MHRA APPROVED 10.08.11 WITH PIL USER TEST APPLICATION By Julie Boothroyd at 2:55 pm, Aug 12, 2011 P0137T PATIENT INFORMATION LEAFLET NAPROXEN Tablets BP 250mg & 500mg Please read all of this leaflet carefully before you start taking this medicine. Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. 2. 3. 4. 5. 6. What Naproxen Tablets are and what they are used for Before you take Naproxen Tablets How to take Naproxen Tablets Possible side effects How to store Naproxen Tablets Further information 1. What Naproxen Tablets are and what they are used for Naproxen belongs to a group of medicines called Non-Steroidal Anti-inflammatory Drugs (NSAIDs). It is used to treat painful muscles and joints caused by conditions such as rheumatoid arthritis, osteoarthrosis, ankylosing spondylitis, juvenile rheumatoid arthritis, acute gout and acute musculoskeletal disorders. 2. Before you take Naproxen Tablets Do not take these tablets if you: • • • • • • are allergic to naproxen, naproxen sodium, or to any of the other ingredients (see section 6) have had any form of allergic reaction to aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or painkillers e.g. ibuprofen or diclofenac have a stomach ulcer, perforation or bleeding, or have previously had two or more episodes of these in the past have ever had stomach bleeding or perforation caused by taking NSAIDs have severe heart, liver or kidney failure are more than 6 months pregnant. Check with your doctor before taking these tablets if you: • • • • • • • are elderly or weak, as you may be more likely to suffer side effects (see section 4) have, or have ever had asthma as naproxen might bring on an attack, any allergies (like hayfever), swelling of the face, throat, lips, eyes or tongue, blocked or runny nose, or lumps in your nose (polyps) have heart, liver or kidney problems have problems with the way that your blood clots have a history of problems with your stomach or intestines e.g. ulcerative colitis or Crohn’s disease have systemic lupus erythematosus (SLE) or mixed connective tissue disorder (an immune system disorder) are in the first 6 months of pregnancy, think you may be pregnant or you are breastfeeding. Taking other medicines: Check with your doctor or pharmacist before taking these tablets if you are taking other medicines, including any that you can buy without a prescription. This is especially important if you are taking: • medicines to thin the blood/prevent clotting (anticoagulants or anti-platelet drugs) such as warfarin, heparin, clopidogrel • paracetamol, aspirin or any other non-steroidal anti-inflammatory drugs • medicines called hydantoins, used to treat epilepsy e.g. phenytoin • a sulfonylurea (to treat diabetes) e.g. glipizide • antibiotic medicines called sulfonamides, often used to treat urinary tract infections • medicines to treat high blood pressure e.g water tablets (diuretics such as furosemide), propranolol and other beta blockers, or ACE inhibitors e.g. enalapril • lithium, used to treat mental illness • methotrexate, used to treat some types of cancer, you are having radiation therapy, or taking any medicines that depress bone marrow • ciclosporin or tacrolimus (to prevent rejection following organ or bone marrow transplants) • probenecid, used to treat gout • medicines to treat heart problems e.g. digoxin • oral steroids (used in replacement therapy and to treat inflammation) e.g. hydrocortisone • selective serotonin reuptake inhibitors (to treat depression e.g. fluoxetine) • mifepristone (used to terminate a pregnancy) • quinolone antibiotics (for infections) e.g. ciprofloxacin • zidovudine (to treat HIV infection). Other special warnings: • • • • • This medicine is not recommended for children under 16 years of age, except for the treatment of juvenile rheumatoid arthritis in children over 5 years of age. This medicine can affect the results of laboratory tests. Before you have any tests, tell your doctor you are taking this medicine. Medicines such as naproxen 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 (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist. Naproxen 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. Pregnancy and breastfeeding: Do not take this medicine if you are more than 6 months pregnant. Check with your doctor before taking if you are in the first 6 months of pregnancy, think you may be pregnant, or you are breast feeding. Effects on driving or operating machinery: Naproxen Tablets may make you feel dizzy, tired, drowsy, or depressed or have problems with your eyesight and balance, or have difficulty sleeping. If you think this medicine has affected you do not drive or operate machinery. Important information about some ingredients of Naproxen Tablets: These tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Also contains the colourant sunset yellow E110 which may cause allergic reactions. 