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CLOPIDOGREL ALET 75 MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Clopidogrel Alet 75 mg film-coated tablets
Clopidogrel (as besilate)
Read all of this leaflet carefully before you start using this medicine.
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. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Clopidogrel Alet is and what it is used for
2. Before you take Clopidogrel Alet
3. How to take Clopidogrel Alet
4. Possible side effects
5. How to store Clopidogrel Alet
6. Further information
1. WHAT CLOPIDOGREL ALET IS AND WHAT IT IS USED FOR
Clopidogrel Alet belongs to a group of medicines called antiplatelet medicinal products.
Platelets are very small structures in the blood, smaller than red or white blood cells, which
clump together during blood clotting. By preventing this clumping, antiplatelet medicinal
products reduce the chances of blood clots forming (a process called thrombosis).
Clopidogrel Alet is taken 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 Alet 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 artherosclerosis), and
- you have previously experienced a heart attack, stroke or have a condition known as
peripheral arterial disease
2. BEFORE YOU TAKE CLOPIDOGREL ALET
Do not take Clopidogrel Alet
- if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of
Clopidogrel Alet
- if you have a medical condition that is currently causing bleeding such as stomach
ulcer or bleeding within the brain;
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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 Clopidogrel Alet.
Take special care with Clopidogrel Alet
If any of the situations mentioned below apply to you, you should tell your doctor before
taking Clopidogrel Alet:
 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 are taking another type of medicine (See “Taking other medicines”)
 if you have kidney or liver disease.
While you are taking Clopidogrel Alet:
• 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 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.
• You should tell your doctor or pharmacist if you notice any side effect not listed in section 4
„POSSIBLE SIDE EFFECTS‟ or if you notice that a side effect gets serious.
Clopidogrel Alet is not intended for use in children or adolescents
Taking other medicines
Some other medicines may influence the use of Clopidogrel Alet or vice versa.
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
The use of oral anticoagulants (medicines used to reduce blood clotting) with Clopidogrel
Alet is not recommended.
You should specifically tell your doctor if you take a non-steroidal anti-inflammatory
medicinal product, usually used to treat painful and/or inflammatory conditions of muscle or

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joints, or if you take heparin or any other medicine used to reduce blood clotting or if you
take a proton pump inhibitor (e.g, omeprazole) for upset stomach.
An occasional use of acetylsalicylic acid (no more than 1000 mg in any 24 hour period)
should generally not cause a problem, but prolonged use in other circumstances should be
discussed with your doctor.
Taking Clopidogrel Alet with food and drink
Clopidogrel Alet may be taken with or without food.
Pregnancy and breast-feeding
It is preferable not to use this product during pregnancy and breast-feeding.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or pharmacist
before taking Clopidogrel Alet. If you become pregnant while taking Clopidogrel Alet,
consult your doctor immediately as it is recommended not to take clopidogrel while you are
pregnant
While taking Clopidogrel Alet, consult your doctor about the breast-feeding of a baby.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Clopidogrel Alet is unlikely to affect your ability to drive or to use machines.
Important information about some of the ingredients of Clopidogrel Alet
Clopidogrel Alet contains lactose monohydrate. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE CLOPIDOGREL ALET
Always take Clopidogrel Alet exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
The usual dose is one 75 mg tablet of Clopidogrel Alet per day to be taken orally with or
without food and at the same time each day.
You should take Clopidogrel Alet for as long as your doctor continues to prescribe it.
If you take more Clopidogrel Alet 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 Alet

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If you forget to take a dose of Clopidogrel Alet, 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 the forgotten individual dose.
If you stop taking Clopidogrel Alet
Do not stop the treatment. Contact your doctor or pharmacist before stopping.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Clopidogrel Alet 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 „Take special care with Clopidogrel Alet).
- 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 (affects 1 to 10 patients in 100) 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 Alet
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 „Take special care with Clopidogrel Alet‟).
Other side effects reported with clopidogrel are:
Common side effects (affects 1 to 10 patients in 100):
Diarrhoea, abdominal pain, indigestion or heartburn.
Uncommon side effects (affects 1 to 10 patients in 1,000):
Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or
intestines, rashes, itching, dizziness, sensation of tingling and numbness.
Rare side effect (affects 1 to 10 patients in 10,000):
Vertigo.
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Very rare side effects (affects less than 1 patient in 10,000):
Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties
sometimes associated with cough; generalized allergic reactions; swelling in the mouth;
blisters of the skin; skin allergy; inflammation of the mouth (stomatitis); decrease in blood
pressure; confusion; hallucinations; joint pain; muscular pain; changes in the way things taste.
In addition, your doctor may identify changes in your blood or urine test results.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5. HOW TO STORE CLOPIDOGREL ALET
Keep out of the reach and sight of children.
Do not store above 30°C.
Store in the original package in order to protect from moisture
Do not use Clopidogrel Alet after the expiry date which is stated on the blisters and the carton
after EXP. The expiry date refers to the last day of that month.
Do not use Clopidogrel Alet if you notice any visible sign of deterioration.
Medicines should not be disposed of via wastewater at household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
environment.
6.

FURTHER INFORMATION

What Clopidogrel Alet contains
The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as clopidogrel
besilate).
The other ingredients are:

Tablet core:
Starch, Pregelatinised
Cellulose, Microcrystalline
Crospovidone
Silica, Colloidal Anhydrous
Stearic Acid
Film-coating:
Carnauba wax
Opadry II Pink Powder 31 K34111 consisting of:
Lactose monohydrate
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Hypromellose (E464)
Titanium dioxide (E171)
Triacetin (E1518)
Iron oxide red (E172)
What Clopidogrel Alet looks like and contents of the pack
Clopidogrel Alet film-coated tablets are pink, round, biconvex, film-coated tablets with „75‟
embossed on one side and a diameter of approximately 8.3 mm.
Clopidogrel Alet is available in blister packs of: 28, 30 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Alet Pharmaceuticals S.A.
26, Aidinou str.Haidari,
12461 Athens
Greece
Manufacturer
Specifar S.A.
1, 28 Octovriou str.,
12351 Ag. Varvara
Athens, Greece
This medicinal product is authorised in the Member States of the EEA under the
following names:
Italy: Clopidogrel Alet 75 mg Compresse Rivestite con Film
Spain: Clopidogrel Alet 75 mg comprimidos recubiertos con película EFG
This leaflet was last approved in
05/2012

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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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