NAXEN™
naproxen 250 mg and 500 mg tablets
What is in this leaflet
This leaflet answers some common questions about NAXEN 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 NAXEN tablets 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 NAXEN tablets are used for
NAXEN contains the active ingredient naproxen.
NAXEN belongs to a group of medicines called Non-Steroidal Anti-Inflammatory
Drugs (or NSAIDs). The action of naproxen can alleviate pain, inflammation and
fever.
NAXEN is used to relieve the symptoms associated with:
- arthritis - characterised by inflammation (heat, pain, swelling or
redness)of the joints
The types of arthritis are: rheumatoid arthritis, osteoarthritis, arthritis
in children - ankylosing spondylitis - immobility and consolidation of the joints
of the spine - tendinitus and bursitis - inflammation of the tendons and
bursa (sac of fluid placed at places in tissue where friction can develop) - gout - a type of arthritis occurring at the periphery joints such
as the toes. - primary dysmenorrhoea - period pain
Your doctor, however, may have prescribed NAXEN tablets for another purpose.
Ask your doctor if you have any questions why NAXEN tablets have been
prescribed for you.
This medicine is available only with a doctor's prescription.
Before you take NAXEN
When you must not take it
Do not take NAXEN if you have had an allergic reaction to:
- naproxen
- aspirin
- other NSAIDs - medicines used to treat headache, period pain and other
aches and pains - any ingredients listed at the end of this leaflet
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
Do not take NAXEN tablets if you:
- are pregnant or breast feeding
- are under 5 years of age
- have an ulcer of the stomach, intestines, duodenum or esophagus (foodpipe)
- have a blood clotting disorder - tendency to bleed when incurring minor
accidents - have liver disease
- have kidney dysfunction
- have asthma
Do not take NAXEN tablets if:
- 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 NAXEN tablets, talk to your
doctor.
Before you start to take it
Tell your doctor or pharmacist if you are allergic to any other medicines,
foods, dyes or preservatives.
Tell your doctor if you are or intend to become pregnant.
NAXEN tablets may cause closure of the fetal ductus arteriosus (a fetal
blood vessel). It may also cause kidney impairment, effect blood clotting and
delay labour and birth. NAXEN may also cause infertility in women. Your doctor
will discuss the risks and benefits of taking this medicine during pregnancy.
Naproxen enters breast milk. NAXEN tablets should not be used by
breast-feeding mothers unless the benefit outweighs the potential risk.
Caution is advised in patients with impaired kidney function
Kidney function tests should be carried out on patients receiving long-term
therapy.
NAXEN tablets should not be given to patients with impaired liver function
except in case of necessity.
Caution is advised in the elderly
The elderly are more likely to get side effects from medicines.
Tell your doctor if you:
- suffer from heartburn, indigestion, stomach ulcers or other stomach
problems. - have a blood clotting disorder
- have heart problems
- have ever had an allergic disease such as lupus
- have skin problems
Tell your doctor if you have an infection.
NAXEN tablets may hide some of the signs of an infection (e.g. pain, fever).
This may make you think, mistakenly, that your infection is not serious.
Tell your doctor if you plan to have surgery
NAXEN tablets can prolong bleeding.
NAXEN is not addictive.
Some patients may experience drowsiness, dizziness, vertigo (sensation of
moving), insomnia or depression with the use of NAXEN tablets. If patients
experience these or similar effects, they should not carry out activities that
require alertness such as operating machinery or driving a vehicle.
If you have not told your doctor about any of the above, tell them before you
start taking NAXEN tablets.
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 NAXEN tablets. These medicines include:
- antacids - medicines used to relieve indigestion such as those containing
sodium bicarbonate, magnesium carbonate, magnesium oxide and aluminium
hydroxide. Antacids affect the absorption rate of naproxen. - probenecid (anti-gout drug) - may effect the rate naproxen is excreted
from the body - aspirin, salicylates or other NSAIDs - may effect the amount of naproxen
in the blood - frusemide - a medicine which causes increased volume of urine
- warfarin - a blood thinning medicine
- lithium - a medicine used to treat some types of depression
- sulphonylureas - medicines used to treat diabetes
- methotrexate - a medicine used to treat arthritis, kidney disease and some
cancers
Naproxen may interfere with some laboratory tests.
