Naproxen 500mg Gastro-Resistant Tablets

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Document: leaflet MAH GENERIC_PL 00142-0439 change

Naproxen 250mg, 375mg and 500mg Gastro-resistant tablets

Rare (affects 1 to 10 users in 10,000) high blood potassium levels (causing irregular, slow heart beat, feeling sick), hair loss, jaundice (yellow skin or eyes), hearing difficulties, inflammation of blood vessels (causing fever, swelling and general unwellness), worsening of asthma, muscle weakness/pain, ulcers on the inner cheeks, gums and tongue, hepatitis - sometimes fatal (symptoms include feeling tired, loss of appetite, feeling or being sick and pale coloured stools).

Very rare (affects less than 1 user in 10,000) changes in the numbers and types of blood cells (if you develop sore throats, nose bleeds or infections consult your doctor), anaemia (may cause fainting, chest pain, breathlessness), fits, aseptic meningitis (may cause fever, feeling or being sick, disorientation, headache, neck stiffness and sensitivity to light), severe skin rash with flushing, blisters or ulcers (Stevens-Johnson syndrome), blisters or sores on the skin, kidney damage or infection (may cause blood in the urine, decrease in amount of urine passed, feeling or being sick), inflammation of the pancreas; pancreatitis (causing fever, stomach pain, sickness). Medicines such as naproxen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Not Known (frequency cannot be estimated from the available data) low amounts of white cells in the blood (may cause fever or frequent infections), runny nose, lowered female fertility (see section 2), sensing things that are not there, high blood creatinine levels seen in blood tests, kidney failure, kidney disease (may cause changes in the need to or amount of urine), thirst, fever, inflammation in the eye (causing eye pain or changes in vision), tingling or "pins and needles', a spinning sensation, abnormal liver function seen in tests, worsening of Parkinson's disease, general feeling of discomfort and illness, swelling of the hands and feet, swelling in the eye (causing headaches or blurred vision).

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.

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You can also report side effects directly via the Yellow Card Scheme at: uk/yellowcard

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

5| How to store

Keep out of the reach and sight of children. Do not store above 25°C. Store in the original package.

Do not use Naproxen GR tablets after the expiry date 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.

0 Further information

What Naproxen GR 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 GR 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 sizes: 56 tablets

Marketing Authorisation Holder and Manufacturer

Actavis, Barnstaple, EX32 8NS

This leaflet was last revised in March 2014


Actavis, Barnstaple, EX32 8NS, UK

AAAG6625 50778110

Read all of this leaflet carefully before ; you start taking this medicine.

: • Keep this leaflet. You may need to read ■ it again.

: • If you have any further questions, ask your doctor or pharmacist.

1 • 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

11 What Naproxen GR tablets are and what they are used for 0 Before you take Naproxen GR tablets

0 How to take Naproxen GR tablets 2 Possible side effects 0 How to store 0 Further information

m 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 ofjoints 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 of the symptoms such as inflammation, swelling, stiffness and joint pain.

•    attacks of gout

   muscle and bone disorders

   painful periods.

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0 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 in Naproxen GR tablets (see section 6)

•    are allergic to aspirin or other nonsteroidal 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 GR 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 antiinflammatory 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


•    drink alcohol

•    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

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•    have a blood clotting disorder

•    are a woman 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 infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration oftreatment.

•    If you have heart problems, previous stroke orthinkthatyou 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 of the stomach. If you experience any unusual symptoms from the stomach you must tell your doctor about it.

•    Taking a painkiller for headachestoo often or for too long can make them worse.

•    Naproxen GRtablets 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, losartan orcandesartan)

•    ciclosporin or tacrolimus

•    mifepristone - do not take NSAIDs 8-12 days after mifepristone

•    SSRI antidepressants

•    zidovudine

•    quinolones (e.g. ciprofloxacin)

•    probenecid

•    methotrexate

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•    bisphosphonates

•    colestyramine (take naproxen 1 hour before or 4 to 6 hours after colestyramine to avoid interference with absorption)

•    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 GR in the first 6 months of pregnancy and must not take Naproxen GR in the last 3 months of pregnancy or during labour.

If you are breast-feeding, you should not take Naproxen GRtablets.

Driving and using machines

Naproxen GRtablets 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.


If you need any blood or urine tests tell your doctoryou are taking Naproxen GRtablets. The tablets may need to be stopped 48 hours before a test, as they may interfere with the results.

E] How to take Naproxen GRtablets

Always take Naproxen GRtablets 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 breakthem.


Your doctor should prescribe as low a dose as possible. This will reduce any side effects you may experience.

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•    Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis

500mg-1 g a day in two doses at twelve hourly intervals. If 1 g 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

lOmg per kg of body weight a day, taken in two doses at twelve hourly intervals.

Elderly with kidney disease

Dosage may be reduced in the elderly.

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 casualty department immediately if you have taken more tablets than you should.

Symptoms of an overdose are headache, feeling or being sick, heartburn, diarrhoea, disorientation, bleeding ofthe 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 one you have missed.

3 Possible side effects

Like all medicines. Naproxen GRtablets can cause side-effects, although not everybody gets them. If any ofthe side effects get worse, or if you notice any not listed in this leaflet, please tell your doctor or pharmacist.

Stop taking Naproxen tablets and contact your doctor immediately if you

•    have indigestion, heartburn, pains in your stomach or other abnormal stomach symptoms, feeling or being sick (you may have an ulcer or inflammation in the stomach or gut)

•    pass blood in your faeces (stools/motions) or black tarry looking stools (signs of bleeding and perforation ofthe stomach and intestines).

•    vomit any blood or dark particles that look like coffee grounds

•    have an allergic reaction:

-    swelling ofthe face, mouth, tongue, airways or body

-    skin reactions including: hives (pale/red raised skin with severe itching), blistered skin, itchy skin rash, blood spots, bruising or discolouring ofthe skin, raised purple rashes, red skin patches, a severe rash with reddening, peeling and swelling ofthe skin that resembles burns, bumpy rashes, blisters, dermatitis (skin shedding, itching, swelling)

-    difficulty breathing or wheezing, coughing up blood.

Tell your doctor if you notice any of the following side effects

The most commonly observed adverse events are gastrointestinal in nature.

Feeling sick, being sick, diarrhoea, wind, constipation and worsening of colitis and Crohn's disease have been reported following administration.

Water retention (may cause swelling in the limbs), high blood pressure and heart failure have been reported in association with NSAID therapy.

Common (affects 1 to 10 users in 100) confusion, headache, ringing in the ears, changes in vision (you should go for an eye test if you notice changes in vision), tiredness, drowsiness, dizziness, rashes.

Uncommon (affects 1 to 10 users in 1,000) depression, irregular heartbeat (palpitations), abnormal dreams, forgetfulness, difficulty concentrating, sensitivity ofthe skin to light (may cause blistering), difficulty sleeping.

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