FROBEN TABLETS 50MG

Active substance: FLURBIPROFEN MILLED

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Flurbiprofen 50 mg Tablets
Flurbiprofen 100 mg Tablets
Flurbiprofen

IMPORTANT INFORMATION
Read all this leaflet carefully
before you start taking this
medicine
• Keep this leaflet as you may
need to read it again
• This leaflet provides a
summary of the information
currently available about
Flurbiprofen Coated Tablets
• For further information or
advice ask your doctor or
pharmacist
• This medicine is for you only
and should never be given
to anyone else, even if they
appear to have the same
symptoms as you
• Tell your doctor or
pharmacist if you experience
any serious side effects or
any side effects that are not
listed in this leaflet.

Leaflet contents:
1. What are Flurbiprofen Coated Tablets and
what are they used for?
2. What should you know before taking
Flurbiprofen Coated Tablets?
3. How should you take Flurbiprofen Coated
Tablets?
4. Possible side effects of Flurbiprofen
Coated Tablets.
5. How to store Flurbiprofen Coated Tablets.
6. Further information about Flurbiprofen
Coated Tablets.
1. What are Flurbiprofen Coated Tablets
and what are they used for?
Flurbiprofen Coated Tablets belong to a
group of medicines called non-steroidal antiinflammatory drugs (NSAIDs). They can be
used to relieve pain and inflammation (redness,
heat and swelling) in conditions such as:
• osteoarthritis (a bone disorder, which is
seen mostly in older persons, in which the
joints become painful and stiff)
• rheumatoid disease (inflammation of
the joints and sometimes surroundings
tissues)
• ankylosing spondylitis (arthritis of the
spine)
• swollen joints, frozen shoulder, bursitis
(inflammation of the bursa), tendinitis
(inflammation of tendons), tenosynovitis
(inflammation of the covering layer of a
tendon)
• low back pain, sprains and strains.
Flurbiprofen Coated Tablets can also be
used to treat other painful conditions such as
toothache, pain after operations, period pain
and migraine.
The active substance in Flurbiprofen Coated
Tablets is flurbiprofen "EP". Flurbiprofen
50 mg Coated Tablets contains 50 mg
of flurbiprofen "EP" and Flurbiprofen
100 mg Coated Tablets contains 100 mg of
flurbiprofen "EP".
2. What should you know before taking
Flurbiprofen Coated Tablets?
Do not take this medicine if:
• You are sensitive (allergic) to
any of the ingredients in the
tablets? These are listed in
Section 6. Ingredients known to
cause allergic reactions are also
listed at the end of this section.
• You currently have a peptic ulcer (ulcer in
your stomach or duodenum), ulcerative 1

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colitis, Crohn’s disease or bleeding in
your stomach, or have had two or more
episodes of peptic ulcers, stomach
bleeding or perforation in the past.
• You suffer from asthma or you have
ever had an allergic reaction or suffered
from wheezing after taking flurbiprofen,
ibuprofen, aspirin or other anti-inflammatory
pain killers.
• You are in the last trimester (last 3 months)
of pregnancy.
• You have been told by your doctor that
you have severe heart failure, liver failure
or kidney failure.
Tell your doctor before you take this
medicine if the answer to any of the
following questions is ‘YES’:
• Are you pregnant or planning to become
pregnant, or are you breastfeeding?
Flurbiprofen Coated Tablets may make
it more difficult to become pregnant.
You should inform your doctor if you are
planning to become pregnant or if you
have problems becoming pregnant.
• Do you have systemic lupus
erythematosus (SLE, sometimes
known as lupus) or a connective tissue
disease (autoimmune diseases affecting
connective tissue)?
• Do you suffer from liver or kidney disease
or have you ever been told you have liver
or kidney disease?
• Do you suffer from heart problems or
have you ever been told you have heart
problems?
Medicines such as Flurbiprofen Coated
Tablets may be associated with a small
increased risk of heart attack (myocardial
infarction) or stroke. Any risk is more likely
with high doses and prolonged treatment.
Do not exceed the recommended dose
or duration of treatment. If you have heart
problems, previous stroke or think that you
might be at risk of these conditions (e.g.
if you have high blood pressure, diabetes,
high cholesterol or are a smoker) you
should discuss your treatment with your
doctor or pharmacist.
• Have you been diagnosed as having a
condition that affects the time it takes your
blood to clot?
• Have you been told by your doctor that
you have an intolerance to some sugars?
Please see “Important information on
some of the ingredients of Flurbiprofen
Coated Tablets” at the end of this section.

