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FLURBIPROFEN 50MG TABLETS

Active substance(s): FLURBIPROFEN MILLED

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Flurbiprofen 50 mg or 100 mg Tablets
Flurbiprofen
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as yours.
• If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet
What is in this leaflet
1. What Flurbiprofen is and what it is used for
2. What you need to know before you take Flurbiprofen
3. How to take Flurbiprofen
4. Possible side effects
5. How to store Flurbiprofen
6. Contents of the pack and other information

1. What Flurbiprofen is and what it is used for
The name of your medicine is Flurbiprofen 50 mg or 100 mg Tablets. The
active ingredient is Flurbiprofen.
Flurbiprofen belongs to a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
It 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 surrounding
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 can also be used to treat other painful conditions such as
toothache, pain after operations, period pain and migraine.

2. What you need to know before you take Flurbiprofen
Do not take this medicine if:

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• You are allergic (hypersensitive) to any of the ingredients in the
tablets listed in Section 6.
• You currently have a peptic ulcer (ulcer in your stomach or duodenum),
ulcerative 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you:
• Are pregnant, planning to become pregnant or breastfeeding. Flurbiprofen
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.
• Have systemic lupus erythematosus (SLE, sometimes known as lupus)
or a connective tissue disease (autoimmune diseases affecting connective
tissue)
• Suffer from liver or kidney disease or if you have ever been told you
have liver or kidney disease
• Suffer from heart problems or if you have you ever been told that you
have heart problems.
Medicines such as Flurbiprofen 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 been diagnosed with a condition that affects the time it takes your
blood to clot
• Have been told by your doctor that you have an intolerance to some
sugars.
Other medicines and Flurbiprofen
Tell your doctor or pharmacist if you are taking, have recently taken or
might take 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 (e.g. 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 (used to treat depression)
• 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. prednisolone, 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, breast feeding and fertility
• The use of Flurbiprofen whilst pregnant or breast-feeding should be
avoided.
• Flurbiprofen should not be used in the last three months (last trimester) of
pregnancy.
• If you are pregnant, thinking of becoming pregnant or are breast feeding
you must tell your doctor before taking Flurbiprofen.
Driving and Using Machines
Flurbiprofen may make you dizzy, drowsy, confused or affect your
vision. If any of these apply to you do not drive, operate machinery or
take part in activities where these effects may put you or others at risk.
Other information about Flurbiprofen Tablets
Your doctor may give you another medicine to be taken with Flurbiprofen
tablets to help protect your stomach, if they think you are at risk of
getting a stomach ulcer or bleeding in your stomach.
Flurbiprofen Tablets contain Sunset yellow FCF (E110) and Sugars
• Flurbiprofen tablets contain sunset yellow FCF (E110) which
may cause allergic reactions.
• Also contains sucrose, glucose and lactose. If you have been told by
your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicinal product
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PATIENT LEAFLET: INFORMATION FOR THE USER

Always take Flurbiprofen 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 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.
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 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 - not recommended for children.
If you forget to take your Flurbiprofen 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 tablets than you should, contact a
doctor or go to the nearest hospital casualty department immediately and
take your tablets with you.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets 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 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,

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provide more information on the safety of this medicine.

5. How to store Flurbiprofen
• Keep this medicine out of the sight and reach of children
• Do not use this medicine after the expiry date (EXP) which is stated
on the carton. The expiry date refers to the last day of that month.
• Store in the original package
• Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Flurbiprofen tablets contain
• The active substance is flurbiprofen. Each coated tablet contains 50mg
or 100mg Flurbiprofen.
• Sucrose, Lactose anhydrous, Maize starch, Titanium dioxide, Povidone,
Liquid glucose, Magnesium stearate, Stearic acid, Colloidal anhydrous
silica, French chalk for tablets, Opalux ASF 2230 Yellow (contains
Quinolone yellow Al Lake (E104), Sunset yellow FCF Al Lake (E110),
Sodium benzoate), Sandarac tablet varnish, Carnauba wax powder.
What Flurbiprofen tablets look like and contents of the pack.
• Flurbiprofen 50mg and 100mg Tablets are yellow, sugar coated tablets
smooth in texture with a polished surface.
• The 50mg strength is available in packs of 10, 20, 100 or 500 tablets.
• The 100mg strength is available in packs of 10, 30, 100 or 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Name and address:
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom
Telephone:
0044 (0)1442 200922
Fax:
0044 (0)1442 873717
Email:
info@bristol-labs.co.uk
Flurbiprofen 50mg Tablets; PL 17907/0324
Flurbiprofen 100mg Tablets; PL 17907/0325
This leaflet was last revised in June 2014.
To request a copy of this leaflet in braille, large print or audio format,
please contact the licence holder at the address (or telephone, fax,
email) above.
V2 13-06-14 D0

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3. How to take Flurbiprofen

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).
• 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).
• 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).
• Severe headache and/or blurred or disturbed vision (which may be due
to an increase in your blood pressure) or seeing/hearing strange things.
Flurbiprofen 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 may be associated with a small increased
risk of heart attack (myocardial infarction) or stroke.
Very rarely Flurbiprofen 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

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Check with your doctor if you know you are allergic to any of the
ingredients.

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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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