Prasugrel Stadafarma 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Prasugrel STADAFARMA 10 mg film-coated tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Prasugrel Stadafarma is 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. How to store Prasugrel Stadafarma
6. Contents of the pack and other information

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

Prasugrel Stadafarma contains the active substance prasugrel, which belongs to a group of medicines called antiplatelet agents. Platelets are very small blood cells. When a blood vessel is damaged, for example by a cut, platelets clump together to help form a blood clot (thrombus).

Therefore, platelets are essential to help stop bleeding.

However, the formation of clots in hardened blood vessels, such as arteries, can be very dangerous because they block the flow of blood, leading to a heart attack (myocardial infarction), stroke (cerebrovascular accident), or death. Clots in arteries supplying blood to the heart may also reduce blood flow, causing unstable angina (severe chest pain).

Prasugrel inhibits platelet aggregation, thereby reducing the likelihood of blood clot formation.

You have been prescribed prasugrel because you have suffered a myocardial infarction or unstable angina and have been treated with 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 risk of future myocardial infarction or stroke (cerebrovascular accident), or of dying from such atherothrombotic events. Your doctor will also prescribe you acetylsalicylic acid, another antiplatelet agent.

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

Do NOT take Prasugrel Stadafarma:

• if you are allergic to prasugrel or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction may include skin rash, itching, facial swelling, lip swelling, or difficulty breathing. If this has happened to you, consult your doctor immediately.
• if you have a condition causing bleeding, such as stomach or intestinal bleeding.
• if you have ever had a stroke or a transient ischemic attack (TIA).
• if you have severe liver disease.

Warnings and precautions

• Before taking Prasugrel Stadafarma:

Talk to your doctor or pharmacist before starting prasugrel if any of the following apply to you:

• If you are at high risk of bleeding because:

  • you are 75 years of age or older. Your doctor should prescribe a daily dose of 5 mg, as patients over 75 years have an increased risk of bleeding.
  • you have recently suffered a serious injury.
  • you have recently undergone surgery (including certain dental procedures).
  • you have recently experienced or have a history of recurrent stomach or intestinal bleeding (e.g., stomach ulcer 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 problems.
  • you are taking other types of medicines (see "Other medicines and Prasugrel Stadafarma").
  • you are scheduled to undergo surgery (including certain dental procedures) within the next seven days. Your doctor may instruct you to temporarily stop treatment with prasugrel 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 treatment with prasugrel. If, after taking prasugrel, you experience an allergic reaction such as rash, itching, facial swelling, lip swelling, or difficulty breathing, contact your doctor immediately.

• While taking Prasugrel Stadafarma:

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

Children and adolescents

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

Other medicines and Prasugrel Stadafarma

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, dietary supplements, or 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).

When administered together with prasugrel, these medicines may increase the risk of bleeding.

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

Only take other medicines while taking prasugrel if your doctor has told you that it is safe to do so.

Pregnancy and breastfeeding

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

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

Driving and using machines

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

Prasugrel Stadafarma contains lactose.

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Prasugrel Stadafarma

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose of prasugrel is 10 mg once daily. Your treatment will start with a single 60 mg loading dose.

If your body weight is less than 60 kg or you are over 75 years of age, the dose is 5 mg of prasugrel daily.

Your doctor will also instruct you to take acetylsalicylic acid and specify the exact dose you should take (usually between 75 mg and 325 mg daily).

Method of administration

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

It is important 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, contact your doctor or pharmacist immediately, or call the Poison Information Service at telephone number: 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 medicine packaging and leaflet to the healthcare professional.

If you forget to take Prasugrel Stadafarma

If you forget to take your scheduled daily dose, take prasugrel as soon as you remember. If you forget to take your dose for an entire day, take your usual dose the next day. Do not take a double dose to make up for the missed dose.

If you stop taking Prasugrel Stadafarma

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Contact your doctor immediately if you experience any of the following signs:

• sudden numbness or weakness in the arm, leg, or face, especially if it only affects one side of the body.
• sudden confusion, difficulty speaking or understanding others.
• sudden difficulty walking, or loss of balance or coordination.
• sudden dizziness or severe headache without a known cause.

All of these may be signs of a stroke. Stroke is an uncommon adverse effect of prasugrel in patients who have never previously had a stroke or transient ischemic attack (TIA).

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

• fever and skin bruising appearing as localized red spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 2 “What you need to know before you start taking Prasugrel Stadafarma”).
• rash, itching, or swelling of the face, swelling of lips/tongue, or difficulty breathing. These may be signs of a severe allergic reaction (see section 2 “What you need to know before you start taking Prasugrel Stadafarma”).

Tell your doctor promptly if you experience any of the following signs:

• blood in urine.
• rectal bleeding, blood in stools, or black stools.
• uncontrollable bleeding, for example after a cut.

All of these may be signs of bleeding, the most common adverse effect with prasugrel. Although uncommon, serious bleeding can be fatal.

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

• bleeding in the stomach or intestine
• bleeding at the site of needle injection
• nosebleeds
• skin rash
• small red spots on the skin (petechiae)
• blood in urine
• bruising (bleeding under the skin at the injection site, or in a muscle, causing swelling)
• low hemoglobin or red blood cell count (anemia)
• bruising

Uncommon adverse effects (may affect up to 1 in 100 people)

• allergic reaction (rash, itching, swelling of lips/tongue, or difficulty breathing)
• spontaneous bleeding in the eye, rectum, gums, or in the abdomen around internal organs
• bleeding after surgery
• bleeding when coughing
• blood in stools

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

• low platelet count in blood
• subcutaneous hematoma (bleeding under the skin, causing swelling)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Prasugrel Stadafarma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Prasugrel Stadafarma

• The active substance 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 package contents

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou 5

08960 - Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18,

61118 - Bad Vilbel,

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2,

1190 – Vienna,

Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Prasugrel AL 10 mg Filmtabletten

Spain: Prasugrel STADAFARMA 10 mg comprimidos recubiertos con película EFG

France: PRASUGREL EG LABO 10 mg comprimé pelliculé

United Kingdom: Prasugrel STADA 10 mg film-coated tablets

Date of the most recent review of this leaflet: April 2019

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