Prafsia

Package leaflet: Information for the user

Prafsia 10 mg film-coated tablets, 5 mg film-coated tablets

prasugrel
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Prafsia is and what it is used for

Prafsia, which contains the active substance prasugrel, 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 if it is cut, platelets clump together to help form a blood clot (thrombus). Therefore, platelets are essential in helping to stop bleeding. However, if clots form inside a hardened blood vessel, such as an artery, they can be very dangerous because they may block the blood flow, causing a heart attack (myocardial infarction), stroke, or death. Clots in the arteries supplying blood to the heart can also reduce blood flow, causing unstable angina (severe chest pain).
Prafsia inhibits platelet aggregation and therefore reduces the likelihood of blood clots forming.
Prafsia has been prescribed for you because you have previously had a heart attack or unstable angina and have been treated with a procedure to open blocked heart arteries. You may also have had one or more stents placed to keep open a blocked or narrowed artery supplying blood to the heart. Prafsia reduces the risk that you will have another heart attack or stroke, or die from such atherothrombotic events. Your doctor will also prescribe you acetylsalicylic acid (i.e. aspirin), another antiplatelet medicine.

2. What you should know before taking Prafsia

Do not take Prafsia

• If you are allergic to prasugrel or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as a skin rash,
  itching, swelling of the face, swelling of the lips, or shortness of breath. If any of these occur, inform your doctor immediately.
• If you have a medical condition causing active bleeding, such as bleeding in the stomach or intestines.
• If you have previously had a stroke or a transient ischaemic attack (TIA).
• If you suffer from severe liver disease.

Warnings and precautions

• Before taking Prafsia:

Consult your doctor before taking Prafsia.
Before taking Prafsia, inform your doctor if any of the following situations apply to you:

• If you have a condition that increases your risk of bleeding, such as:
  • age 75 years or older. Your doctor will prescribe a daily dose of 5 mg, as there is a higher risk of bleeding in patients aged 75 years or older
  • a recent severe injury
  • a recent surgical procedure (including certain dental procedures)
  • recent or recurrent bleeding in the stomach or intestines (e.g. gastric ulcer or colon polyp)
  • body weight less than 60 kg. Your doctor will prescribe a daily dose of 5 mg of Prafsia if your body weight is less than 60 kg
  • moderate kidney or liver disease
  • if you are taking certain medicines (see "Other medicines and Prafsia" below)
  • if you are scheduled to undergo a planned surgical procedure (including certain dental procedures) within the next seven days. Your doctor may advise you to temporarily stop taking Prafsia due to an increased risk of bleeding
• If you have had allergic reactions (hypersensitivity) to clopidogrel or to any other antiplatelet agent, inform your doctor before starting treatment with Prafsia. If, after starting Prafsia, you experience allergic reactions such as skin rash, itching, swelling of the face, swelling of the lips, or shortness of breath, you must inform your doctor immediately.
• While taking Prafsia:

Inform your doctor immediately if you develop a medical condition called Thrombotic Thrombocytopenic Purpura (TTP), which may include fever and bruising under the skin appearing as tiny red spots, with or without unexplained severe fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 'Possible side effects'). Children and adolescents
Prafsia must not be used in children and adolescents under 18 years of age.
Other medicines and Prafsia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription, dietary supplements, or herbal remedies.
It is particularly important that you inform your doctor if you are being treated with:

• clopidogrel (an antiplatelet medicine),
• warfarin (an anticoagulant),
• "non-steroidal anti-inflammatory drugs" to relieve pain and reduce fever (such as ibuprofen, naproxen, etoricoxib).

When used in combination with Prafsia, these medicines may increase the risk of bleeding.
Inform your doctor if you are taking morphine or other opioids (used to treat severe pain). Take other medicines while on Prafsia treatment only if your doctor says you may do so.
Pregnancy and breastfeeding
Inform your doctor if you are pregnant or planning a pregnancy while taking Prafsia. You should use Prafsia only after discussing with your doctor the potential benefits and any possible risks to the unborn child.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
It is unlikely that Prafsia will affect your ability to drive or operate machinery.
Prafsia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially 'sodium-free'.

3. How to take Prafsia

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

The usual dose of Prafsia is 10 mg daily. Treatment will start with a single 60 mg dose. If your body weight is less than 60 kg or if you are over 75 years of age, the dose is 5 mg of Prafsia daily.

