Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using NAPROSYN?
NAPROSYN contains the active ingredient naproxen. NAPROSYN is used to relieve pain
and reduces inflammation (swelling, redness and soreness) that may occur with different
types of arthritis, muscle and bone injuries, after setting broken or dislocated bones,
with period pain, headache, migraines, after surgery, or dental pain. For more information,
see Section
1. Why am I using NAPROSYN? in the full CMI.
2. What should I know before I use NAPROSYN?
Do not use if you have ever had an allergic reaction to naproxen, aspirin or any other
NSAID medicine, or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section
2. What should I know before I use NAPROSYN? in the full CMI.
3. What if I am taking other medicines?
4. How do I use NAPROSYN?
Your doctor will tell you how many NAPROSYN tablets to take each day. Take the tablets
during or immediately after food with a full glass of water or milk. More instructions
can be found in Section
4. How do I use NAPROSYN? in the full CMI.
5. What should I know while using NAPROSYN?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using NAPROSYN.
Tell your doctor if you get an infection while using NAPROSYN.
Tell your doctor if you feel the tablets are not helping your condition.
Call your doctor straight away if you become pregnant while taking NAPROSYN.
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Things you should not do
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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 tells you to.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how NAPROSYN
affects you.
NAPROSYN may cause dizziness or light-headedness in some people. If this occurs, do
not drive.
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Drinking alcohol
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Tell your doctor if you drink alcohol. If you drink alcohol, dizziness or light-headedness
may be worse.
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Looking after your medicine
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Keep the tablets in a cool dry place away from moisture, heat or sunlight. Store below
30°C.
Do not keep your tablets in the refrigerator.
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6. Are there any side effects?
Tell your doctor immediately if you notice any of these serious side effects: difficulty
hearing, deafness, severe or persistent headache, severe skin rashes, yellowing of
the skin or eyes, bleeding or bruising more easily than normal, reddish or purplish
blotches under the skin, fast or irregular heartbeats, eye problems such as blurred
vision, sore red eyes, itching, unusual weight gain, or swelling of ankles or legs.
Call your doctor straight away or go straight to the Emergency Department at your
nearest hospital if you notice any of these very serious side effects: vomiting blood
or what looks like coffee grounds, bleeding from the back passage, black sticky bowel
motions or bloody diarrhoea, severe dizziness, spinning sensation, severe pain or
tenderness in any part of the stomach, swelling of the face, lips or tongue which
may cause difficulty swallowing, difficulty breathing, wheezing or shortness of breath,
sudden or severe itching, skin rash or hives, fainting, seizures or fits, pain or
tightness in the chest, flu-like symptoms with a rash on the face then an extended
rash with a high temperature and enlarged lymph nodes. For more information, including
what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient: naproxen
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using NAPROSYN. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using NAPROSYN.
Where to find information in this leaflet:
1. Why am I using NAPROSYN?
NAPROSYN contains the active ingredient naproxen. NAPROSYN belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs
(or NSAIDs).
NAPROSYN is used to relieve pain and reduce inflammation (swelling, redness and soreness)
that may occur:
in different types of arthritis including rheumatoid arthritis, osteoarthritis and
ankylosing spondylitis
in muscle and bone injuries such as sprains, strains, lower back pain (lumbago), rheumatism
and tendonitis, such as tennis elbow
after setting broken or dislocated bones
with menstrual cramps (period pain)
with headache, including migraines
following surgery
due to dental pain
Although NAPROSYN can relieve the symptoms of pain and inflammation, it will not cure
your condition.
Your doctor may have prescribed NAPROSYN for another reason.
Ask your doctor if you have any questions why NAPROSYN has been prescribed for you.
2. What should I know before I use NAPROSYN?
Warnings
Do not use NAPROSYN if:
you are allergic to naproxen, aspirin or any other NSAID medicines, or any of the
ingredients listed at the end of this leaflet. 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 taking any of these medicines, ask your doctor or pharmacist.
If you are allergic to aspirin or NSAID medicines and use NAPROSYN, these symptoms
may be severe. 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
Always check the ingredients to make sure you can use this medicine.
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 currently have a peptic ulcer (i.e. stomach or duodenal ulcer), or have had one
before
you have severe liver disease
you have recently had or are about to have heart bypass surgery
you are taking other medications which contain naproxen or naproxen sodium (e.g. Proxen®, Naprogesic®, Anaprox® or Inza®)
you have severe heart failure
you are in the 3rd trimester of pregnancy
Do not give NAPROSYN to a child under the age of 2 years. The safety and effectiveness of NAPROSYN in children under 2 years of age has not
been established.
