Patient leaflet - Naproxen 250 mg gastro-resistant tablets
1 What Naproxen GR tablets are and what they are used for
Naproxen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in joints and muscles.
Naproxen GR tablets are used to treat:
- diseases of joints such as rheumatoid arthritis (including in children), osteoarthritis and ankylosing spondylitis. Naproxen GR tablets cannot cure arthritis but are used to give relief of some symptoms such as inflammation, swelling, stiffness and joint pain
attacks of gout
Naproxen 250mg, 375mg and 500mg Gastro-resistant tablets
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- muscle and bone disorders
- painful periods.
2 What you need to know before you take Naproxen GR tablets
Do not take Naproxen GR tablets if you:
- are allergic to naproxen or to any of the other ingredients of this medicine (listed in section 6)
- have or have had stomach or duodenum (gut) ulcers, bleeding in the stomach or intestines (gastrointestinal bleeding)
- have or have had two or more episodes of peptic ulcers, stomach bleeding or perforation while taking NSAIDs
- 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 severe liver, kidney or heart failure
are in the last three months of pregnancy.
If you are not sure about any of the above conditions, please ask your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Naproxen GR 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
- If you use other non-steroidal anti-inflammatory medicines (NSAIDs) or any medication which may cause bleeding or ulcers in the stomach
- If you have a history of gastrointestinal disease e.g. ulcerative colitis, Crohn’s disease
- If you smoke
If you drink alcohol
- Elderly patients have a higher risk of getting side effects, especially from the stomach
- If you have or have had high blood pressure or any liver, kidney or heart problems
- If you have or have had bronchial asthma, other breathing problems or nasal polyps
- If you have systemic lupus erythematosus or other connective tissue disorders
- Sudden shortness of breath, chest pain, nausea, these could be signs of hyperkalaemia.
- Meningitis (symptoms include a stiff neck, headache, feeling or being sick, fever, sensitivity to bright light and confusion).
- Liver problems including yellowing of the skin or whites of your eyes (jaundice); feeling tired, loss of appetite, feeling or being sick, pale coloured stools (hepatitis shown in blood tests).
Other side effects (frequency not known, cannot be estimated from the available data): Stomach or gut problems:
- Heartburn; nausea, vomiting, constipation; diarrhoea; flatulence; indigestion; abdominal discomfort or pain.
Blood disorders:
- Changes to the number and types of blood cells causing illness such as anaemia or an increased risk of infections.
Mental illness:
- Difficulty sleeping (insomnia); abnormal dreams; depression; confusion; seeing, hearing or believing things which are not real (hallucinations).
Nervous system:
- Fits or seizures; dizziness; headache; light-headedness; drowsiness; pins and needles or numbness of your hands and feet; difficulty concentrating or forgetfulness.
Eyes and ears:
- Changes to your eyesight; eye pain; changes to your hearing including ringing in your ears (tinnitus) or loss of hearing; spinning sensation (vertigo).
Heart and circulation:
- Swelling of hands, feet or legs (oedema); fluttering feeling in your chest (palpitations); high blood pressure; problems with the way your heart pumps blood around the body or damage to blood vessels (signs include chest pain, tiredness, shortness of breath, feeling faint, general pain).
Chest:
- Difficulty breathing, wheezing or coughing; pneumonia or swelling of your lungs.
Urinary:
- Blood in your urine; kidney problems.
General:
Thirst; fever; feeling generally tired or unwell; sore mouth or mouth ulcers; muscle pain or weakness; problems for women in getting pregnant; sweating; hair loss.
This medicine contains potassium, less than 1 mmol (39 mg) per gastro-resistant tablet, i.e. essentially ‘potassium-free’.
Tests
If you need any blood or urine tests tell your doctor you are taking Naproxen GR tablets. The tablets may need to be stopped 48 hours before a test, as they may interfere with the results.
3 How to take Naproxen GR tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Swallow whole with or after food with water, do not crush or break them.
Recommended 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 12 hour intervals 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.
Elderly or patients with liver or kidney impairment
Reduced dosage may be given to the elderly, or patients with liver or kidney disease. Naproxen should not be given to patients with a baseline creatinine clearance below 30ml/min.
Use in children and adolescents Children over 5 years for juvenile rheumatoid arthritis
10mg per kg of body weight a day, taken in two doses at 12 hour intervals.
If you take more Naproxen GR tablets than you should
It is important not to take too many tablets. Contact your doctor, pharmacist or nearest hospital emergency department immediately if you have taken more tablets than you should. Symptoms of overdose are headache, feeling or being sick, heartburn, diarrhoea, disorientation, bleeding of the stomach or intestines, unconsciousness, drowsiness, dizziness, ringing or buzzing in the ears, fainting, fits and excitation.
