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Information for Consumers

Revised: 11 June 2015

Consumer Medicine Information

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:

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:

Symptoms of an allergic reaction to these medicines may include:

Do not take NAXEN tablets if you:

Do not take NAXEN tablets if:

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:

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:

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:

Tell your doctor immediately, or go to your nearest Accident and Emergency Centre, if you notice any of the following:

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.

Sponsor

Douglas Pharmaceuticals Ltd
Central Park Drive, Lincoln
Auckland 1008

Date of preparation: 19th January 2004

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