What Is in This Leaflet 1. What Flurbiprofen Coated Tablets Are

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What is in this leaflet 1. What Flurbiprofen Coated Tablets are and Package Leaflet: what they are used for Information for the Patient 2. What you need to know before you take Flurbiprofen Coated Tablets Flurbiprofen 50 mg 3. How to take Flurbiprofen Coated Tablets Coated Tablets 4. Possible side effects Flurbiprofen 100 mg 5. How to store Flurbiprofen Coated Tablets Coated Tablets 6. Contents of the pack and other information 1. What Flurbiprofen Coated Tablets are Flurbiprofen and what they are 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: IMPORTANT INFORMATION • osteoarthritis (a bone disorder, which is seen mostly in older persons, in which the joints Read all of this leaflet carefully become painful and stiff) before you start taking this medicine • rheumatoid disease (inflammation of the because it contains important joints and sometimes surrounding tissues) information for you. • ankylosing spondylitis (arthritis of the spine) • swollen joints, frozen shoulder, bursitis • Keep this leaflet. You may need to (inflammation of the bursa), tendinitis read it again. (inflammation of tendons), tenosynovitis • If you have any further questions, (inflammation of the covering layer of a ask your doctor or pharmacist. tendon) • This medicine has been prescribed • low back pain, sprains and strains. for you only. Do not pass it on to others. It may harm them even if Flurbiprofen Coated Tablets can also be their signs of illness are the same used to treat other painful conditions such as as yours. toothache, pain after operations, period pain • If you get any side effects, talk to and migraine. your doctor or pharmacist. This The active substance in Flurbiprofen Coated includes any possible side effects Tablets is flurbiprofen. Flurbiprofen 50 mg not listed in this leaflet. See section 4. Coated Tablets contains 50 mg of flurbiprofen and Flurbiprofen 100mg Coated Tablets contains 100 mg of flurbiprofen. 2. What you need to know before you take Flurbiprofen Coated Tablets Do not take Flurbiprofen Coated Tablets: • 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. • If you have, or have had 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. • If 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. 1

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Description Flurbiprofen_50mg_100mg_100 Date: 01 Mar 19 Time: 19:30

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v3/Jul 2017 • If you are in the last trimester (last 3 months) are used to treat high blood pressure of pregnancy. • Anti-coagulants (to prevent blood clots e.g. • If you have been told by your doctor that warfarin) you have severe heart failure, liver failure or • Lithium kidney failure. • Zidovudine (an anti-viral drug) • If you currently have acute dehydration. • Methotrexate (used to treat certain cancers) Warnings and precautions • Ciclosporin and tacrolimus (immunosup- Talk to your doctor or pharmacist before pressants used to dampen down your taking Flurbiprofen Coated Tablets immune response) • Medicines known as corticosteroids • If you are pregnant or planning to become (used in the treatment of inflammatory pregnant, or you are breastfeeding diseases e.g. prednisone, dexamethasone, Flurbiprofen Coated Tablets may make it hydrocortisone) more difficult to become pregnant. You • Anti-depressant medication known as should inform your doctor if you are planning selective serotonin reuptake inhibitors to become pregnant or if you have problems (SSRls) (e.g. fluoxetine and paroxetine) becoming pregnant. • Antibiotics called quinolones (such as • If you have systemic lupus erythematosus ciprofloxacin) (SLE, sometimes known as lupus) or a • Mifepristone (now or in the last 12 days) connective tissue disease (autoimmune • Any other anti-inflammatory pain killers, diseases affecting connective tissue). including aspirin and the group of drugs • If you suffer from liver or kidney disease or known as COX-2 inhibitors e.g. celecoxib, have you ever been told you have liver or lumiracoxib. kidney disease. Pregnancy, breast-feeding and fertility • If you suffer from heart problems or have you ever been told you have heart problems. The use of Flurbiprofen Coated Tablets whilst Medicines such as Flurbiprofen Coated pregnant or breast-feeding should be avoided. Tablets may be associated with a small Flurbiprofen Coated Tablets should not be increased risk of heart attack (myocardial used in late (the last three months) pregnancy. infarction) or stroke. Any risk is more likely If you are pregnant or breast-feeding, think with high doses and prolonged treatment. you may be pregnant or are planning to have a Do not exceed the recommended dose baby, ask your doctor or pharmacist for advice or duration of treatment. If you have heart before taking this medicine. problems, previous stroke or think that you Driving and using machines might be at risk of these conditions (e.g. if Flurbiprofen Coated Tablets may make you you have high blood pressure, diabetes, feel dizzy, drowsy or tired and/or you may have high cholesterol or are a smoker) you should problems with your sight. If the tablets affect discuss your treatment with your doctor or you in this way do not drive, operate machinery pharmacist. or do anything that requires you to be alert. • If you have you been diagnosed as having a condition that affects the time it takes your Flurbiprofen Coated Tablets contain glucose, blood to clot sucrose and lactose • If you have been told by your doctor that you If you have been told by your doctor that have an intolerance to some sugars. Please you have an intolerance to some sugars you see “Flurbiprofen Coated Tablets contain should check with your doctor before taking glucose, sucrose and lactose” at the end Flurbiprofen Coated Tablets. of this section. Other information about Flurbiprofen Coated Other medicines and Flurbiprofen Coated Tablets: Tablets Your doctor may give you another medicine to Tell your doctor or pharmacist if you are taking, be taken with Flurbiprofen Coated Tablets to have recently taken or might take any other help protect your stomach, if they think you are medicines. In particular, tell your doctor or at risk of getting a stomach ulcer or bleeding in pharmacist if you are taking and of the following your stomach. medicines: If you take a painkiller for headaches for a • Diuretics (known as water tablets e.g. prolonged length of time, it can make them furosemide, spironolactone) worse. • Cardiac glycosides (medicines used for Avoid alcohol intake while taking Flurbiprofen heart conditions, such as digoxin) Coated Tablets, since this may increase the risk • ACE inhibitors (e.g. captopril) or Angiotensin of some side-effects listed in Section 4 . II antagonists (e.g. losartan). These medicines 2

