ZYLLT
Zyllt 75 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 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
1. What Zyllt is and what it is used for 4.
Possible side effects
2. What you need to know before you take Zyllt 5. How to store Zyllt
3. How to take Zyllt
6. other information
1. What Zyllt is and what it is used for
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 should 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 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.
2. What you need to know before you take Zyllt
Do not take Zyllt:
• If you are allergic 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
(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.
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
- 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,
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 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.
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 medicine.
Zyllt contains hydrogenated castor oil This may cause
stomach upset and diarrhoea.
3. How to take Zyllt
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or pharmacist if you are not
sure.
If you have experienced severe chest pain (unstable angina
or heart attack), 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 to be taken orally with or without food, and at the same time
each day.
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.
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 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 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 effect (may affect up to 1 in 1000 people): Vertigo.
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 of food.
In addition, your doctor may identify changes in your blood
or urine test results. If you get any side effects, talk to your doctor or
pharmacist.
5. How to store Zyllt
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.
6. other information
What Zyllt contains
- The active substance is clopidogrel. Each film-coated
tablet contains 75 mg of clopidogrel (as hydrogen sulphate).
- The other ingredients are anhydrous lactose (see section 2
‘Zyllt contains lactose’), microcrystalline cellulose, pregelatinised maize
starch, macrogol 6000, hydrogenated castor oil (see section 2 ‘Zyllt contains
hydrogenated castor oil’) in the tablet core and hypromellose (E464), titanium
dioxide (E171), red iron oxide (E172), talc and propylene glycol in the
filmcoating.
What Zyllt looks like and contents of the pack
The film-coated tablets are pink, round and slightly convex.
Boxes 28 film-coated tablets in blisters are available.