NAPROSYN®
Naproxen
250mg and 500mg tablets
750mg and 1000mg sustained release (SR) tablets
250mg and 500mg enteric coated (EC) tablets
25mg/mL suspension
What is in this leaflet
This leaflet answers some common questions about NAPROSYN tablets and
suspension. NAPROSYN tablets are available in plain tablets, sustained release
tablets and enteric coated tablets. Throughout this leaflet all three types of
tablets are collectively referred to as tablets.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of
you taking NAPROSYN tablets or suspension against the benefits expected for you.
If you have any concerns about taking this medicine, ask your doctor or
pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What NAPROSYN is used for
NAPROSYN contains the active ingredient naproxen.
NAPROSYN relieves pain and reduces inflammation (swelling, redness and heat)
associated with:
- different types of arthritis including rheumatoid arthritis,
osteoarthritis - arthritis in children (juvenile arthritis)
- ankylosing spondylitis (a disease of the joints in the spine)
- muscle and bone ailments such as sprains, strains, lower back pain
(lumbago), rheumatism and tendonitis (eg. tennis elbow) - gout (a disease with painful swollen joints)
- pain following surgery
- period pain
NAPROSYN belongs to a group of medicines called Non-Steroidal Anti-Inflammatory
Drugs (or NSAIDs). There are many different types of NSAIDs used to treat pain
and inflammation.
Your doctor, however, may have prescribed NAPROSYN for another purpose.
Ask your doctor if you have any questions why NAPROSYN has been prescribed
for you.
NAPROSYN is not addictive.
This medicine is available only with a doctor's prescription.
Before you take NAPROSYN
When you must not take it
Do not take NAPROSYN if:
- you have an allergic reaction to NAPROSYN, or any ingredients listed at
the end of this leaflet or you have had an allergic reaction to aspirin or any
other NSAID medicine, including other naproxen containing medicines such as
Synflex®, Naxen® or Naprogesic®.
Many medicines used to treat headache, period pain and other aches and pains
contain aspirin or NSAID medicines. If you are not sure if you are allergic to
any of these medicines, ask your pharmacist.
Symptoms of an allergic reaction to these medicines may include:- asthma, wheezing or shortness of breath
- swelling of the face, lips or tongue which may cause difficulty in
swallowing or breathing - hives, itching or skin rash
- fainting
If you are allergic to aspirin or NSAID medicines and take NAPROSYN,
these symptoms may be severe.
- aspirin or other NSAIDs have given you asthma, or rhinitis (hayfever
symptoms such as runny nose, stuffiness, watery eyes, sneezing, itchy nose,
throat and eyes) in the past - you are vomiting blood or material that looks like coffee grounds
- you are bleeding from the rectum (back passage), have black sticky bowel
motions (stools) or bloody diarrhoea - you have a peptic ulcer (i.e. stomach or duodenal ulcer)
- you have a tendency to spontaneously bleed or bleed when incurring minor
accidents (haemorrhagic diathesis) - you have liver disease
- you have asthma
- the package is torn or shows signs of tampering
- the expiry date printed on the pack has passed
If you take this medicine after the expiry date has passed, it may not
work as well.
If the pharmacist has repacked the medicine for you, there may not be an
expiry date on the pack.
If you are not sure if you should be taking NAPROSYN, talk to your doctor.
Do not give NAPROSYN to children under 2 years of age.
The safety and effectiveness in children under 2 have not been established.
Before you start to take it
Tell your doctor if:
- you are pregnant or plan to become pregnant
NAPROSYN may make it more difficult to get pregnant and is not recommended
in women trying to get pregnant. NAPROSYN may affect your developing baby if
you take it during pregnancy. If it is necessary for you to take NAPROSYN,
your doctor will discuss the risks and benefits of taking it during pregnancy.
