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TUXEDON 75 MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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 TUXEDON is and what it is used for
2. Before you take TUXEDON
3. How to take TUXEDON
4. Possible side effects
5. How to store TUXEDON
6. Further information
1.   WHAT TUXEDON IS AND WHAT IT IS
  USED FOR
TUXEDON 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).
TUXEDON 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 TUXEDON 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, 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.
2.  BEFORE YOU TAKE TUXEDON
Do not take TUXEDON
–– if you are allergic (hypersensitive) to clopidogrel
or any of the other ingredients of TUXEDON
–– if you have a medical condition that is currently
causing bleeding such as 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
TUXEDON.
Take special care with TUXEDON
If any of the situations mentioned below apply
to you, you should tell your doctor before taking
TUXEDON
• 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 TUXEDON:
• 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.
TUXEDON is not intended for use in children or
adolescents
Taking other medicines
Some other medicines may influence the use of
TUXEDON 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 TUXEDON 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 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.
If you have experienced severe chest pain (unstable
angina or heart attack), you may be prescribed
TUXEDON 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 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 TUXEDON with food and drink
TUXEDON 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 TUXEDON. If you become pregnant while
taking TUXEDON, consult your doctor immediately
as it is recommended not to take clopidogrel while
you are pregnant.
While taking TUXEDON, 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
TUXEDON is unlikely to affect your ability to drive
or to use machines.
Important information about some of the
ingredients of TUXEDON
TUXEDON 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.

PharmaCode

TUXEDON 75 mg film-coated tablets
Clopidogrel (as clopidogrel besilate)

4. POSSIBLE SIDE EFFECTS
Like all medicines, TUXEDON 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 TUXEDON).
–– 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 TUXEDON
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 TUXEDON).
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.
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 TUXEDON
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 TUXEDON 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 TUXEDON if you notice any visible sign
of deterioration.
Medicines should not be disposed of via wastewater
or 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 TUXEDON contains
The active substance is clopidogrel. Each tablet
contains 75 mg of clopidogrel (as clopidogrel besilate).
The other ingredients are:
Tablet core:
Maize Starch, Pregelatinised
Cellulose, Microcrystalline
Crospovidone Type A
Silica, Colloidal Anhydrous
Stearic Acid Type 50
Film-coating:
Carnauba wax
Lactose monohydrate
Hypromellose (E464)
Titanium dioxide (E171)
Triacetin (E1518)
Iron oxide red (E172)
What TUXEDON looks
like and contents
of the pack
TUXEDON film-coated tablets are pink, round,
biconvex, film-coated tablets with ‘75’ embossed on
one side and a diameter of approximately 8.3 mm.
TUXEDON is available in blister packs of: 28, 84
film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
ICN Polfa Rzeszów S.A.
2 Przemysłowa Street,
35-959 Rzeszów
Poland
Manufacturer
Specifar Pharmaceuticals
ICN Polfa Rzeszów S.A.
1, 28 Octovriou str.
2 Przemysłowa Street,
123 51, Ag.Varvara
35-959 Rzeszów
Athens,
Poland
Greece
This medicinal product is authorised in the
Member States of the EEA under the following
names:
UK: TUXEDON 75 mg Film coated tablets
BG: TUXEDON 75 mg Фипмирана табпетка
CZ: TUXEDON 75 mg potahované tablety
HU: TUXEDON 75 mg Filmtabletten
PL:
TUXEDON 75 mg
RO: TUXEDON 75 mg Comprimat filmat
SK:
TUXEDON 75 mg
This leaflet was last approved in 09/10/2009.

PharmaCode

3. HOW TO TAKE TUXEDON
Always take TUXEDON 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 TUXEDON
per day to be taken orally with or without food and at
the same time each day.
In addition, if you have experienced severe chest pain
(unstable angina or heart attack), your doctor may
give you 300 mg of TUXEDON (4 tablets of 75 mg)
as a single dose at the start of the treatment.
Then the usual dose is one 75 mg tablet of
TUXEDON per day to be taken orally with or
without food and at the same time each day.
You should take TUXEDON for as long as your
doctor continues to prescribe it.
If you take more TUXEDON than you should
Contact your doctor or the nearest hospital
emergency department because of the increased risk
of bleeding.
If you forget to take TUXEDON
If you forget to take a dose of TUXEDON, 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
doses.
If you stop taking TUXEDON
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.

Expand Transcript

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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