Skip to Content

FLURBIPROFEN TABLETS BP 100MG

Active substance(s): FLURBIPROFEN

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

FLURBIPROFEN 50 mg Tablets
FLURBIPROFEN 100 mg Tablets
Active substance: flurbiprofen
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 get serious, or if you notice any side effect not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1.
What Flurbiprofen tablets are and what they
are used for
2.
Before you take Flurbiprofen tablets
3.
How to take Flurbiprofen tablets
4.
Possible side effects
5.
How to store Flurbiprofen tablets
6.
Further information
1. What Flurbiprofen tablets are and what they
are used for
Flurbiprofen belongs to a group of medicines called
non-steroidal anti-inflammatory drugs. It causes a
reduction in the levels of prostaglandins, which are
substances believed to be responsible for causing
pain and inflammation.
Flurbiprofen tablets are used to treat painful
and inflammatory conditions of the joints and
spine such as:
• rheumatoid disease
• osteoarthritis
• ankylosing spondylitis
2. Before you take Flurbiprofen tablets
Do NOT take Flurbiprofen tablets if you:
• are allergic (hypersensitive) to
- flurbiprofen
- aspirin, ibuprofen, or other non-steroidal antiinflammatory drugs
- any of the other ingredients of flurbiprofen
tablets (see section 6 “Further information”)
• suffer from
- a peptic ulcer (ulcer in your stomach or
duodenum) or bleeding in your stomach, or
have had two or more episodes of peptic
ulcers, stomach bleeding or perforation.
- bowel problems (e.g. ulcerative colitis,
Crohn’s disease)
Take special care with Flurbiprofen tablets if
you:
• have had stomach pains, felt sick or have had
heartburn after taking aspirin or other nonsteroidal anti-inflammatory drugs in the past
• suffer from
- asthma
- kidney, liver or heart trouble
- high blood pressure
• bleed easily
• are elderly (you may be more sensitive to the
effects of flurbiprofen tablets)
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 (for
example if you have high blood pressure, diabetes
or high cholesterol or are a smoker) you should
discuss your treatment with your doctor or

pharmacist.
Flurbiprofen may make it more difficult to become
pregnant.
Taking other medicines:
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a
prescription.
Especially:
• diuretics (water tablets used to rid the body of
excess water)
• anticoagulants (used to thin the blood, such as
warfarin)
• other non-steroidal anti-inflammatory drugs
(such as aspirin, ibuprofen)
• medicines that suppress the immune system
(such as ciclosporin and tacrolimus)
• corticosteroids (such as prednisolone)
• methotrexate (medicine to treat cancer)
• mifepristone (used during labour)
• quinolone antibiotics (such as ciprofloxacin)
• medicines used for high blood pressure (such as
propranolol)
• lithium (used to treat depression)
• cardiac glycosides (used to treat heart failure and
alterations of heart rhythm such as digoxin)
Pregnancy and breast-feeding:
Do not take flurbiprofen tablets if you are
pregnant. It may harm the unborn child. Tell your
doctor if you are pregnant, think you might be
pregnant or if you intend to become pregnant. You
should inform your doctor if you are planning to
become pregnant or if you have problems
becoming pregnant.
Do not take flurbiprofen tablets while breastfeeding. Flurbiprofen is passed to your baby
through your breast milk. If you have to continue
treatment with flurbiprofen tablets, you should stop
breast-feeding.
Driving and using machines:
Flurbiprofen may cause dizziness, drowsiness,
tiredness or visual disturbances. Do not drive or
use machines if you are affected.
Important information about some of the
ingredients of Flurbiprofen tablets:
This medicine contains lactose (milk sugar),
sucrose and sunset yellow (E110). If you have
been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicinal product. Sunset yellow
may cause allergic reactions.
3. How to take Flurbiprofen tablets
Always take flurbiprofen tablets exactly as your
doctor has told you. You should check with your
doctor if you are not sure.
Swallow the tablets with a drink of water. The
tablets are best taken with or after food.

