Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - prasugrel

Document Subject

Generated Narrative: MedicinalProductDefinition mp0b50019879610f5c496f0994be72cd16

identifier: http://ema.europa.eu/identifier/EU/1/18/1273/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Prasugrel Viatris 5 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-0b50019879610f5c496f0994be72cd16

identifier: http://ema.europa.eu/identifier/EU/1/18/1273/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - prasugrel

Attesters

What is in this leaflet

1. What Prasugrel Viatris is and what it is used for
2. What you need to know before you take 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

Prasugrel Viatris, which contains the active substance prasugrel, belongs to a group of medicines called antiplatelet agents. Platelets are very small cell particles 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 to help stop bleeding. If clots form within a hardened blood vessel such as an artery they can be very dangerous as they can cut off the blood supply, causing a heart attack (myocardial infarction), stroke or death. Clots in arteries supplying blood to the heart may also reduce the blood supply, causing unstable angina (a severe chest pain).

Prasugrel Viatris inhibits the clumping of platelets and so reduces the chance of a blood clot forming.

You have been prescribed Prasugrel Viatris because you have already had a heart attack or unstable angina and you have been treated with a procedure to open blocked arteries in the heart. You may also have had one or more stents placed to keep open a blocked or narrowed artery supplying blood to the heart. Prasugrel Viatris reduces the chances of you having a further heart attack or stroke or of dying from one of these atherothrombotic events. Your doctor will also give you acetylsalicylic acid (e.g. aspirin), another antiplatelet agent.

Do not take Prasugrel Viatris if you

are allergic to prasugrel or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath. If this has happened to you, tell your doctor immediately.

have a medical condition that is currently causing bleeding, such as bleeding from your stomach or intestines.

have ever had a stroke or a transient ischaemic attack (TIA).

have severe liver disease.

39/Warnings and precautions

• Before you take Prasugrel Viatris:

Talk to your doctor before taking Prasugrel Viatris.

You should tell your doctor before taking Prasugrel Viatris if any of the situations mentioned below apply to you:

• If you have an increased risk of bleeding such as:

age of 75 years or older. Your doctor should prescribe a daily dose of 5 mg as there is a greater risk of bleeding in patients older than 75 years

a recent serious injury

recent surgery (including some dental procedures)

recent or recurrent bleeding from the stomach or intestines (e.g. a stomach ulcer or colon polyps)

body weight of less than 60 kg. Your doctor should prescribe a daily dose of 5 mg of Prasugrel Viatris if you weigh less than 60 kg

renal (kidney) disease or moderate liver problems

taking certain types of medicines (see Other medicines and Prasugrel Viatris below)

planned surgery (including some dental procedures) in the next seven days. Your doctor may wish you to stop taking Prasugrel Viatris temporarily due to the increased risk of bleeding

• If you have had allergic reactions (hypersensitivity) to clopidogrel or any other anti-platelet agent please tell your doctor before starting treatment with Prasugrel Viatris. If you then take Prasugrel Viatris and experience allergic reactions that may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath you need to tell your doctor immediately.

• While you are taking Prasugrel Viatris:

You should tell your doctor immediately if you develop a medical condition called Thrombotic Thrombocytopaenic Purpura (or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 Possible side effects ).

Children and adolescents Prasugrel Viatris should not be used in children and adolescents below 18 years of age.

Other medicines and Prasugrel Viatris Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, dietary supplements and herbal remedies.

It is particularly important to tell your doctor if you are being treated with: clopidogrel (an anti-platelet agent), warfarin (an anti-coagulant), non-steroidal anti-inflammatory drugs for pain and fever (such as ibuprofen, naproxen, etoricoxib).
If given together with Prasugrel Viatris these medicines may increase the risk of bleeding.

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

Only take other medicines while you are on Prasugrel Viatris if your doctor tells you that you can.

Pregnancy and breast-feeding If you are pregant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

40/Tell your doctor if you become pregnant or are trying to become pregnant while you are taking Prasugrel Viatris. You should use Prasugrel Viatris only after discussing with your doctor the potential benefits and any potential risks to your unborn child.

If you are breast-feeding, ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines Prasugrel Viatris is unlikely to affect your ability to drive or use machines.

Prasugrel Viatris 5 mg contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium- free .

Prasugrel Viatris 10 mg contains sunset yellow FCF aluminium lake (E110) and sodium Sunset yellow FCF aluminium lake is a colouring agent, which may cause allergic reactions. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium- free .

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose of prasugrel is 10 mg per day. You will start the treatment with a single dose of 60 mg. If you weigh less than 60 kg or are more than 75 years of age, the dose is 5 mg Prasugrel Viatris per day. Your doctor will also tell you to take acetylsalicylic acid, and (s)he 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 your dose at around the same time every day. Do not break or crush the tablet.

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

If you take more Prasugrel Viatris than you should Contact your doctor or hospital straight away, as you may be at risk of excessive bleeding. You should show the doctor your pack of Prasugrel Viatris.

If you forget to take Prasugrel Viatris If you miss your scheduled daily dose, take Prasugrel Viatris when you remember. If you forget your dose for an entire day, just resume taking Prasugrel Viatris at its usual dose the next day. Do not take a double dose to make up for a forgotten dose.

