Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - plavix

Document Subject

Generated Narrative: MedicinalProductDefinition mp35e93ff91e96bbfad7fee25117b58d56

identifier: http://ema.europa.eu/identifier/EU/1/98/069/001 - Cartons of 28 film-coated tablets in PVC/PVDC/Alu blisters

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Plavix 75 mg film-coated tablets

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-35e93ff91e96bbfad7fee25117b58d56

identifier: http://ema.europa.eu/identifier/EU/1/98/069/001 - Cartons of 28 film-coated tablets in PVC/PVDC/Alu blisters

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - plavix

Attesters

What is in this leaflet

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

Plavix contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood which clump together during blood clotting. By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis).

Plavix is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).

You have been prescribed Plavix to help prevent blood clots and reduce the risk of these severe events because:

• You have a condition of hardening of arteries (also known as atherosclerosis), and
• You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or
• You have experienced a severe type of chest pain known as unstable angina or myocardial infarction (heart attack). For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow. You may also be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.
• You have experienced symptoms of a stroke which go away within a short period of time (also known as transient ischemic attack) or an ischemic stroke mild in severity. You may also be given acetylsalicylic acid by your doctor starting within the first 24 hours.
• You have an irregular heartbeat, a condition called atrial fibrillation , and you cannot take medicines known as oral anticoagulants (vitamin K antagonists) which prevent new clots from forming and prevent existing clots from growing. You should have been told that oral anticoagulants are more effective than acetylsalicylic acid or the combined use of Plavix and acetylsalicylic acid for this condition. Your doctor should have prescribed Plavix plus acetylsalicylic acid if you cannot take oral anticoagulants and you do not have a risk of major bleeding.

Do not take Plavix

• If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
• If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
• If you suffer from severe liver disease.

If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Plavix.

Warnings and precautions If any of the situations mentioned below apply to you, you should tell your doctor before taking Plavix:

• if you have a risk of bleeding such as

• a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer).
• a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
• a recent serious injury.
• a recent surgery (including dental).
• a planned surgery (including dental) in the next seven days.

• if you have had a clot in an artery of your brain (ischemic stroke) which occurred within the last seven days.
• if you have kidney or liver disease.
• if you have had an allergy or reaction to any medicine used to treat your disease.

• if you had a past medical history of non-traumatic brain hemorrhage. 

While you are taking Plavix:

• You should tell your doctor if a surgery (including dental) is planned.
• You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic 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 ).
• If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4. Possible side effects ).
• Your doctor may order blood tests.

Children and adolescents Do not give this medicine to children because it does not work.

Other medicines and Plavix
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Some other medicines may influence the use of Plavix or vice versa.

You should specifically tell your doctor if you take

• medicines that may increase your risk of bleeding such as: * oral anticoagulants, medicines used to reduce blood clotting, * a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, * heparin or any other injectable medicine used to reduce blood clotting, * ticlopidine, or other antiplatelet agents, * a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression, * rifampicin (used to treat severe infections)
• omeprazole or esomeprazole, medicines to treat upset stomach,
• fluconazole or voriconazole, medicines to treat fungal infections,
• efavirenz, or other anti-retroviral medicines (used to treat HIV infections),
• carbamazepine, a medicine to treat some forms of epilepsy,
• moclobemide, medicine to treat depression,
• repaglinide, medicine to treat diabetes,
• paclitaxel, medicine to treat cancer,
• opioids: while you are treated with clopidogrel, you should inform your doctor before being prescribed any opioid (used to treat severe pain),
• rosuvastatin (used to lower your cholesterol level).

If you have experienced severe chest pain (unstable angina or heart attack), transient ischemic attack or ischemic stroke in mild severity, you may be prescribed Plavix in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever. An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.

Plavix with food and drink
Plavix may be taken with or without food.

Pregnancy and breast-feeding
It is preferable not to take this product during pregnancy.

If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Plavix. If you become pregnant while taking Plavix, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.

You should not breast-feed while taking this medicine. If you are breast-feeding or planning to breast-feed, talk to your doctor before taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine.

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

Plavix contains lactose If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

Plavix contains hydrogenated castor oil
This may cause stomach upset or diarrhoea.

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

The recommended dose, including for patients with a condition called atrial fibrillation (an irregular heartbeat), is one 75 mg tablet of Plavix per day to be taken orally with or without food, and at the same time each day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg or 600 mg of Plavix (1 or 2 tablets of 300 mg or 4 or 8 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Plavix per day as described above.

If you have experienced symptoms of a stroke which go away within a short period of time (also known as transient ischemic attack) or an ischemic stroke mild in severity, your doctor may give you 300 mg of Plavix (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Plavix per day as described above with acetylsalicylic acid for 3 weeks. Then the physician would prescribe either Plavix alone or acetylsalicylic acid alone.

You should take Plavix for as long as your doctor continues to prescribe it.

If you take more Plavix than you should Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.

If you forget to take Plavix

If you forget to take a dose of Plavix, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.

