• Keep this leaflet. You may need to read it again while you are receiving your treatment.
• If you have any further questions, please ask your doctor or nurse.
• This medicine has been prescribed for you. Do not pass it onto 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.

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, naproxen sodium or any of the other ingredients of this medicine (listed in section 6)
• Aspirin, other NSAIDs or any other pain relief medicines (such as ibuprofen or diclofenac).

• You have now or have ever had any problems with your stomach or gut (intestine) like an ulcer or bleeding
• You are taking Mifamurtide (used in anti-tumour treatment)
• You have previously experienced bleeding or perforation in your stomach while taking NSAIDs
• You have serious problems with your liver, kidney or heart
• You are in the last three months of pregnancy.

Do not take Naproxen Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Naproxen Tablets.

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.

Talk to your doctor or pharmacist before taking Naproxen Tablets if any of the following apply to you:

• Asthma or allergies (like hayfever) or have had swelling of the face, lips, eyes or tongue in the past
• A feeling of weakness (perhaps because of an illness) or you are an older person
• Lumps in your nose (polyps) or you sneeze a lot or have a runny, blocked, or itchy nose (rhinitis)
• Problems with your kidneys or liver
• Problems with the way that your blood clots
• Problems with the blood vessels (arteries) anywhere in your body
• Too much fat (lipid) in your blood (hyperlipidaemia)
• An autoimmune condition, such as ‘systemic lupus erythematosus’ (SLE, causes joint pain, skin rashes and fever) and colitis or Crohn’s disease (conditions causing inflammation of the bowel, bowel pain, diarrhoea, vomiting and weight loss).
• Heart trouble or high blood pressure
• Chicken pox or shingles.

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Naproxen Tablets

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.

Serious skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS)) have been reported in association with Naproxen Tablets. Stop using Naproxen Tablets and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.’

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:

• other non-steroidal anti-inflammatory drugs (NSAIDs) e.g. COX II inhibitors (used for pain and inflammation)
• phenytoin to treat or prevent convulsions, anticoagulants to thin your blood, such as warfarin, heparin, clopidogrel and ticlopidine or some antibiotics such as ciprofloxacin and sulphonamides to treat infection, as the levels of all these medicines in your blood may increase when you start taking Naproxen
• antibacterials, (such as aminoglycosides) concomitant use with Naproxen could decrease the function of your kidneys.
• furosemide, amiloride, triampterene or other water tablets, as these may not work as well when you start taking Naproxen
• lithium or moclobemide to treat mental illness, as your body may not be able to clear these as quickly when you start taking Naproxen
• mifamurtide, used in anti-tumour treatment
• methotrexate (for rheumatoid arthritis)
• cardiac glycosides (e.g. digoxin), used to treat heart problems, and other drugs (e.g. disopyramide) used to control heart rhythm
• probenecid, for gout, as the dose of Naproxen you will need will be lower than usual
• certain drugs used to treat diabetes - chlorpropamide, glibenclamide, gliclazide and tolbutamide
• drugs for high blood pressure including ACE inhibitors (e.g. lisinopril), beta-blockers (e.g. propranolol) and angiotensin II antagonists (e.g. losartan)
• ritonavir or zidovudine, used to treat viral infections, can increase the risk of toxicity or damage to the blood.
• oxipentifylline, used for poor circulation
• drugs used to lower cholesterol (e.g. colestyramine)
• corticosteroids (e.g. prednisolone), used to treat allergic conditions and inflammation
• penicillamine, concomitant use with Naproxen can lead to decreased kidney function
• mifepristone (used in abortions)
• ciclosporin and tacrolimus (used after transplant surgery)
• aspirin/acetylsalicylic acid to prevent blood clots
• alcohol
• SSRI antidepressants (for depression), such as fluoxetine
• cholestyramine (for high cholesterol) (take naproxen 1 hour before or 4 to 6 hours after cholestyramine to avoid interference with absorption).

If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Naproxen Tablets

• You should not take Naproxen Tablets during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, Naproxen Tablets can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring
• Do not take Naproxen Tablets if you are in the last three months of pregnancy as it can harm the baby. Naproxen Tablets can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• Naproxen may make it more difficult to become pregnant. You should tell your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Naproxen Tablets may make you tired, drowsy, dizzy, have problems with your eyesight. Talk to your doctor if any of these happen to you and do not drive or use any tools or machines.

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’.

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 1250mg (5 x Naproxen 250mg 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.

Check with your doctor if you are not sure.

Swallow the tablets whole with a little water, with or after food.

You should make sure that you have enough to drink (stay well hydrated) when you are taking Naproxen Tablets. This is particularly important for people who have problems with their kidneys. While you are taking Naproxen Tablets your doctor will want to see you to check you are on the right dose for you and look for any side effects.

This is particularly important if you are elderly.

If you take more Naproxen Tablets than you should, contact your doctor or go to a hospital straight away. Take the container and any remaining tablets with you.

If you forget to take Naproxen Tablets, skip the missed dose. Then take you next dose as normal. 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.

Stop taking Naproxen Tablets and tell your doctor immediately if any of the following side effects happen. You may need urgent medical treatment:

Serious stomach or gut problems, signs include

• Bleeding from the stomach, seen as vomit which has blood in it, or bits that look like coffee grounds
• Bleeding from your back passage (anus), seen as passing black sticky bowel motions (stools) or bloody diarrhoea
• Ulcers or holes forming in your stomach or gut. Signs include upset stomach, stomach pain, fever, feeling or being sick
• Problems with your pancreas. Signs include severe stomach pain which spreads to your back
• Worsening of ulcerative colitis or Crohn’s disease, seen as pain, diarrhoea, vomiting and weight loss.

Allergic reactions, signs include:

• Sudden swelling of your throat, face, hands or feet
• Difficulty breathing, tightness in your chest
• Skin rashes, blisters or itching.

Severe skin rashes, signs include:

• A severe rash, blisters or ulcers (Stevens-Johnson syndrome)
• A severe rash with reddening, peeling and swelling of the skin that resembles burns (toxic epidermal necrolysis)
• Blistering of skin when exposed to sunlight (porphyria cutanea tarda) seen most on arms, face and hands
• Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS). See also section 2
• A distinctive cutaneous allergic reaction known as fixed drug eruption, that usually recurs at the same site(s) on re-exposure to the medication and may look like round or oval patches of redness and swelling of the skin, blistering (hives), itching.

Liver problems, signs include:

• Yellowing of your skin or the whites of your eyes (jaundice)
• Feeling tired, loss of appetite, feeling or being sick and pale coloured stools (hepatitis) and problems (including hepatitis), shown in blood tests.

Heart attack, signs include:

• Chest pain which may spread to your neck and shoulders and down your left arm.

Stroke, signs include:

• Muscle weakness and numbness. This may only be on one side of your body
• A suddenly altered sense of smell, taste, hearing or vision, confusion.

Meningitis, signs include:

• Fever, feeling or being sick, a stiff neck, headache, sensitivity to bright light and confusion (most likely in people with autoimmune conditions such as ‘systemic lupus erythematosus’).

If you notice any of the serious side effects mentioned above, stop taking Naproxen Tablets and tell your doctor straight away.

Stomach and gut

• Heartburn, indigestion, stomach ache, feeling sick or being sick, constipation, diarrhoea, wind.

Blood

• Blood problems, like anaemia or changes to the numbers of white blood cells.

Mental illness

• Having difficulty sleeping or changes in your patterns of dreaming
• Depression
• Confusion or seeing and possibly hearing things that are not there (hallucinations).

Nervous system

• Headache
• Fits or seizures, feeling dizzy or light-headed or sleepy
• Pins and needles or numbness of your hands and feet
• Difficulty with your memory or concentration.

Eyes and ears

• Changes to your eyesight, eye pain
• Changes to your hearing, including ringing in the ears (tinnitus) and hearing loss
• Dizziness that causes problems with your balance.

Heart and circulation

• Swelling of your hands, feet or legs (oedema), this may be with chest pains, tiredness, and shortness of breath (cardiac failure)
• A fluttering feeling in your heart (palpitations), slow heart beat or high blood pressure
• Problems with the way your heart pumps blood around the body or damage to your blood vessels. Signs may include tiredness, shortness of breath, feeling faint, general pain.

Chest

• Difficulty breathing, including shortness of breath, wheezing or coughing
• Pneumonia or swelling of your lungs.

Skin and hair

• Skin rashes including redness, hives, pimples and blisters on your body and face
• Bruising, itching, sweating, skin being more sensitive to the sun or hair loss.

Urinary

• Blood in your water (urine) or kidney problems.

Other

• Thirst, fever, feeling tired or generally unwell
• A sore mouth or mouth ulcers
• Muscle pain or weakness
• Problems for women in getting pregnant
• ‘Systemic lupus erythematosus’ (SLE). Signs include fever, rash, problems with your kidneys and joint pain.

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.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report suspected adverse drug reactions (ADRs) to the MHRA through the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard, the free Yellow Card app available in Apple App Store or Google Play. Alternatively you can call 0800731 6789 for free, Monday to Friday between 9am and 5pm.

By reporting side effects you can help provide more information on the safety of this medicine.

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.

Marketing Authorisation Holder:

Manufacturer: