SUMMARY CMI

IBUPROFEN/CODEINE-WGR 200/12.8 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.

1. Why am I using IBUPROFEN/CODEINE-WGR?

IBUPROFEN/CODEINE-WGR contains the active ingredients Ibuprofen and Codeine phosphate. IBUPROFEN/CODEINE-WGR is used to provide temporary relief of acute moderate pain and inflammation.

For more information, see Section 1. Why am I using IBUPROFEN/CODEINE-WGR? in the full CMI.

2. What should I know before I use IBUPROFEN/CODEINE-WGR?

Do not use if you have ever had an allergic reaction to IBUPROFEN/CODEINE-WGR 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 IBUPROFEN/CODEINE-WGR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with IBUPROFEN/CODEINE-WGR 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.

4. How do I use IBUPROFEN/CODEINE-WGR?

• The usual dose of IBUPROFEN/CODEINE-WGR 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 IBUPROFEN/CODEINE-WGR? in the full CMI.

5. What should I know while using IBUPROFEN/CODEINE-WGR?

For more information, see Section 5. What should I know while using IBUPROFEN/CODEINE-WGR? in the full CMI.

6. 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 they worry 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

IBUPROFEN/CODEINE-WGR 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

IBUPROFEN/CODEINE-WGR 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

IBUPROFEN/CODEINE-WGR 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 IBUPROFEN/CODEINE-WGR 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 IBUPROFEN/CODEINE-WGR

Using IBUPROFEN/CODEINE-WGR with other medicines that can make you feel drowsy such as sleeping tablets (e.g. benzodiazepines), other pain relievers, antihistamines, antidepressants, antipsychotics, gabapentinoids (e.g. gabapentin and pregabalin), cannabis oil and alcohol 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 IBUPROFEN/CODEINE-WGR.

FULL CMI

IBUPROFEN/CODEINE-WGR 200/12.8 Tablets

Active ingredients: Ibuprofen 200 mg and Codeine phosphate hemihydrate 12.8 mg

Consumer Medicine Information (CMI)

This leaflet provides important information about using IBUPROFEN/CODEINE-WGR. 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 IBUPROFEN/CODEINE-WGR.

Where to find information in this leaflet:

1. Why am I using IBUPROFEN/CODEINE-WGR?
2. What should I know before I use IBUPROFEN/CODEINE-WGR?
3. What if I am taking other medicines?
4. How do I use IBUPROFEN/CODEINE-WGR?
5. What should I know while using IBUPROFEN/CODEINE-WGR?
6. Are there any side effects?
7. Product details

1. Why am I using IBUPROFEN/CODEINE-WGR?

IBUPROFEN/CODEINE-WGR 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.

IBUPROFEN/CODEINE-WGR is used to provide temporary relief of acute moderate pain and inflammation in 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.

2. What should I know before I use IBUPROFEN/CODEINE-WGR?

Warnings

Do not give IBUPROFEN/CODEINE-WGR to children under the age of 12 years.

Do not use IBUPROFEN/CODEINE-WGR 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 IBUPROFEN/CODEINE-WGR these symptoms may be severe
• you are in the last three months of pregnancy or are breastfeeding
• 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 inhibitor (MAOIs) or within 14 days of stopping treatment with a MAOI.

Do not take IBUPROFEN/CODEINE-WGR if the packaging is torn or shows signs of tampering.

Do not take IBUPROFEN/CODEINE-WGR 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 IBUPROFEN/CODEINE-WGR 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 IBUPROFEN/CODEINE-WGR.

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 or pharmacist if you are pregnant or intend to become pregnant.

IBUPROFEN/CODEINE-WGR is not recommended during the last 3 months of pregnancy. Your doctor will decide if you should take IBUPROFEN/CODEINE-WGR during the first 6 months of pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

IBUPROFEN/CODEINE-WGR should not be taken while breastfeeding.

Addiction

You can become addicted to IBUPROFEN/CODEINE-WGR even if you take it exactly as prescribed. IBUPROFEN/CODEINE-WGR 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 IBUPROFEN/CODEINE-WGR. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking IBUPROFEN/CODEINE-WGR suddenly, so it is important to take it exactly as directed by your doctor.

Tolerance

Tolerance to IBUPROFEN/CODEINE-WGR may develop, which means that the effect of the medicine may decrease. If this happens, more may be needed to maintain the same effect.

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 IBUPROFEN/CODEINE-WGR 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
• medicines that affect serotonin levels (serotonergic medicines)
• 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 IBUPROFEN/CODEINE-WGR 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, vitamins or supplements you are taking and if these affect IBUPROFEN/CODEINE-WGR.

4. How do I use IBUPROFEN/CODEINE-WGR?

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 IBUPROFEN/CODEINE-WGR 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 IBUPROFEN/CODEINE-WGR until your doctor tells you to stop.

How to take it

• Take IBUPROFEN/CODEINE-WGR by mouth with fluid. It may also be taken with or immediately after food.

How long to take it

• You should not take IBUPROFEN/CODEINE-WGR 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 IBUPROFEN/CODEINE-WGR 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 IBUPROFEN/CODEINE-WGR as recommended by your doctor. If overdose symptoms occur, seek immediate medical advice.

If you use too much IBUPROFEN/CODEINE-WGR

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 IBUPROFEN/CODEINE-WGR 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 IBUPROFEN/CODEINE-WGR, 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.

5. What should I know while using IBUPROFEN/CODEINE-WGR?

Things you should do

• If you are about to be started on any new medicine tell your doctor and pharmacist that you are taking IBUPROFEN/CODEINE-WGR.
• Remind any doctor, dentist or pharmacist you visit that you are using IBUPROFEN/CODEINE-WGR.
• If you are going to have surgery, tell your doctor you are taking IBUPROFEN/CODEINE-WGR.

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 IBUPROFEN/CODEINE-WGR

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 IBUPROFEN/CODEINE-WGR to anyone else, even if they have the same condition as you.
• Do not use IBUPROFEN/CODEINE-WGR 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 IBUPROFEN/CODEINE-WGR affects you.

IBUPROFEN/CODEINE-WGR may cause dizziness light-headedness or drowsiness in some people. If this occurs, do not drive or operate machinery. If you drink alcohol, dizziness, lightheadedness and/or drowsiness may be worse.

Drinking alcohol

Tell your doctor if you drink alcohol.

Using IBUPROFEN/CODEINE-WGR 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.

IBUPROFEN/CODEINE-WGR 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.

6. 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.

Less serious side effects

Serious side effects

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 available with a doctor's prescription.

What IBUPROFEN/CODEINE-WGR contains

Do not take this medicine if you are allergic to any of these ingredients.

What IBUPROFEN/CODEINE-WGR looks like

White to off-white coloured, caplet shaped film-coated tablet plain on both sides, supplied in blister packs.

(Aust R 435171).

Blister packs of 10, 12, 15, 20, 24 and 30 tablets.

Who distributes IBUPROFEN/CODEINE-WGR

Wagner Pharmaceuticals Pty Ltd
6 Albert Street
Preston VIC 3072
Tel: 1800 936 140

This leaflet was prepared in August 2024.

Published by MIMS March 2025