If you forget for more than 12 hours, simply take the next single dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

For the 7, 14, 28 and 84 tablets pack sizes, you can check the day on which you last took a tablet of Plavix by referring to the calendar printed on the blister.

If you stop taking Plavix

Do not stop the treatment unless your doctor tells you so. Contact your doctor or pharmacist before stopping.

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.

Contact your doctor immediately if you experience:

• fever, signs of infection or extreme tiredness. These may be due to rare decrease of some blood cells.
• signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 Warnings and precautions ).
• swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin. These may be the signs of an allergic reaction.

The most common side effect reported with Plavix is bleeding. Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed, blood in the urine. In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.

If you experience prolonged bleeding when taking Plavix If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 Warnings and precautions ).

Other side effects include: Common side effects (may affect up to 1 in 10 people):
Diarrhoea, abdominal pain, indigestion or heartburn.

Uncommon side effects (may affect up to 1 in 100 people):
Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.

Rare side effect (may affect up to 1 in 1000 people):
Vertigo, enlarged breasts in males.

Very rare side effects (may affect up to 1 in 10,000 people):
Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in taste or loss of taste of food.

Side effects with frequency not known (frequency cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain, persistent low blood sugar symptoms.

In addition, your doctor may identify changes in your blood or urine test results.

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.

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 and on the blister, after EXP. The expiry date refers to the last day of that month.

Refer to the storage conditions on the carton. If Plavix is supplied in PVC/PVDC/aluminium blisters, store below 30 C. If Plavix is supplied in all aluminium blisters, it does not require any special storage conditions.

Do not use this medicine if you notice any visible sign of deterioration.

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 Plavix contains
The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate).

The other ingredients are (see section 2 Plavix contains lactose and Plavix contains hydrogenated castor oil ):

• Tablet core: mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose,
• Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172) and titanium dioxide (E171),
• Polishing agent: carnauba wax.

What Plavix looks like and contents of the pack

Plavix 75 mg film-coated tablets are round, biconvex, pink, engraved on one side with the number 75
and on the other side with the number 1171 . Plavix is supplied in cardboard cartons containing:

• 7, 14, 28, 30, 84, 90 and 100 tablets in PVC/PVDC/Aluminium blisters or in all aluminium blisters
• 50x1 tablets in PVC/PVDC/Aluminium blisters or in all aluminium unit-dose blisters.
  Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers

Marketing Authorisation Holder:
Sanofi Winthrop Industrie 82 avenue Raspail 94250 Gentilly France

Manufacturers: Sanofi Winthrop Industrie 1, rue de la Vierge, Ambar s & Lagrave, F-33565 Carbon Blanc cedex, France or Delpharm Dijon 6, boulevard de l'Europe, F-21800 Qu tigny, France or Sanofi S.r.l. Strada Statale 17, Km 67019 Scoppito (AQ) Italy or Sanofi Winthrop Industrie 30-36 avenue Gustave Eiffel 37100 Tours France

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

Belgi /Belgique/Belgien Sanofi Belgium T l/Tel: +32 (0)2 710 54 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91
Swixx Biopharma EOOD : +359 (0)2 4942 Luxembourg/Luxemburg Sanofi Belgium
T l/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

esk republika sanofi-aventis, s.r.o. Tel: +420 233 086 Magyarorsz g SANOFI-AVENTIS Zrt. Tel.: +36 1 505 0Danmark Sanofi A/S Tlf: +45 45 16 70 Malta Sanofi S.r.l. Tel: +39 02 39394Deutschland Sanofi-Aventis Deutschland GmbH Tel.: 0800 52 52 Tel. aus dem Ausland: +49 69 305 21 Nederland Sanofi B.V. Tel: +31 20 245 4Eesti Swixx Biopharma O
Tel: +372 640 10 Norge sanofi-aventis Norge AS Tlf: +47 67 10 71
Sanofi-Aventis AEBE : +30 210 900 16 sterreich sanofi-aventis GmbH Tel: +43 1 80 185 0

Espa a sanofi-aventis, S.A. Tel: +34 93 485 94 Polska sanofi-aventis Sp. z o.o. Tel: +48 22 280 00 France Sanofi Winthrop Industrie T l: 0 800 222 Appel depuis l tranger: +33 1 57 63 23 Portugal Sanofi - Produtos Farmac uticos, Lda Tel: +351 21 35 89 Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 Rom nia Sanofi Romania SRL Tel: +40 (0) 21 317 31 Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 Slovenija Swixx Biopharma d.o.o. Tel: +386 1 235 51 sland Vistor hf. S mi: +354 535 7Slovensk republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 Italia Sanofi S.r.l. Tel: 800 536 Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200
C.A. Papaellinas Ltd. : +357 22 741Sverige Sanofi AB Tel: +46 (0)8 634 50 Latvija Swixx Biopharma SIA Tel: +371 6 616 47 United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2This leaflet was last revised in Month YYYY.

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/

Package leaflet: Information for the user

Plavix 300 mg film-coated tablets
clopidogrel

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you have any side effects, including any side effects not listed in this leaflet, talk to your doctor or pharmacist. See section 4.