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Description Flurbiprofen_50mg_100mg_100 Date: 01 Mar 19 Time: 19:30

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v3/Jul 2017 3. How to take Flurbiprofen Coated • Severe skin reactions such as blistering of the Tablets skin, mouth, eyes and genitals (symptoms of some severe skin conditions that may occur Always take this medicine exactly as your rarely with Flurbiprofen Coated Tablets). doctor has told you. Check with your doctor or pharmacist if you are not sure. Tell your doctor IMMEDIATELY and stop taking the tablets if you experience: Take your Flurbiprofen Coated • Unexplained stomach pain or other abnormal Tablets with or after food with a stomach symptoms, indigestion, heartburn, glass of water. feeling sick and/or vomiting. The recommended dose is: • Increased bruising or bleeding, fever, Adult -The usual daily dose is 150 to 200 mg, sore throat, mouth ulcers, tiredness and spread throughout the day. If you are taking a tendency to get infections (symptoms of Flurbiprofen 50 mg Coated Tablets this will blood disorders that may occur rarely with be three or four times a day. If you are taking Flurbiprofen Coated Tablets). Flurbiprofen 100 mg Coated Tablets this will be • Yellowing of the eyes and/or skin. This is a sign one or two tablets a day. Sometimes a mixture that your liver may not be working properly. of the two strengths of tablet will be prescribed. You may also experience symptoms such as The dose may be increased by your doctor to a tiredness, flu-like symptoms, poor appetite/ maximum of 300 mg a day. loss of appetite and pain in your abdomen Period Pain - At the start of the symptoms, (just under your ribs). 100 mg (either two Flurbiprofen 50 mg Coated • Tiredness, swelling or puffiness in the Tablets or one Flurbiprofen 100 mg Coated face, abdomen, thighs or ankles, passing Tablet), followed by 50 mg or 100 mg every 4 to less urine or problems urinating and back 6 hours. The maximum dose is 300 mg a day. pain (symptoms of kidney problems that Elderly -Some elderly patients may be more may occur rarely with Flurbiprofen Coated prone to side effects. Your doctor will take this Tablets). into account when deciding the dose you will • Severe headache and/or blurred or disturbed need and may monitor you for side effects. vision (which may be due to an increase Children - Flurbiprofen Coated Tablets are not in your blood pressure) or seeing/hearing recommended for children. strange things. If you take more Flurbiprofen Coated Tablets Flurbiprofen Coated Tablets has sometimes than you should (an overdose) you should been associated with heart failure. This is contact a doctor or go to the nearest hospital when your heart does not function as well as it casualty department immediately and take should. Symptoms can include tiredness and a your tablets with you. lack of energy, breathlessness and swelling of the legs due to a build up of fluid. If you forget to take Flurbiprofen Coated Tablets take them as soon as you remember, Medicines such as Flurbiprofen Coated Tablets unless it is almost time for your next dose. If it may be associated with a small increased risk is, do not take the missed dose at all. Do not of heart attack (myocardial infarction) or stroke. take a double dose to make up for a forgotten Very rarely Flurbiprofen Coated Tablets may tablet. cause aseptic meningitis (inflammation of the protective membrane surrounding the brain). 4. Possible side effects Other side effects which have also been Like all medicines, this medicine can cause reported may include: side effects, although not everybody gets them. Common (may affect up to 1 in 10 people) If you suffer from any of the following at • Headache, dizziness any time during your treatment stop taking • Indigestion, nausea, vomiting, diarrhoea, Flurbiprofen Coated and seek immediate constipation, wind medical help: • Tiredness, malaise (a general feeling of • Severe headache, high temperature, stiffness being unwell) of the neck or intolerance to bright light • Raised levels of liver enzymes in the blood • Pass blood in your faeces (stools/motions) • Fluid retention • Pass black tarry stools Uncommon (may affect up to 1 in 100 people) • Vomit any blood or dark particles that look • Anaemia (decreased amount of red blood like coffee grounds. cells) • Swelling of the face, lips or tongue, • Hypersensitivity unexplained wheezing, shortness of breath • Tingling or numbness in the hands or feet or skin rash. (paraesthesia) 3

