SUMMARY CMI
Maxydol
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 Maxydol?
Maxydol contains the active ingredient paracetamol, codeine phosphate hemihydrate and doxylamine succinate. Maxydol is used for temporary relief of acute moderate pain.
For more information, see Section 1. Why am I using Maxydol? in the full CMI.
2. What should I know before I use Maxydol?
Do not use if you have ever had an allergic reaction to Maxydol 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 or are breastfeeding.
You may develop addiction, dependence, and tolerance.
For more information, see Section 2. What should I know before I use Maxydol? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Maxydol 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 Maxydol?
The standard dose for adults is 1 or 2 tablets for severe pain, taken every 4 to 6 hours if necessary. More instructions can be found in Section 4. How do I use Maxydol? in the full CMI.
5. What should I know while using Maxydol?
Things you should do |
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Things you should not do |
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Driving or using machines |
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Drinking alcohol |
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Looking after your medicine |
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For more information, see Section 5. What should I know while using Maxydol? in the full CMI.
6. Are there any side effects?
The common side effects include drowsiness, constipation, nausea, vomiting, dizziness, skin rashes sweating and blurred vision. Serious side effects include difficulty breathing or swelling of the face, lips, mouth or other parts of the body, hives. 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
Maxydol 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
Maxydol 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
Maxydol 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 during use, but the risk is higher when first starting Maxydol 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 Using Maxydol
Using Maxydol 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 and alcohol may result in severe drowsiness, decreased awareness, breathing problems, 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 Maxydol.
FULL CMI
Maxydol
Active ingredient(s): Paracetamol, Codeine phosphate hemihydrate and Doxylamine succinate
Consumer Medicine Information (CMI)
This leaflet provides important information about using Maxydol. 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 Maxydol.
Where to find information in this leaflet:
1. Why am I using Maxydol?
2. What should I know before I use Maxydol?
3. What if I am taking other medicines?
4. How do I use Maxydol?
5. What should I know while using Maxydol?
6. Are there any side effects?
7. Product details
1. Why am I using Maxydol?
Maxydol contains the active ingredients paracetamol, codeine phosphate hemihydrate and doxylamine succinate. Paracetamol is an analgesic. It also helps in reducing fever. Codeine phosphate is an analgesic and doxylamine succinate is an antihistamine with calmative effects.
In combination, paracetamol, codeine phosphate and doxylamine produce greater analgesia than any of these drugs alone. Maxydol tablets contain no aspirin.
Maxydol is used to provide effective temporary relief of moderate to severe pain when other analgesics have proven not to be effective and discomfort associated with headache (including tension and migraine), period pain, toothache, muscle pain, backache, rheumatic pain, neuralgia, pain associated with trauma or surgery and other pain where a combined analgesic & calmative action is required.
2. What should I know before I use Maxydol?
Warnings
Do not use Maxydol if:
- you are allergic to paracetamol, codeine phosphate hemihydrate, doxylamine succinate, or any of the ingredients listed at the end of this leaflet.
- Always check the ingredients to make sure you can use this medicine.
- you have or have had any of the following medical conditions:
- severe and/or acute respiratory disease
- respiratory depression (shallow breathing) or respiratory insufficiency (difficulty breathing)
- severe liver failure or impaired liver function
- other problems with breathing such as, shallow breathing, difficulty breathing, or slow breathing.
- G6PD deficiency, a human enzyme deficiency - you are a CYP 2D6 ultra-rapid metaboliser (a fast metaboliser of codeine by the CYP 2D6 enzyme)
- you have an allergic reaction to paracetamol, codeine or doxylamine
- you are aged between 12-18 years of age and may have lowered respiratory function including having had your tonsils or adenoids removed
- you are pregnant or in labour, especially if the baby is premature.
- you are breastfeeding or planning to breastfeed.
- you have a history of drug dependence, including alcohol dependence.
- If you are using antidepressant medication (Monoamine Inhibitors (MAOIs), or have stopped taking antidepressant medication within the past 14 days
- the person going to take the tablets is under 12 years.
- The expiry date has passed.
- The packaging is torn/damaged or shows signs of tampering.
