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FROBEN TABLETS 50MG

Active substance(s): FLURBIPROFEN MILLED / FLURBIPROFEN MILLED / FLURBIPROFEN MILLED

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Froben 50 mg Tablets
Froben 100 mg Tablets
Flurbiprofen
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
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.
Leaflet contents:
1. What are Froben Tablets and what are they used for?
2. What should you know before taking Froben Tablets?
3. How should you take Froben Tablets?
4. Possible side effects of Froben Tablets.
5. How to store Froben Tablets.
6. Further information about Froben Tablets.
1. What are Froben Tablets and what are they used for?
Froben 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.
Froben Tablets can also be used to treat other painful conditions such as toothache, pain
after operations, period pain and migraine.
The active substance in Froben Tablets is flurbiprofen EP. Froben 50 mg Tablets contain 50
mg of flurbiprofen and Froben 100mg Tablets contain 100 mg of flurbiprofen EP.

2. What should you know before taking Froben Tablets?
Do not take this medicine if:
 You are sensitive (allergic) 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? 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 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 Froben 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)
· 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
(SSRls) (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 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 breastfeeding you must tell your doctor before taking Froben.
Driving and using machines:

Froben 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 Froben Tablets:
Your doctor may give you another medicine to be taken with Froben 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 Froben Tablets:
Froben 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 Froben Tablets.
3. How should you take Froben Tablets?
Always take Froben 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 Froben 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
Froben 50 mg this will be three or four times a day. If you are taking Froben 100 mg 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 Froben 50 mg tablets or one
Froben 100 mg 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 - Froben Tablets are not recommended for children.
If you forget to take your Froben 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 Froben 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 Froben Tablets
As with all medicines, Froben 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 et 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 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
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.
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. How should you store Froben Tablets?
Your tablets should be stored in a safe place out of the sight and reach of children, your medicine
could harm them.
They should be kept in their original packaging, do not take Froben Tablets after the 'use by'
date shown on the carton.

Do not store above 25oC
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.

6. Further information about Froben Tablets
The active substance in Froben Tablets is flurbiprofen. The tablets are white and come in two
strengths: Froben 50mg tablets contain 50mg of flurbiprofen EP and Froben 100mg tablets
contain 100mg of flurbiprofen EP. Each pack contains 100 tablets.
Other ingredients of Froben Tablets:
sucrose, lactose, talc, maize starch, titanium dioxide (E171), povidone, liquid glucose,
magnesium stearate, stearic acid, colloidal silica, sandarac gum and carnauba wax.
Marketing Authorisation Holder:
Mylan Products Ltd
20 Station Close
Potters Bar
Herts
EN6 1TK
United Kingdom
Manufacturer:
Famar L’ Aigle
Z.I. No.1 Route de Crulai
61303 L’Aigle Cedex
France

This leaflet was last revised in July 2016

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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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