Nurofen Plus

01/30/2021 | Medications

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

NUROFEN PLUS TABLETS
 
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.
 
WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine.

Why am I using Nurofen Plus?

Nurofen Plus contains the active ingredients Ibuprofen and Codeine phosphate. Nurofen Plus is used to provide temporary relief of acute moderate pain and inflammation. For more information, see Section 1. Why am I using Nurofen Plus? in the full CMI.

What should I know before I use Nurofen Plus?

Do not use if you have ever had an allergic reaction to Nurofen Plus 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.
You may develop addiction, dependence and tolerance. For more information, see Section 2. What should I know before I use Nurofen Plus? in the full CMI.

What if I am taking other medicines?

Some medicines may interfere with Nurofen Plus and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

How do I use Nurofen Plus?

The usual dose of Nurofen Plus is 2 tablets then, if necessary 1 or 2 tablets every 4 to 6 hours.
More instructions can be found in Section 4. How do I use Nurofen Plus? in the full CMI.

What should I know while using Nurofen Plus?

Things you should do
Remind any doctor, dentist or pharmacist you visit that you are using Nurofen Plus.
Talk to you doctor about pain control if Nurofen Plus is not helping.
Tell your doctor if you become pregnant while taking Nurofen Plus.
Things you should not do
Do not take more than 6 tablets in 24 hours.
Do not give Nurofen Plus to children under the age of 12 years
Do not take Nurofen Plus for more than three days at a time
Driving or using machines
Be careful before you drive or use any machines or tools 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.
Drinking alcohol
Do not drink alcohol while taking Nurofen Plus.
Looking after your medicine
Store below 25°C
Store in a cool dry place away from moisture, heat or sunlight.
For more information, see Section 5. What should I know while using Nurofen Plus? in the full CMI.

Are there any side effects?

Call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you notice any of the following side effects; 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. These may be the sign of an allergic reaction.
Speak to your doctor if you have any of the following common side effects and theyworry you; nausea or vomiting, constipation, or dizziness, light-headedness, drowsiness.
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.
 
WARNING:
Limitations of use
Nurofen Plus should only be used when your doctor decides that other treatment options are not able to effectively manage your pain or you cannot tolerate them.
Hazardous and harmful use
Nurofen Plus poses risks of abuse, misuse and addiction which can lead to overdose and death. Your doctor will monitor you regularly during treatment.
Life threatening respiratory depression
Nurofen Plus can cause life-threatening or fatal breathing problems (slow, shallow, unusual or no breathing) even when used as recommended. These problems can occur at any time, but the risk is higher when first starting Nurofen Plus and after a dose increase, if you are older, or have an existing problem with your lungs. Your doctor will monitor you and change the dose as appropriate.
Use of other medicines while taking Nurofen Plus
Using Nurofen Plus with other medicines that can make you feel drowsy such as sleepingtablets (e.g. benzodiazepines), other pain relievers, antihistamines, antidepressants,antipsychotics, gabapentinoids (e.g. gabapentin and pregabalin), cannabis oil andalcohol may result in severe drowsiness, decreased awareness, breathing difficulties,coma and death. Your doctor will minimise the dose and duration of use and monitor you for signs and symptoms of breathing difficulties and sedation. You must not drink alcohol while using Nurofen Plus
 
Active ingredients: Ibuprofen 200mg and Codeine phosphate hemihydrate 12.8mg
 
 
Consumer Medicine Information (CMI)
This leaflet provides important information about using Nurofen Plus. You should also speak to your doctor or pharmacist if you would like further informationor if you have any concerns or questions about using Nurofen Plus.
Where to find information in this leaflet:
1. Why am I using Nurofen Plus?
2. What should I know before I use Nurofen Plus?
3. What if I am taking other medicines?
4. How do I use Nurofen Plus?
5. What should I know while using Nurofen Plus?
6. Are there any side effects?
7. Product details

Why am I using Nurofen Plus?

Nurofen Plus contains 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 and/or inflammation (swelling, redness, soreness) and fever. Codeine is an opioid analgesic that works in the brain and spinal cord to relieve pain.
Nurofen Plus is used to provide temporary relief of acute moderate pain and inflammationin patients over the age of 12 years.
After taking codeine, the body changes codeine into the active morphine by a special liver enzyme. However, about 8% of people may experience less pain relief compared to others, as their bodies do not change codeine to morphine as well as others.

What should I know before I use Nurofen Plus?

Warnings

Do not give Nurofen Plus to children under the age of 12 years.