Check with your doctor if you have:
- any allergies to
- any other medicines
- aspirin or any other non-steroidal anti-inflammatory drugs (NSAID)
- any other substances, such as foods, preservatives or dyes - have or have had any medical conditions, especially the following:
- a history of drug or alcohol dependence. Caution is particularly for use in adolescents and young adults with a history of drug and/or alcohol abuse.
- kidney problems
- liver problems
- heart problems
- difficulty breathing, wheezing, chronic cough, asthma or other chronic breathing conditions
- intolerance to pain relieving medicine
- prone to angle closure glaucoma (high pressure in the eye)
- head injury or trauma
- low blood pressure
- you are a CYP 2D6 ultra-rapid metaboliser
- chronic alcohol use including recent cessation of alcohol intake
- low glutathione reserves
- Gilbert's syndrome
- prostate problems
- thyroid problems
- Multiple sclerosis
- urinary, bowel or gallbladder conditions
- have problems with the adrenal glands
- convulsions, fits or seizures
- pre-existing opioid dependence
- chronic constipation
- difficulty or inability to pass urine
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.
Do not take Maxydol during the third trimester of pregnancy.
Do not take codeine during labour, especially if the baby is premature.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Do not take this medicine if you are breastfeeding or plan to breastfeed.
Use in children
- Do not give Maxydol to children under 12 years.
If you are over 65 years of age
Talk to your doctor or pharmacist about how much to take.
Elderly patients are more likely to have less effective kidney function due to age. This may increase the risk of side effects.
Addiction
You can become addicted to Maxydol even if you take it exactly as prescribed. Maxydol 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 Maxydol. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking Maxydol suddenly, so it is important to take it exactly as directed by your doctor.
Tolerance
Tolerance to Maxydol may develop, which means that the effect of the medicine may decrease. If this happens, more may be needed to maintain the same effect.
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.
Maxydol given to the mother during labour can cause breathing problems and signs of withdrawal in the newborn.
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.
Tell your doctor or pharmacist if you are taking any other medicines, which contain paracetamol, codeine or doxylamine.
Do not take Maxydol with Monoamine Oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs.
Some medicines may interfere with Maxydol and affect how it works. It includes:
- Antihistamines
- Any medicine which thins the blood
- Metoclopramide or domperidone, a medicine used to control nausea and vomiting
- medicines used to treat epilepsy or fits
- Propantheline, a medicine used to treat stomach ulcers
- chloramphenicol, an antibiotic used to treat ear and eye infections
- Flucloxacillin, zidovudine or rifampicin, medicines used to treat infections
- medicines used to help you relax, sleep or relieve anxiety, such as sedatives, hypnotics, gabapentinoids, cannabis and centrally active anti-emetic
- Tranquillisers (medicines used for anxiety or nerves)
- Benzodiazepines (medicines used as sedatives or to treat anxiety)
- Antihypertensives (medicines used to treat high blood pressure)
- monoamine oxidase inhibitors, medicines used to treat depression, if taken within the last 14 days
- medicines used to treat alcohol and/or opioid dependence (e.g. naltrexone, buprenorphine or methadone).
- other opioids analgesics used to treat pain
- medicines containing alcohol (ethanol), e.g. some cough syrups
- Chelating resin
- Antidepressants
- Antipsychotics (medicines used to treat mental illnesses)
Medicines that may decrease the effect of Maxydol include:
- Medicines that inhibit the liver enzyme, CYP 2D6 inhibitors such as fluoxetine, paroxetine, bupropion, cinacalcet, and methadone.
- Medicines that increase the activity of the liver enzyme, CYP 3A4 inducers such as rifampicin.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Maxydol.
4. How do I use Maxydol?
How much to take
- Adults and children over 12 years: Take 1-2 tablets every 4-6 hours as necessary.
- Do not exceed 8 tablets in a 24-hour period. Do not give to children under 12 years of age.
- Follow the instructions provided and use written on the medicine's label.
- Talk to your doctor or pharmacist if you do not understand the instructions on the box.
WARNING:
Keep to the recommended dose.
- Adults: Do not take this medicine for longer than a few days at a time unless advised to by a doctor.
- Adolescents and children over 12 years of age: Do not take this medicine for longer than 48 hours at a time unless advised to by a doctor.
