FROBEN TABLETS 50MG

Active substance: FLURBIPROFEN MILLED

View full screen / Print PDF » Download PDF ⇩

Transcript
Flurbiprofen 50 mg Tablets
Flurbiprofen 100 mg Tablets
Flurbiprofen

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.

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.

1. What are Flurbiprofen Coated Tablets
and what are they used for?
Flurbiprofen Coated Tablets belong to a
group of medicines called non-steroidal
anti-inflammatory 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 BP. Flurbiprofen 50 mg
Coated Tablets contains 50 mg of flurbiprofen
BP and Flurbiprofen 100 mg Coated Tablets
contains 100 mg of flurbiprofen BP.
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

FM-H8012653_d2

PAGE 1

colitis, Crohn’s disease or bleeding in
diuretics (known as water tablets e.g.
your stomach, or have had two or more
furosemide, spironolactone)
cardiac glycosides (medicines used for
episodes of peptic ulcers, stomach
heart conditions, such as digoxin)
bleeding or perforation in the past.
ACE inhibitors (eg captopril) or
You suffer from asthma or you have
Angiotensin II antagonists (e.g.
ever had an allergic reaction or suffered
losartan). These medicines are used to
from wheezing after taking flurbiprofen,
treat high blood pressure
ibuprofen, aspirin or other anti-inflammatory
anti-coagulants (to prevent blood clots
pain killers.
e.g. warfarin)
You are in the last trimester (last 3 months)
lithium
of pregnancy.
zidovudine (an anti-viral drug)
You have been told by your doctor that
methotrexate (used to treat certain
you have severe heart failure, liver failure
cancers)
or kidney failure.
ciclosporin and tacrolimus
Tell your doctor before you take this
(immunosuppressants used to dampen
medicine if the answer to any of the
down your immune response)
following questions is ‘YES’:
medicines known as corticosteroids
Are you pregnant or planning to become
(used in the treatment of inflammatory
pregnant, or are you breastfeeding?
diseases e.g. prednisone,
Flurbiprofen Coated Tablets may make
dexamethasone, hydrocortisone)
it more difficult to become pregnant.
anti-depressant medication known as
You should inform your doctor if you are
selective serotonin reuptake inhibitors
planning to become pregnant or if you
(SSRIs) (e.g. fluoxetine and paroxetine)
have problems becoming pregnant.
antibiotics called quinolones (such as
Do you have systemic lupus
ciprofloxacin)
erythematosus (SLE, sometimes
aminoglycosides (a type of antibiotic
known as lupus) or a connective tissue
e.g. streptomycin and gentamicin)
disease (autoimmune diseases affecting
mifepristone (now or in the last 12 days)
connective tissue)?
any other anti-inflammatory pain killers,
Do you suffer from liver or kidney disease
including aspirin and the group of
or have you ever been told you have liver
drugs known as COX-2 inhibitors e.g.
or kidney disease?
celecoxib, lumiracoxib.
Do you suffer from heart problems or
have you ever been told you have heart
Pregnancy and breast-feeding:
problems?
The use of Flurbiprofen Coated Tablets
Medicines such as Flurbiprofen Coated
whilst pregnant or breast-feeding should be
Tablets may be associated with a small
avoided. Flurbiprofen Coated Tablets should
increased risk of heart attack (myocardial
infarction) or stroke. Any risk is more likely not be used in late (the last three months)
of pregnancy. If you are pregnant, thinking
with high doses and prolonged treatment.
of becoming pregnant or are breastfeeding
Do not exceed the recommended dose
you must tell your doctor before taking
or duration of treatment. If you have heart
problems, previous stroke or think that you Flurbiprofen Coated Tablets.
might be at risk of these conditions (e.g.
Driving and Using Machines:
if you have high blood pressure, diabetes,
Flurbiprofen Coated Tablets may make you
high cholesterol or are a smoker) you
feel dizzy or drowsy. If the tablets affect you
should discuss your treatment with your
in this way do not drive, operate machinery
doctor or pharmacist.
or do anything that requires you to be alert.
Have you been diagnosed as having a
condition that affects the time it takes your
Other information about Flurbiprofen
blood to clot?
Coated Tablets:
Have you been told by your doctor that
Your doctor may give you another medicine
you have an intolerance to some sugars?
to be taken with Flurbiprofen Coated Tablets
Please see “Important information on
to help protect your stomach, if they think
some of the ingredients of Flurbiprofen
Coated Tablets” at the end of this section. you are at risk of getting a stomach ulcer or
bleeding in your stomach.
Are you taking any of the following
medicines:
FM-H8012653
2

FM-H8012653_d2

PAGE 2

Important information on some of the
ingredients of Flurbiprofen Coated Tablets:
Flurbiprofen Coated Tablets contain sunset
yellow (E110) and soya lecithin (soya oil) and
these may cause allergic reactions. Do not
take Flurbiprofen Coated Tablets if you know
you are allergic to these ingredients or if you
are allergic to peanut or soya. Flurbiprofen
Coated Tablets also 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.
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
3

FM-H8012653_d2

PAGE 3

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.
If any of these become troublesome or last
more than a few days, tell your doctor. Tell
your doctor if you experience any other side
effects that are not listed in this leaflet.

6. Further information about Flurbiprofen
Coated Tablets
The active substance in Flurbiprofen 50 mg
and 100 mg Coated Tablets is flurbiprofen
BP. The tablets are yellow and come in
two strengths: Flurbiprofen 50 mg Coated
Tablets contain 50 mg of flurbiprofen BP
and are marked ‘F50’ in black. Flurbiprofen
100 mg Coated Tablets contain 100 mg of
flurbiprofen BP and are marked ‘F100’ in
black. Each pack contains 100 tablets.
Other ingredients of Flurbiprofen Coated
Tablets:
sucrose, lactose, talc (French chalk for
tablets), maize starch, titanium dioxide
(E171), povidone, liquid glucose, magnesium
stearate, stearic acid, colloidal silicon
dioxide, quinoline yellow (E104), sandarac
tablet varnish, carnauba wax, shellac, black
iron oxide, sunset yellow (E110), black iron
oxide (E172) and sodium benzoate. They may
also contain small amounts of soya lecithin
(E322) and dimethicone.
Marketing Authorisation Holder:
Abbott Laboratories Ltd., Abbott House,
Vanwall Business Park, Vanwall Road,
Maidenhead, Berkshire, SL6 4XE, UK.
Manufacturer: Rottendorf Pharma SARL,
ZI No 2 Batterie 1000, 59309 Valenciennes
Cedex, France.
Distributor: Mylan, Potters Bar,
Hertfordshire, EN6 1TD, United Kingdom.
This leaflet was last revised in April 2013.

5. How should you store Flurbiprofen
Coated Tablets?
Your tablets should be stored in a safe place
out of the reach and sight 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.
FM-H8012653

FM-H8012653_d2

PAGE 4

4

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
(web3)