Do not take NAPROSYN if you are in labour as it may harm you and/or affect the
baby. - you are breast-feeding or plan to breast-feed
NAPROSYN passes into breast milk. Your doctor will discuss the risks and
benefits of taking NAPROSYN if you are breast-feeding. - you have or have had any other health problems, especially the following:
- rhinitis, nasal polyps
- heartburn, indigestion, stomach ulcers or other stomach problems
- kidney or liver disease
- heart problems
- swelling of the hands, ankles or feet
- a tendency to bleed easily
- you are on a low sodium diet
- you have low salt levels in your blood
- swelling of the face, lips, mouth, tongue or throat which may cause
difficulty in swallowing or breathing
- you currently have an infection
If you take NAPROSYN while you have an infection, the tablets or suspension
may hide some of the signs of an infection (e.g. pain, fever). This may make
you think, mistakenly, that you are better or that your infection is not
serious. - you plan to have surgery
NAPROSYN can prolong bleeding. - you are elderly
Older people may require a lower dose.
- you are allergic to any other medicines, foods, dyes or preservatives.
If you have not told your doctor about any of the above, tell them before you
start taking NAPROSYN.
Taking other medicines
Tell your doctor if you are taking any other medicines including any that
you have bought from a pharmacy, supermarket or healthfood shop.
Some medicines may interfere with NAPROSYN. These medicines include:
- aspirin, salicylates or other NSAID medicines
- lithium (Lithicarb®, Priadel®), a medicine used to
treat some types of depression - probenecid, a medicine used to treat gout
- frusemide (Diurin®, Lasix®), a diuretic, also called
fluid or water tablets. - phenytoin (Dilantin®) a medicine used to treat epilepsy
- methotrexate (Methoblastin®, Ledertrexate®), a
medicine used to treat arthritis, kidney disease and some cancers - warfarin (Coumadin®, Marevan®), a medicine used to
stop blood clots - a group of medicines called beta-blockers used to treat high blood
pressure - certain antibiotics called sulphonamides (Trisul® ,
Apo-Sulfatrim®, Salazopyrin®) - some medicines used to treat diabetes called sulphonylureas (Diamicron®,
Apo-Gliclazide®, Minidiab®, Gliben®)
These medicines may be affected by NAPROSYN, or may affect how well it works.
You may need to use different amounts of your medicine, or you may need to take
different medicines. Your doctor will advise you.
Your doctor or pharmacist has more information on medicines to be careful
with or avoid while taking NAPROSYN.
Ask your doctor or pharmacist if you are not sure about this list of
medicines.
How to take NAPROSYN
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
How much to take
Take NAPROSYN exactly as your doctor has prescribed.
Your doctor will tell you how many NAPROSYN tablets or how much suspension
you or your child should take each day. Your doctor may give you a lower dose if
you are older or have certain health problems.
Adults
- The usual dose is 500mg to 1000mg a day depending upon your condition.
Children
The usual dose for children over 5 years is 10mg/kg/day given as two divided
doses at 12 hour intervals.
How to take it
Swallow NAPROSYN tablets whole with a glass of water.
Shake NAPROSYN suspension gently before use. Swallow NAPROSYN suspension
followed by a glass of water if desired.
When to take it
Take NAPROSYN at about the same time each day.
It does not matter whether you take NAPROSYN with food or not. However, if
you take NAPROSYN after food this may help reduce the possibility of an upset
stomach.
Taking your medicine at the same time each day will have the best effect. It
will also help you remember when to take the tablets.
How long to take it
Continue taking NAPROSYN until your doctor tells you to stop.
As with other NSAID medicines, if you are using NAPROSYN for arthritis, it
will not cure your condition but it should help to control pain, swelling and
stiffness. If you have arthritis, NAPROSYN should be taken every day for as long
as your doctor prescribes.
For pain, sprains and strains, NAPROSYN is usually needed for shorter
periods.
For period pain (menstrual cramps), NAPROSYN is usually taken during each
menstrual cycle as soon as period pains begin and continued for up to 5 days, if
necessary.
For gout, NAPROSYN is usually taken until the attack has passed.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take
your next dose when you are meant to. Otherwise, take it as soon as you remember
and then continue taking it as you would normally.
Do not double a dose to make up for the one you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering your dose, ask your pharmacist for some
hints.
