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FLURBIPROFEN 100MG COATED TABLETS

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Ref: 1387/010714/1/F

Flurbiprofen 100mg Coated Tablets
Patient Information Leaflet
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.
Your medicine is called Flurbiprofen 100mg Coated Tablets and will be
referred to as Flurbiprofen Coated Tablets throughout the rest of this leaflet.
Please note that the leaflet also contains information about other strengths
of the medicine, Flurbiprofen 50mg Coated Tablets.
In this leaflet:
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.

* 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)

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 you should 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 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)?

* 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.
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.

Ref: 1387/010714/1/B

Flurbiprofen 100mg Coated Tablets
Patient Information Leaflet (continued)
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.

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
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.

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.
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.

How should you store Flurbiprofen Coated Tablets?

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Do not take flurbiprofen after the expiry date which is stated on the blisters.
If your doctor tells you to stop taking this medicine, take any remaining
medicine back to the pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
If your medicine becomes discoloured or show any other signs of
deterioration, ask your pharmacist who will advise you what to do.
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 about Flurbiprofen Coated
Tablets?

What this medicine contains:
The active substance is flurbiprofen.
Each coated tablet contains 100mg flurbiprofen.
The other ingredients are: glucose, sucrose, lactose, maize starch, povidone,
magnesium stearate, stearic acid, talc, titanium dioxide (E171), sandarac,
carnauba wax, colloidal anhydrous silica and black printing ink.
What this medicine looks like and contents of the pack
Flurbiprofen 100 mg tablets are sugar-coated, white, round tablets with F100
printed on one side in black ink
Flurbiprofen 100mg tablets are available in blister packs containing 100
tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Abbott Laboratories, S.A. Avenida de
Burgos, 91 28050, Madrid, Spain and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1387

Flurbiprofen 100mg Tablets

Revision date: 01/07/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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