If you forget to take Naproxen GR tablets
If you forget to take your tablets, take your forgotten 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 a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side-effects, although not everybody gets them. If any of the side effects get worse, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Stop taking Naproxen GR tablets and see your doctor or go to your nearest hospital emergency department immediately if you experience any of the following serious side effects (frequency not known, cannot be estimated from the available data):
- An allergic reaction: swelling of the face, mouth, tongue, airways or body; difficulty breathing or wheezing, coughing up blood; skin reactions including hives (pale/red raised skin with severe itching), itchy skin rash, blood spots, bruising or discolouring of the skin, raised purple rashes, red skin patches, bumpy rashes, blisters, dermatitis (skin shedding, itching, swelling).
- Severe skin rash with flushing, 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 (pseudoporphyria). 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.
- Heart attack or stroke.
- Serious stomach problems: ulcer or inflammation in the stomach or gut (causing indigestion, heartburn, pains in your stomach, feeling or being sick); worsening of colitis and Crohn’s disease (pain, diarrhoea, vomiting, weight loss); black tarry looking stools (signs of bleeding and perforation of the stomach and intestines); vomiting blood or dark particles that look like coffee grounds; pancreatitis (causing fever, stomach pain, sickness).
- If you have a blood clotting disorder
- Naproxen can cause serious skin reactions, some fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with naproxen. Stop using Naproxen GR tablets and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4
- Naproxen tablets may hide the symptoms of an infection
- If you develop visual disturbances while taking Naproxen you should have an eye examination
- Taking a painkiller for headaches too often or for too long can make them worse
- If you are a woman trying to become pregnant or undergoing investigation of infertility.
When taking Naproxen GR tablets, inflammation in your kidney may occur. Signs and symptoms may include decreased volume of urine or blood in your urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should report such signs to the treating physician.
Children
Do not give this medicine to children under 5 years old.
Other medicines and Naproxen GR tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Especially:
- aspirin/acetylsalicylic acid to prevent blood clots
- other NSAIDs such as 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’) (e.g. furosemide)
- medicines to treat high blood pressure (e.g. captopril, ramipril, losartan or candesartan)
- ciclosporin or tacrolimus
- mifepristone – do not take NSAIDs 8-12 days after mifepristone
- SSRI antidepressants
- zidovudine
- quinolones (e.g. ciprofloxacin)
- probenecid
- methotrexate
- antacid
- bisphosphonates
- colestyramine (take naproxen 1 hour before or 4 to 6 hours after colestyramine to avoid interference with absorption)
lithium
- hydantoins
- sulfonamides
- sulfonylureas (e.g. glibenclamide or gliclazide)
- cardiac glycosides.
Naproxen GR tablets with food
Naproxen GR tablets should preferably be taken with or after food.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant, are planning to have a baby or if you have problems becoming pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Naproxen GR tablets if you are in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. 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 take Naproxen GR 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 GR 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.
Breast-feeding
If you are breast-feeding, you should not take Naproxen GR tablets.
Fertility
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.
Driving and using machines
Naproxen GR tablets may make you feel dizzy, drowsy or tired and may cause blurred vision. Make sure you are not affected before you drive or operate machinery.
Naproxen GR 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.
This medicine contains less than 1 mmol sodium (23 mg) per gastro-resistant tablet, that is to say essentially ‘sodium-free’.
Reporting of side effects
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 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 GR tablets
Keep this medicine out of the sight and reach of children.
Do not store above 25ºC. Store in the original package.
Do not take this medicine after the expiry date which is stated on the label/carton. The expiry date refers to the last day of that month. 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 GR tablets contain
- The active substance (the ingredient that makes the medicine work) is naproxen. Each gastro-resistant tablet contains either 250mg, 375mg or 500mg of the active substance.
- The other ingredients are: methacrylic acid-ethylacrylate copolymer (1:1), lactose, magnesium stearate, maize starch, crospovidone, propylene glycol, sodium hydroxide, triethyl citrate, titanium dioxide (E171), potassium sorbate (E202), sodium citrate (E331), xanthan gum (E415), hydroxypropyl cellulose (E463), purified talc (E553).
What Naproxen GR tablets look like and contents of the pack
Naproxen 250mg gastro-resistant tablets are white, round, biconvex, gastro-resistant tablets. Naproxen 375mg gastro-resistant tablets are white, oval, biconvex, shallow concave, gastro-resistant tablets.
Naproxen 500mg gastro-resistant tablets are white, oval, biconvex, deep concave, gastro-resistant tablets.
Pack sizes: 56 tablets.
Marketing Authorisation Holder and Manufacturer
Accord, Barnstaple, EX32 8NS, UK