Prasugrel Teva-Ratiopharm 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Prasugrel Teva-ratiopharm 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, consult 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 may 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.

Contents of the leaflet

1. What Prasugrel Teva-ratiopharm is and what it is used for
2. What you need to know before taking Prasugrel Teva-ratiopharm
3. How to take Prasugrel Teva-ratiopharm
4. Possible side effects
5. How to store Prasugrel Teva-ratiopharm
6. Contents of the pack and other information

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

Prasugrel Teva-ratiopharm 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 for helping to 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, or death. Clots in arteries supplying blood to the heart may also reduce blood flow, causing unstable angina (severe chest pain).

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

You have been prescribed Prasugrel Teva-ratiopharm because you have had 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 Teva-ratiopharm reduces the risk of future heart attacks or strokes, or of dying from such atherothrombotic events. Your doctor will also prescribe you acetylsalicylic acid (e.g., aspirin), another antiplatelet agent.

2. What you need to know before taking Prasugrel Teva-ratiopharm

Do not take Prasugrel Teva-ratiopharm:

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

Warnings and precautions

• Before taking Prasugrel Teva-ratiopharm:

Consult your doctor or pharmacist before starting Prasugrel Teva-ratiopharm 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 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 or repeatedly experienced stomach or intestinal bleeding (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 problems
  • you are taking other medicines (see “Use with other medicines”)
  • 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 you experience an allergic reaction after taking Prasugrel Teva-ratiopharm—such as rash, itching, facial swelling, lip swelling, or difficulty breathing—contact your doctor immediately.

• While taking Prasugrel Teva-ratiopharm:

You must contact your doctor immediately if you develop a condition called Thrombotic Thrombocytopenic Purpura (TTP). TTP is associated with fever and bruising (ecchymoses) under the skin appearing 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 Teva-ratiopharm must not be used in children or adolescents under 18 years of age.

Use of Prasugrel Teva-ratiopharm with other medicines

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), or non-steroidal anti-inflammatory drugs (NSAIDs) for pain and fever (such as ibuprofen, naproxen, etoricoxib). When used 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 on Prasugrel Teva-ratiopharm if your doctor has instructed you to do so.

Pregnancy and breastfeeding

If you are pregnant or planning to become pregnant, consult your doctor before using this medicine. You should take prasugrel only after discussing with your doctor the potential benefits and any potential risks to the fetus.

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.

Driving and using machines

It is unlikely that Prasugrel Teva-ratiopharm will affect your ability to drive or operate machinery.

Prasugrel Teva-ratiopharm contains sodium stearyl fumarate

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

3. How to take Prasugrel Teva-ratiopharm

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

The recommended dose is 10 mg once daily. Your treatment will start with a single 60 mg 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 the exact dose you should take (usually between 75 mg and 325 mg daily).

You may take Prasugrel Teva-ratiopharm with or without food. Take your dose at approximately the same time each day.

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

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

If you take more Prasugrel Teva-ratiopharm than you should

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

If you forget to take Prasugrel Teva-ratiopharm

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 of Prasugrel Teva-ratiopharm the next day. Do not take a double dose to make up for missed doses.

If you stop taking Prasugrel Teva-ratiopharm

Do not stop your treatment without consulting your doctor. If you stop treatment with Prasugrel Teva-ratiopharm 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 side effects

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 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 severe dizziness or headache without a known cause.

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

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

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

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

• Blood in urine.
• Rectal bleeding, blood in stools or black stools.
• Uncontrolled bleeding, for example after a cut.

All of these may be signs of bleeding, the most common side effect with prasugrel. Although uncommon, serious bleeding can lead to death.

Common side 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 bruises on the skin (ecchymosis)
• Blood in urine
• Bruising (bleeding under the skin at the injection site, or in a muscle, causing swelling)
• Low haemoglobin or red blood cell count (anaemia)
• Bruising

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

• Low platelet count in blood
• Subcutaneous haematoma (bleeding under the skin, causing swelling)

Reporting of side effects

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

5. Storage of Prasugrel Teva-ratiopharm

Keep this medicine out of sight and reach of children.

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

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Prasugrel Teva-ratiopharm

• The active substance is prasugrel (as prasugrel hydrobromide). Each film-coated tablet contains 10 mg of prasugrel (as prasugrel hydrobromide).
• The other excipients are:

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

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

Appearance of the product and contents of the pack

Prasugrel Teva-ratiopharm 10 mg are beige, oval-shaped, film-coated tablets marked with “P10” on one side and a score line on the other side.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

Alcobendas 28108 Madrid

Spain

Manufacturer

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

Date of the most recent revision of the package leaflet: May 2019

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82929/P_82929.html

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