NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
MERSYNDOL FORTE®
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 taking Mersyndol Forte?
Mersyndol Forte contains the active ingredients paracetamol, codeine phosphate hemihydrate and doxylamine succinate. Mersyndol Forte is for the short-term management of severe pain where your doctor decides other treatment options are ineffective, are not recommended, not tolerated, or otherwise inappropriate to manage your pain. For more information, see Section 1. Why am I taking Mersyndol Forte? in the full CMI.
What should I know before I take Mersyndol Forte?
Do not take Mersyndol Forte if you have ever had an allergic reaction to Mersyndol Forte or any of the ingredients listed at the end of this CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,or are pregnant or plan to become pregnant, are breastfeeding or planning to breastfeed. For more information, see Section 2. What should I know before I take Mersyndol Forte? in the full CMI.
What if I am taking other medicines?
Some medicines may interfere with Mersyndol Forte 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 take Mersyndol Forte?
The usual dose for adults and children between 12 and 18 years is one or two tablets every 4-6 hours as needed for relief.
More instructions can be found in Section 4. How do I take Mersyndol Forte? in the full CMI.
What should I know while taking Mersyndol Forte?
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Things you should do
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Remind any doctor, surgeon, dentist or pharmacist you visit that you are using Mersyndol Forte.
Keep all your appointments, including those for blood tests.
Call your doctor straight away if you feel you need to change the dose, take it for longer periods of time, or you feel very unwell when you are not taking it and feel better when you are taking it again.
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Things you should not do
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Do not take more than 8 tablets in a 24-hour period.
Do not stop taking Mersyndol Forte or change the dose without checking with your doctor, or use it to treat any other complaints unless your doctor or pharmacist tells you to.
Do not give Mersyndol Forte to anyone else, even if they have the same condition as you.
Do not take high doses of Mersyndol Forte for long periods of time unless your doctor tells you to.
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Driving or using machines
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Do not drive a car, operate machinery, or do anything else that could be dangerous while taking Mersyndol Forte.
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Drinking alcohol
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Do not drink alcohol while taking Mersyndol Forte.
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Looking after your medicine
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Store below 25°C. Store in a cool, dry place away from direct sunlight.
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For more information, see Section 5. What should I know while taking Mersyndol Forte? in the full CMI.
Are there any side effects?
Common side effects include skin rash, constipation, nausea, vomiting, dizziness, drowsiness, sweating, blurred vision. Serious side effects include, wheezing, difficulty breathing or shallow breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or 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.
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WARNING:
Limitations of use
Mersyndol Forte should only be used if your doctor decides other treatment options are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain.
Hazardous and harmful use
Mersyndol Forte contains codeine which may be habit forming. Misuses, abuse, or addiction may lead to overdose and death. Your doctor will assess your risks and monitor your treatment regularly.
Life threatening respiratory depression
Serious, life-threatening, or fatal respiratory depression (shallow or difficulty breathing) may occur with the use of Mersyndol Forte. Your doctor will assess your risk of respiratory depression and monitor your treatment regularly.
Concomitant use of benzodiazepines and other central nervous system (CNS) depressants,including alcohol
Using opioids while taking benzodiazepines (medicines used as sedatives or to treat anxiety), gabapentinoids (medicines used for epilepsy or neuropathic pain), antihistamines, antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in extreme drowsiness and sleepiness, respiratory depression (shallow or difficulty breathing), coma, and death. Your doctor will limit your dosage and duration of use and monitor you regularly. Do not drink alcohol while taking Mersyndol Forte.
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Active ingredient(s): paracetamol, codeine phosphate hemihydrate and doxylamine succinate
Consumer Medicine Information (CMI)
This leaflet provides important information about taking Mersyndol Forte. You should also speak to your doctor or pharmacist if you would like further informationor if you have any concerns or questions about using Mersyndol Forte.
Where to find information in this leaflet:
1. Why am I taking Mersyndol Forte?
2. What should I know before I take Mersyndol Forte?
3. What if I am taking other medicines?
4. How do I take Mersyndol Forte?
5. What should I know while taking Mersyndol Forte?
6. Are there any side effects?
7. Product details
Why am I taking Mersyndol Forte?
Mersyndol Forte contains three active ingredients,
paracetamol,
codeine phosphate hemihydrate, and
doxylamine succinate.
