Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - zyllt

Document Subject

Generated Narrative: MedicinalProductDefinition mp3309175bd74a8d4a368db89c295b9d95

identifier: http://ema.europa.eu/identifier/7 film-coated tablets: EU/1/09/553/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Zyllt 75 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

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-3309175bd74a8d4a368db89c295b9d95

identifier: http://ema.europa.eu/identifier/7 film-coated tablets: EU/1/09/553/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - zyllt

Attesters

What is in this leaflet

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

Zyllt 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). Zyllt 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 Zyllt 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 Zyllt and acetylsalicylic acid for this condition. Your doctor should have prescribed Zyllt plus acetylsalicylic acid if you cannot take oral anticoagulants and you do not have a risk of major bleeding.

Do not take Zyllt

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

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 Zyllt:

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 Zyllt 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 Zyllt 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 Zyllt 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. Zyllt with food and drink Zyllt may be taken with or without food. Pregnancy and breast-feeding It is preferable not to take this medicine during pregnancy. If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Zyllt. If you become pregnant while taking Zyllt, 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 Zyllt is unlikely to affect your ability to drive or to use machines. Zyllt contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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 Zyllt 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 Zyllt (4 or 8 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Zyllt 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 Zyllt (4 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Zyllt per day as described above with acetylsalicylic acid for 3 weeks. Then the physician would prescribe either Zyllt alone or acetylsalicylic acid alone. You should take Zyllt for as long as your doctor continues to prescribe it. If you take more Zyllt than you should Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding. If you forget to take Zyllt If you forget to take a dose of Zyllt, 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. If you stop taking Zyllt 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 Zyllt 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 Zyllt 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 effects (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 out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Store in the original package in order to protect from moisture and light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away you no longer use. These measures will help to protect the environment.

What Zyllt contains

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

The other ingredients are lactose (see section 2 Zyllt contains lactose ), microcrystalline cellulose, pregelatinised maize starch, macrogol 6000 and hydrogenated castor oil in the tablet core and hypromellose (E464), titanium dioxide (E171), red iron oxide (E172), talc and propylene glycol in the film-coating. What Zyllt looks like and contents of the pack The film-coated tablets are pink, round and slightly convex. Boxes of 7, 14, 28, 30, 50, 56, 60, 84, 90 and 100 film-coated tablets in blisters are available. Not all pack sizes may be marketed. Marketing Authorisation Holder KRKA, d.d., Novo mesto, marje ka cesta 6, 8501 Novo mesto, Slovenia Manufacturer KRKA, d.d., Novo mesto, marje ka cesta 6, 8501 Novo mesto, Slovenia KRKA-POLSKA Sp. z o.o., ul. R wnoleg a 5, 02-235 Warszawa, Poland KRKA - FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien KRKA Belgium, SA. T l/Tel: + 32 (0) 487 50 73 Lietuva UAB KRKA Lietuva Tel: + 370 5 236 27

Te .: + 359 (02) 962 34 Luxembourg/Luxemburg KRKA Belgium, SA. T l/Tel: +32 (0) 487 50 73 62 (BE) esk republika KRKA R, s.r.o. Tel: + 420 (0) 221 115 Magyarorsz g KRKA Magyarorsz g Kereskedelmi Kft. Tel.: + 36 (1) 355 8Danmark KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE) Malta E. J. Busuttil Ltd. Tel: + 356 21 445 Deutschland TAD Pharma GmbH Tel: + 49 (0) 4721 606-0 Nederland KRKA Belgium, SA. Tel: + 32 (0) 487 50 73 62 (BE) Eesti KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0)6 671 Norge KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE)

KRKA
: + 30 2100101 sterreich KRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 Espa a KRKA Farmac utica, S.L. Tel: + 34 911 61 03 Polska KRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7France KRKA France Eurl T l: + 33 (0)1 57 40 82 Portugal KRKA Farmac utica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 Hrvatska KRKA FARMA d.o.o. Tel: + 385 1 6312 Rom nia KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 Ireland KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3Slovenija KRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 sland LYFIS ehf. S mi: + 354 534 3Slovensk republika KRKA Slovensko, s.r.o. Tel: + 421 (0) 2 571 04 Italia KRKA Farmaceutici Milano S.r.l. Suomi/Finland KRKA Finland Oy Tel: + 39 02 3300 8Puh/Tel: +358 20 754 5 KI.PA. (PHARMACAL) LIMITED : + 357 24 651 Sverige KRKA Sverige AB Tel: + 46 (0)8 643 67 66 (SE) Latvija KRKA Latvija SIA Tel: + 371 6 733 86 United Kingdom (Northern Ireland) KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3This leaflet was last revised in MM/YYYY. Detailed information on this medicine is available on the European Medicines Agency web site: