Consumer Medication Information Leaflet (RiMUP)
CoPlavix® 75/100 mg film-coated tablets
Clopidogrel (75 mg) / Acetylsalicylic acid (100 mg)
What is in this leaflet
1. What CoPlavix is used for
2. How CoPlavix works
3. Before you use CoPlavix
4. How to take CoPlavix
5. While you are using CoPlavix
6. Side effect
7. Storage and Disposal of CoPlavix
8. Product description
9. Manufacturer and Product
Registration Holder
10. Date of revision
What CoPlavix is used for
CoPlavix is taken by adult to prevent
blood clots forming in hardened arteries
which can lead to atherothrombotic
events (such as stroke, heart attack, or
death).You have been prescribed
CoPlavix in place of the two separate
medicines, clopidogrel and ASA, to help
prevent blood clots because you have
experienced a severe type of chest pain
known as ‘unstable angina’ or heart
attack (myocardial infarction). For the
treatment of this condition your doctor
may have placed a stent in the blocked
or narrowed artery to restore effective
blood flow.
- a medical condition that puts you at risk
How CoPlavix works
CoPlavix contains clopidogrel and
acetylsalicylic acid (ASA) 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 in
some types of blood vessels (called
arteries), antiplatelet medicinal products
reduce the chances of blood clots
forming (a process called
atherothrombosis).
Before you use CoPlavix
-When you must not use it
Do not take CoPlavix:
• If you are allergic (hypersensitive)
to clopidogrel, acetylsalicylic acid
(ASA) or any of the other
ingredients of CoPlavix.
• If you are allergic to other products
called non-steroidal anti-
inflammatory products
usually used to treat painful and/or
inflammatory conditions of
muscles or joints.
• If you have a medical condition that
include the combination of asthma,
MY/COP/0822/SmPC1121
nasal discharge (runny nose) and
polyps (a type of growth in the
nose).
• 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 suffer from severe kidney
disease.
• If you are in your last trimester of
pregnancy
Use in children
CoPlavix is not intended for use in
children or adolescents less than 18 years
of age. There is a possible association
between acetylsalicylic acid (ASA) and
Reye’s Syndrome when products
containing ASA are given to children or
adolescents with a viral infection. Reye’s
Syndrome is a very rare disease which
can be fatal.
-Before you start to use it
If any of the situations mentioned below
apply to you, you should tell your doctor
before taking CoPlavix:
• if you have a risk of bleeding such
as:
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 in the last seven days.
• if you have kidney or liver disease.
• if you have a history of asthma or
allergic reactions.
• if you have gout.
• if you drink alcohol, because of the
increased risk of bleeding or
gastrointestinal injury.
• if you have a condition known as
glucose-6-phosphate dehydrogenase
(G6PD) deficiency because of the
risk of a particular form of anaemia
(low number of red blood cells).
Taking other medicines
Please 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 CoPlavix 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,
- ASA or another 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 to
treat depression,
- rifampicin (used to treat severe
infections)
- omeprazole or esomeprazole,
medicines to treat upset
stomach,
- methotrexate, a medicine used
to treat severe joint disease
(rheumatoid arthritis) or skin
disease (psoriasis),
- acetazolamide, a medicine used
to treat glaucoma (increased
ocular pressure) or epilepsy or
to increase urine flow,
- probenecid, benzbromarone, or
sulfinpyrazone, medicines used
to treat gout,
- fluconazole or voriconazole, ,
medicines to treat fungal
infections,
- efavirenz or tenofovir, or other
anti-retroviral medicines (used
to treat HIV infections),
- valproic acid, valproate or
carbamazepine, medicines to
treat some forms of epilepsy,
the varicella vaccine, a
medicine used to prevent
chickenpox or shingles, within
6 weeks of taking CoPlavix, or
if you have active chickenpox
1

or shingles infection,
- moclobemide, medicine to treat
depression,
- repaglinide, medicine to treat
diabetes,
- paclitaxel, medicine to treat
cancer,
- nicorandil, medicine to treat
cardiac chest pain,
- opioids: while you are treated
with clopidogrel, you should
inform your doctor before being
prescribed any opioids (used to
treat severe pain).
- rosuvastatin (used to lower your
cholesterol level).
• You should stop other clopidogrel
treatment while you are taking
CoPlavix.
• An occasional use of ASA (no
more than 1,000 mg in any 24-hour
period) should generally not cause
a problem, but prolonged use of
ASA in other circumstances
should be discussed with your
doctor or pharmacist.
Pregnancy and Breast-feeding
Do not take CoPlavix during third the calendar printed on the blister.
trimester of pregnancy.
It is preferable not to take this medicine -If you take more
during first and second trimesters of Contact your doctor or the nearest Do not stop the treatment unless your
pregnancy.
• If you are pregnant or suspect that
you are pregnant, you should tell While you are using it
your doctor or your pharmacist -Things you must do
before taking CoPlavix. If you
become pregnant while taking
CoPlavix, consult your doctor
immediately as it is recommended
not to take CoPlavix while you are
pregnant.
• 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.
• If you have any further questions on
the use of this product, ask your
doctor or pharmacist
How to use CoPlavix
-How much to take
Always take CoPlavix exactly as your
doctor or pharmacist has told you.
Check with your doctor or pharmacist
if you are not sure.
The recommended dose is one tablet of
CoPlavix per day to be taken orally with
a glass of water, with or without food.
MY/COP/0822/SmPC1121
Consumer Medication Information Leaflet (RiMUP)
-When to use it you should contact your doctor
You should take your medicine at the straightaway (see section ‘Side
same time each day. Effect’).
• Your doctor may order blood tests.
-How long to use it -Things you must not do
Depending on your condition, your Do not take CoPlavix during third
doctor will determine the length of time trimester of pregnancy.
for which you need to take CoPlavix. If It is preferable not to take this product
you have had a heart attack, it should be during first and second trimesters of
prescribed for at least four weeks. In any pregnancy.
case, you should take it for as long as You should not breastfeed while using
your doctor continues to prescribe it. this medicine.
-If you forget to use it
If you forget to take a dose of CoPlavix, -Things to be careful of
but remember within 12 hours of your Important information about some of the
usual time, take your tablet straightaway ingredients of CoPlavix
and then take your next tablet at the CoPlavix contains lactose. If you have
usual time. been told by your doctor that you have an
intolerance to some sugars (e.g. lactose),
If you forget for more than 12 hours, contact your doctor before taking this
simply take the next single dose at the medicine.
usual time. Do not take a double dose to
make up for the forgotten individual CoPlavix also contains hydrogenated
doses. castor oil which may cause stomach
For the 14, 28 and 84 tablets pack sizes upset or diarrhoea.
you can check the day on which you last
took a tablet of CoPlavix by referring to Driving and using machines
CoPlavix should not affect your ability
to drive or to use machines.
too much (overdose)
hospital emergency department because doctor tells you so. Contact your doctor
of the increased risk of bleeding. or pharmacist before stopping.
If you have been told by your doctor to
stop treatment temporarily ask your
• You should tell your doctor doctor when to restart the treatment.
- if a surgery (including dental) is
Side Effect
planned.
Like all medicines, CoPlavix can cause
- if you have any stomach or
side effects, although not everybody gets
abdominal pain or bleeding in
them.
the stomach or bowels (red
The frequency of possible side effects
stools or black stools).
listed below is defined using the
• You should also tell your doctor following convention:
immediately if you develop a - very common (affects more than 1 user
medical condition (also known as in 10)
Thrombotic Thrombocytopenic - common (affects 1 to 10 users in 100)
Purpura or TTP) that includes fever - uncommon (affects 1 to 10 users in
and bruising under the skin that may 1,000)
appear as red pinpoint dots, with or - rare (affects 1 to 10 users in 10,000)
without unexplained extreme - very rare (affects less than 1 user in
tiredness, confusion, yellowing of 10,000)
the skin or eyes (jaundice) (see - not known (frequency cannot be
section ‘Side Effect). estimated from the available data)
• If you cut or injure yourself, it may
take longer than usual for bleeding Contact your doctor immediately if
to stop. This is linked to the way you experience:
your medicine works as it prevents
- fever, signs of infection or extreme
the ability of blood clots to form.
tiredness. These may be due to rare
For minor cuts and injuries e.g.,
decrease of some blood cells.
cutting yourself, shaving, this is
- signs of liver problems such as
usually of no concern. However, if
yellowing of the skin and/or the eyes
you are concerned by your bleeding,
2
 Consumer Medication Information Leaflet (RiMUP)

(jaundice), whether or not associated allergic reactions, kidney disease, low Tablet coating: lactose monohydrate,
with bleeding which appears under the blood sugar, gout (a condition of hypromellose (E464), titanium dioxide
skin as red pinpoint dots, and/or painful, swollen joints caused by uric (E171), triacetin (E1518), red iron
confusion. acid crystals) and worsening of food oxide (E172) Polishing agent: carnauba
- swelling in the mouth or skin allergies, a particular form of anaemia wax
disorders such as rashes and itching, (low number of red blood cells) (see MAL Numbers:
blisters of the skin. These may be the section Before you use CoPlavix) . MAL12115075AZ
signs of an allergic reaction.
In addition, your doctor may identify
changes in your blood or urine tests. Manufacturer and Product
The most common side effect which
Registration Holder
has been seen with CoPlavix is If any of the side effects gets serious, or
bleeding. Bleeding may occur as if you notice any side effects not listed Manufacturer
bleeding in the stomach or bowels, in this leaflet, please tell your doctor or Sanofi Winthrop Industrie
bruising, haematoma (unusual pharmacist. 1, rue de la Vierge
bleeding or bruising under the skin), You may report any side effects or Ambares et Lagrave
nose bleed, blood in the urine. In a adverse drug reactions directly to the 33565 Carbon Blanc Cedex
small number of cases, bleeding in the National Centre for Adverse Drug France.
eye, inside the head, the lung or the Reaction Monitoring by visiting the
joints has also been reported. website npra.gov.my [Consumers→ Product Registration Holder
Reporting Side Effects to Medicines Sanofi-aventis (Malaysia) Sdn. Bhd.
If you experience prolonged (ConSERF) or Vaccines (AEFI)] Unit TB-18-1, Level 18, Tower B, Plaza
bleeding when taking CoPlavix. 33
If you cut or injure yourself, it may Storage and Disposal of CoPlavix No.1 Jalan Kemajuan, Seksyen 13,
take longer than usual for bleeding to -Storage 46200 Petaling Jaya,
stop. This is linked to the way your Keep out of the reach and sight of Selangor Darul Ehsan,
medicine works as it prevents the children. Malaysia.
ability of blood clots to form. Do not use CoPlavix after the expiry
For minor cuts and injuries e.g., cutting date which is stated on the carton and Date of revision
yourself, shaving, this is usually of no on the blister, after EXP. The expiry date 02/08/2022
concern. However, if you are concerned refers to the last day of the month. Store Serial Number
by your bleeding, you should contact below 25°C. NPRA (R1/3) 01082022/233
your doctor straight away. Do not use CoPlavix if you notice any
visible sign of deterioration
The other side effects which have been
seen with CoPlavix are: -Disposal
Common side effects: Diarrhoea, Do not throw away any medicines via
abdominal pain, indigestion or wastewater or household waste. Ask
heartburn. your pharmacist how to throw away
medicines you no longer use. These
Uncommon side effects: Headache, measures will help to protect the
stomach ulcer, vomiting, nausea, environment.
constipation, excessive gas in stomach
or intestines, rashes, itching, dizziness, Product Description
sensation of tingling and numbness. -What it looks like?
Rare side effect: Vertigo, enlarged CoPlavix 75 mg/100 mg film-coated
breasts in males. tablets (tablets) are oval, slightly
biconvex, light pink, engraved on one
Very rare side effects: Jaundice; severe side with ‘C75’ and ‘A100’on the
abdominal pain with or without back other side.
pain; fever, breathing difficulties
sometimes associated with cough; -Ingredients:
generalised allergic reactions(for -Active ingredient:
example, overall sensation of heat with The active substances are clopidogrel
sudden general discomfort until and acetylsalicylic acid. Each tablet
fainting); swelling in the mouth; blisters contains 75 mg of clopidogrel (as
of the skin; skin allergy; inflammation of hydrogen sulphate) and 100 mg of
the mouth (stomatitis); decrease in blood acetylsalicylic acid.
pressure; confusion; hallucinations;
joint pain; muscular pain; changes in -Inactive ingredients:
taste or loss of taste of food, Tablet core: mannitol (E421), macrogol
inflammation of small vessels. 6000, microcrystalline cellulose, low
Side effects with frequency not known: substituted hydroxypropylcellulose,
ulcer perforation, ringing in the ears, maize starch, hydrogenated castor oil,
hearing loss, sudden life-threatening stearic acid and colloidal anhydrous
silica.
MY/COP/0822/SmPC1121 3