Flurbiprofen Tablets Bp 50mg
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• Ifyou 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 ifyou 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 ifyou:
• 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.
Ifyou have heart problems, previous stroke or think that you might be at risk of these conditions (for example ifyou 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 ifyou 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 ifyou are pregnant, think you might be pregnant or ifyou intend to become pregnant. You should inform your doctor ifyou are planning to become pregnant or ifyou have problems becoming pregnant.
Do not take flurbiprofen tablets while breastfeeding. Flurbiprofen is passed to your baby through your breast milk. Ifyou 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 ifyou are affected.
Important information about some of the ingredients of Flurbiprofen tablets:
This medicine contains lactose (milk sugar), sucrose and sunset yellow (E110). Ifyou 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 ifyou 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.
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)
STOPTAKING 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
• 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
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 ParkView 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
GENUS PHARMACEUTICALS