In case of overdose
Immediately telephone your doctor or National Poisons Information Centre
(telephone 0800 POISON or 0800 764 766) for advice, or go to your nearest
Accident and Emergency Centre if you think that you or anyone else may have
taken too much NAPROSYN. Do this even if there are no signs of discomfort or
poisoning.
You may need urgent medical attention.
The following are some symptoms, which may or may not occur.
- drowsiness, dizziness
- pain or tenderness in the stomach
- stomach upset including nausea (feeling sick), vomiting, heartburn,
indigestion or cramps - convulsions (fits)
- confusion
- unable to breathe
Keep telephone numbers for these places handy.
If you are not sure what to do, contact your doctor or pharmacist.
While you are taking NAPROSYN
Things you must do
Tell all doctors, dentists and pharmacists who are treating you that you
are taking NAPROSYN.
Tell your doctor if you become pregnant while taking NAPROSYN.
If you are going to have surgery, tell your doctor you are taking
NAPROSYN.
Tell your doctor you are taking NAPROSYN if you are going to have any
laboratory tests. NAPROSYN can affect the results of some of these tests.
If you get an infection while using NAPROSYN, tell your doctor.
NAPROSYN may hide some of the signs of an infection and may make you think,
mistakenly, that you are better or that it is not serious. Signs of an infection
may include fever, pain, swelling and redness.
Tell your doctor if, for any reason, you have not taken your medicine
exactly as prescribed. Otherwise, your doctor may think that it was not
effective and change your treatment unnecessarily.
Tell your doctor if you feel the tablets or suspension are not helping
your condition.
Be sure to keep all your appointments with your doctor so that your
progress can be checked.
Things you must not do
Do not stop taking NAPROSYN or change the dose without first checking with
your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not give NAPROSYN to anyone else even if they have the same condition
as you.
Do not use NAPROSYN to treat other complaints unless your doctor says to.
Do not take any other medicines whether they require a prescription or not
without first telling your doctor or consulting a pharmacist.
Things to be careful of
Be careful driving or operating machinery until you know how NAPROSYN
affects you.
NAPROSYN may cause dizziness, light-headedness, drowsiness or a spinning
sensation (vertigo) in some people. Make sure you know how you react to NAPROSYN
before you drive a car, operate machinery, or do anything else that could be
dangerous.
Side Effects
Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are taking NAPROSYN.
NAPROSYN helps most people but it may have unwanted side effects.
All medicines can have side effects. Sometimes they are serious. You may need
medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
- stomach upset including nausea (feeling sick), heartburn, indigestion
- constipation, diarrhoea, pain in the stomach
- dizziness, light-headedness, drowsiness
- spinning sensation (vertigo)
- headache
- buzzing or ringing in the ears
- sore or dry mouth or tongue (stomatitis)
- feeling thirsty
- skin eruptions, rash, itching, sweating
These are the more common side effects of NAPROSYN. Mostly these are mild.
Tell your doctor immediately, or go to your nearest Accident and Emergency
Centre, if you notice any of the following:
- severe pain or tenderness in any part of the stomach
- eye problems such as blurred vision
- fast or irregular heartbeats, also called palpitations
- difficulty hearing, deafness
- bleeding or bruising more easily than normal, reddish-purplish or
blue-black blotches under the skin - unusual weight gain, swelling of ankles or legs
- vomiting blood or material that looks like coffee grounds
- bleeding from the back passage (rectum), black sticky bowel motions
(stools) or bloody diarrhoea, or blood in the urine - swelling of the face, lips or tongue which may cause difficulty in
swallowing or breathing - asthma, wheezing, shortness of breath
- sudden or severe itching, skin rash, hives
- fainting, seizures or fits
- depression (feelings of deep sadness and unworthiness)
- inability to sleep (insomnia), difficulty concentrating
- yellowing of the skin or eyes
- shooting pain from the stomach to the back (pancreatitis)
These are serious side effects. You may need urgent medical attention.
Serious side effects are rare.
