Prospecto:information for the user

Prasugrel Teva 10 mg film-coated tablets

Read this prospectus carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctor or pharmacist.

-This medicine has been prescribedonlyto you, and you must not give it to other people even iftheyhavethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,eveniftheyare not listed in this prospectus. See section 4.

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

2.What you need to knowbeforestarting totake Prasugrel Teva

3.How to take Prasugrel Teva

4.Possible adverse effects

5Storage of Prasugrel Teva

6.Contents of the pack and additional information

Prasugrel Teva contains the active ingredient 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 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).

Prasugrel Teva inhibits platelet aggregation, thereby reducing the possibility of blood clots forming.

You have been prescribed Prasugrel Teva because 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. Prasugrel Teva reduces the possibility of future myocardial infarction, stroke (cerebrovascular accident) or death due to one of these atherothrombotic events. Your doctor will also prescribe acetylsalicylic acid (e.g. aspirin), another antiplatelet agent.

Do not take Prasugrel Teva:

• If you are allergic to prasugrel or any of the other components of this medication (listed in section 6). 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 doctor immediately.
• If you have a disease that is causing bleeding, such as stomach or intestinal bleeding.
• If you have ever had a stroke or a transient ischemic attack (TIA).
• If you have a severe liver disease.

Warnings and precautions

• Before taking Prasugrel Teva:

Consult your doctor or pharmacist before starting to take Prasugrel Teva 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 had a serious injury
• You have recently undergone surgery (including some dental procedures)
• You have recently or recurrently had stomach or intestinal 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 disease
• You are taking another type of medication (see “Use of other medications”)
• You are planning to undergo surgery (including some dental procedures) in the next seven days. Your doctor may indicate that you temporarily suspend the 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 the treatment with prasugrel. If after taking Prasugrel Teva, 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 doctor immediately.

• While taking Prasugrel Teva:

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

Use of Prasugrel Teva with other medications

Inform your doctor if you are taking, have taken recently, or may need to take any other medication, even those purchased 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 Teva only if your doctor indicates that you can do so.

Pregnancy and lactation

If you are pregnant or intend to become pregnant, consult your doctor before using this medication.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 may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Prasugrel Teva is unlikely to affect your ability to drive and operate machinery.

Prasugrel Teva contains sucrose stearate

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

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

The recommended dose 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 Teva with or without food. Take your dose every day at approximately the same time.

The tablet can be divided into equal doses. Do not crush the tablet.

It is essential that you inform your doctor, dentist, and pharmacist that you are taking Prasugrel Teva.

If you take more Prasugrel Teva than you should

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

If you forgot to take Prasugrel Teva

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 Teva the next day. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Prasugrel Teva

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

If you have any other questions 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:

They 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:

Inform your doctorquicklyif you experience any of the following symptoms:

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

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

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

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

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 theSistema Español de Farmacovigilancia de medicamentos de Uso Humano: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe blister and on the packagingafter CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C,

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

Composition of Prasugrel Teva

• The active ingredient is prasugrel (as prasugrel hydrobromide). Each film-coated tablet contains 10 mg of prasugrel (as prasugrel hydrobromide).
• The othersexcipientsare:

Core: microcrystalline cellulose, mannitol, hypromellose, low-substituted hydroxypropylcellulose, glycerol dibehenate, and sucrose stearate.

Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), and red iron oxide (E172).

Appearance of the product and content of the container

Prasugrel Teva 10 mg are beige-colored, oval-shaped, film-coated tablets marked with “P10” on one face and with a notch on the other face.

Prasugrel Teva 10 mg is available in blister packs or single-dose blisters of 10, 14, 28, 28x1, 30, 30x1, 56, 84, 90, 90x1, and 98 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder

Teva Pharma, S.L.U.

c/Anabel Segura, 11 Edificio Albatros, B 1st floor

Alcobendas 28108 Madrid

Spain

Responsible for manufacturing

Merckle GmbH

Ludwig-Merckle-Strasse 3, Blaubeuren

89143 Baden-Wuerttemberg

Germany

or

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

Last review date of thisleaflet:May 2019

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