Naproxen 250mg, 375mg and 500mg EC tablets
Read this leaflet carefully before you start to take this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Naproxen EC tablets are and what they are used for
- 2. Before you take Naproxen EC tablets
- 3. How to take Naproxen EC tablets
- 4. Possible side effects
- 5. How to store
- 6. Further information
What Naproxen EC tablets are and what they are used for
Naproxen belongs to a group of medicines called non-steriodal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in joints and muscles.
Naproxen EC tablets are used to treat:
- diseases of joints such as rheumatoid arthritis (including in children), osteoarthritis and ankylosing spondylitis. Naproxen EC tablets cannot cure arthritis but is used to give relief of some symptoms such as inflammation, swelling, stiffness and joint pain.
- attacks of gout
- muscle and bone disorders
- painful periods.
Before you take Naproxen EC tablets
Do not take Naproxen EC tablets if you:
- are allergic to naproxen or to any of the other ingredients of Naproxen EC tablets (see section 6)
- are allergic to aspirin or other non-steroidal anti-inflammatory medicines (NSAIDs), or you have developed signs of asthma (wheezing), runny nose, swelling of the skin or rash when taking these medicines
- have or have had stomach or duodenum (gut) ulcers, bleeding in the stomach or intestines (gastrointestinal bleeding) or have had two or more episodes of peptic ulcers, stomach bleeding or perforation
- are in the last three months of pregnancy or if you are breast feeding
- have severe liver, kidney or heart failure.
If you are not sure about any of the above conditions, please ask your doctor.
Check with your doctor before taking Naproxen EC tablets if you:
- are on a low potassium diet, as this product contains potassium sorbate. High blood levels of potassium can cause stomach upset and diarrhoea
- use other non-steroidal anti-inflammatory medicines (NSAIDs) or any medication which may cause bleeding or ulcers in the stomach
- have a history of gastrointestinal disease e.g. ulcerative colitis, Crohn’s disease
- are elderly
- have or have had high blood pressure or any liver, kidney or heart problems
- have or have had bronchial asthma, other breathing problems or nasal polyps
- have systemic lupus erythematosus or other connective tissue disorders
- are a women trying to become pregnant or undergoing investigation of infertility.
Other warnings
- Medicines such as naproxen may be associated with a small increased risk of heart attack (myocardial infaraction) 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.
- If you are elderly or frail, you have a higher risk of getting side effects, especially from the stomach. If you experience any unusual symptoms from the stomach you must tell your doctor about it.
- Naproxen EC tablets may hide the symptoms of an infection.
Taking other medicines.
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. Especially:
- other NSAIDs such as aspirin or COX II inhibitors
- medicines which thin the blood or which prevent blood clotting (e.g. heparin or warfarin)
- corticosteroids (e.g. prednisolone), if needed the doctor will reduce the dose of the steroid slowly and monitor for side effects.
- diuretics (“water tablets”) such as furosemide
- medicines to treat high blood pressure (e.g. captopril, ramipril or propranolol)
- ciclosporin or tacrolimus
- mifepristone – do not take NSAIDs 8-12 days after mifepristone
- SSRI antidepressants
- zidovudine
- quinolones (e.g. ciprofloxacin)
- probenecid
- methotrexate
- lithium
- hydantoins (e.g. phenytoin)
- sulphonamides (e.g. sulfamethoxazole)
- sulphonylureas (e.g. glibenclamide or gliclazide)
- cardiac glycosides (e.g. digoxin).
Pregnancy and breast-feeding
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.
You should not take Naproxen EC in the first 6 months of pregnancy and must not take Naproxen EC in the last 3 months of pregnancy or during labour.
If you are breast-feeding, you should not take Naproxen EC tablets.
Driving and using machines
Naproxen EC tablets may cause dizziness, drowsiness or affect your vision.
Make sure you are not affected before you drive or operate machinery.
Sugar intolerance
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains lactose.
Tests
If you need any blood or urine tests tell your doctor you are taking Naproxen EC tablets. The tablets may need to be stopped 48 hours before a test, as they may interefere with the results.
How to take Naproxen EC tablets
Always take Naproxen EC tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Swallow whole with or after food with water, do not crush or break them.
Dose
Your doctor should prescribe as low a dose as possible. This will reduce any side effects you may experience.
