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FROBEN SR 200MG

Active substance: FLURBIPROFEN

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FROBEN SR
Flurbiprofen 200 mg
Slow Release
Capsules
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
Froben SR
• 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.

Leaflet contents:
1.
2.
3.
4.
5.
6.

What is Froben SR and what is it used for?
What should you know before taking Froben SR?
How should you take Froben SR?
Possible side effects of Froben SR.
How should you store Froben SR?
Further information about Froben SR.

1. What is Froben SR and what is it used for?
Froben SR belongs to a group of medicines called non-steroidal
anti-inflammatory 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
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.
The active ingredient in Froben SR is flurbiprofen and each capsule
contains 200 mg in a sustained-release (slow-release) formulation. This
is designed to release flurbiprofen gradually into your blood stream
throughout the day.

2. What should you know before taking Froben SR?
Do not take this medicine if:
• You are sensitive (allergic) to any of the ingredients in the
capsules? 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
breast-feeding? Froben 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)?
• 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 Froben 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?

• 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 (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
· 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. prednisone, dexamethasone,
hydrocortisone)
· anti-depressant medication known as selective serotonin reuptake
inhibitors (SSRIs) (such as 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 Froben whilst pregnant or breast-feeding should be avoided.
Froben should not be used in late (the last three months) of pregnancy.
If you are pregnant, thinking of becoming pregnant or are
breast-feeding you must tell your doctor before taking Froben.
Driving and Using Machines:
Froben may make you feel dizzy or drowsy. If the capsules affect you in
this way do not drive, operate machinery or do anything that requires
you to be alert.

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Other information about Froben SR:
Your doctor may give you another medicine to be taken with Froben SR
to help protect your stomach, if they think you are at risk of getting a
stomach ulcer or bleeding in your stomach.
Froben SR contains soya lecithin (soya oil). If you are allergic to peanut
or soya, do not take this medicinal product.

3. How should you take Froben SR?
Always take Froben SR 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 Froben SR with or after food with a glass of
water, preferably in the evening. If you have difficulty
swallowing the capsules, they may be opened up and the
granules taken with some food or drink. You should not
crush or chew the granules as this may affect the
slow-release action.
Dosage:
Adult - The usual dose is one capsule each evening, after food.
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 - Froben SR is not recommended for children.
If you forget to take your Froben SR take it 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 Froben SR than you should (an overdose) you
should contact a doctor or go to the nearest hospital casualty
department immediately and take your capsules with you.

4. Possible side effects of Froben SR
As with all medicines, Froben SR 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 Froben 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 capsules 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 Froben).
• Severe skin reactions such as blistering of the skin, mouth, eyes and
genitals (symptoms of some severe skin conditions that may occur
rarely with Froben).
• 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 Froben).
• Severe headache and/or blurred or disturbed vision (which may be due
to an increase in your blood pressure) or seeing/hearing strange things.
Froben 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 Froben may be associated with a small increased
risk of heart attack (myocardial infarction) or stroke.
Very rarely Froben 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.

after the 'use by' date shown on the bottle.
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 capsules if your doctor tells you to.

6. Further information about Froben SR
The active substance in Froben SR is flurbiprofen BP, in a
sustained-release (slow-release) formulation. The capsules are yellow
and are marked “FSR”. Each pack contains 30 capsules.
Other ingredients of Froben SR: microcrystalline cellulose, Eudragit
RS 100 (acrylic/methacrylic acid ester copolymer), magnesium stearate,
polyethylene glycol and colloidal silicon dioxide. The capsule shell is
made of gelatin with small amounts of quinoline yellow (E104), titanium
dioxide (E171), iron oxide (E172), red iron oxide, erythrosine, shellac,
glycerin, dimethicone and black iron oxide.
Froben SR also contains soya lecithin (soya oil).
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.
Leaflet was last approved in
01/2010

5. How should you store Froben SR?
Your capsules 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 Froben SR
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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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