B. PACKAGE LEAFLET
P ackage leaflet: Information for the user
Zyllt 75 mg f ilm-coated tablets
Clopidogrel
Read all of this l eaflet 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 prescr ibed 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
- What Zyllt is and what it is used for
- What you need to know before you take Zyllt
- How to take Zyllt
- Possible side effects
- How to store Zyllt
- Contents of the pack and other infor ma tion
1. W hat Zyllt is and w hat it is used for
Zyllt contains clopidogrel and be longs 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, antiplatel et 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 a therothrombotic events (such as stroke, heart attack, or death).
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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 should also be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as t o prevent blood clotting) by your doctor.
- 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 for ming and prevent exist ing 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 acetylsalicyli c acid if you cannot take ‘oral anticoagulants’ and you do not have a risk of major bleeding.
2. What you need to know before you take Zyllt
Do not take Zyllt:
- I f you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in s ection 6).
- I f you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain.
- I f 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 h ad a clot in an artery of your brain (ischaemic 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.
Whil e 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 a nd bruising under the skin that may appear as red pinpoint dots, wit h or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see se ction 4 ‘ POSSIBLE SIDE EFFECTS’).
- If you cut or injure yourself, it may take longer t han 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 yo ur bleeding, you should contact your doctor straightaway (see se ction 4 ‘ POSSIBLE SIDE EFFECTS’).
- Your doctor may order blood tests.
Ch ildren and adolescents
Do not give this medicine to children because it does not work.
O ther medicines and Zyllt
T ell y our doctor or pharmacist if you are taking, have recently taken or m ight 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 do ctor if you take
- oral anticoagulants, medicines used to reduce blood clotting,
- a non-ste roidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints,
- heparin or any other injectable medicine used to re duce blood clotting,
- omeprazole, esomeprazole or cimetidine, medicines to treat upset stomach,
- fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines to treat bacterial and fungal infections,
- carbamazepine, or oxcarbazepine, medicines to t re at some forms of epilepsy,
- ticlop idine, other antiplatelet agent,
- a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression,
- moclobemide, medicine to treat depression.
If you have experienced severe chest pain (unstable angina or heart attack), 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 acetylsa li cylic 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.
Pregnancy and breast-feeding
It is preferable not to take this medicine during pr egnancy.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist befor e taking Zyllt. If you become pregnant while taking Zyllt, consult your doctor immediately as it is recommended not to take clopidogrel whil e 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.
As k your doctor or pharmacist for advice before taking any medicine.
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