Adults
- Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis
500mg-1g a day in two doses at twelve hourly intervals. If 1g a day is needed this can be given as two 500mg doses or as a single dose. - Attack of gout
Initially 750mg as a single dose then 250mg every 8 hours until the attack has passed. - Muscle and bone disorders and painful periods
Initially 500mg as a single dose then 250mg every 6-8 hours as necessary. Up to a maximum of 1250mg a day may be given after the first day.
Children over 5 years for juvenile rheumatoid arthritis
10mg per kg of body weight a day, taken in two doses at twelve hour intervals.
Elderly with kidney disease
Dosage may be reduced in the elderly.
If you take more Naproxen EC tablets than you should
It is important not to take too many tablets. Contact your doctor, pharmacist or nearest hospital casualty department immediately if you have taken more tablets than you should.
Symptoms of an overdose are feeling or being sick, heartburn, drowsiness, fits and indigestion.
If you forget to take Naproxen EC tablets
If you forget to take your tablets, take your next dose as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for one you have missed.
Possible side effects
Like all medicines, Naproxen EC tablets can cause side effects, although not everybody gets them.
Stop taking Naproxen tablets and contact your doctor immediately if you
- develop stomach or intestinal ulcers or bleeding, indigestion, heartburn or abdominal pain (pains in your stomach) or other abnormal stomach symptoms
- 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 if you notice any of the following side effects
- Allergic reaction: an itchy skin rash, blood spots, bruising or discolouring of the skin, red patches (erythema multiforme), a severe rash with reddening, peeling and swelling of the skin that resembles burns (epidermal necrolysis), or any other severe reactions like swelling of the face, mouth, tongue or airways, feeling and being sick, difficulty breathing or wheezing.
- Nervous system: fits, headache, ringing in the ears, a spinning sensation, difficulty concentrating and sleeping, inflammation of the optic nerve, disturbed vision, tingling or “pins and needles”, depression, confusion, sensing things that are not there, dizziness, feeling of general discomfort and illness, tiredness, drowsiness, aseptic meningitis (may cause fever, feeling or being sick, disorientation, headache, neck stiffness and light intolerance).
- Skin: rashes which may be red, itchy or blisters, hair loss, swelling of the face or body, sensitivity of the skin to light, red patches (erythema multiforme), severe skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson syndrome) or a severe rash with reddening, peeling and swelling of the skin that resembles burns (epidermal necrolysis).
- Stomach and intestines: stomach, duodenal or intestinal bleeding, ulcers or perforation, feeling or being sick, diarrhoea, wind, constipation, inflammation of the stomach lining (gastritis), worsening of colitis and Crohn’s disease.
- Kidneys: kidney damage or failure and blood in the urine.
- Other: changes in the numbers and types of blood cells (if you develop sore throats, nose bleeds or infections consult your doctor), water retention, hearing difficulties, swelling of the hands and feet, lung damage, jaundice (yellow skin or eyes), high blood potassium levels, mouth ulcers, inflammation of blood vessels, inflammation of the liver, heart failure.
- Medicines such as naproxen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
If any of the side effects get worse, or if you notice any not listed in this leaflet, please tell your doctor or pharmacist.
How to store
Keep out of the reach and sight of children.
Do not store above 25ºC. Store in the original package.
Do not use Naproxen EC tablets after the expiry date which is stated on the label/carton/bottle. The expiry date refers to the last day of that month.
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.
Further information
What Naproxen EC tablets contain
- The active substance (the ingredient that makes the medicine work) is 250mg, 375mg or 500mg of naproxen.
- The other ingredients are methacrylic acid-ethylacrylate copolymer (1:1), lactose, magnesium stearate, maize starch, crospovidone, propylene glycol, shellac glaze, sodium hydroxide, triethyl citrate, titanium dioxide (EI71), iron oxide black (E172), potassium sorbate (E202), sodium citrate (E331), xanthan gum (E415), hydroxypropyl cellulose (E463), purified talc (E553), beeswax.
What Naproxen EC tablets look like and contents of the pack
250mg tablets are white, round, biconvex, enteric-coated tablets.
375mg and 500mg tablets are white, oval, biconvex, enteric-coated tablets.
Pack size is 56.
Marketing Authorisation Holder and Manufacturer
This leaflet was last revised in July 2008
50211463
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