Dosage:
Adults:
The usual dose is 50 mg 3 or 4 times a day. If the
condition is severe your doctor may increase the
dose to 100 mg 3 times a day. Do not increase the
dose unless told to do so by your doctor.
Elderly:
Your doctor will start you on the lowest
recommended dose – usually 50 mg 3 or 4 times a
day.
If you take more Flurbiprofen tablets than you
should:
Tell your doctor or pharmacist or contact your
nearest casualty department immediately. Take the
pack and any remaining tablets with you to show
what you have swallowed.







ringing in the ears
tiredness
malaise
drowsiness
sensitivity of the skin to the sun

Rarely, kidney trouble may occur.
Medicines such as flurbiprofen may be associated
with a small increased risk of heart attack
(myocardial infarction) or stroke.
Flurbiprofen can also cause an increase in your
blood pressure.
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 Flurbiprofen tablets

If you forget to take Flurbiprofen tablets:
If you forget to take a dose of flurbiprofen tablets,
take it as soon as you remember, unless it is nearly
time to take the next one. If it is, do not take the
missed dose at all. Just take the next dose at the
right time.
If you stop using Flurbiprofen tablets:
Do not stop or change your treatment before
talking to your doctor.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, flurbiprofen tablets can cause
side effects, although not everyone gets them.
If you experience any of the following side effects
STOP taking this medicine and tell your doctor
IMMEDIATELY:
• pass blood in your faeces (stools/motions)
• passing black tarry stools
• vomiting any blood or dark particles that look
like coffee grounds
• skin rashes or itching for the first time
• wheezing or shortness of breath
• persistent sore throat
• high temperature
• yellowing of your skin or the whites of your eyes
• blurred or disturbed vision
• hallucinations (seeing/hearing strange things)
• fluid retention (e.g. swollen ankles)
• bleeding or bruising easily
• anaemia (symptoms include excessive tiredness,
breathlessness on exertion, poor resistance to
infection and abnormal paleness of the skin)
• aseptic meningitis (symptoms include headache,
stiff neck, nausea, vomiting, fever and
disorientation)
STOP TAKING the medicine and tell your doctor if
you experience:
• indigestion or heartburn
• abdominal pain (pains in your stomach) or other
abnormal stomach symptoms
Other side effects which have occasionally been
reported are:
• vomiting
• nausea (feeling sick)
• diarrhoea
• flatulence (wind)
• constipation
• inflammation of the bowel (colitis) or Crohn’s
disease
• mouth ulcers
• headache
• dizziness
• spinning sensation (vertigo)
• tingling of the hands and feet
• mood swings
• confusion

Do not store above 25°C.
Keep out of the reach and sight of children.
Do not use flurbiprofen tablets after the expiry date
which is stated on the container. The expiry date
refers to the last day of that month.
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 Flurbiprofen tablets contain:
The active substance is flurbiprofen.
Each coated tablet contains 50 mg or 100 mg
flurbiprofen.
The other ingredients are:
lactose monohydrate, maize starch, povidone,
colloidal anhydrous silica, stearic acid, magnesium
stearate, talc, calcium carbonate, acacia, sucrose,
polyvinylacetate phthalate, sodium benzoate
(E211), polyvinylpyrrolidone, yellow carnauba wax,
white
beeswax,
shellac,
soya
lecithin,
dimethylpolysiloxane, titanium dioxide (E171),
quinoline yellow aluminium lake (E104), sunset
yellow aluminium lake (E110), iron oxide black
(E172).
What Flurbiprofen tablets look like and
contents of the pack:
Flurbiprofen 50 mg tablets are yellow, circular,
sugar coated tablets printed with F50.
Flurbiprofen 100 mg tablets are yellow, circular,
sugar coated tablets printed with F100.
Flurbiprofen 50 mg tablets are available in packs
containing 50, 84, 100, 250, 500 or 1,000 tablets.
Flurbiprofen 100 mg tablets are available in packs
containing 50, 60, 84, 100, 250, 500 or 1,000
tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder:
Genus Pharmaceuticals
Park View House
65 London Road, Newbury
Berkshire RG14 1JN
UK
Manufacturer:
Clonmel Healthcare Ltd
Waterford Road
Clonmel, Co. Tipperary
Ireland.
This leaflet was last approved in March 2009.

* Trademark

Expand view ⇕

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.

Hide