Prospecto:Information for the User

Prasugrel Qualigen 10 mg Film-Coated Tablets

Prasugrel Qualigen 5 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 your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

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

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

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

3.How to take Prasugrel Qualigen

4.Possible adverse effects

5Storage of Prasugrel Qualigen

6. Contents of the pack and additional information

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

You have been prescribed Prasugrel Qualigen 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 Qualigen 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 PrasugrelQualigen:

• If you are allergic (hypersensitive) to prasugrel or to any of the other components ofPrasugrel Qualigen.You may recognize an allergic reaction as a skin rash, itching, swelling of the face, swelling of the lips or difficulty breathing. If this has happened to you, consult your doctorimmediately.
• If you have a condition 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 PrasugrelQualigen:

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

• If you have a high risk of bleeding because:

• If you have had allergic reactions (hypersensitivity) to clopidogrel or to any other antiplatelet agent, please inform your doctor before starting treatment with prasugrel. If after taking PrasugrelQualigen, you experience an allergic reaction that you can recognize by a rash, itching, swelling of the face, swelling of the lips or difficulty breathing, contactimmediatelyyour doctor.

• While taking Prasugrel Qualigen:

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

Use of PrasugrelQualigenwithother 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 are taking morphine or other opioids (used to treat acute pain).

Use other medications while taking Prasugrel Qualigen only if your doctor instructs you to do so.

Pregnancy andlactation

If you are pregnant or intend to become pregnant, consultyour doctor before using this medication.You should take prasugrel only after discussing the potential benefits and any potential risk to the fetus with your doctor.

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

Driving and operating machinery

It is unlikely that Prasugrel Qualigen will affect your ability to drive and operate machinery.

Prasugrel Qualigen contains lactose and saccharose

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

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

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

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

The recommended doseis10 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 Qualigen 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 Qualigen.

If you take morePrasugrelQualigenthan you should

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

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

If you forgot to takePrasugrel Qualigen

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

If you interrupt the treatment withPrasugrel Qualigen

Do not interrupt your treatment without consulting your doctor, if you interrupt the treatment with Prasugrel Qualigen 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:

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.

This medication does not require special storage conditions.

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 pointat 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 Qualigen

• The active ingredient is prasugrel.
• Prasugrel Qualigen 5 mg: each film-coated tablet contains 5 mg of prasugrel.
• Prasugrel Qualigen 10 mg: each film-coated tablet contains 10 mg of prasugrel.
• The other components are: crospovidone, lactose monohydrate, sodium croscarmellose (E468), microcrystalline cellulose (E460), sucrose stearate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518), red iron oxide (E172) (dose of 10 mg), yellow iron oxide (E172), and talc (E553b).

Appearance of the product and content of the container

Prasugrel Qualigen 5 mg are yellow film-coated tablets, oblong and biconvex, with the inscription “F1” on one face.

Prasugrel Qualigen 10 mg are orange film-coated tablets, oblong and biconvex, with the inscription “F2” on one face.

Prasugrel Qualigen is available in aluminum/aluminum blister packs, containing 28 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí – Barcelona

Spain

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí – Barcelona

Spain

Last review date of this prospectus: August 2021

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/)