• Are you taking any of the following medicines:
• diuretics (known as water tablets e.g.
furosemide, spironolactone)
• cardiac glycosides (medicines used for
heart conditions, such as digoxin)
• ACE inhibitors (eg captopril) or
Angiotensin II antagonists (e.g.
losartan). These medicines are used to
treat high blood pressure
• anti-coagulants (to prevent blood clots
e.g. warfarin)
• lithium
• zidovudine (an anti-viral drug)
• methotrexate (used to treat certain
cancers)
• ciclosporin and tacrolimus
(immunosuppressants used to dampen
down your immune response)
• medicines known as corticosteroids
(used in the treatment of inflammatory
diseases e.g. prednisone,
dexamethasone, hydrocortisone)
• anti-depressant medication known as
selective serotonin reuptake inhibitors
(SSRIs) (e.g. fluoxetine and paroxetine)
• antibiotics called quinolones (such as
ciprofloxacin)
• aminoglycosides (a type of antibiotic
e.g. streptomycin and gentamicin)
• mifepristone (now or in the last 12 days)
• any other anti-inflammatory pain killers,
including aspirin and the group of
drugs known as COX-2 inhibitors e.g.
celecoxib, lumiracoxib.
Pregnancy and breast-feeding:
The use of Flurbiprofen Coated Tablets
whilst pregnant or breast-feeding should be
avoided. Flurbiprofen Coated Tablets should
not be used in late (the last three months)
of pregnancy. If you are pregnant, thinking
of becoming pregnant or are breastfeeding
you must tell your doctor before taking
Flurbiprofen Coated Tablets.
Driving and Using Machines:
Flurbiprofen Coated Tablets may make you
feel dizzy or drowsy. If the tablets affect you
in this way do not drive, operate machinery
or do anything that requires you to be alert.
Other information about Flurbiprofen
Coated Tablets:
Your doctor may give you another medicine
to be taken with Flurbiprofen Coated Tablets
to help protect your stomach, if they think
you are at risk of getting a stomach ulcer or
bleeding in your stomach.

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Important information on some of the
ingredients of Flurbiprofen Coated Tablets:
Flurbiprofen Coated Tablets contain glucose,
sucrose and lactose. If you have been told
by your doctor that you have an intolerance
to some sugars you should check with your
doctor before taking Flurbiprofen Coated
Tablets.
3. How should you take Flurbiprofen
Coated Tablets?
Always take Flurbiprofen Coated Tablets
exactly as your doctor has told you. If you
are not sure refer to the label on the carton or
check with your doctor or pharmacist.
Take your Flurbiprofen Coated
Tablets with or after food with a
glass of water.
Dosage:
Adult -The usual daily dose is 150 to 200 mg,
spread throughout the day. If you are taking
Flurbiprofen 50 mg Coated Tablets this will
be three or four times a day. If you are taking
Flurbiprofen 100 mg Coated Tablets this will
be one or two tablets a day. Sometimes a
mixture of the two strengths of tablet will be
prescribed. The dose may be increased by
your doctor to a maximum of 300 mg a day.
Period Pain - At the start of the symptoms,
100 mg (either two Flurbiprofen 50 mg
Coated Tablets or one Flurbiprofen 100 mg
Coated Tablet), followed by 50 mg or 100 mg
every 4 to 6 hours. The maximum dose is
300 mg a day.
Elderly -Some elderly patients may be more
prone to side effects. Your doctor will take
this into account when deciding the dose
you will need and may monitor you for side
effects.
Children - Flurbiprofen Coated Tablets are
not recommended for children.
If you forget to take your Flurbiprofen
Coated Tablets take them as soon as you
remember, unless it is almost time for your
next dose. If it is, do not take the missed
dose at all. Never double up on a dose to
make up for the one you have missed.
If you take more Flurbiprofen Coated
Tablets than you should (an overdose) you
should contact a doctor or go to the nearest
hospital casualty department immediately
and take your tablets with you.