If you are not sure if you should start taking NAPROSYN, talk to your doctor.
Check with your doctor if you:
have allergies to any other substances, such as foods, preservatives or dyes
have or have had any medical conditions, especially the following:
heartburn, indigestion, stomach ulcers or other stomach problems
vomiting blood or bleeding from the back passage
bowel or intestinal problems such as ulcerative colitis
kidney or liver disease
heart failure
high blood pressure or heart problems
swelling of the ankles or feet
a tendency to bleed or other blood problems, such as anaemia
currently have an infection. If you take NAPROSYN while you have an infection, the
signs may be hidden (e.g. pain, fever). This may make you think, mistakenly, that
you are better or that it is not serious.
you plan to have surgery. NAPROSYN can prolong bleeding.
If you have not told your doctor about any of the above, tell them before you take
any NAPROSYN.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or intend to become 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.
NAPROSYN may impair fertility and is not recommended in women attempting to conceive.
Tell your doctor if you are breast-feeding or intend to breast-feed.
NAPROSYN passes into breast milk. The effect on the baby is not known.
Use in children
There is no specific information available to recommend the use of NAPROSYN in children
under 5 years.
Use in people over 65 years
Older people may be at more risk of developing stomach ulcers and hence your doctor
may prescribe a lower dose.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with NAPROSYN and affect how it works. These include:
antacids, medicines used to treat indigestion and heartburn
aspirin, salicylates or other NSAID medicines
cholestyramine, a medicine used to treat high cholesterol levels
diuretics, also called fluid or water tablets
lithium, a medicine used to treat some types of depression
probenecid, a medicine used to treat gout
phenytoin, a medicine used to treat epilepsy
methotrexate, a medicine used to treat arthritis and some cancers
sucralfate, a medicine used to treat and prevent stomach ulcers
warfarin, a medicine used to prevent blood clots
heparin, a medicine used to prevent blood clots
medicines used to treat high blood pressure including ACE inhibitors, angiotensin
receptor antagonists and beta-blockers
some medicines used to treat diabetes
sodium bicarbonate, a medicine used to treat stomach upset or ulcers
steroids, medicines used to treat inflammation
serotonin reuptake inhibitors, also known as SSRIs, medicines used to treat some types
of depression
zidovudine, a medicine used to treat HIV infection
You may need to use different amounts of your medicine, or you may need to use different
medicines. Your doctor will advise you.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect NAPROSYN.
4. How do I use NAPROSYN?
How much to take
Take NAPROSYN exactly as your doctor has prescribed.
Your doctor will tell you how many NAPROSYN tablets to take each day. If you are an
older patient, your doctor may give you a lower dose.
Follow the instructions provided and use NAPROSYN until your doctor tells you to stop.
They may differ from the information contained in this leaflet.
Sprains, strains, and period pain
The recommended dose is 500 mg given initially, then 250 mg every 6 to 8 hours as
needed. The total dose in one day should not exceed 1250 mg.
Migraine headache
The recommended dose is 750 mg taken at the first sign of a migraine. An additional
dose of 250 mg to 500 mg can be taken at least an hour after the initial dose, if
required. The total dose in one day should not exceed 1250 mg.
Arthritis
The recommended dose is 375 mg to 1000 mg a day, divided in two doses.
When to take NAPROSYN
Take the tablets during or immediately after food with a full glass of water or milk.
This may help reduce the possibility of an upset stomach.
How long to take NAPROSYN
Do not take NAPROSYN for longer than your doctor says.
Depending on your condition, you may need to use NAPROSYN, only once, for a few days,
a few weeks or for longer periods.
For sprains and strains, NAPROSYN is usually only needed for a few days.
If you are taking 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.
Ask your doctor if you are not sure how long to take NAPROSYN for.
If you forget to take NAPROSYN
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 take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you use too much NAPROSYN
If you take too much NAPROSYN, you may experience drowsiness, pain or tenderness in
the stomach, stomach upset including nausea (feeling sick), vomiting, heartburn, indigestion
or cramps. If you think that you have used too much NAPROSYN, you may need urgent
medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using NAPROSYN?
Things you should do
Ask your doctor and pharmacist before you start taking any new medicines.
Tell your doctor you are taking NAPROSYN if you are going to have surgery
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.
