Leaflet: information for the user

Prasugrel STADAFARMA 10 mg film-coated tablets

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, 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 must 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 leaflet. See section 4.

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

2. What you need to know before taking Prasugrel Stadafarma

3. How to take Prasugrel Stadafarma

4. Possible side effects

5. Storage of Prasugrel Stadafarma

6. Contents of the pack and additional information

Prasugrel Stadafarma contains the active ingredient prasugrel, 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).

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

You have been prescribed prasugrel 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 reduces the likelihood of future myocardial infarctions, stroke (cerebrovascular accident) or death due to one of these atherothrombotic events. Your doctor will also prescribe aspirin, another antiplatelet agent.

Do not take Prasugrel Stadafarma:

-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, facial swelling, lip swelling, or difficulty breathing. If this has occurred, consult your doctorimmediately.

-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 Stadafarma:

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 surgery (including some dental procedures)

-you have recently or recurrently suffered stomach or intestinal bleeding (e.g., stomach ulcers or colon polyps)

-you weigh less than 60 kg. If you weigh less than 60 kg, 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 “Other medications and Prasugrel Stadafarma”)

-you are planning to undergo surgery (including some dental procedures) in the next seven days. Your doctor may instruct you to temporarily suspend 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 treatment with prasugrel. If you experience an allergic reaction after taking prasugrel, which can be recognized by a rash, itching, facial swelling, lip swelling, or difficulty breathing, contact your doctorimmediately.

•While taking Prasugrel Stadafarma:

You should contact your doctor immediately if you develop a disease called Thrombotic Thrombocytopenic Purpura (or TTP) that is associated with fever and hematomas under the skin that may 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.

Other medications and Prasugrel Stadafarma

Inform your doctor if you are taking, have taken recently, or may need to take any other medication, including 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)
• “Non-steroidal anti-inflammatory drugs” for pain and fever (such as ibuprofen, naproxen, etoricoxib).

If administered 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 only if your doctor instructs you to do so.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication

You should take prasugrel only after discussing the potential benefits and any potential risks to the fetus with your doctor.

Driving and operating machinery

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

Prasugrel Stadafarma contains lactose.

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

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

Dosage

The recommended 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).

Administration Form

You can take prasugrel with or without food. Take your dose every day approximately at the same time. Swallow the tablet whole, do not break or crush the tablet.

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

If you take more Prasugrel Stadafarma than you should

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. Contact your doctor or hospital directly as you may be at risk of excessive bleeding. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Prasugrel Stadafarma

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 the treatment with Prasugrel Stadafarma

Do not interrupt your treatment without consulting your doctor, if you interrupt the 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 can cause side effects, although not everyone will experience them.

Contact your doctor immediately if 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.

•severe sudden dizziness or headache without a 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 (TIA).

You must also contact your doctor immediately if you notice any of the following symptoms::

•fever and bruising 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 Stadafarma”).

•an eruption, 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 Stadafarma”).

Inform your doctor quickly if you experience any of the following symptoms:

•blood in urine.

•rectal bleeding, blood in stools, or black stools.

•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 cause death.

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 red blood cell count or hemoglobin (anemia)

•bruising

Uncommon 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 stools

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

•low platelet count in the blood

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

Reporting of side effects

If you experienceany 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 after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Prasugrel Stadafarma

-The active ingredient is prasugrel.

Each tablet contains 10 mg of prasugrel (as hydrochloride).

-The other components are mannitol, maltodextrin, lactose monohydrate, microcrystalline cellulose, hypromellose, crospovidone (type B), magnesium stearate. Coating: hypromellose, lactose monohydrate, triacetin, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

Appearance of the product and contents of the packaging

Prasugrel Stadafarma 10 mg tablets are beige, oval, biconvex, coated with a film with a length of approximately 10.0 mm and a width of approximately 5.1 mm.

Prasugrel Stadafarma is available in blister packs of 10, 28, 30, 90 and 98 tablets.

Only some sizes of packaging may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratorios, S.L.

Frederic Mompou 5

08960 - Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse 2-18,

61118 - Bad Vilbel,

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2,

1190 – Vienna,

Austria

This medicine is authorized in the Member States of the European Economic Area with the following names:

Germany:Prasugrel AL 10 mg Filmtabletten

Spain:Prasugrel STADAFARMA 10 mg film-coated tablets

France:PRASUGREL EG LABO 10 mg coated tablet

United Kingdom:Prasugrel STADA 10 mg film-coated tablets

Date of the last review of this leaflet:April 2019

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