SURGAM TABLETS 300MG

Active substance: TIAPROFENIC ACID

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Surgam 300 mg Tablets
tiaprofenic acid
Is this leaflet hard to
see or read?
Phone 0845 372 7101
for help
Read all of this leaflet carefully
before you start taking 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. See section 4.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Surgam is and what it is used for
Before you take Surgam
How to take Surgam
Possible side effects
How to store Surgam
Further information

1. What Surgam is and what
it is used for
The name of your medicine is Surgam
300 mg Tablets (called Surgam in this
leaflet). Surgam contains a medicine called
tiaprofenic acid. This belongs to a group of
medicines called ‘non-steroidal antiinflammatory drugs’ (NSAIDs). It works by
blocking some chemicals in your body that
normally cause inflammation.
It is used to treat the swelling, pain, heat,
redness and stiffness in your joints and
muscles in the following:
• Rheumatoid arthritis (inflammation of
the joints)
• Osteoarthritis (where the cushioning
(cartilage) between the bone joints is
damaged)
• Lower back pain
• Sprains and strains
• Pain and inflammation after an operation
• Other painful inflammatory joint or
muscle problems

2. Before you take Surgam

Take special care with Surgam

Do not take this medicine and
tell your doctor if:
You are allergic (hypersensitive) to
tiaprofenic acid or any of the other
ingredients of Surgam (listed in
Section 6 below)
Signs of an allergic reaction include: a
rash, swallowing or breathing problems,
swelling of your lips, face, throat or
tongue
-1-

You are allergic (hypersensitive) to any
other similar medicines (non-steroidal
anti-inflammatory drugs or NSAIDs) such
as aspirin or ibuprofen
You have or ever had an ulcer (burning,
aching pain with an empty feeling and
hunger) or bleeding in your stomach or
gut
You have or ever had asthma
You have severe heart problems
You have kidney or liver problems
You have or ever had problems passing
water (urine) such as pain, blood in
your urine or passing water more often
than usual
You are in the last three months of
pregnancy (see ‘pregnancy and
breast-feeding’ below)
Do not take this medicine if any of the
above apply to you. If you are not sure,
talk to your doctor or pharmacist before
taking Surgam.

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Check with your doctor or
pharmacist before taking your
medicine if:

L You often have or ever had something
called ‘rhinitis’ (runny nose, itching,
sneezing and stuffy nose – for example
if you have hayfever)
L You often have or ever had something
called ‘urticaria’ (itchy lumpy rash)
L You have ulcerative colitis or
Crohn’s disease

L You have a disease affecting the skin,
joints or kidney called ‘Sytemic Lupus
Erythematous’ (SLE)
L You are elderly
L You have blood problems (such as
unusual bruising or bleeding)
L You have ever had high blood pressure
(hypertension)
L You have ever had heart problems such
as a stroke
L You have diabetes
L You have ever had a high cholesterol
level
L You are a smoker
L You think you might be at risk of heart
problems such as stroke
L You are in the first six months of
pregnancy (see ‘pregnancy and
breast-feeding’ below)
L You are planning to become pregnant
or you have problems becoming
pregnant. Surgam may make it more
difficult to become pregnant
If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking Surgam.

Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines. This includes medicines you buy
without a prescription, including herbal
medicines. This is because Surgam can
affect the way some other medicines work.

Also some medicines can affect the way
Surgam works.
In particular, tell your doctor if you are
taking any of the following:
• Other non-steroidal anti-inflammatory
drugs such as aspirin, ibuprofen,
celecoxib, etodolac or meloxicam
• Water tablets (diuretics) such as
spironolactone, triamterene or amiloride
used to increase the flow of your water
(urine)
• Antibiotics such as quinolone, sulphonamides
or aminoglycosides (for infections)
• Corticosteroids such as prednisolone (for
inflammation, allergies or some types of
cancer)
• Medicines for lowering your blood sugar
such as medicines for diabetes
• Medicines for lowering your blood
pressure (antihypertensives)
• Medicines called ‘cardiac glycosides’ such
as digoxin (for heart failure)
• Medicine to stop your blood clotting such as
heparin, warfarin, clopidogrel or triclopidine
• Medicine to dissolve blood clots such as
streptokinase, altepase, reteplase or
tenecteplase
• Ciclosporin – used after an organ
transplantation to help prevent rejection
• Medicines for depression such as fluoxetine,
sertraline, citalopram or paroxetine
• Mifepristone - for terminating a
pregnancy. It is important not to use
Surgam for at least 8–12 days after
taking Mifepristone
-2-






Lithium - for some types of mental illness
Phenytoin - for epilepsy
Methotrexate - for some types of cancer
Probenecid - used with a medicine
called cidofovir to stop kidney damage
• Tacrolimus - used after an organ
transplant
• Zidovudine - an antiviral drug
Please tell your doctor if you are taking
any of these medicines.

Pregnancy and breast-feeding
Talk to your doctor before taking this
medicine if:
• You are pregnant, might become
pregnant, or think you may be pregnant
• You are breast-feeding or planning to
breast-feed
Ask your doctor or pharmacist for advice
before taking any medicine if you are
pregnant or breast-feeding.

Driving and using machines
You may feel sleepy, dizzy, faint or your
eyesight may be affected while taking this
medicine. If this happens, do not drive or
use any tools or machines.