Paracetamol is an analgesic (pain-relieving medicine) and antipyretic (lowers body temperature). Codeine phosphate hemihydrate is a potent analgesic that helps to relieve pain. The body must convert codeine into morphine before it can provide pain relief. Doxylamine succinate is an antihistamine which can help to relieve tension and nausea associated with pain. This may be especially useful in the treatment of tension headache, migraine and period pain.
Mersyndol Forte is used for the short-term management of severe pain for which other treatment options have failed, are not recommended, not tolerated or are otherwise inappropriate to provide sufficient management of pain. This may include toothache and other dental pain, pain from injury or surgery, or headache pain.
What should I know before I take Mersyndol Forte?
Warnings
Do not use Mersyndol Forte 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 diseases,
such as bronchitis, acute asthma, emphysema, acute chronic obstructive pulmonary disease(COPD).
Other problems with breathing such as, shallow breathing, difficulty breathing, orslow breathing.
Glucose-6-phosphate-dehydrogenase deficiency (an enzyme deficiency that may lead toanaemia)
you very rapidly metabolise codeine into morphine.
Known intolerance to paracetamol.
Severe liver disease or liver failure
if you have diarrhoea caused by antibiotics or poisoning.
if you are in the third trimester of pregnancy or in labour, especially if the baby is premature.
if you are breastfeeding or planning to breastfeed.
if you have a history of drug dependence, including alcohol dependence.
if you are already taking Monoamine Oxidase Inhibitors (MAOIs) such as selegiline or moclobemide, or within 14 days of stopping MAOIs.
if you have experienced allergy (generalised rash or shortness of breath) to morphine or oxycodone.
the person going to take the tablets is under 12 years.
if you are aged between 12 and 18 years of age and have had your tonsils or adenoids removed to treat sleep apnoea.
Check with your doctor if you:
have 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:
Liver problems
Gilbert’s syndrome
Kidney problems
Heart problems
Low blood pressure
Lung problems, difficulty breathing, wheezing, chronic cough, asthma, or other chronicbreathing conditions
Intolerance to pain relieving medicine
Chronic alcohol use, or if you recently stopped taking alcohol
Opioid dependence
A history of drug and/or alcohol abuse. Caution is particularly recommended for usein adolescents and young adults with a history of drug and/or alcohol abuse.
Low levels of glutathione
Recent stomach, intestine or urinary tract surgery
Gall bladder problems or your gall bladder has been removed
Obstructive and inflammatory bowel disease or other bowel problems
Chronic constipation
Multiple sclerosis
Prostate problems
Retaining urine
Problems passing urine
Underactive thyroid
Adrenal gland problems such as Addison’s disease
Head injury
Brain tumour, stroke or other problems with the brain
Fits or seizures
take any medicines for any other condition
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 Mersyndol Forte during the third trimester of pregnancy.
Do not take Mersyndol Forte during labour, especially if the baby is premature.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Do not take Mersyndol Forte if you are breastfeeding or planning to breastfeed.
Use in children
Do not give Mersyndol Forte to children under 12 years.
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 Mersyndol Forte with Monoamine Oxidase inhibitors (MAOIs), such as selegiline or moclobemide, or within 14 days of stopping MAOIs.
Some medicines can interfere with Mersyndol Forte including:
Medicines causing sleepiness or drowsiness, such as sedatives or tranquilisers
Benzodiazepines (medicines used as sedatives or to treat anxiety). The use of opioids and benzodiazepines together may increase the risk of drowsiness, difficulties in breathing, coma and may be life-threatening.
Medicines containing alcohol (ethanol), such as some cough syrups
Cough suppressants or antitussives
Medicines used to treat alcohol and/or opioid dependence, such as naltrexone or buprenorphine
Medicines used to treat depression
Phenothiazines and antipsychotic agents (medicines used to treat mental disorders)
Some types of antihistamines
Aspirin or any other non-steroidal anti-inflammatory drugs (NSAID)
Gabapentinoids (medicines used for epilepsy or neuropathic pain)
Cannabis
Medicines used to stop or prevent vomiting (anti-emetics), such as metoclopramide or domperidone
Medicines used to treat diarrhoea, such as kaolin or loperamide
Medicines used to thin the blood, such as warfarin
Propantheline (medicine used to treat stomach ulcers)
Medicines used to treat epilepsy or fits, such as phenytoin
Other pain relief medication
Medicines used to treat high blood pressure
Colestyramine (medicine used to treat bile problems or lower cholesterol)
Chelating resin
Chloramphenicol, an antibiotic used to treat ear and eye infections
Neuromuscular blocking agents such as cisatracurium (medicines used during surgical procedures)
Flucloxacillin, zidovudine or rifampicin (medicines used to treat infections)
Medicines that may decrease the effect of Mersyndol Forte 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, vitaminsor supplements you are taking and if these affect Mersyndol Forte.
How do I take Mersyndol Forte?
How much to take
Adults and children between 12 and 18 years
The usual adult dose is one or two tablets every 4 to 6 hours as needed for relief.
Do not take more than 8 tablets in a 24-hour period.
Mersyndol Forte must not be used in in children under 12 years.
Follow the instructions provided and use Mersyndol Forte until your doctor tells you to stop. Their directions may differ from the information contained in this leaflet.
How to take Mersyndol Forte
Swallow the prescribed dose of Mersyndol Forte whole with a glass of water. It can be taken with or without food.
If you forget to take Mersyndol Forte
If you miss your dose at the usual time, take it as soon as you remember. If it isalmost time for your next dose, skip the dose you missed and take your next dose whenyou 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 take too much Mersyndol Forte
If you think that you have used too much Mersyndol Forte, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre (in Australia
by calling 13 11 26; in New Zealand 0800 764 766), or
by calling 13 11 26; in New Zealand 0800 764 766), 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.
What should I know while taking Mersyndol Forte?
Things you should do
Remind any doctor including surgeons, dentist or pharmacist you visit that you are taking Mersyndol Forte.
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.
Things you should not do
Do not give Mersyndol Forte to anyone else, even if they have the same condition as you.
Do not take Mersyndol Forte to treat any other complaints unless your doctor tells you to.
Do not take high doses of the medicine for long periods of time unless your doctor tells you to.
Do not stop taking Mersyndol Forte or change the dose without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how MersyndolForte affects you.
Mersyndol Forte may cause drowsiness, dizziness, affect eyesight, or hand-eye coordination in some people. Do not drive a car, operate machinery, or do anything else that could be dangerous while taking Mersyndol Forte.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol and codeine taken together may increase the risk of sedation, respiratory problems, coma or may be life-threatening.
Do not drink alcohol while you are taking Mersyndol Forte.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Keep your tablets in the pack until it is time to take them.
Store below 25°C.
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
do not store it in the car or on window sills.
Keep it where young children cannot reach it.
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
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Less serious side effects
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What to do
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Skin rash
Sweating
Constipation
Nausea
Vomiting
Drowsiness
Blurred vision
Increased sensitivity to pain or increased levels of pain
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Speak to your doctor if you have any of these less serious side effects and they worryyou.
These side effects are usually mild.
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Serious side effects
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Serious side effects
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What to do
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Unusual or extreme mood swings
Headache
Dizziness, light-headedness
Flushing of the face
Shortness of breath
Irregular heartbeat
Mouth ulcers, fever and sore throat
Bleeding, bruising more easily
Severe blisters and bleeding in the lips, eyes, mouth, nose and genitals
Stomach pain
Slow or shallow breathing
Hepatitis (symptoms include loss of appetite, itching, yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine)
Painful red areas with blisters and peeling layers of skin which may be accompanied by fever and/or chills
Allergic reactions:
Swelling of the face, lips, tongue or other parts of the body
Rash, itching or hives on the skin
Wheezing, difficulty breathing, or shallow breathing
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Call your doctor straight away, or go straight to the Emergency Department at yournearest hospital if you notice any of these serious side effects.
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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 Mersyndol Forte contains
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Active ingredient
(main ingredient)
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Paracetamol – 450 mg
Codeine phosphate hemihydrate – 30 mg
Doxylamine succinate – 5 mg
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Other ingredients
(inactive ingredients)
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Sodium starch glycollate
Purified talc
Magnesium stearate
Crospovidone
Povidone
Pregelatinised maize starch
Stearic acid
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Potential allergens
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No
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Mersyndol Forte does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.
Do not take this medicine if you are allergic to any of these ingredients.
What Mersyndol Forte looks like
Mersyndol Forte is a round, white tablet embossed with M on one side and on the other side MERSYNDOL and FORTE either side of a break line. Mersyndol Forte is available in a blister pack of 20 tablets.
Australian Registration Number: AUST R 10109
Who distributes Mersyndol Forte
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Toll Free Number (medical information): 1800 818 806
Email: [email protected]
12-24 Talavera Road
Macquarie Park NSW 2113
Toll Free Number (medical information): 1800 818 806
Email: [email protected]
This leaflet was prepared in June 2020.
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