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Description Flurbiprofen_50mg_100mg_100 Date: 01 Mar 19 Time: 19:30

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v3/Jul 2017 • Ringing in the ears (tinnitus) 6. Contents of the pack and other • Unexpected sensitivity of the skin to the sun information • Skin rash, itching, purpura (red or purple spots on the skin) What Flurbiprofen Coated Tablets contains • Visual impairment, vertigo The active substance in Flurbiprofen 50 mg and • Asthma 100 mg Coated Tablets is flurbiprofen. • Mouth ulcers, stomach and lower gut ulcers The other ingredients are sucrose, lactose, • Gastritis (inflammation, irritation or swelling talc, maize starch, titanium dioxide (E171), of the stomach lining) povidone, liquid glucose, magnesium stearate, Rare (may affect up to 1 in 1000 people) stearic acid, colloidal silica, sandarac gum and • Depression, confusion carnauba wax. • Somnolence (feeling very sleepy) What Flurbiprofen Coated Tablets looks like • Insomnia (having difficulty with sleeping) and contents of the pack • Bronchospasm (difficulty in breathing or Flurbiprofen 50 mg and 100 mg Coated Tablets wheezing) are white, sugar-coated tablets. Flurbiprofen TB C Very rare (may affect up to 1 in 10,000 people) Coated Tablets are available in packs containing • Hallucinations 10,20,30,100 and 500 tablets. • Inflammation of the pancreas Not all pack sizes may be marketed. • Increase in blood clotting time • Decrease in blood cell count (feeling tired, increased risk of bleeding or bruising, Marketing Authorisation Holder: weakness, short of breath, increase in Mylan products Limited infections, fever, confusion, abnormal 20 Station Close, paleness) Potters Bar, Other effects which have been but for which Hertfordshire, EN6 1TL, the frequency is not known may include: • Optic neuritis (inflammation of the optic United Kingdom nerve) • Stroke Manufacturer: • Worsening of colitis or Crohn’s disease Famar L’ Aigle • Hepatitis Z.I. No.1 Route de Crulai Reporting of side effects 61303 L’Aigle Cedex If you get any side effects, talk to your doctor, France pharmacist or nurse. This includes any possible side effects not listed in this leaflet. This leaflet was last revised in February 2019. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Flurbiprofen Coated Tablets Your tablets should be stored in a safe place out of the sight and reach of children, your medicine could harm them. Do not use this medicine after the expiry date which is stated on the carton after “Exp”. The expiry date refers to the last day of the month. Do not store above 25oC and keep in the original packaging. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 1761901 4

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Description Flurbiprofen_50mg_100mg_100 Date: 01 Mar 19 Time: 19:30

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v3/Jul 2017