Do not use Nurofen Plus if:

you are allergic to ibuprofen, codeine, other opioids, or any medicine containing ibuprofen, aspirin or other NSAIDs 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 NSAIDs. If you are not sure if you are taking any of these medicines, ask your pharmacist.
Always check the ingredients to make sure you can use this 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 NSAIDs and take Nurofen Plus these symptoms may be severe.
you are in the last three months of pregnancy or are breast- feeding.
you are vomiting blood or material that looks like coffee grounds
you are bleeding from the rectum (back passage), have black sticky bowel motions (stool) or bloody diarrhoea
you have peptic ulcer (i.e. stomach or duodenal ulcer) or have had one before.
you are using other NSAIDS
you have chronic constipation or shallow breathing, or severe diarrhoea.
You consume regular and heavy amounts of alcohol.
You are a CYP2D6 ultra- rapid metaboliser.
If you have severe liver impairment
If you have heart or kidney problems
If you are currently taking a Monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping treatment with a MAOI.
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.
Do not give Nurofen Plus to children under 12 years or to those aged 12 -18 years in whom respiratory function may be compromised.

Check with your doctor if you:

have or have had any other medical conditions:
difficulty breathing, wheezing, chronic cough, allergies, asthma or other breathing conditions
a history of drug dependence, including alcohol dependence
skin rash (dermatitis)
skin irritation
a history of stomach ulcer.
liver disease.
kidney disease.
heart problems/failure, including. swelling of ankles or feet.
Thyroid problems or low blood pressure.
a head injury or intracranial pressure.
prostatic problems.
stomach problems or recent stomach surgery.
Tell your doctor if you take sedatives (medicines used to help you relax or sleep).
Tell your doctor if you have allergies to:
any other medicines including aspirin, or other NSAID medicines.
any other substances, such as foods, preservatives or dyes.
If you have not told your doctor about any of the above, tell him/her before you start taking Nurofen Plus.
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

Check with your doctor if you are pregnant or intend to become pregnant.
Nurofen Plus is not recommended during the last 3 months of pregnancy. Your doctor will decide if you should take Nurofen Plus during the first 6 months of pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Nurofen Plus should not be taken while breastfeeding.

Addiction

You can become addicted to Nurofen Plus even if you take it exactly as prescribed. Nurofen Plus may become habit forming causing mental and physical dependence. If abused it may become less able to reduce pain.

Dependence

As with all other opioid containing products, your body may become used to you taking Nurofen Plus. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking Nurofen Plus suddenly, so it is important to take it exactly as directed by your doctor.

Tolerance

Tolerance to Nurofen Plus may develop, which means that the effect of the medicine may decrease. If this happens, more may be needed to maintain the same effect.

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 Nurofen Plus and affect how it works.
These include:
medicines used to help you relax, sleep or relieve anxiety, such as barbiturates and sedatives.
aspirin, salicylates or other NSAID medicines.
Warfarin or other medicines used to prevent blood clots.
medicines that are used to treat high blood pressure including diuretics (fluid tablets)
methotrexate.
zidovudine.
lithium
mifeprisone, quinolone antibiotics
medicines used to relieve stomach cramps, prevent travel sickness and to treat Parkinson’s disease.
medicines used to treat diarrhoea (e.g. kaolin, pectin, loperamide).
metoclopramide, a medicine used to treat nausea and vomiting
selective serotonin reuptake inhibitors (SSRIs), and monoamine oxidase inhibitors (MAOIs), medicines used to treat some types of depression
quinidine, a medicine used to treat abnormal or irregular heart beat
phenothiazines and antipsychotic agents, medicines used to treat mental disorders
medicines such as cyclosporin, tacrolimus, prednisone, prednisolone and cortisone which reduce the activity of your immune system
probenecid-medicines used to treat gout
phenytoin – medicine used to treat epilepsy
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 will advise you.
Check with your doctor or pharmacist if you are not sure about what medicines, vitaminsor supplements you are taking and if these affect Nurofen Plus.

How do I use Nurofen Plus?

Follow all directions given to you by your pharmacist or doctor carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your pharmacist or doctor for help.

How much to take and when to take it

The usual dose of Nurofen Plus is 2 tablets then, if necessary 1 or 2 tablets every 4 to 6 hours. Do not take more than six tablets in 24 hours.
Follow the instructions provided and use Nurofen Plus until your doctor tells you to stop.

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 three days at a time.
If your symptoms persist, worsen or new symptoms develop, talk to your doctor.
Talk to your doctor about pain control if Nurofen Plus is not helping.
Depending on your body’s individual ability to break down codeine, you may be getting reduced benefit or experience signs of overdose even when you take Nurofen Plus as recommended by your doctor. If overdose symptoms occur, seek immediate medical advice.

If you use too much Nurofen Plus

If you or someone else receive too much (overdose), and experience one or more of the symptoms below, immediately and call triple zero (000) for an ambulance. Keep the person awake by talking to them or gently shaking them every now and then. You should follow the above steps even if someone other than you have accidentally used Nurofen Plus that was prescribed for you. If someone takes an overdose they may experience one or more of the following symptoms:
Slow, unusual or difficult breathing
Drowsiness, dizziness or unconsciousness
Slow or weak heartbeat
Nausea or upset stomach, vomiting and/or gastric irritation
Convulsions, fits or unconsciousness
Excitability
Blurred vision, ringing in the ears, or rapid uncontrollable movements of the eyes.
If you think you or someone else may have used too much Nurofen Plus, 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.
When seeking medical attention, take this leaflet and remaining medicine with you to show the doctor. Also tell them about any other medicines or alcohol which have been taken.

What should I know while using Nurofen Plus?

Things you should do

If you are about to be started on any new medicine tell your doctor and pharmacist that you are taking Nurofen Plus.
Remind any doctor, dentist or pharmacist you visit that you are using Nurofen Plus.
If you are going to have surgery, tell your doctor you are taking Nurofen Plus.
Talk to doctor if your symptoms do not improve.
Your doctor will assess your condition and decide if you should continue to take the medicine.

Call your doctor straight away if you:

Become pregnant while taking Nurofen Plus

Things you should not do

Do not take high doses of the medicine for long periods of time unless your doctor tells you to. Products containing codeine should not be taken for prolonged periods. Codeine may be habit forming.
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 unless your doctor tells you to.
Do not take more than the recommended dose unless your doctor tells you to.
Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how NurofenPlus 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 and/or drowsiness may be worse.

Drinking alcohol

Tell your doctor if you drink alcohol.
Using Nurofen Plus with alcohol may result in severe drowsiness, decreased awareness, breathing difficulties, coma and death.

Withdrawal

Continue taking your medicine for as long as your doctor tells you. If you stop having this medicine suddenly, your pain may worsen and you may experience some or all of the following withdrawal symptoms:
nervousness, restlessness, agitation, trouble sleeping or anxiety
body aches, weakness or stomach cramps
loss of appetite, nausea, vomiting or diarrhoea
increased heart rate, breathing rate or pupil size
watery eyes, runny nose, chills or yawning
increased sweating.
Nurofen Plus given to the mother during labour can cause breathing problems and signs of withdrawal in the newborn.

Looking after your medicine

Keep the tablets in the original pack until it is time to take the dose. If you take them out they will not keep well.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place where the temperature stays below 25°C 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.
Heat and dampness can destroy some medicines.
Keep medicines 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.

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.

Are there any side effects?

All medicines can have side effects. 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.

Less serious side effects

Less serious side effects
What to do
Gastrointestinal related:
stomach upset including nausea (feeling sick), vomiting
heartburn, indigestion
constipation
diarrhoea, pain in the stomach
loss of appetite
Head and neurology related:
sleeplessness, nightmares
change in mood e.g. depression, restlessness, irritability
sore or dry mouth or tongue
dizziness, light-headedness, drowsiness
headache
hearing disturbance
Respiratory related:
shallow breathing
cough suppression
Speak to your doctor if you have any of these less serious side effects and they worryyou.

Serious side effects

Serious side effects
What to do
Gastrointestinal related:
severe pain or tenderness in the stomach
vomiting blood or material that looks like coffee grounds.
bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea.
Allergy related:
shallow breathing or shortness of breath
flushing of the face
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
symptoms of sunburn (such as redness, itching, swelling, blistering) which may occur more quickly than normal
Heart related:
fast heart beat
Skin related:
yellowing of the skin and eyes, also called jaundice
sudden or severe itching, skin rash, hives, skin peeling
Urinary related:
a change in the colour of urine passed, blood in the urine
a change in the amount or frequency of urine passed, burning feeling when passing urine
unusual weight gain, swelling of ankles or legs
Infection related:
signs of frequent or worrying infections such as fever, severe chills, sore throat or mouth ulcers
Bleeding related:
bleeding or bruising more easily than normal, reddish or purplish blotches under the skin
signs of anaemia, such as tiredness, being short of breath, and looking pale
Head and neurology related:
unusual or extreme mood swings
dizziness, light-headedness
severe dizziness, spinning sensation
severe or persistent headache
difficulty hearing, deafness
tingling or numbness of the hands or feet
Eyes related:
eye problems such as blurred vision, sore red eyes, itching
Call your doctor straight away, or go straight to the Emergency Department at yournearest hospital if you notice any of these serious side effects.
Tell your doctor or pharmacist if you notice anything else that may be making youfeel 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 stoptaking any of your medicines.

Product details

This medicine is only available with a doctor’s prescription.

What Nurofen Plus contains

Active ingredient
(main ingredient)
Ibuprofen and Codeine phosphate hemihydrate
Other ingredients
(inactive ingredients)
Microcrystalline cellulose, Sodium starch glycollate, Hypromellose, Pregelatinised maize starch, Talc, Opaspray white colouring
Potential allergens
Nurofen Plus is gluten-free and lactose-free
Do not take this medicine if you are allergic to any of these ingredients.

What Nurofen Plus looks like

Nurofen Plus tablets are white capsule shaped tablets marked ‘N+’ on one side. (Aust R 116620).
Nurofen Plus is available in blister packs of *4, *6, *12, *24 & 30 tablets.
*not available in Australia

Who distributes Nurofen Plus

Reckitt Benckiser, Sydney NSW, Australia
This leaflet was prepared in December 2020.

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