Tell your doctor if you plan to have any laboratory tests done.
These medicines may be affected by NAXEN, 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 NAXEN.
Ask your doctor or pharmacist if you are not sure about this list of
medicines.
How NAXEN tablets are taken
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 NAXEN tablets exactly as your doctor has prescribed.
Your doctor will tell you how many NAXEN tablets you or your child should
take each day. Your doctor may give you a lower dose if you are older or have
kidney or liver problems.
Adults
The usual dose is 500 mg to 1000 mg a day depending upon your condition.
Children
The usual dose for children over 5 years is 10 mg/kg/day given as two divided
doses at 12 hour intervals.
How to take it
Swallow NAXEN tablets whole with a glass of water. NAXEN tablets may be taken
with or without meals.
However, it is recommended you take NAXEN tablets with meals during long-term
treatment for conditions such as arthritis, as this may help reduce the
possibility of an upset stomach.
When to take it
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 NAXEN tablets until your doctor tells you to stop.
As with other NSAID medicines, if you are using NAXEN tablets for arthritis,
it will not cure your condition but it should help to control pain, swelling and
stiffness.
If you have arthritis, NAXEN tablets should be taken every day for as long as
your doctor prescribes.
If you have tendinitis and bursitis, NAXEN tablets are usually needed for
shorter periods.
If you have primary dysmenorrhoea (period pain), NAXEN tablets are usually
taken during each menstrual cycle as soon as period pains begin and continued
for up to 5 days, if necessary.
For gout, NAXEN tablets are 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.
While you are taking NAXEN
Things you must do
Tell all doctors, dentists and pharmacists who are treating you, that you
are taking NAXEN tablets.
Tell your doctor if you become pregnant while taking NAXEN tablets.
If you are going to have surgery, tell your doctor you are taking NAXEN
tablets.
Tell your doctor you are taking NAXEN tablets if you are going to have any
laboratory tests.
If you get an infection while using NAXEN tablets, tell your doctor.
Tell your doctor if you feel the tablets 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 NAXEN tablets 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 NAXEN tablets to anyone else even if they have the same
condition as you.
Do not use NAXEN tablets 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 NAXEN tablets
affect you.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are taking NAXEN tablets.
NAXEN tablets help 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:
- Gastrointestinal: inflammation of the mouth, nausea, heartburn,
indigestion, constipation, diarrhoea, pain in the stomach - Central Nervous System: dizziness, drowsiness, headache,
light-headedness, vertigo (spinning sensation) - Special Senses: buzzing or ringing in the ears
- Skin: skin eruptions, rash, itching, sweating
- General: feeling thirsty
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
- ulcers in the mouth
- vomiting
- eye problems such as blurred vision
- fast or irregular heartbeats
- 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
- chills and fever
- fragile skin and blistering
- 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
- inflammation of the skin
- sudden or severe itching, skin rash, hives
- fainting, seizures or fits
- depression (feelings of deep sadness and unworthiness)
- inability to sleep (insomnia), difficulty concentrating
- discomfort and muscle pain
- yellowing of the skin or eyes
- loss of hair
- 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.
Do not be alarmed by this list of possible side effects. You may not
experience any of them.
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 many NAXEN tablets. Do this even if there are no signs of discomfort
or poisoning.
Storage
Keep your tablets 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 NAXEN tablets in a cool dry place where the temperature stays below
30°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 NAXEN tablets where children cannot reach them.
A locked cupboard at least one-and-a-half metres above the ground is a good
place to store medicines.
Disposal
If your doctor tells you to stop taking NAXEN tablets, or the medicine has
passed its expiry date, ask your pharmacist what to do with any remaining
tablets.
Product description
What it looks like
250 mg tablet: Yellow, biconvex, round tablet of 11mm diameter with
one face engraved NX250 and having a bisecting score.
They come in bottles of 100s and 500s.
500 mg tablet: Yellow, biconvex, oval tablet of 19mm length, one face
engraved NX500 with a bisecting score and the other face plain.
They come in bottles of 100s and 500s.
Other ingredients
Lactose, maize cornflour, polyvinylpyrrolidinone, sodium starch glycolate,
magnesium stearate, FD&C yellow No 6, and D&C yellow No 10.