PRASUGREL STADAFARMA 10 mg FILM-COATED TABLETS

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

Do not take Prasugrel Stadafarma:

• if you are allergic to prasugrel or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can be recognized as a skin rash, itching, swelling of the face, swelling of the lips or difficulty breathing. If this has happened to you, contact your doctor immediately.
• if you have a condition that is causing bleeding, such as stomach or intestinal bleeding.
• 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 Stadafarma:

Tell your doctor or pharmacist before you start taking prasugrel if you are in any of the following situations:

• If you are at high risk of bleeding because:
  • you are 75 years or older. Your doctor should prescribe a daily dose of 5 mg because patients over 75 years have a higher risk of bleeding.
  • you have recently had a serious injury.
  • you have recently had surgery (including some dental procedures).
  • you have recently had or frequently have 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 medicines (see "Other medicines and Prasugrel Stadafarma").
  • you are scheduled to have surgery (including some dental procedures) in the next 7 days. Your doctor may tell you to temporarily stop taking 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, swelling of the face, swelling of the lips 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) associated with fever and bruising under the skin that can appear as red spots, with or without extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").

Children and adolescents

Prasugrel should not be used in children and adolescents under 18 years of age.

Other medicines and Prasugrel Stadafarma

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, dietary supplements, and herbal products. It is especially important that you inform your doctor if you are being treated with:

• clopidogrel (an antiplatelet agent).
• warfarin (an anticoagulant).
• "non-steroidal anti-inflammatory medicines" for pain and fever (such as ibuprofen, naproxen, etoricoxib).

If these medicines are given with prasugrel, they may increase the risk of bleeding.

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

Use other medicines while taking prasugrel only if your doctor tells you to.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should take prasugrel only after talking to your doctor about the potential benefits and any potential risk to the fetus.

Driving and using machines

Prasugrel is unlikely to affect your ability to drive or use machines.

Prasugrel Stadafarma contains lactose.

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Prasugrel Stadafarma

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Dose

The recommended dose of prasugrel is 10 mg once daily. Your treatment will start with a one-time dose of 60 mg.

If you weigh less than 60 kg or are over 75 years old, the dose is 5 mg of prasugrel once daily.

Your doctor will also tell you to take aspirin and the exact dose you should take (usually between 75 mg and 325 mg once daily).

Method of administration

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

It is important that you tell your doctor, dentist, and pharmacist that you are taking prasugrel.

If you take more Prasugrel Stadafarma than you should

If you have taken more than the prescribed dose, contact your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken. Contact your doctor or hospital directly as you may be at risk of excessive bleeding. It is recommended to take the packaging and the package leaflet of the medicine to the healthcare professional.

If you forget to take Prasugrel Stadafarma

If you forget to take your prescribed daily dose, take prasugrel when you remember. If you forget to take your dose for a whole day, take your usual dose of prasugrel the next day. Do not take a double dose to make up for forgotten doses.

If you stop taking Prasugrel Stadafarma

Do not stop taking your treatment without consulting your doctor, if you stop taking prasugrel too soon, the risk of having a heart attack may increase.

If you have any further questions on 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 everybody gets them.

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

• 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 others.
• sudden difficulty walking or loss of balance or coordination.
• sudden severe headache or dizziness without known cause.

All these can 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 ischaemic attack (TIA).

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

• fever and bruising under the skin that can appear as red spots, with or without extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 2 "What you need to know before you take Prasugrel Stadafarma").
• a rash, itching, swelling of the face, swelling of the lips or difficulty breathing. These can be signs of a severe allergic reaction (see section 2 "What you need to know before you take Prasugrel Stadafarma").

Tell your doctor as soon as possible 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 these can be signs of bleeding, the most common side effect with prasugrel. Although rare, severe bleeding can cause death.

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

• bleeding in the stomach or intestine.
• bleeding at the injection site.
• nasal bleeding.
• skin rash.
• small red bruises on the skin (ecchymosis).
• blood in urine.
• haematoma (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 the lips/tongue, or difficulty breathing).
• spontaneous bleeding in the eye, rectum, gums, or in the abdomen around the 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 the blood.
• subcutaneous haematoma (bleeding under the skin, causing swelling).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency via their website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Prasugrel Stadafarma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Prasugrel Stadafarma

• The active substance is prasugrel.

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

• The other ingredients 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 pack contents

Prasugrel Stadafarma 10 mg film-coated tablets are beige, oval, biconvex, film-coated 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.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 – Wien,

Austria

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Prasugrel AL 10 mg Filmtabletten

Spain: Prasugrel STADAFARMA 10 mg film-coated tablets EFG

France: PRASUGREL EG LABO 10 mg film-coated tablet

United Kingdom: Prasugrel STADA 10 mg film-coated tablets

Date of last revision of this leaflet:April 2019

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