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NUROFEN PLUS

Ibuprofen 200mg and Codeine phosphate 12.8mg

Consumer Medicine Information

What is in this Leaflet?

This leaflet answers some common questions about NUROFEN PLUS. 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 pharmacist has weighed the risks of you taking NUROFEN PLUS against the benefits this medicine is expected to have for you.

If you have any concerns about taking this medicine, ask your pharmacist or doctor.

Keep this leaflet with the medicine.

You may need to read it again

What NUROFEN PLUS is used for

NUROFEN PLUS tablets contain the active ingredients Ibuprofen and Codeine phosphate. Ibuprofen belongs to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDS). These medicines work by relieving pain, inflammation (swelling, redness, soreness) and fever. Codeine is an opioid analgesic that works in the brain and spinal cord to relieve pain.

NUROFEN PLUS relieves strong pain and inflammation associated with migraine headache, tension headache, headache, period pain, dental pain, back pain, neuralgia, rheumatic pain, arthritic pain and muscular pain.

NUROFEN PLUS is not recommended for use in children under the age of 12 years.

Before You Take NUROFEN PLUS

When you must not take it

Do not take NUROFEN PLUS if you have an allergy to:

Ibuprofen, codeine or other opioids, or any of the ingredients listed at the end of this leaflet.
Aspirin.
any other NSAID medicine.

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 NUROFEN PLUS these symptoms may be severe.

Do not take NUROFEN PLUS if you are also taking any other medicines that contain NSAIDS, whether prescribed by your doctor or obtained without prescription.

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 pharmacist.

Do not take NUROFEN PLUS during the last 3 months of pregnancy.

NUROFEN PLUS should not be taken during pregnancy except under medical supervision. All NSAIDS should not be taken during the last three months of pregnancy.

Do not take NUROFEN PLUS if:

1.you are vomiting blood or material that looks like coffee grounds.
2.you are bleeding from the rectum (back passage), have black sticky bowel motions (stools) or bloody diarrhoea.
3.you have a stomach ulcer.
4.you have chronic constipation or shallow breathing, or severe diarrhoea.
5.You consume regular and heavy amounts of alcohol.

Do not take NUROFEN PLUS if the packaging is torn or shows signs of tampering.

Do not take NUROFEN PLUS if the expiry date (EXP) printed on the pack has passed.

If you take this medicine after the expiry date has passed, it may not work as well.

If you are not sure whether you should start taking NUROFEN PLUS, contact your pharmacist or doctor.

Before you start to take it

Tell your pharmacist or doctor if:

1.you are pregnant or intend to become pregnant

NUROFEN PLUS is not recommended to be used during pregnancy. Your doctor will decide if you should take NUROFEN PLUS.

2.you are breast-feeding or plan to breast-feed

NUROFEN PLUS is not recommended while you are breast-feeding. If there is a need to consider NUROFEN PLUS while you are breast-feeding, your pharmacist or doctor will discuss with you the benefits and risks of using it.

3.you have any medical conditions, especially the following:
a history of stomach ulcer.
liver disease.
kidney disease.
heart failure, including.
swelling of ankles or feet.
asthma , or have suffered in the past from asthma.
thyroid problems or low blood pressure.
a head injury or intercranial pressure.
Prostatic problems.
Stomach problems or recent stomach surgery.

Taking other medicines

Tell your pharmacist or doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may interfere with each other. These include:

aspirin, salicylates or other NSAID medicines .
Warfarin or other medicines used to stop blood clots or thin the blood.
medicines that are used to treat high blood pressure eg diuretics (fluid tablets) or heart problems.
Methotrexate.
Zidovudine.
lithium and other medicines used to treat depression eg MAOIs (even if taken within the last 14 days).
medicines used to relieve stomach cramps.
medicines used to treat diarrhoea (eg. kaolin, pectin, loperamide).
Metoclopramide.
other opioid pain killers.

These medicines may be affected by NUROFEN PLUS or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist will advise you.

Your pharmacist and doctor have more information on medicines to avoid or be careful with while taking NUROFEN PLUS.

How to Take NUROFEN PLUS

How much to take

The usual dose of NUROFEN PLUS is 2 tablets then, if necessary 1 or 2 tablets every 4 hours.

Do not take more than six tablets in 24 hours.

If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

How to take it

Take NUROFEN PLUS by mouth with fluid. It may also be taken with or immediately after food.