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4. Possible side effects of Flurbiprofen
Coated Tablets
As with all medicines, Flurbiprofen Coated
Tablets may cause side effects, although they
are usually mild and not everyone will suffer
from them. If any side effects become serious
or if you notice any side effects that are not
listed in this leaflet, please tell your doctor or
pharmacist.
If you suffer from any of the following at
any time during your treatment stop taking
Flurbiprofen Coated Tablets and seek
immediate medical help:
• Severe headache, high temperature,
stiffness of the neck or intolerance to
bright light
• Pass blood in your faeces (stools/motions)
• Pass black tarry stools
• Vomit any blood or dark particles that look
like coffee grounds.
Tell your doctor immediately and stop
taking the tablets if you experience:
• Unexplained stomach pain or other
abnormal stomach symptoms, indigestion,
heartburn, feeling sick and/or vomiting.
• Swelling of the face, lips or tongue,
unexplained wheezing, shortness of breath
or skin rash.
• Increased bruising or bleeding, fever,
sore throat, mouth ulcers, tiredness and a
tendency to get infections (symptoms of
blood disorders that may occur rarely with
Flurbiprofen Coated Tablets).
• Severe skin reactions such as blistering
of the skin, mouth, eyes and genitals
(symptoms of some severe skin conditions
that may occur rarely with Flurbiprofen
Coated Tablets).
• Yellowing of the eyes and/or skin. This is
a sign that your liver may not be working
properly. You may also experience
symptoms such as tiredness, flu-like
symptoms, poor appetite/ loss of appetite
and pain in your abdomen (just under your
ribs).
• Tiredness, swelling or puffiness in the
face, abdomen, thighs or ankles, passing
less urine or problems urinating and back
pain (symptoms of kidney problems that
may occur rarely with Flurbiprofen Coated
Tablets).
• Severe headache and/or blurred or
disturbed vision (which may be due to an
increase in your blood pressure) or seeing/
hearing strange things.
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Flurbiprofen Coated Tablets has sometimes
been associated with heart failure. This is
when your heart does not function as well as
it should. Symptoms can include tiredness
and a lack of energy, breathlessness and
swelling of the legs due to a build up of fluid.
Medicines such as Flurbiprofen Coated
Tablets may be associated with a small
increased risk of heart attack (myocardial
infarction) or stroke.
Very rarely Flurbiprofen Coated Tablets
may cause aseptic meningitis (inflammation
of the protective membrane surrounding the
brain).
Other unusual effects may include:
• headache
• dizziness
• tingling of hands and feet
• ringing in the ears
• diarrhoea, constipation, wind
• unexpected sensitivity of the skin to the sun
• tiredness, malaise (a general feeling of
being unwell)
• mood swings, depression
• hallucinations, confusion.
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.

6. Further information about Flurbiprofen
Coated Tablets
The active substance in Flurbiprofen 50 mg
and 100 mg Coated Tablets is flurbiprofen
"EP". The tablets are white and come in two
strengths: Flurbiprofen 50mg tablets contain
50mg of flurbiprofen EP and Flurbiprofen
100mg tablets contain 100mg of flurbiprofen
EP. Each pack contains 100 tablets.
Other ingredients of Flurbiprofen Coated
Tablets:
sucrose, lactose, talc, maize starch, titanium
dioxide (E171), povidone, liquid glucose,
magnesium stearate, stearic acid, colloidal
silica, sandarac gum and carnauba wax.
Marketing Authorisation Holder:
Abbott Laboratories Ltd., Abbott House,
Vanwall Business Park, Vanwall Road,
Maidenhead, Berkshire, SL6 4XE, UK.
Manufacturer:
Famar L’ Aigle
Z.I. No.1 Route de Crulai
61303 L’Aigle Cedex
France
Distributor: Mylan, Potters Bar,
Hertfordshire, EN6 1TL, United Kingdom.
This leaflet was last revised in April 2014.

5. How should you store Flurbiprofen
Coated Tablets?
Your tablets should be stored in a safe place
out of the sight and reach of children, your
medicine could harm them. They should be
kept in their original packaging, do not take
Flurbiprofen Coated Tablets after the ‘use by’
date shown on the carton.
Do not store above 25°C.
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. Only keep the
tablets if your doctor tells you to.
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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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