Zyllt

Package leaflet: Information for the user

Zyllt 75 mg film-coated tablets

clopidogrel
Please read all of 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, as it may 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 Zyllt is and what it is used for
  2. What you need to know before taking Zyllt
  3. How to take Zyllt
  4. Possible side effects
  5. How to store Zyllt
  6. Contents of the pack and other information

1. What Zyllt is and what it is used for

Zyllt contains clopidogrel and belongs to a group of medicines called platelet aggregation inhibitors. Platelets are microscopic blood components that clump together during blood clotting. By preventing this aggregation, platelet aggregation inhibitors reduce the likelihood of blood clot formation (a process known as thrombosis).
Zyllt is taken by adults to prevent the formation of blood clots (thrombi) in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Zyllt has been prescribed to you to help prevent blood clot formation and to reduce the risk of these serious events because:

• you have a condition known as hardening of the arteries (also called atherosclerosis), and
• you have previously had a heart attack, a stroke, or a condition known as peripheral arterial disease, or
• you have previously experienced severe chest pain known as "unstable angina" or "myocardial infarction" (heart attack). To treat this condition, your doctor may have inserted a stent into the blocked or narrowed artery to restore blood flow. Your doctor may also have prescribed you acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting).
• you have had stroke symptoms that disappeared within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke. Your doctor may prescribe you acetylsalicylic acid 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) that prevent the formation of new clots and the progression of existing ones. You will have been informed that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of Zyllt and acetylsalicylic acid in treating this condition. If you cannot take “oral anticoagulants” and do not have an increased risk of bleeding, your doctor may have prescribed you Zyllt plus acetylsalicylic acid.

2. What you need to know before taking Zyllt

Do not take Zyllt

• If you are allergic (hypersensitive) to clopidogrel or to any of the excipients of this medicine (listed in section 6).
• If you have active bleeding, such as a stomach ulcer or bleeding in the brain.
• If you suffer from severe liver disease.

If you think any of these situations apply to you, or if you are unsure, consult your doctor before using Zyllt.

Warnings and precautions

Inform your doctor before taking Zyllt if you have any of the following conditions:

• if you are at 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 within any tissue, organ, or joint of the body)
  • a recent severe injury
  • recent surgery (including dental surgery)
  • planned surgery (including dental surgery) within the next seven days
• if you have had a blood clot in a brain artery (ischaemic stroke) that 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 condition
• if you have previously had a non-traumatic brain haemorrhage.

While taking Zyllt:

• You must inform your doctor if you are scheduled for surgery (including dental surgery)
• You must inform your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) which includes fever and skin bruising appearing as red spots, with or without unexplained extreme fatigue, 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 the bleeding to stop. This is due to the way the medicine works, as it prevents blood clots from forming. For minor cuts or injuries, such as shaving cuts or small cuts, this usually does not cause problems. However, if you are concerned about bleeding, contact your doctor immediately (see section 4 "Possible side effects")
• Your doctor may prescribe blood tests for you

Children and adolescents
Do not give this medicine to children, as it is not effective.

Other medicines and Zyllt
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Some medicines may affect the use of Zyllt or vice versa.
You must inform your doctor precisely if you are taking:

• medicines that may increase your risk of bleeding such as:
  • oral anticoagulants, medicines used to reduce blood clotting,
  • a non-steroidal anti-inflammatory drug, generally used to treat painful and/or inflammatory conditions of muscles 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 limited to fluoxetine or fluvoxamine), medicines normally used to treat depression,
  • rifampicin (used to treat serious infections),
• omeprazole or esomeprazole, medicines used to treat stomach problems,
• fluconazole or voriconazole, medicines used to treat fungal infections,
• efavirenz or other antiretroviral medicines (used to treat HIV infection),
• carbamazepine, a medicine used to treat certain forms of epilepsy,
• moclobemide, a medicine used to treat depression,
• repaglinide, a medicine used to treat diabetes,
• paclitaxel, a medicine used to treat cancer,
• opioids: while being treated with clopidogrel, you must inform your doctor before being prescribed any opioid (used to treat severe pain),
• rosuvastatin (used to lower cholesterol levels).

If you have had severe chest pain (unstable angina or heart attack), a transient ischaemic attack, or a mild ischaemic stroke, you may have been prescribed Zyllt in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever. Occasional use of acetylsalicylic acid (not more than 1,000 mg within 24 hours) should generally not cause problems, but prolonged use in other circumstances should be discussed with your doctor.

Zyllt with food and drink
Zyllt can be taken with or without food.