How long to take it

You should not take NUROFEN PLUS for more than a few days.

If your symptoms persist, worsen or new symptoms develop, talk to your pharmacist.

If you take too much (overdose)

If you take too much of this medicine you may experience nausea or upset stomach, vomiting and gastric irritation, drowsiness, dizziness or very slow, laboured breathing. You may also experience blurred vision, ringing in the ears, or rapid uncontrollable movements of the eyes. Excitability, convulsions and unconsciousness may be experienced in rare cases. If you think you have taken too many NUROFEN PLUS tablets, talk to your pharmacist or doctor, or contact the Poisons Information Centre (Tel 13 1126).

While You Are Using NUROFEN PLUS

Things you must do

If you become pregnant while taking NUROFEN PLUS tell your doctor immediately.

If you are about to be started on any new medicine tell your doctor and pharmacist that you are taking NUROFEN PLUS.

Tell all of the doctors, dentists and pharmacists that are treating you that you are taking NUROFEN PLUS.

If you are going to have surgery, tell your doctor you are taking NUROFEN PLUS.

Things you must not do

Do not give NUROFEN PLUS to anyone else, even if they have the same condition as you.

Do not use NUROFEN PLUS to treat any other complaints.

Things to be careful of

Be careful driving or operating machinery until you know how NUROFEN PLUS affects you.

NUROFEN PLUS may cause dizziness, light-headedness or drowsiness in some people. If this occurs, do not drive or operate machinery. If you drink alcohol, dizziness, light-headedness or drowsiness may be worse.

Products containing codeine should not be taken for prolonged periods. Codeine may be habit forming.

Side Effects

Check with your pharmacist or doctor as soon as possible if you have any problems while taking NUROFEN PLUS, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

Like other medicines, NUROFEN PLUS can cause some side effects in rare cases. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.

Ask your pharmacist or doctor to answer any questions you may have.

Tell your pharmacist or doctor if you notice any of the following and they worry you:

stomach upset including nausea (feeling sick), vomiting.
heartburn, indigestion.
diarrhoea, pain in the stomach.
dizziness, light-headedness, drowsiness.
Constipation.
shallow breathing.
cough suppression.
Headache.
hearing disturbance.

These are the more common side effects of NUROFEN PLUS and are usually mild and short lived.

If any of the following happen, stop taking NUROFEN PLUS and tell your doctor immediately or go to casualty at your nearest hospital:

vomiting blood or material that looks like coffee grounds.
bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea.
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing.
asthma, wheezing, shortness of breath, pain or tightness in the chest
sudden or severe itching, skin rash, hives, skin peeling
easy bruising

These are very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.

Some people may get other side effects while taking NUROFEN PLUS. Tell your doctor or pharmacist if you notice anything else that worries you.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After Using NUROFEN PLUS

Storage

Keep the tablets in the pack until it is time to take the dose.

If you take them out they will not keep well.

Keep the tablets in a cool dry place where the temperature stays below 25 degrees C.

Do not store NUROFEN PLUS or any other medicine in the bathroom or near a sink.

Do not leave the tablets in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep the 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

When you stop taking NUROFEN PLUS or it has passed its expiry date, ask your pharmacist what to do with any tablets that are left over.

More Information

If you have any further questions or if you are not sure about anything relating to the use of NUROFEN PLUS, your doctor or pharmacist can best assist you.

Product Description

What it looks like

NUROFEN PLUS tablets are white capsule shaped tablets marked `N+` on one side.

Ingredients

NUROFEN PLUS contains 200mg ibuprofen and 12.8mg codeine phosphate as the active ingredients.

The other ingredients in NUROFEN PLUS are:

microcrystalline cellulose
sodium starch glycollate
hypromellose
maize starch
talc
Opaspray white colouring

Nurofen Plus tablets are gluten-free and lactose-free.

Packaging

Nurofen Plus is available in blister packs of 12, 24, 48 & 72 tablets.

Supplier

NUROFEN PLUS is sponsored in Australia by:

Boots Healthcare Australia Pty Ltd
101 Waterloo Road
North Ryde NSW 2113
ACN 000 071 278
The ARTG number is:
AUST R 116620
This leaflet was prepared in February 2005.

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Nurofen Plus Ibuprofen 200mg/Codeine Phosphate 12.8mg Tablets (Pack of 30)