, you experience an allergic reaction that can be recognized by a rash, itching, swelling of the face, swelling of the lips, or difficulty breathing, contact your doctorimmediately.

•While taking prasugrel:

You should contact your doctor immediately if you develop a disease called Thrombotic Thrombocytopenic Purpura (or TTP). TTP is associated with fever and bruises (hematomas) under the skin that appear as localized red spots, with or without extreme fatigue, confusion, yellow discoloration 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.

Use of Prasugrel Combix and other medications

Inform your doctor if you are taking, have taken recently, or might have to take any other medication, even those acquired 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 “nonsteroidal anti-inflammatory drugs” for pain and fever (such as ibuprofen, naproxen, etoricoxib). If administered together with prasugrel, these medications may increase the risk of bleeding.

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

Use other medications while taking prasugrel only if your doctor indicates that you can 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 the potential benefits and any potential risks to the fetus with your doctor.

If you are pregnant or breastfeeding, or if you think you might be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

Prasugrel is unlikely to affect your ability to drive and operate machines.

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

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The usual dose of prasugrel is 10 mg per day. Your treatment will begin with a single dose of 60 mg. If your weight is less than 60 kg or you are over 75 years old, the dose is 5 mg of prasugrel per day. Your doctor will also instruct you to take acetylsalicylic acid and the exact dose you should take (usually between 75 mg and 325 mg per day).

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

It is essential 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 directly as you may be at risk of excessive bleeding. You must show your doctor the packaging of prasugrel.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Prasugrel Combix

If you forgot to take your daily scheduled dose, take prasugrel when you remember. If you forget to take your dose for an entire day, take your usual dose of prasugrel the next day. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Prasugrel Combix

Do not stop your treatment without consulting your doctor. If you stop treatment with prasugrel too soon, the risk of suffering a myocardial infarction may increase.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Contact your doctorimmediatelyif you experience any of the following symptoms:

• 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 other people.

• Sudden difficulty walking or loss of balance or coordination.

• Sudden severe dizziness or severe headache without known cause.

These may 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 ischemic attack.

You must also contact your doctorimmediatelyif you notice any of the following symptoms:

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

• A rash, itching, or swelling of the face, swelling of the lips/lips, or difficulty breathing. These may be signs of a severe allergic reaction (see section 2 “What you need to know before starting to take prasugrel”).

Inform your doctorrapidlyif you experience any of the following symptoms:

• Blood in urine.

• Rectal bleeding, blood in stool, or black stool.

• Uncontrolled bleeding, for example after a cut.

These may be signs of bleeding, the most common side effect of prasugrel. Although rare, severe bleeding can be fatal.

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

• Bleeding in the stomach or intestines

• Bleeding at the injection site

• Nasal bleeding

• Skin rash

• Small red spots on the skin (ecchymosis)

• Blood in urine

• Hematoma (bleeding under the skin at the injection site, or in a muscle, causing swelling)

• Low hemoglobin or red blood cell count (anemia)

• Bruising

Rare side effects (may affect up to 1 in 100 people)

• Allergic reaction (rash, itching, swelling of the lips/lips, or difficulty breathing)

• Spontaneous bleeding of the eye, rectum, gums, or around internal organs in the abdomen

• Bleeding after surgery

• Bleeding when coughing

• Blood in stool

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

• Low platelet count in blood

• Subcutaneous hematoma (bleeding under the skin, causing swelling)

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30° C. Store in the original packaging, to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Prasugrel Combix

• The active ingredient 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), macrogol (E1521), yellow iron oxide (E172), talc (E553b), red iron oxide (E172), and black iron oxide (E172)).

Appearance of the product and content of the container

Prasugrel Combix is a film-coated tablet, brown in color, oval in shape, engraved with “P10” on one side and smooth on the other.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Combix Laboratories, S.L.U.

C/ Badajoz 2, Building 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing:

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

Last review date of this leaflet: November 2019

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.