16 East Park Road, Leicester, LE5 4QA. Tel 0116 201 3300 Customer Crescent Pharma Colours Used Description Naproxen Tablets 250mg and 500mg Leaflet Black Code Ref P0137T Keyline (Does not print) Cutter Ref - Size 210 x 297 mm Min. Point Size 8.5pt Page Numbers 1 of 2 Market UK Language English Proof By Scott Renshaw Proof No. Seven Date 09/06/11 File Location 19886/21876/386436 Fax 0116 201 3312 ISDN 0116 246 4123 Clearly mark any amendments on one proof and return to Chesapeake. Approved & Proceed Signature Amend & Re-submit Amend & Proceed Date Your Artwork/Disk has been translated through our Digital Artwork System into a format compatible with that of the Litho Printing Process. Warning! We cannot accept responsibility for any errors in this proof after approval. The artwork received has been significantly adjusted, revised or reset by us from disk or hard copy. Whilst we take extreme care at all times to ensure accuracy, the final responsibility must be taken by our customer. If you sign this proof you are signifying full approval of design and text. 150mm Pharma code N/A 3. How to take Naproxen Tablets Swallow the tablets whole with water. Take with or after food. The dose is different for different medical conditions and patients. Always take the medicine exactly as directed by your doctor. The label will tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist. Adults: For rheumatoid arthritis, osteoarthrosis and ankylosing spondylitis: The usual daily dose is 500mg to 1g taken in two doses at 12-hour intervals, or the dose may be taken all at once. For attacks of gout: The usual dose is 750mg in one dose or 250mg every 8 hours until the attack has gone. For acute musculoskeletal disorders: A first dose of 500mg followed by 250mg at 6-8 hour intervals. After the first day, the maximum daily dose is 1250mg. Children aged over 5 years: For juvenile rheumatoid arthritis only: The daily dose is calculated by your doctor and is usually 10mg per kg of body weight, taken in two doses at 12-hour intervals. Elderly patients and people with liver and kidney problems: Your doctor may have told you to take a lower dose than the usual adult dose stated above. Follow your doctor’s instructions. If you are elderly, your doctor may want to do some tests after you start taking these tablets to check you are not bleeding in your stomach or intestines. If you have taken too many tablets: Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified. If you forget to take a dose: If you miss a dose of this medicine take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with your normal dosing schedule. DO NOT DOUBLE THE DOSES. 4. Possible side effects Like all medicines, naproxen can cause side effects, although not everybody gets them. There will be fewer side effects if you take the lowest effective dose for the shortest time necessary. If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek IMMEDIATE medical help: • pass blood in your faeces (stools/motions), pass black tarry stools, vomit any blood or dark particles that look like coffee granules. These may be signs of a stomach ulcer or bleeding in your stomach. STOP TAKING the medicine and tell your doctor if you experience: • indigestion or heartburn • abdominal pain (pains in your stomach) or other abnormal stomach symptoms • allergic reactions which can include skin rash, itching, bruising, painful red areas, peeling or blistering, dizziness, difficulty in breathing, wheezing or shortness of breath, swollen face, throat, lips, hands or fingers • blistering of skin when exposed to sunlight • yellowing of your skin or the whites of your eyes and/or pale stools, dark urine, loss of appetite as these may be signs of liver problems • passing more or less urine than normal, cloudy or foamy urine, blood in urine, pain in the back, swelling (particularly of the ankles) as these may be signs of kidney problems. If you get any of the following very rare effects stop taking the tablets and tell your doctor as soon as possible: • inflammation of the pancreas causing severe pain in the abdomen and back • Stevens-Johnson syndrome or toxic epidermal necrolysis (serious illnesses causing blistering of the skin, mouth, eyes and genitals). Other effects include: • high blood pressure, oedema (water retention), heart