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The product code(s) for this leaflet is: PL 29831/0150.
Naproxen 250mg & 500mg Tablets
Naproxen 250mg and 500mg Tablets
Naproxen
(Referred to as Naproxen Tablets in this leaflet)
1. What Naproxen Tablets are and what they are used for
2. What you need to know before you take Naproxen Tablets
3. How to take Naproxen Tablets
4. Possible side effects
5. How to store Naproxen Tablets
6. Contents of the pack and other information
Naproxen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAID). It is a painkiller and antipyretic (reduces fever). Naproxen works by reducing inflammation and relieving pain, swelling and stiffness in the joints and muscles. There are a number of painful conditions that can affect your joints and muscles, which can be helped by taking Naproxen. These conditions include:
Talk to your doctor or pharmacist before taking Naproxen Tablets:
Tell your doctor if any of the above applies to you.
Medicines such as Naproxen 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; however, short-term used in those with no cardiovascular risk may also experience a small increased risk in thrombotic events. 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.
There is a risk of bleeding or perforation of the stomach and stomach ulcers with the use of Naproxen. This is higher in the elderly, if you have a history of stomach ulcer, or if you smoke. Increased risk with dose of naproxen. If you think that you might be at risk of these conditions, you should speak to your doctor or pharmacist.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription, or any of the following:
There may be some problems when naproxen is taken with alcohol, including bleeding of the stomach and stomach ulcers.
Naproxen Tablets with food and drink - You should swallow Naproxen Tablets with a glass of water, preferably with or after food.
Taking naproxen late in pregnancy can cause delayed or prolonged labour and may cause bleeding problems, kidney problems and problems with the circulation of the blood in newborn babies.
Do not drive or operate machinery if you feel drowsy or have blurred vision after taking Naproxen Tablets.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially ‘sodium – free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
These tablets should be taken as instructed after meals. The dose you should take will depend on what you are taking Naproxen for.
Adults: Rheumatoid Arthritis, Osteoarthritis and Ankylosing
Spondylitis: 250mg or 500mg twice a day.
Acute gout: 750mg is taken at once then 250mg every eight hours until the attack has passed.
Musculo-Skeletal Disorders (sprains etc): the usual dose is 500mg followed by 250mg every six to eight hours, up to a maximum 1250 mg (5 x Naproxen 250 mg tablets) per day after the first day.
Elderly: If you are elderly the dose you take will be similar to other adults but should be the lowest dose that is effective.
Children: In children over 5 years with juvenile rheumatoid arthritis 10mg/kg bodyweight per day is usually given, in divided doses.
If you take more Naproxen Tablets than you should, contact your doctor or nearest hospital emergency department immediately. Symptoms of overdose include drowsiness, apnoea, heartburn, indigestion, feeling and being sick. Take the container and any remaining tablets with you.
If you forget to take Naproxen Tablets take it as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.
Do not stop taking Naproxen Tablets without talking to your doctor, even if you feel better. It is important that you take the full course of Naproxen prescribed by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very serious side effects - If any of the following happen, stop taking Naproxen Tablets and tell your doctor immediately or go to your nearest hospital emergency department:
Naproxen Tablets can make colitis and Crohn’s disease worse.
Occasionally stomach ulcers may develop.
Some anti-inflammatory/pain relieving medicines (particularly at high doses and in long-term treatment) may be associated with a small increased risk of heart attack or stroke.
Rare (occurring in less than 1 in 1,000 patients): high blood pressure, effects on the kidneys or liver, decreased vision due to clouding of the cornea, or papilloedema (intracranial pressure causing optic disc swelling, symptoms include headache.). Blood disorders (which may cause fever, sore throat, mouth ulcers, flu-like symptoms, severe exhaustion, prolonged bleeding, unexplained bleeding or bruising).
Unknown Frequency: a mild form of meningitis (aseptic-meningitis), causing headache, neck stiffness, fever, confusion, feeling or being sick, allergic reaction, skin rashes, itchy/runny nose, hair loss, menstrual disturbances in women, impotence in men, reversible infertility, nervousness, nightmares, Insomnia, depression, sleeplessness, lack of concentration, feeling dizzy or confused, loss of memory, feeling or being sick, feeling generally unwell, giddiness, drowsiness, tiredness, blood in the urine, wind, indigestion, heartburn, mouth ulcers, headache, heart condition, cough, weakness, pins and needles or slight swelling of the hands and feet, fluid in the tissues, red or purple discolouration of the skin, yellow skin (jaundice), inflammation of the lungs, inflammation of the blood vessels (vasculitis), upset stomach, stomach or abdominal pain and diarrhoea, flatulence, constipation, stomach ulcers, nausea, vomiting, hallucinating, hearing problems, ringing in the ears and changes in eyesight.
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 national reporting systems listed below:
United Kingdom:
or search for MHRA Yellow Card in the Google Play or Apple App Store.
Malta:
By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date, which is shown on the label or carton. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
The active substance is naproxen.
Other ingredients are lactose, maize starch, povidone, sodium starch glycollate, magnesium stearate, yellow lake CLF 3076 which consists of E104 (quinoline yellow aluminium lake) and E172 (iron oxide).
The tablets are available in two strengths of 250mg and 500mg.
Naproxen 250mg Tablets are yellow, circular, flat faced tablets marked NXN 250 with a breakline on one face and CP on the reverse.
Naproxen 500mg Tablets are yellow capsule shaped tablets marked NXN 500 with a breakline on one face and CP on the reverse.
Naproxen Tablets are available in blister packs of 28 tablets in cartons.
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Product name Reference number
Naproxen 250mg Tablets 29831/0150
Naproxen 500mg Tablets 29831/0149
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This leaflet was last revised in 07/2018.
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