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Naproxen 250mg and 500mg tablets

Read this leaflet carefully before you start to take this medicine.

Keep this leaflet. You may need to read it again.

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

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:

1. What Naproxen tablets are and what they are used for

2. Before you take Naproxen tablets

3. How to take Naproxen tablets

4. Possible side effects

5. How to store

6. Further information

What Naproxen tablets are and what they are used for

Naproxen belongs to a group of medicines called non-steriodal anti-inflammatory drugs (NSAIDs), which are used to reduce inflammation and pain in joints and muscles.

Naproxen tablets are used to treat:

diseases of joints such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis. Naproxen cannot cure arthritis but is used to give relief of some symptoms such as inflammation, swelling, stiffness and joint pain.

attacks of gout

muscle and bone disorders such as cervical spondylitis, low back pain, strains and sprains, muscular pain and stiffness (fibrositis) and inflammation of tendons (tenosynovitis).

Before you take Naproxen tablets

Do not take Naproxen tablets if you:

are in the last three months of pregnancy or if you are breast-feeding

are allergic to naproxen or to any of the other ingredients of Naproxen tablets (see section 6)

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 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

have severe liver, kidney (not receiving dialysis) 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 tablets if you:

use other non-steroidal anti-inflammatory 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

are elderly

have or have had high blood pressure or any liver, kidney or heart problems

have or have had bronchial asthma or allergic disease

have systemic lupus erythematosus or other connective tissue disorders

are a women 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 infaraction) or stroke. Any risk is more likely with high doses and prolonged treatment. 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.

If you are elderly or frail, you have a higher risk of getting side effects, especially from the stomach. If you experience any unusual symptoms from the stomach you must tell your doctor about it.

Naproxen tablets 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 such as warfarin

corticosteroids

diuretics (“water tablets”) (e.g. furosemide)

medicines to treat high blood pressure (e.g. captopril, ramipril or propranolol)

ciclosporin or tacrolimus

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

SSRI antidepressants

zidovudine

quinolone antibiotics

probenecid

methotrexate

lithium

hydantoins

sulphonamides

sulphonylureas

cardiac glycosides (e.g. digoxin or digitoxin).

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

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

Driving and using machines

Naproxen 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.

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.

Tests

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

How to take Naproxen tablets

Always take Naproxen tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Swallow with or after food.

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
Initially a dose of 750mg-1g may be given then 500mg-1g a day in two doses at twelve hour intervals, or as one dose taken in either the morning or evening.

Attack of gout
Initially 750mg as a single dose then 250mg every 8 hours until the attack has passed.

Muscle and bone disorders
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 under 16 years

Naproxen tablets should not be used in children under 16 years of age.

Elderly

Dosage may be reduced in the elderly.

If you take more Naproxen 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 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 tablets

If you forget to take your tablets, take your next 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.

Possible side effects

Like all medicines, Naproxen tablets 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 tablets and contact your doctor immediately if you

develop stomach or intestinal ulcers or bleeding, indigestion, heartburn or abdominal pain (pains in your stomach) or other abnormal stomach symptoms

Pass blood in your faeces (stools/motions)

Pass black tarry stools

Vomit any blood or dark particles that look like coffee grounds.

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

Allergic reaction: an itchy skin rash, blood spots, bruising or discolouring of the skin, red patches (erythema multiforme), a severe rash with reddening, peeling and swelling of the skin that resembles burns (epidermal necrolysis), or any other severe reactions like swelling of the face, mouth, tongue or airways, feeling and being sick , difficulty breathing or wheezing.

Nervous system: fits, headache, ringing in the ears, a spinning sensation, difficulty concentrating and sleeping, inflammation of the optic nerve, disturbed vision, tingling or “pins and needles”, depression, confusion, sensing things that are not there, dizziness, feeling of general discomfort and illness, tiredness, drowsiness, aseptic meningitis (may cause fever, feeling or being sick, disorientation, headache, neck stiffness and light intolerance).

Skin: rashes which may be red, itchy or blisters, hair loss, swelling of the face or body, sensitivity of the skin to light, severe skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson syndrome).

Heart: water retention, increased blood pressure and heart failure.

Liver: abnormal liver function, hepatitis and jaundice (yellow skin or
eyes).

Stomach and intestines: stomach, duodenal or intestinal bleeding, ulcers or perforation, feeling or being sick, diarrhoea, wind, constipation, inflammation of the stomach lining (gastritis), worsening of colitis and Crohn’s disease.

Blood: changes in the numbers and types of blood cells (if you develop sore throats, nose bleeds or infections consult your doctor).

Kidneys: kidney damage or failure and blood in the urine.

Other: hearing difficulties, swelling of the hands and feet, lung damage, high blood potassium levels, mouth ulcers, inflammation of blood vessels, inflammation of the pancreas (pancreatitis).

Medicines such as naproxen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

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.

How to store

Keep out of the reach and sight of children.

Store below 25ºC in a dry place. Protect from light.

Do not use Naproxen tablets after the expiry date which is 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.

Further information

What Naproxen tablets contain

The active substance (the ingredient that makes the medicine work) is naproxen. Each tablet contains either 250mg or 500mg of the active substance.

The other ingredients are lactose, magnesium stearate, maize starch, polyvidone, E172, E463.

What Naproxen tablets look like and contents of the pack

Naproxen tablets are yellow, uncoated tablets.

Marketing Authorisation Holder and Manufacturer

Actavis

Barnstaple

EX32 8NS

This leaflet was last revised in September 2008