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CLOPEZ 75 MG FILM-COATED TABLETS

Active substance(s): CLOPIDOGREL BISULFATE

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Package leaflet: Information for the user

CLOPEZ

75 mg film- coated tablet

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

1. What Clopez is and what it is used for

Clopez 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).
Clopez 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 Clopez 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 Clopez
and acetylsalicylic acid for this condition. Your doctor
should have prescribed Clopez 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 Clopez
Do not take Clopez
• If you are allergic to clopidogrel or to 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 Clopez.
Warnings and precautions
If any of the situations mentioned below apply to you,
you should tell your doctor before taking Clopez:
• 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),

Clopez_tbl_UK_172x310mm_mock up 6.indd 1

- 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 Clopez:
• 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 Clopez
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 Clopez 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, other antiplatelet agent,
• a selective serotonin reuptake inhibitor (including
but not restricted to fluoxetine or fluvoxamine),
medicines usually used to treat depression,
- omeprazole or esomeprazole, medicines to treat
upset stomach,
- fluconazole or voriconazole, medicines to treat fungal
infections,
-
efavirenz, a medicine to treat HIV (human
immunodeficiency virus) 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.
If you have experienced severe chest pain (unstable
angina or heart attack), you may be prescribed Clopez
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.
Clopez with food and drink
Clopez may be taken with or without food.
Pregnancy and breast-feeding
It is preferable not to use this product during pregnancy.
If you are pregnant or suspect that you are pregnant,
you should tell your doctor or pharmacist before taking
Clopez. If you become pregnant while taking Clopez,
consult your doctor immediately as it is recommended
not to take clopidogrel while you are pregnant.

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You should not breastfeed while taking this medicine.
If you are breastfeeding or planning to breastfeed, talk
to your doctor before taking this medicine.
Ask your doctor or pharmacist for advice before taking
any medicine.
Driving and using machines
Clopez is unlikely to affect your ability to drive or to use
machines.
Clopez 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.

3. How to take Clopez

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 Clopez 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
of Clopez (4 tablets of 75 mg) once at the start of treatment.
Then, the recommended dose is one 75 mg tablet of
Clopez per day as described above.
You should take Clopez for as long as your doctor continues
to prescribe it.
If you take more Clopez than you should
Contact your doctor or the nearest hospital emergency
department because of the increased risk of bleeding.
If you forget to take a Clopez
If you forget to take a dose of Clopez, 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 Clopez
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 reported with
clopidogrel 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
Clopez
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’).

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 1,000 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 of food.
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 Yellow
Card Scheme.
Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Clopez

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 after EXP. The expiry date refers to
the last day of that month.
Do not store above 25°C. Store in the original package.
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.

6. Contents of the pack and other information
What Clopez contains
• The active substance is clopidogrel.
Each film-coated tablet contains 75 mg clopidogrel (in
a form of clopidogrel hydrogen sulfate).
• Other ingredients are (see section 2 ‘Clopez contains
lactose’) Lactose monohydrate; Maize starch, partially
pregelatinised; Croscarmellose Sodium; Povidone; Silica,
Colloidal Anhydrous; Butylhydroxytoluene (E321); Glycerol
dibehenate; Hypromellose; Cellulose microcrystalline;
Titanium dioxide (E171); Colour red iron oxide (E172).
What Clopez looks like and contents of the pack
Clopez 75 mg film-coated tablets are red-pink coloured,
round, biconvex, film-coated tablets with debossed Latin
letter C on one side.
The film-coated tablets are immediate packed in pressthrough blisters (PVC/TE/PVdC/Aluminium), containing
10 tablets on each blister. The lithographed cardboard box
containing 30 tablets (3 blisters) and an instruction leaflet.
Marketing Authorisation Holder and Manufacturer
ALKALOID-INT d.o.o.,
Šlandrova ulica 4, 1231 Ljubljana – Črnuče, Slovenia
Tel.: 386 1 300 42 90
Fax: 386 1 300 42 91
email: info@alkaloid.si
This medicinal product is authorised in the Member
States of the EEA under the following names:
Bulgaria
Czech Republic
Slovenia
Romania
UK

Clopez 75 mg film-coated tablets
Clopez 75 mg potahované tablety
Clopez 75 mg filmsko obložene tablete
Clopez 75 mg comprimate filmate
Clopez 75 mg film-coated tablets

Clopez 75 mg film-coated tablets, PL 34088/0002
This leaflet was last revised in

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

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11-Dec-15 12:16:14 PM

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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