This is not a complete list of all possible side effects. Others may occur in
some people and there may be some side effects not yet known.
Tell your doctor if you notice anything else that is making you feel
unwell, even if it is not on this list.
Ask your doctor or pharmacist if you don't understand anything in this list.
Do not be alarmed by this list of possible side effects. You may not
experience any of them.
After taking NAPROSYN
Storage
Keep your tablets or suspension in the original container and protect from
light until it is time to take them.
If you take the medicine out of its container it may not keep well.
Keep NAPROSYN tablets in a cool dry place where the temperature stays
below 30°C.
Keep NAPROSYN suspension in a cool dry place where the temperature stays
below 25°C.
Do not store it, or any other medicine, in a bathroom or near a sink.
Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep NAPROSYN where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good
place to store medicines.
Do not keep your tablets or suspension in the refrigerator.
Disposal
If your doctor tells you to stop taking NAPROSYN, or the medicine has
passed its expiry date, ask your pharmacist what to do with any tablets or
suspension that are left over.
Product description
Availability
NAPROSYN tablets come in 250mg and 500mg strengths. Both strengths come in
blister packs of 100 tablets.
NAPROSYN EC tablets are available in 250mg and 500mg strengths. The 250mg
tablet comes in a bottle of 120 tablets. The 500mg tablet comes in a bottle of
60 tablets.
NAPROSYN SR tablets are available in 750mg and 1000mg strengths. Both tablet
strengths come in bottles of 90 tablets.
NAPROSYN suspension comes in a 25mg/mL strength. The suspension comes in a
bottle containing 240mL.
What NAPROSYN looks like
Naprosyn 250mg Tablet
A round, yellow, uncoated tablet embossed 'NPR LE 250' on one face and a
breakline on the other.
Naprosyn 500 mg Tablet
An oblong yellow tablet engraved 'NPR LE 500' on one face and a breakline on the
other.
Naprosyn SR (sustained release) 750 mg Tablet
A capsule shaped, peach coloured tablet, 'NPR SR-750' on one side.
Naprosyn SR (sustained release) 1000 mg Tablet
A capsule shaped, peach coloured tablet, 'NPR SR-1000' on one side.
Naprosyn EC (enteric coated) 250mg Tablet
A flat, white, round tablet, inscribed 'NPR EC 250' on one side. The '250' is
imprinted below NPR EC.
Naprosyn EC (enteric coated) 500mg Tablet
A capsule shaped, white tablet inscribed 'NPR EC 500' on one side. The '500' is
imprinted below NPR EC.
Naprosyn 25mg/mL suspension
A white to off-white suspension containing evenly distributed particles, with a
pineapple-orange odour.
Ingredients
Active ingredient - naproxen
- each NAPROSYN 250mg tablet contains 250 mg naproxen
- each NAPROSYN 500mg tablet contains 500 mg naproxen
- each NAPROSYN SR 750mg tablet contains 750mg naproxen
- each NAPROSYN SR 1000mg tablet contains 1000mg naproxen
- each NAPROSYN EC 250mg tablet contains 250mg naproxen
- each NAPROSYN EC 500mg tablet contains 500mg naproxen
- each bottle of NAPROSYN suspension contains 25mg of naproxen per mL
Inactive ingredients -
NAPROSYN 250mg and 500mg tablets
Povidone (K90), croscarmellose sodium (Type A), magnesium stearate, iron oxide,
purified water.
NAPROSYN SR 750mg and 1000mg tablets
Hydroxypropyl methyl cellulose, magnesium stearate, FD&C Yellow No. 6, purified
water.
NAPROSYN EC 250mg and 500mg tablets
Povidone (K90), croscarmellose sodium (Type A), magnesium stearate, purified
water, methacrylic acid polymer (Type C), talc, sodium hydroxide, triethyl
citrate, black printing ink.
NAPROSYN 25mg/mL suspension
Sucrose, sorbitol, sodium chloride, aluminium magnesium silicate, fumaric acid,
methyl hydroxybenzoate, imitation orange flavour, imitation pineapple flavour,
purified water.