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CLOPIDOGREL WINTHROP 75 MG FILM-COATED TABLETS

Active substance(s): CLOPIDOGREL HYDROGEN SULFATE

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8078
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HELVETICA NEUE
9PT
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S. Valentin
11/02/2016
S. Valentin
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Libellé : NOT CLOPIDOG ALMUS 75 CP DC RL GB
Packaging Administration : Sanofi Ambarès - France

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Clopidogrel 75 mg film-coated tablets
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 Clopidogrel is and what it is used for
2. What you need to know before you take Clopidogrel
3. How to take Clopidogrel
4. Possible side effects
5. How to store Clopidogrel
6. Contents of the pack and other information

2. What you need to know before you take Clopidogrel
Do not take Clopidogrel
• 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.

1. What Clopidogrel is and what it is used for
Clopidogrel 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).

If you think any of these apply to you, or if you are in any doubt at
all, consult your doctor before taking Clopidogrel.
Warnings and precautions
Talk to your doctor or pharmacist before taking Clopidogrel:
• 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.

Clopidogrel 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 Clopidogrel 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
1

Plan
No printable color:
Pantone Process Black
Used color printable:
This artwork proof indicates colour position only.
Please refer to Pantone Colour Formula

8078
1
HELVETICA NEUE
9PT
Code LAETUS
Color
Fonts
Font size
Country GRANDE BRETAGNE
Format 170X210- DC
Brand mark logo Country requirement CRGB-V1-05/2012
04/02/2016
S. Valentin
11/02/2016
S. Valentin
Creation date
By
Modification date
By
631573
618709
Notice
2
Item code
Based on
Article
Proof n°

Libellé : NOT CLOPIDOG ALMUS 75 CP DC RL GB
Packaging Administration : Sanofi Ambarès - France

- fluconazole or voriconazole, medicines to treat bacterial and
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 kidney or liver disease.
• if you have had an allergy or reaction to any medicine used to treat
your disease.
While you are taking Clopidogrel:
• 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.

If you have experienced severe chest pain (unstable angina or heart
attack), you may be prescribed Clopidogrel 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.
Clopidogrel with food and drink
Clopidogrel may be taken with or without food.
Pregnancy and breast-feeding
It is preferable not to take this product during pregnancy.
If you are pregnant or suspect that you are pregnant, you should tell
your doctor or your pharmacist before taking Clopidogrel. If you
become pregnant while taking Clopidogrel, 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.

Children and adolescents
Do not give this medicine to children because it does not work.
Other medicines and Clopidogrel
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 Clopidogrel 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
bloodclotting.
• 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.

Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Clopidogrel is unlikely to affect your ability to drive or to use
machines.
Clopidogrel contains lactose monohydrate. 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.
Clopidogrel contains hydrogenated castor oil
This may cause stomach upset or diarrhoea.
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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 75mg tablet
of Clopidogrel 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 Clopidogrel (4 tablets
of 75 mg) once at the start of treatment. Then, the recommended
dose is one 75-mg tablet of Clopidogrel per day as described above.
You should take Clopidogrel for as long as your doctor continues to
prescribe it.

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 Clopidogrel
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').

If you take more Clopidogrel than you should
Contact your doctor or the nearest hospital emergency department
because of the increased risk of bleeding.
If you forget to take Clopidogrel
If you forget to take a dose of Clopidogrel, but remember within
12 hours of your usual time, take your tablet straightaway and then
take your next tablet at the usual time.

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

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.

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.

Used color printable:

For the 7, 14, 28 and 84 tablets pack sizes, you can check the day
on which you last took a tablet of Clopidogrel by referring to the
calendar printed on the blister.
If you stop taking Clopidogrel
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.

This artwork proof indicates colour position only.
Please refer to Pantone Colour Formula

8078
1
HELVETICA NEUE
9PT
Code LAETUS
Color
Fonts
Font size
Country GRANDE BRETAGNE
Format 170X210- DC
Brand mark logo Country requirement CRGB-V1-05/2012
04/02/2016
S. Valentin
11/02/2016
S. Valentin
Creation date
By
Modification date
By
631573
618709
Notice
2
Item code
Based on
Article
Proof n°

Libellé : NOT CLOPIDOG ALMUS 75 CP DC RL GB
Packaging Administration : Sanofi Ambarès - France

- 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.

3. How to take Clopidogrel

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

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.

4. Possible side effects

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.

In addition, your doctor may identify changes in your blood or urine
test results.
3

Plan
No printable color:

Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Manufacturers:
ZENTIVA, k.s., Prague, Czech Republic
Sanofi Winthrop Industrie, Ambares et Lagrave, France

Pantone Process Black

5. How to store Clopidogrel
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 and on the blister, after EXP. The expiry date
refers to the last day of that month.
Glass bottle: Store in the original package in order to protect from
moisture.
After opening store at temperature below 25 °C and use within
3 months.

This leaflet was last revised 02/2016

PVC/PVDC/Aluminium blister: Store below 30°C in the original
package in order to protect from moisture.
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.

What Clopidogrel contains
The active substance is clopidogrel. Each tablet contains 75 mg of
clopidogrel (as hydrogen sulfate).
The other ingredients are mannitol (E421), hydrogenated castor oil,
microcrystalline cellulose, macrogol 6000 and low-substituted
hydroxypropylcellulose in the tablet core, and lactose monohydrate
(milk sugar), hypromellose (E464), triacetin (E1518), iron oxide red
(E172), titanium dioxide (E171), and carnauba wax in the tablet
coating.
What Clopidogrel looks like and contents of the pack
Clopidogrel are round, biconvex, pink, film-coated tablets , approx.
8.5 mm in length engraved on one side with the number "75" and
on the other side with the number "1171". They are supplied in
cardboard cartons containing 7, 14, 28, 30, 84, 90 and 100 tablets

631573
170X210-DC

Used color printable:

6. Contents of the pack and other information

This artwork proof indicates colour position only.
Please refer to Pantone Colour Formula

8078
1
HELVETICA NEUE
9PT
Code LAETUS
Color
Fonts
Font size
Country GRANDE BRETAGNE
Format 170X210- DC
Brand mark logo Country requirement CRGB-V1-05/2012
04/02/2016
S. Valentin
11/02/2016
S. Valentin
Creation date
By
Modification date
By
631573
618709
Notice
2
Item code
Based on
Article
Proof n°

Libellé : NOT CLOPIDOG ALMUS 75 CP DC RL GB
Packaging Administration : Sanofi Ambarès - France

in PVC/PVDC/Aluminium blisters, or 28, 30 and 90 tablets in brown
glass bottle with white HDPE closure and desiccant.

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 Yellow card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on
the safety of this medicine.

4

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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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