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

You may take Prafsia with or without food. Take Prafsia at about the same time each day. Do not break or crush the tablet.

It is important that you inform your doctor, pharmacist, and dentist that you are taking Prafsia.

If you take more Prafsia than you should

Contact your doctor or the nearest hospital immediately due to the risk of excessive bleeding. Show your doctor the pack of Prafsia.

If you forget to take Prafsia

If you forget to take your daily dose, take Prafsia as soon as you remember. If you forget to take the dose for the entire day, simply take your normal dose of Prafsia the next day. Do not take a double dose to make up for the missed dose.

If you stop taking Prafsia

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

If you have any doubts about how to use 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 notice any of the following side effects:

• Sudden numbness or weakness in an arm, leg or face, especially if limited to one side of the body.
• Sudden confusion, difficulty speaking or understanding what others are saying.
• Sudden difficulty walking or loss of balance or coordination.
• Sudden dizziness or severe sudden headache without a known cause.

All of the symptoms listed above may be signs of a stroke. Stroke is an uncommon side effect of Prafsia in patients who have never had a stroke or transient ischaemic attack (TIA).
Additionally, contact your doctor immediately if you notice any of the following side effects:

• Fever and bruising under the skin appearing as tiny red spots, with or without unexplained severe tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 2 ‘Before you take Prafsia’).
• A skin rash, itching, or swelling of the face, swelling of the lips/tongue, or breathlessness. All of these may be signs of a serious allergic reaction (see section 2 ‘What you need to know before taking Prafsia’).

Contact your doctor promptly if you notice any of the following side effects:

• Blood in the urine.
• Bleeding from the rectum, blood in the stools, or black stools.
• Uncontrolled bleeding, for example from a cut.

All of the symptoms listed above may be signs of bleeding, the most common side effect with Prafsia. Although uncommon, serious bleeding can be life-threatening.

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

• Bleeding in the stomach or intestines
• Bleeding at the site of a needle puncture
• Nosebleeds
• Skin rash
• Small red bruises on the skin (purpura)
• Blood in the urine
• Haematoma (bleeding under the skin at the site of injection, or in a muscle, causing swelling)
• Low haemoglobin or low red blood cell count (anaemia)
• Bruising

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

• Allergic reaction (skin rash, itching, swelling of lips/tongue, or breathlessness)
• Spontaneous bleeding from the eye, rectum, gums, or in the abdominal area around internal organs
• Bleeding after surgery
• Coughing up blood
• Blood in the stools

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

• Low number of platelets in the blood
• Subcutaneous haematoma (bleeding under the skin causing swelling)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prafsia

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 blister and packaging after
Exp. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Prafsia contains

• The active substance is prasugrel. Prafsia 10 mg: Each tablet contains 10 mg of prasugrel (as hydrochloride). Prafsia 5 mg: Each tablet contains 5 mg of prasugrel (as hydrochloride).
• The other components are: Microcrystalline cellulose (E460), mannitol (E421), croscarmellose sodium (E468), hypromellose (E464), magnesium stearate (E470b), hydroxypropylcellulose (E463), talc (E553b), titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (only in 10 mg tablets) (E172).

Description of the appearance of Prafsia and contents of the pack
Prafsia 10 mg: The tablets are dark beige, double-arrow shaped, approximately 11.1 mm long, 5.3 mm wide and 3.8 mm thick, with "10" engraved on one side.
Prafsia 5 mg: The tablets are yellow, double-arrow shaped, approximately 9.9 mm long, 4.7 mm wide and 2.5 mm thick, with "5" engraved on one side.
Prafsia 10 mg is available in DESSIFLEX-Aluminum/PE blisters containing 28, 30, 56 and 98 tablets.
Prafsia 5 mg is available in DESSIFLEX-Aluminum/PE blisters containing 28 and 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Pharmathen S.A.
Dervenakion 6
Pallini, Attiki
153 51, Greece

Manufacturer
Pharmathen S.A.
Dervenakion 6
Pallini, Attiki
153 51, Greece
Pharmathen International S.A.
Industrial Park Sapes,
Rodopi Prefecture, Block No 5,
Rodopi 69300,
Greece

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