Pregnancy and breastfeeding
It is preferable not to take this medicine during pregnancy.
If you are pregnant or think you may be pregnant, inform your doctor or pharmacist before taking Zyllt. If you become pregnant while taking Zyllt, consult your doctor immediately, as taking Zyllt during pregnancy is not recommended.
You must not breastfeed while taking this medicine.
If you are breastfeeding or planning to breastfeed, consult your doctor before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

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

Zyllt contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Zyllt

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose, including for patients diagnosed with "atrial fibrillation" (an irregular heartbeat), is one 75 mg Zyllt tablet daily, taken orally either during or apart from meals, at the same time each day.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe you an initial dose of 300 mg or 600 mg of Zyllt (4 or 8 tablets of 75 mg) once at the beginning of treatment.
Afterwards, the recommended dose is one 75 mg Zyllt tablet daily, as described above.
If you have experienced stroke-like symptoms that disappear within a short period of time (also known as transient ischemic attack) or a mild ischemic stroke, your doctor may prescribe you an initial dose of 300 mg of Zyllt (4 tablets of 75 mg) once at the beginning of treatment. Afterwards, the recommended dose is one 75 mg Zyllt tablet daily, as described above, in combination with acetylsalicylic acid for 3 weeks. After this period, your doctor will prescribe either Zyllt alone or acetylsalicylic acid alone.
Zyllt should be taken for as long as your doctor considers it necessary.
If you take more Zyllt than you should
Contact your doctor or go to the nearest hospital emergency department, due to 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 one tablet immediately and then take the next dose at your regular time.
If more than 12 hours have passed, simply take your next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Zyllt
Do not stop treatment unless your doctor has told you to do so. Before stopping, consult your doctor or pharmacist.
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 everybody gets them.
Contact your doctor immediately if you experience:

• fever, signs of infection, or severe weakness. These effects may be due to a rare reduction in certain blood cells.
• signs of liver problems such as yellowing of the skin and/or eyes (jaundice), with or without bleeding appearing under the skin as red spots, and/or confusion (see section 2 "Warnings and precautions").
• swelling in the mouth or skin problems such as rash, itching, or skin blisters. These may be signs of an allergic reaction. The most commonly reported side effect with Zyllt is bleeding. Bleeding may occur as gastrointestinal bleeding, bruising, haematomas (unusual or subcutaneous bruising), nosebleeds, or blood in the urine. In rare cases, bleeding in the eye, intracranial bleeding, in the lungs, or in the joints has also been reported.

If you experience prolonged bleeding while taking Zyllt
If you cut or injure yourself, it may take longer than usual for the bleeding to stop. This is due to the way the medicine works, as it prevents the formation of blood clots. For minor cuts or injuries, such as self-inflicted cuts or shaving, this usually does not cause problems. However, if you are concerned about bleeding, contact your doctor immediately (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 stomach burning.

Uncommon side effects (may affect up to 1 in 100 people):
Headache, gastric ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, rash, itching, dizziness, tingling or numbness sensations.

Rare side effects (may affect up to 1 in 1,000 people):
Dizziness, breast enlargement 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, shortness of breath sometimes associated with cough; generalized allergic reactions (for example, widespread feeling of warmth with sudden general malaise up to fainting); mouth swelling; skin blisters; skin allergy; mouth pain (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; changes or loss of taste.

Side effects with unknown frequency (frequency cannot be estimated from the available data): hypersensitivity reactions with chest or abdominal pain, persistent symptoms of hypoglycaemia.

Additionally, your doctor may detect changes in blood and urine test results.

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 through 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 Zyllt

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and on the
blister after EXP. The expiry date refers to the last day of that month.
Store the medicine in its original packaging to protect it from moisture and light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Zyllt contains

• The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulfate).
• The other ingredients are: lactose (see section 2, 'Zyllt contains lactose'), microcrystalline cellulose, pregelatinized corn starch, macrogol 6000, hydrogenated castor oil in the tablet core, and hypromellose (E464), titanium dioxide (E171), iron oxide red (E172), talc, propylene glycol in the tablet coating.

Description of the appearance of Zyllt and package contents
The film-coated tablets are pink, round and slightly convex. They are supplied in packages containing blisters with 7, 14, 28, 30, 50, 56, 60, 84, 90 and 100 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warszawa, Poland
KRKA - FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62

България (Bulgaria)
КРКА България ЕООД
Teл.: + 359 (02) 962 34 50

Česká republika (Czech Republic)
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Danmark (Denmark)
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Deutschland (Germany)
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Eesti (Estonia)
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0)6 671 658

Ελλάδα (Greece)
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613

España (Spain)
KRKA Farmacéutica, S.L.
Tel: + 34 911 61 03 80

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Hrvatska (Croatia)
KRKA – FARMA d.o.o.
Tel: + 385 1 6312 100

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710

Ísland (Iceland)
LYFIS ehf.
Sími: + 354 534 3500

Italia (Italy)
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Κύπρος (Cyprus)
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882

Latvija (Latvia)
KRKA Latvija SIA
Tel: + 371 6 733 86 10

Lietuva (Lithuania)
UAB KRKA Lietuva
Tel: + 370 5 236 27 40

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: +32 (0) 487 50 73 62 (BE)

Magyarország (Hungary)
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Malta
E. J. Busuttil Ltd.
Tel: + 356 21 445 885

Nederland (Netherlands)
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)

Norge (Norway)
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Österreich (Austria)
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

Polska (Poland)
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

România (Romania)
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Slovenija (Slovenia)
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Slovenská republika (Slovakia)
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501

Suomi/Finland
KRKA Finland Oy
Puh/Tel: +358 20 754 5330

Sverige (Sweden)
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)

United Kingdom (Northern Ireland)
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710

This patient information leaflet was last approved on

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/