Prasugrel Viatris

Italy
Brand name Prasugrel Viatris
Form tablets, film-coated
Active substance / Dosage
PRASUGREL
Prescription type Prescription only
ATC code
B01AC22
Registration number 046634
Manufacturer VIATRIS LIMITED

Table of Contents

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Package leaflet: Information for the user

Prasugrel Viatris 5 mg film-coated tablets, 10 mg film-coated tablets

prasugrel
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 other people, even if they have the same symptoms as you, because it could be harmful.
  • If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Prasugrel Viatris, which contains the active substance prasugrel, belongs to a group of medicines called platelet aggregation inhibitors (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). Thus, platelets are essential in helping to stop bleeding. However, if clots form inside hardened blood vessels, such as arteries, they can be very dangerous because they may block the flow of blood, leading to a heart attack (myocardial infarction), stroke, or death. Clots in the arteries supplying blood to the heart can also reduce blood flow to the heart muscle, causing unstable angina (severe chest pain).
Prasugrel Viatris inhibits platelet aggregation and therefore reduces the likelihood of blood clots forming.
Prasugrel Viatris has been prescribed for you because you have previously had a heart attack or unstable angina and have undergone a procedure to open blocked heart arteries. You may also have had one or more stents placed in the blocked or narrowed artery to restore blood flow. Prasugrel Viatris reduces the risk that you will have another heart attack, stroke, or die from such atherothrombotic events. Your doctor will also prescribe you acetylsalicylic acid (i.e. aspirin), another antiplatelet agent.

2. What you need to know before taking Prasugrel Viatris

Do not take Prasugrel Viatris

  • 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, facial swelling, 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 ischemic attack (TIA).
  • If you suffer from severe liver disease.

Warnings and precautions

  • Before taking Prasugrel Viatris:

Talk to your doctor before taking Prasugrel Viatris.
If any of the following conditions apply to you, inform your doctor before taking Prasugrel Viatris:

  • 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 and above.
    • Recent severe trauma
    • Recent surgery (including certain dental procedures)
    • Recent or recurrent bleeding in the stomach or intestines (e.g. gastric ulcer or colon polyp)
    • Body weight below 60 kg. Your doctor will prescribe a daily dose of 5 mg of Prasugrel Viatris if your body weight is below 60 kg
    • Moderate kidney or liver disease
    • If you are taking certain medicines (see “Other medicines and Prasugrel Viatris”)
    • If you are scheduled to undergo elective surgery (including certain dental procedures) within the next seven days. Your doctor may advise you to temporarily stop taking Prasugrel Viatris due to an increased risk of bleeding
  • If you have previously experienced allergic (hypersensitivity) reactions to clopidogrel or any other antiplatelet medicine, inform your doctor before starting treatment with Prasugrel Viatris. If, after starting Prasugrel Viatris, you experience allergic reactions such as skin rash, itching, facial swelling, swelling of the lips, or shortness of breath, you must inform your doctor immediately.
  • While taking Prasugrel Viatris:

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

Other medicines and Prasugrel Viatris
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those without a prescription, dietary supplements, and herbal preparations.
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 (NSAIDs) used to relieve pain and reduce fever (such as ibuprofen, naproxene, etoricoxib).

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When administered concomitantly with Prasugrel Viatris, these medicines may increase the risk of bleeding.
Inform your doctor if you are taking morphine or other opioids (used to treat severe pain).
Only take other medicines during treatment with Prasugrel Viatris if your doctor says you may do so.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Inform your doctor if you become pregnant or are planning a pregnancy while taking Prasugrel Viatris. You should use Prasugrel Viatris only after discussing with your doctor the potential benefits and any potential risks to the unborn child.
If you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
It is unlikely that Prasugrel Viatris will affect your ability to drive or operate machinery.

Prasugrel Viatris 5 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

Prasugrel Viatris 10 mg contains Sunset Yellow aluminium lake FCF (E110) and sodium
Sunset Yellow aluminium lake FCF is an azo dye which may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Prasugrel Viatris

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The usual dose of prasugrel is 10 mg once 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 Prasugrel Viatris daily. Your doctor will also instruct you to take acetylsalicylic acid; they will tell you the exact dose to take (usually between 75 mg and 325 mg daily).
You may take Prasugrel Viatris with or without food. Take Prasugrel Viatris every day at about the same time. Do not crush or break the tablet.
It is important that you inform your doctor, dentist, and pharmacist that you are taking Prasugrel Viatris.
If you take more Prasugrel Viatris than you should
Contact your doctor or the nearest hospital immediately due to the risk of excessive bleeding. Show your doctor the packaging of your Prasugrel Viatris.
If you forget to take Prasugrel Viatris
If you forget to take a dose, take Prasugrel Viatris as soon as you remember. If you forget to take the dose for the entire day, simply take your normal dose of Prasugrel Viatris the next day. Do not take a double dose to make up for a forgotten dose.
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If you stop taking Prasugrel Viatris:
Do not stop treatment with Prasugrel Viatris without first consulting your doctor. If you stop treatment with Prasugrel Viatris too early, your risk of myocardial infarction may be higher.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
You must contact your doctor immediately if you notice any of the following side effects:

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

All of the above may be signs of a stroke. Stroke is an uncommon side effect of Prasugrel Viatris in patients who have never had a stroke or transient ischaemic attack (TIA).
Also 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, or yellowing of the skin or eyes (jaundice) (see section 2, 'What you should know before taking Prasugrel Viatris').
  • A skin rash, itching, or swelling of the face, swelling of the lips/tongue, or shortness of breath. All of these may be signs of a serious allergic reaction (see section 2, 'What you should know before taking Prasugrel Viatris').

You should 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 above may be signs of bleeding, the most common side effect with Prasugrel Viatris. 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 from a needle puncture site
  • Nosebleeds
  • Skin rash
  • Small red bruises on the skin (purpura)
  • Blood in the urine
  • Haematoma (bleeding under the skin at the site of an injection or in a muscle, causing swelling)
  • Low haemoglobin or low red blood cell count (anaemia)
  • Bruising

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

  • Allergic reaction (skin rash, itching, swelling of lips/tongue, or shortness of breath)
  • Spontaneous bleeding from the eye, rectum, gums, or in the abdomen 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prasugrel Viatris

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 bottle and the carton after
"Exp.". The expiry date refers to the last day of that month.
Prasugrel Viatris 5 mg: Do not store above 30°C. Store in the original packaging to protect the medicine from moisture.
Prasugrel Viatris 10 mg: Do not store above 25°C. Store in the original packaging to protect the medicine from moisture.
Blister packs only: Do not store above 30°C. Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Prasugrel Viatris contains

  • The active substance is prasugrel.
    Prasugrel Viatris 5 mg: Each film-coated tablet contains prasugrel besilate equivalent to 5 mg of prasugrel.
    Prasugrel Viatris 10 mg: Each film-coated tablet contains prasugrel besilate equivalent to 10 mg of prasugrel.
  • Other excipients are:
    Prasugrel Viatris 5 mg: microcrystalline cellulose; mannitol; crospovidone; anhydrous colloidal silica; magnesium stearate; polyvinyl alcohol; talc; titanium dioxide (E171); glycerol monocaprylocaprate; sodium lauryl sulfate; yellow iron oxide (E172). See section 2 “Prasugrel Viatris 5 mg contains sodium”.

Prasugrel Viatris 10 mg: microcrystalline cellulose; mannitol; crospovidone; anhydrous colloidal silica;
magnesium stearate; polyvinyl alcohol; talc; titanium dioxide (E171); glycerol monocaprylocaprate;
sodium lauryl sulfate; yellow iron oxide (E172); sunset yellow aluminium lake FCF (E110),
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red iron oxide (E172). See section 2 “Prasugrel Viatris 10 mg contains sunset yellow aluminium
lake FCF (E110) and sodium”.

Description of the appearance of Prasugrel Viatris and pack contents
The film-coated tablets of Prasugrel Viatris 10 mg are beige, capsule-shaped, biconvex, measuring 11.15 mm × 5.15 mm, with ‘PH4’ engraved on one side and ‘M’ on the other.
The medicine is available in plastic bottles containing a desiccant and 28 or 30 film-coated tablets, and in blister packs containing 28, 30, 84, 90 or 98 film-coated tablets, and in perforated blister packs containing 30 × 1 or 90 × 1 film-coated tablets.
The film-coated tablets of Prasugrel Viatris 5 mg are beige, capsule-shaped, biconvex, measuring 8.15 mm × 4.15 mm, with ‘PH3’ engraved on one side and ‘M’ on the other.
The medicine is available in plastic bottles containing a desiccant and 28 or 30 film-coated tablets, and in blister packs containing 28, 30, 84 or 98 film-coated tablets.
Do not swallow or remove the desiccant contained in the bottle.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturer
Mylan Hungary Kft
Mylan utca 1, Komárom, 2900, Hungary
McDermott Laboratories Limited t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange State, Dublin 13, Ireland

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0) 2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300

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Eesti Norge
Viatris OÜ Tel: + 372 6363 052 Viatris AS
Tlf: + 47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Arcana Arzneimittel GmbH
Τηλ: +30 2100 100 002 Tel: +43 1 416 2418

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z.o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél : +33 4 37 25 75 00 Tel: + 351 21 412 72 00

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: + 40 372 579 000

Ireland Slovenija
Mylan Ireland Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 02 612 46921 Puh/Tel: + 358 20 720 9555

Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ: +357 22863100 Tel: + 46 (0)8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 18711600

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu .
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