If you stop taking Prasugrel Viatris Do not stop taking Prasugrel Viatris without consulting your doctor; if you stop taking Prasugrel Viatris too soon, your risk of a heart attack may be higher.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

41/Contact your doctor immediately if you notice any of the following:

• Sudden numbness or weakness of the arm, leg or face, especially if only on one side of the body
• Sudden confusion, difficulty speaking or understanding others
• Sudden difficulty in walking or loss of balance or co-ordination
• Sudden dizziness or sudden severe headache with no 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:

• Fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice). (see section 2 What you need to know before you take Prasugrel Viatris )
• A rash, itching, or a swollen face, swollen lips/tongue, or shortness of breath. These may be signs of a severe allergic reaction (see section 2 What you need to know before you take Prasugrel Viatris )

Tell your doctor promptly if you notice any of the following:

• Blood in your urine
• Bleeding from your rectum, blood in your stools or black stools
• Uncontrollable 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, severe bleeding can be life-threatening.

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

• Bleeding in the stomach or bowels
• Bleeding from a needle puncture site
• Nose bleeds
• Skin rash
• Small red bruises on the skin (ecchymoses)
• Blood in urine
• Haematoma (bleeding under the skin at the site of an injection, or into 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, swollen lips/tongue, or shortness of breath)
• Spontaneous bleeding from the eye, rectum, gums or in the abdomen around the internal organs
• Bleeding after surgery
• Coughing up blood
• Blood in stools

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

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

Reporting of side effects If you get 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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

42/

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 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 package in order to protect from moisture.

Prasugrel Viatris 10 mg: Do not store above 25 C. Store in the original package in order to protect from moisture. Blister packs only: Do not store above 30 C. Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What Prasugrel Viatris contains

The active substance is prasugrel. Prasugrel Viatris 5 mg: Each film-coated tablet contains prasugrel besilate equivalent to 5 mg prasugrel. Prasugrel Viatris 10 mg: Each film-coated tablet contains prasugrel besilate equivalent to 10 mg prasugrel.

The other ingredients are: Prasugrel Viatris 5 mg: microcrystalline cellulose, mannitol, crospovidone, silica colloidal anhydrous, magnesium stearate, polyvinyl alcohol, talc, titanium dioxide (E171), glyceryl monocaprylocaprate, sodium lauryl sulfate, iron oxide yellow (E172). See section 2 Prasugrel Viatris 5 mg contains sodium .

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

What Prasugrel Viatris looks like and contents of the pack

Prasugrel Viatris 10 mg film-coated tablets are beige film-coated, capsule shaped, biconvex tablets, of dimensions 11.15 mm 5.15 mm, debossed with PH4 on one side of the tablet and M on the other side. This 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, 98 and in perforated blister packs containing 30 x 1 and 90 x 1 film-coated tablets.

Prasugrel Viatris 5 mg film-coated tablets are yellow film-coated, capsule shaped, biconvex tablets, of dimensions 8.15 mm 4.15 mm, debossed with PH3 on one side of the tablet and M on the other side. This 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.

43/Do not eat or remove the desiccant contained in the bottle Not all pack sizes may be marketed.

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

Manufacturer Mylan Hungary Kft Mylan utca 1, Kom rom, 2900, Hungary

McDermott Laboratories Limited t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange State, Dublin 13, Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgi /Belgique/Belgien Viatris T l/Tel: + 32 (0)2 658 61 Lietuva Mylan Healthcare UAB
Tel: +370 5 205 1

: +359 2 44 55 Luxembourg/Luxemburg Viatris T l/Tel: + 32 (0)2 658 61 (Belgique/Belgien)

esk republika Viatris CZ s.r.o. Tel: + 420 222 004 Magyarorsz g Viatris Healthcare Kft. Tel.: + 36 1 465 2Danmark Viatris ApS Tlf: +45 28 11 69 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 Deutschland Viatris Healthcare GmbH Tel: +49 800 0700 Nederland Mylan BV Tel: +31 (0)20 426 3Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: + 372 6363 Norge Viatris AS Tlf: + 47 66 75 33
Viatris Hellas Ltd : +30 2100 100 sterreich Arcana Arzneimittel GmbH Tel: +43 1 416 2Espa a Viatris Pharmaceuticals, S.L.U. Tel: + 34 900 102 Polska Mylan Healthcare Sp. Z.o.o. Tel.: + 48 22 546 64 France Viatris Sant
T l : +33 4 37 25 75 Portugal Mylan, Lda. Tel: + 351 21 412 72 44/Hrvatska Viatris Hrvatska d.o.o. Tel: +385 1 23 50 Rom nia BGP Products SRL Tel: + 40 372 579 Ireland Mylan Ireland Limited Tel: +353 1 8711Slovenija Viatris d.o.o. Tel: + 386 1 23 63 sland Icepharma hf. S mi: +354 540 8Slovensk republika Viatris Slovakia s.r.o. Tel: +421 2 32 199 Italia Viatris Italia S.r.l. Tel: + 39 02 612 46Suomi/Finland Viatris Oy Puh/Tel: + 358 20 720 9
Varnavas Hadjipanayis Ltd
: +357 2220 7Sverige Viatris AB Tel: + 46 (0)8 630 19 Latvija Mylan Healthcare SIA Tel: +371 676 055 United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: