Naproxen 500mg Tablets – patient leaflet, side effects, dosage

1. What Naproxen 500mg Tablets are and what they are used for

Naproxen 500mg Tablets contain a medicine called naproxen. This is a NSAIDs (non-steroidal anti-inflammatory drugs).

Naproxen 500mg Tablets can lessen pain, swelling, redness and heat (inflammation) and is used to treat adults for:

• Problems with your muscles, joints and tendons, like strains, gout, ankylosing spondylitis (pain and stiffness

  in the neck and back) or arthritis.

• Women, while having period pain.

It can also be used in children over 5 years with rheumatoid arthritis.

You must talk to a doctor if you do not feel better or if you feel worse.

2. What you need to know before you take Naproxen 500mg Tablets

DO NOT take Naproxen 500mg Tablets, if you are allergic (hypersensitive) to:

• Naproxen or any of the other ingredients of Naproxen 500mg Tablets (listed in section 6) • Aspirin, other NSAIDs (non- steroidal anti-inflammatory drug) or any other pain relief medicines (such as

  ibuprofen or diclofenac)

DO NOT take Naproxen 500mg Tablets if you,

• have developed signs of asthma (wheezing), runny nose, lumps in your nose or swelling of the skin or rash

  when taking these medicines.

• have now or have ever had any problems with your stomach or gut (intestine) like an ulcer or bleeding. • have previously experienced bleeding or perforation in your stomach while taking NSAIDs. • have severe problems with your kidneys, liver or hearrt
• are in the last 3 months of pregnancy.

Do not take Naproxen 500mg Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Naproxen 500mg Tablets.

Warnings and precautions

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 500mg 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 the blood vessels (arteries) anywhere in your body.
• Too much fat (lipid) in your blood (hyperlipidaemia).
• Problems with your kidneys or liver.
• Problems with the way that your blood clots.

• An autoimmune condition, such as ‘systemic lupus erythematosus’ (SLE, that 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.

• Serious skin reactions including (Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction

  with eosinophilia and systemic symptoms (DRESS)) have been reported in association with Naproxen. Stop using Naproxen and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before you take Naproxen 500mg Tablets

Other medicines and Naproxen 500mg Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. In particular, tell your doctor or pharmacist if you are taking:

• Other painkillers, like aspirin, ibuprofen, diclofenac and paracetamol.

• Medicines that prevent blood clotting like, asprin/ acetylsalicylic acid, warfarin, heparin or clopidogrel. • A diuretics (water tablets) (for high blood pressure), such as furosemide

  • A ‘cardiac glycoside’ used to treat heart problems, such as digoxin.
  • A steroid used to treat swelling and inflammation, like hydrocortisone, prednisolone and dexamethasone. • Probenecid, a medicine to treat gout.
  • Certain medicines used to treat mental illness, such as lithium or ‘SSRIs’ selective serotonin reuptake inhibitors such as Fluoxetine or Citalopram.
  • A hydantoin used to treat epilepsy, such as phenytoin.
  • An 'ACE inhibitor' or any other medicine for high blood pressure like cilazapril, enalapril or propranolol. • Sulfonamide medicines, like hydrochlorothiazide, acetazolamide, indapamide and including sulfonamide antibiotics used to treat infections.
  • A ‘quinolone antibiotic’ used to treat infections, such as ciprofloxacin or moxifloxacin • A sulfonylurea (for diabetes), like glimepiride or glipizide
  • An angiotensin-II receptor antagonist, like candesartan, eprosartan or losartan.
  • Ciclosporin or tacrolimus, (for skin problems or after an organ transplant).
  • Methotrexate (used to treat skin conditions, arthritis and cancer).
  • Zidovudine, a medicine used to treat AIDS and HIV infections
  • Mifepristone, a medicine used to end pregnancy or to bring on labour if the baby has died. If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Naproxen 500mg Tablets.

It may still be all right for you to take Naproxen 500mg Tablets and your doctor will be able to decide what is suitable for you.

Pregnancy, breast-feeding and fertility

• Do not take Naproxen 500mg Tablets if you are in the last three months of pregnancy, as it can harm your baby. It 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.
• You should not use Naproxen during the first 6 months of pregnancy unless clearly 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 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.
• 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.
• Oral forms (e.g. tablets) of Naproxen can cause adverse effects in your unborn baby. It is not known if the same risk applies to Naproxen when it is used on the skin.

Naproxen 500mg Tablets 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.

Driving and using machines

Naproxen 500mg Tablets may make you tired, drowsy, dizzy, cause blurred vision, difficulty in sleeping or make you feel depressed. Talk to your doctor if any of these happen to you and do not drive or use machines. Naproxen 500mg 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.

3. How to take Naproxen 500mg Tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Medicines such as Naproxen 500mg Tablets may be linked with a small increased risk of heart attack or stroke. Any risk is more likely with higher doses and long term treatment. Do not take more than the recommended dose or exceed the length of the treatment.

Method of administration:

Naproxen 500mg Tablets should be swallowed whole with a glass of water, with or after food. Take your tablets at the same time each day.

The score line is only there to help you break the tablet if you have difficulty swallowing it whole. You should make sure that you have enough to drink (stay well hydrated) when you are taking Naproxen 500mg Tablets. This is particularly important for people who have problems with their kidneys. While you are taking Naproxen 500mg 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. The recommended doses are:

Adults

Muscle, joint or tendon problems and period pain

The usual starting dose is 500 mg, followed by one 250 mg tablet every 6 to 8 hours as needed. Arthritis and ankylosing spondylitis

The usual dose is between 500 mg and 1000 mg.

The dose can be taken all at once, or half the dose may be taken twice a day

Gout

The usual starting dose is 750 mg, followed by one 250 mg tablet every 8 hours as needed. Elderly and patients with liver and kidney problems

The doctor will decide the right dose for you, it will usually be lower than for other adults. Children over 5 years, rheumatoid arthritis

The usual dose is 10 mg per kilogram of body weight each day.

The total daily dose is split into two doses, to be given 12 hours apart.

If you take more Naproxen 500mg Tablets than you should

If you take too many Naproxen 500mg Tablets, talk to your doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Naproxen 500mg Tablets

• If you have missed a dose, skip the missed dose. Then take your next dose as normal.
• Never take a double dose of Naproxen 500mg Tablets to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Medicines such as Naproxen 500mg Tablets may be associated with a small increased risk of heart attack ('myocardial infarction') or stroke.

Serious side effects:

Stop taking Naproxen 500mg Tablets and tell your doctor straight away if any of the following side effects happen. You may need urgent medical treatment:

Allergic reactions, signs include:

• sudden swelling of your throat, face, hands or feet
• difficulty breathing, tightness in your chest
• skin rashes, blisters or itching
• widespread rash
• high body temperature
• 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

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, seen as upset stomach, stomach pain, fever, feeling or being

  sick

• problems with your pancreas, seen as severe stomach pain which spreads to your back
• worsening of ulcerative colitis or Crohn's disease, seen as pain, diarrhoea, vomiting and weight loss Severe skin rashes, signs include:

• a severe rash with blisters or peeling of your skin and possibly blisters in your mouth, throat or eyes. Fever,

  headache, cough and aching body may happen at the same time

• blistering of skin when exposed to sunlight (porphyria cutanea tarda) seen most on arms, face and hands 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, shown

  in blood tests

• liver enzyme elevations

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, which may only be on one side of your body
• a sudden altered sense of smell, taste, hearing, vision or 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 500mg Tablets and tell your doctor straight away

Other possible side effects:

Stomach and gut

• heartburn, indigestion, constipation, stomach ache, feeling sick or being sick, gaseous bowels Blood
• blood problems, like anaemia or changes to the numbers of white blood cells
• blood abnormalities (eosinophilia)

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, 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, 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 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

• 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.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

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 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 Naproxen 500mg Tablets

Keep this medicine out of the sight and reach of children

Do not use this medicine after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last date of that month

Do not store above 25°C. Store in the original package in order to protect from light and moisture. Do not use this medicine if you notice any visible signs of deterioration.

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.

6. Contents of the pack and other information What Naproxen 500mg Tablets contain

• The active substance is naproxen.
• The other ingredients are lactose, maize starch, povidone (E1201), sodium starch glycollate, magnesium stearate (E470b) and quinolone yellow (E104).

What Naproxen 500mg Tablets look like and contents of the pack

Naproxen 500mg Tablets are yellow coloured, capsule shaped uncoated tablets with score line between 'NPY' and '500' embossed on one side and plain on the other side.

Naproxen 500mg Tablets are available in packs of 28, 30, 56, 60, 84, 100, 250, 500 and 1000 tablets. (Not all pack sizes may be marketed).

This leaflet was last revised in September 2026.

Marketing Authorization Holder and Manufacturer:

NOUMED LIFE SCIENCES LIMITED

Noumed House, Shoppenhangers Road

Maidenhead, Berkshire, SL6 2RB, United Kingdom.

To listen to or request a copy of this leaflet in Braille, large print or audio please call, 020 33998960 (UK only)

Please be ready to give the following information:

Product name Reference number Naproxen 500mg Tablets PL 44041/0026

POM

L002604/04

Black Colours