- Maxydol tablets is for minor and temporary ailments and should be used strictly as directed. Prolonged use without medical supervision could be harmful.
- Codeine may be habit forming if taken frequently and over a long period of time.
- If you are not sure how long to take Maxydol tablets, talk to your doctor or pharmacist.
- If your symptoms persist, worsen or new symptoms develop, talk to your pharmacist.
When to take Maxydol
- Maxydol tablets can be taken with or without food.
- If you are not sure when to take it, ask your doctor or pharmacist.
How to take it
- Swallow Maxydol tablets with a glass of water. Maxydol tablets can be taken with or without food.
If you forget to use Maxydol
Maxydol should be used regularly at the same time each day. Do not try to make up for missed doses by taking more than one dose at a time. This may increase the chance of getting an unwanted side effect.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Remember to wait 4 to 6 hours between doses.
Do not take a double dose to make up for the dose you missed.
If you have trouble remembering when to take your medicine, ask your pharmacist for hints.
If you use too much Maxydol
If you or someone else receive too much (overdose), and experience one or more of the symptoms below, immediately 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 Maxydol 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 vomiting
- Convulsions or fits
If you think that you have used too much Maxydol, you may need urgent medical attention.
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.
You may need urgent medical attention. Large amounts of paracetamol can cause liver damage.
If children taken too much Maxydol tablets they can suffer nightmares, hallucinations, fitting or have difficulty sleeping.
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.
Depending on your body's individual ability to break down codeine, you may experience signs of overdose even when you take Maxydol as recommended by your doctor. If overdose symptoms occur, seek immediate medical advice.
5. What should I know while using Maxydol?
Things you should do
Remind any doctor including surgeons, dentist or pharmacist you visit that you are taking Maxydol.
Keep all your appointments, including those for blood tests.
Call your doctor straight away if you:
- feel you need to take the medicine for longer periods of time.
- feel you need to take more than the prescribed dose
- feel very unwell when you stop taking the medicine but feel better when you start taking the medicine again.
- are about to start taking any new medicine
- plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking this medicine.
- become pregnant while you are taking this medicine,
Remind any doctor, dentist or pharmacist when you visit that you are using Maxydol.
Things you should not do
- Do not stop taking Maxydol or change the dose without checking with your doctor.
- Do not give Maxydol tablets to anyone else, even if they have the same condition as you.
- Do not use Maxydol tablets to treat any other complaints unless your doctor or pharmacist tells you to.
- Do not take high doses of the medicine for long periods of time unless your doctor tells you to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Maxydol affects you.
Maxydol tablets may cause drowsiness dizziness or lightheadedness in some people especially after the first dose. Do not drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy while taking Maxydol.
Children should not ride bicycles if affected and should be supervised to avoid potential harm.
Drinking alcohol
Tell your doctor if you drink alcohol.
Do not drink alcohol while taking Maxydol.
Drinking alcohol increases the likelihood of becoming drowsy while taking Maxydol. Drinking alcohol and taking paracetamol at the same time can cause liver damage.
Maxydol may be habit forming if taken at high doses for extended periods of time.
Looking after your medicine
- Keep your tablets in the pack until it is time to take them.
- If you take the tablets out of the pack they will not keep well.
- Keep the tablets in a cool dry place where the temperature stays below 25°C.
- Heat and dampness can destroy some medicines.
- A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place 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.
Keep it where young children cannot reach it.
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 about side effects.
Less serious side effects
Less serious side effects | What to do |
Gastrointestinal related:
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
Serious side effects | What to do |
Heart related:
| Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these 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 only available with a doctor's prescription.
What Maxydol contains
Active ingredient (main ingredient) |
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Other ingredients (inactive ingredients) |
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Do not take this medicine if you are allergic to any of these ingredients.
What Maxydol looks like
Maxydol tablets are white capsule-shaped tablets with a breakline on one side. They are available in blister packs of 20 and 40 tablets. (AUST R 277276)
Who distributes Maxydol
Arrow Pharma Pty Ltd
15 – 17 Chapel Street
Cremorne
Victoria
3121
Email id: [email protected]
Phone no: 1 800 569 074
This leaflet was prepared in December 2021.
Published by MIMS April 2022