failure (symptoms may include shortness of breath or swollen ankles), feeling your heartbeat • high levels of blood potassium which can cause abnormal heart rhythm • feeling or being sick, diarrhoea, constipation, flatulence (wind), sore mouth, mouth ulcers, irritation or swelling of the oesophagus • worsening of the symptoms of colitis and Crohn’s disease. • blood disorders including changes in the number of white or red blood cells which may cause pale skin, weakness or breathlessness and increase the risk of bleeding or bruising or make infections more likely • hives, sweating, tender red lumps on the shins, itchy swollen rash on the skin or in the mouth, blisters or pimples containing pus, increased sensitivity to light or loss of hair • headache, confusion, forgetfulness and difficulty concentrating, feeling of dizziness or “spinning”, changes to your hearing including ringing in the ears and hearing loss, drowsiness, light-headedness, fits, eyesight problems (such as blurred, clouded, partial or complete loss of vision, blind spots, halos around lights, eye pain, eye swelling), tingling or numbness in the hands or feet • difficulty sleeping, changes in your patterns of dreaming, confusion, depression, hallucinations • shortness of breath, asthma, or swelling of or fluid in your lungs which may cause breathing problems, cough, coughing up blood, pink frothy sputum, high temperature, excessive sweating, anxiety and pale skin • systemic lupus erythematosus (SLE). This is an allergic condition which causes joint pain, skin rashes and fever • muscle pain or weakness, tiredness, feeling generally unwell, thirst, fever • problems for women in getting pregnant • inflammation of the blood vessels, often with skin rash • aseptic meningitis (especially in patients with auto-immune disorders such as systemic lupus erythematosus and mixed connective tissue disease). Symptoms include fever, headache, stiff neck and back, feeling or being sick, skin rash, eyes being very sensitive to bright light, disorientation and muscle pain • medicines such as naproxen may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Do not be concerned by this list of side effects, you may not get any of them. If you notice any unwanted effects, even one not mentioned here, please tell your doctor or pharmacist. 5. How to store Naproxen Tablets Keep this medicine in the original package and protect from heat, light and moisture. KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal. 6. Further information Ingredients: Naproxen Tablets are available in two strengths and contain either 250mg or 500mg of naproxen as the active ingredient. The tablets also contain the inactive ingredients lactose, maize starch, povidone, sodium starch glycollate, magnesium stearate, quinoline yellow (E104) and sunset yellow (E110). What the medicine looks like: Naproxen Tablets 250mg are yellow, round tablets engraved on one side with company logo and A453 and a breakline on the other side. Naproxen Tablets 500mg are yellow caplet shaped tablets engraved on one side with company logo and A456 and a breakline on the other side. The tablets are available in packs of 28, 42, 50, 56, 84, 100, 112, 250, 500 and 1000 tablets. (Not all pack sizes may be marketed). Who makes this medicine and holds the Product Licence: Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED Date leaflet prepared: May 2011 If you would like this leaflet in a different format please contact the licence holder at the above address. 16 East Park Road, Leicester, LE5 4QA. Tel 0116 201 3300 Customer Crescent Pharma Colours Used Description Naproxen Tablets 250mg and 500mg Leaflet Black Code Ref P0137T Keyline (Does not print) Cutter Ref - Size 210 x 297 mm Min. Point Size 8.5pt Page Numbers 2 of 2 Market UK Language English Proof By Scott Renshaw Proof No. Seven Date 09/06/11 File Location 19886/21876/386436 Fax 0116 201 3312 ISDN 0116 246 4123 Clearly mark any amendments on one proof and return to Chesapeake. Approved & Proceed Signature Amend & Re-submit Amend & Proceed Date Your Artwork/Disk has been translated through our Digital Artwork System into a format compatible with that of the Litho Printing Process. Warning! We cannot accept responsibility for any errors in this proof after approval. The artwork received has been significantly adjusted, revised or reset by us from disk or hard copy. Whilst we take extreme care at all times to ensure accuracy, the final responsibility must be taken by our customer. If you sign this proof you are signifying full approval of design and text. 150mm Pharma code N/A