Tell your doctor if you get an infection while using NAPROSYN. 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 are not helping your condition.
Call your doctor straight away if you:
become pregnant while taking NAPROSYN
Remind any doctor, dentist or pharmacist you visit that you are using NAPROSYN.
Things you should not do
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 tells you to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how NAPROSYN
affects you.
As with other NSAID medicines, NAPROSYN may cause dizziness or light-headedness in
some people. If this occurs do not drive.
Drinking alcohol
Tell your doctor if you drink alcohol.
If you drink alcohol, dizziness or light-headedness may be worse.
Looking after your medicine
Keep your tablets in the blister pack until it is time to take them. If you take the
tablets out of the blister pack they will not keep well.
Keep the tablets in a cool dry place where the temperature stays below 30°C.
Do not keep your tablets in the refrigerator.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. NAPROSYN helps most people with pain due to inflammation,
but it may have unwanted side effects in a few people.
If you do experience any side effects, most of them are minor and temporary. However,
some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Do not be alarmed by this list of possible side effects. You may not experience any
of them.
Less serious side effects
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Less serious side effects
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What to do
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Gut related:
stomach upset including nausea (feeling sick), heartburn, indigestion
loss of appetite
constipation, diarrhoea, pain in the stomach
Head related:
dizziness, light-headedness
headache, drowsiness
buzzing or ringing in the ears
sore or dry mouth or tongue
feeling thirsty
Muscle related:
aching muscles, muscle tenderness or weakness, not caused by exercise
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Speak to your doctor if you have any of these less serious side effects and they worry
you. These side effects of NAPROSYN are usually mild.
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Serious side effects
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Serious side effects
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What to do
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Head related:
difficulty hearing, deafness
severe or persistent headache
Skin related:
severe skin rashes
yellowing of the skin
Bleeding related:
bleeding or bruising more easily than normal, reddish or purplish blotches under the
skin
Heart related:
fast or irregular heartbeats, also called palpitations
Eye related:
eye problems such as blurred vision, sore red eyes, itching
yellowing of the eyes
Other:
unusual weight gain, swelling of ankles or legs
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Tell your doctor immediately if you notice any of these serious side effects. You
may need urgent medical attention.
Serious side effects are rare.
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Very serious side effects
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Very serious side effects
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What to do
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Gastrointestinal or gut related:
vomiting blood or what looks like coffee grounds
bleeding from the back passage (rectum), black sticky bowel motions (stools) or bloody
diarrhoea
Head related:
severe dizziness, spinning sensation
Pain related:
severe pain or tenderness in any part of the stomach
Allergic reaction related:
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
difficulty breathing, wheezing or shortness of breath
sudden or severe itching, skin rash or hives
pain or tightness in the chest
flu-like symptoms with a rash on the face then an extended rash with a high temperature,
increased levels of liver enzymes seen in blood tests and an increase in a type of
white blood cell (eosinophilia) and enlarged lymph nodes.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these very serious side effects. You may need
urgent medical attention or hospitalisation.
These very serious side effects are rare.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
NAPROSYN is not addictive.
What NAPROSYN contains
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Active ingredient
(main ingredient)
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each NAPROSYN tablet contains 250 mg naproxen
each NAPROSYN 500 tablet contains 500 mg naproxen.
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Other ingredients
(inactive ingredients)
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povidone
croscarmellose sodium
iron oxide yellow (172)
magnesium stearate (470)
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Potential allergens
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NAPROSYN tablets do not contain sucrose, tartrazine or any other azo dyes.
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Do not take this medicine if you are allergic to any of these ingredients.
What NAPROSYN looks like
NAPROSYN (250 mg) is a round yellow tablet marked "NPR LE 250" on one side (Aust R
65247).
NAPROSYN 500 is an oblong yellow tablet marked "NPR LE 500" on one side (Aust R 65246).
NAPROSYN tablets are available in 250 mg and 500 mg strengths.
NAPROSYN comes in blister packs of 50.
NAPROSYN is also available as once-daily slow release tablets (NAPROSYN SR)
Who distributes NAPROSYN
NAPROSYN is supplied in Australia by:
Clinect Pty Ltd
120 - 132 Atlantic Drive
Keysborough VIC 3173
Australia
Customer enquiries: 1 800 899 005
Sponsor:
Atnahs Pharma Australia Pty Ltd
Level 10
10 Shelley Street,
SYDNEY, NSW, 2000, Australia
This leaflet was prepared in June 2023.