3. How to take Surgam
Always take Surgam exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.

Taking this medicine




Take this medicine by mouth
Take with or after food
Swallow the tablets whole with a drink
of water




Do not crush or chew your tablets
If you feel the effect of your medicine is
too weak or too strong, do not change
the dose yourself, but ask your doctor

Adults

If you stop taking Surgam

The usual dose of Surgam is 1 tablet twice
a day.

If you have any further questions
on the use of this product, ask your
doctor or pharmacist.

Children
Surgam is not recommended for children.

If you take more Surgam than you
should
If you take more tablets than you should,
tell a doctor or go to a hospital casualty
department straight away. Take the
medicine pack with you. This is so the
doctor knows what you have taken.
High doses of Surgam and prolonged
treatment can increase the chances of you
having a heart attack or stroke (see Section 4:
Possible side effects). Do not exceed the
recommended dose or duration of treatment.

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

Stop taking and see your doctor or
go to a hospital straight away if:






If you forget to take Surgam
If you forget a dose, take it as soon as you
remember. However, if it is nearly time for
the next dose, skip the missed dose. Do
not take a double dose to make up for a
forgotten tablet.



4. Possible side effects

The elderly (over 65 years)
You are more likely to get side effects
while taking Surgam. Your doctor may lower
the number of tablets that you take.



Keep taking your medicine until your doctor
tells you to stop. Do not stop taking
Surgam just because you feel better. If you
stop, your illness may get worse.



You have an allergic reaction. The signs
may include: a rash, swallowing or
breathing problems, swelling of your
lips, face, throat or tongue
Your asthma is getting worse - this may
be a sign of an allergic reaction
You have difficulty breathing, wheezing,
tightness in the chest (something called
‘bronchospasm’)
You have a heart attack (myocardial
infarction) or stroke. Medicines such as
Surgam may be associated with a small
increased risk of heart attack or stroke
(see Section 3: If you take more Surgam
than you should)
You have blistering or bleeding of the
skin around your lips, eyes, mouth, nose
and genitals. You may also have flu-like
symptoms and fever. This may be
something called ‘Stevens-Johnson syndrome’
-3-






You have a severe blistering rash where
layers of your skin may have peeled off
to leave large areas of raw exposed skin
over your body. Also you may feel
generally unwell, with a fever, chills and
aching muscles. This may be something
called ‘Toxic epidermal necrolysis’
You are vomiting any blood or dark
particles that look like coffee grounds,
have severe stomach pains or pass
blood in your stools (faeces) or have
dark tarry stools. These are signs of an
ulcer that has made tiny holes in your
stomach or gut that are bleeding
You have a burning, aching pain in
your stomach, with an empty feeling
and hunger. You may have an ulcer in
your stomach or gut
You feel pain when passing water
(urine), have to pass water more often
than usual or have blood in your urine
Your limbs are swollen (signs of fluid
retention), you feel tired (fatigued) and
generally unwell. You may have
something called ‘kidney toxicity’

Tell your doctor as soon as possible
if you have any of the following
side effects:



You have worsening of your Crohn’s
disease or colitis
You have severe stomach pain, which may
reach through to your back. This could be
a sign of inflammation of the pancreas
(pancreatitis). This is a very rare side
effect
















You have a skin reaction to light or
sunlamps (photosensitivity)
You have skin reactions such as itchy,
lumpy rash (‘urticaria’), redness, blood
spots (‘purpura’), or hair loss, balding
(‘alopecia’)
Your eyes or skin go yellow (jaundice).
This may be a sign of liver problems.
You may have something called
‘hepatitis’. This would also show up in
the results of some blood tests
You bruise more easily than usual or
have bleeding that lasts a long time.
This could be because of a blood
problem called ‘thrombocytopenia’
You have more infections than usual. This
could be because of blood disorders called
‘agranulocytosis’ or ‘neutropenia’
You feel tired, faint, dizzy and have
pale skin (anaemia)
You have pain in your eyes (optic neuritis)
You have problems with your eyesight
You feel depressed, confused or are
having hallucinations
You have stiff neck, headache, nausea,
vomiting, fever or disorientation.

Tell your doctor or pharmacist if any
of the following side effects get
serious or last longer than a few
days. Also tell them if you notice any
side effects not listed in this leaflet.




Indigestion, heartburn, stomach pain,
constipation or wind (flatulence)
Feeling sick (nausea), being sick
(vomiting) or diarrhoea
Decreased appetite (anorexia)





Swelling in the mouth
Headaches
Drowsiness, dizziness or ringing in the
ears (tinnitus)
• Pins and needles (something called
‘paraesthesia’)
These side effects may go away during
treatment as your body gets used to the
medicine.

Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. 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.

5. How to store Surgam
Keep this medicine in a safe place where
children cannot see or reach it.
Do not use Surgam after the expiry date which
is stated on the carton after EXP. The expiry
date refers to the last day of that month.
Store below 25°C. Keep the blister strip in
the outer carton in order to protect from
light. Do not transfer your medicine to
another container.
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.
-4-

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6. Further information
What Surgam contains



Each tablet contains 300 mg of the
active substance, tiaprofenic acid
The other ingredients are maize starch,
poloxamer, magnesium stearate and
purified talc

What Surgam looks like and contents
of the pack
Surgam tablets are white to creamy white
biconvex tablets with the Roussel logo on
one side and a breakline on the other side.
‘Surgam’ and ‘300’ are embossed on the
tablet. They are available in blister packs of
56 tablets.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey,
GU1 4YS, UK.
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
Sanofi Winthrop Industrie,
56 Route de Choisy-au-Bac,
60205 Compiegne, France.

This leaflet was last revised in
October 2013
© sanofi, 1982-2013

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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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