SUMMARY CMI

Mersyndol^®

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 Mersyndol?

Mersyndol contains the active ingredients paracetamol, codeine phosphate hemihydrate and doxylamine succinate. Mersyndol is used for short term use to relieve moderate pain and fever. For more information, see Section 1. Why am I using Mersyndol? in the full CMI.

2. What should I know before I use Mersyndol?

Do not use if you have ever had an allergic reaction to Mersyndol 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.

For more information, see Section 2. What should I know before I use Mersyndol? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Mersyndol 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 Mersyndol?

• The standard dose of this medicine for adults and children 12 years or over is one or two tablets/caplets every 4-6 hours as needed for pain relief.

More instructions can be found in Section 4. How do I use Mersyndol? in the full CMI.

5. What should I know while using Mersyndol?

For more information, see Section 5. What should I know while using Mersyndol? in the full CMI.

6. Are there any side effects?

Common side effects include skin rash, constipation, nausea, vomiting, dizziness, drowsiness, sweating, 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

Mersyndol should only be used when doctor decides other treatment options are not able to effectively manage your pain or you cannot tolerate them.

Hazardous and harmful use

Mersyndol contains codeine which may be habit forming. Mersyndol poses risks of abuse, misuse and addiction which can lead to overdose and death. Your doctor will assess your risks and monitor you regularly during treatment.

Life threatening respiratory depression

Mersyndol can cause life-threatening or fatal breathing problems (slow, shallow, unusual or no breathing) even when recommended. These problems can occur at any time during use, but the risk is higher when first starting Mersyndol 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 Mersyndol

Using Mersyndol with other medicines can make you feel drowsy such as sleeping tablets (benzodiazepines (medicines used as sedatives or to treat anxiety), other pain relievers, antihistamines, antidepressants, antipsychotics, gabapentinoids (medicines used for epilepsy or neuropathic pain), antihistamines, cannabis or other central nervous system (CNS) depressants, including 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 Mersyndol.

FULL CMI

Mersyndol^®

Active ingredients: paracetamol, codeine phosphate hemihydrate and doxylamine succinate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Mersyndol. 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 Mersyndol.

Where to find information in this leaflet:

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

1. Why am I using Mersyndol?

Mersyndol is a type of analgesic used for the short-term use to relieve moderate pain and fever.

Mersyndol 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. Paracetamol and codeine work together to stop the pain messages from getting through to the brain. Doxylamine succinate is an antihistamine with calmative effects

2. What should I know before I use Mersyndol?

Warnings

Do not use Mersyndol 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 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
  - Difficulty breathing, wheezing, chronic cough, asthma, or other chronic breathing conditions
  - Intolerance to pain relieving medicine
  - You are a CYP 2D6 ultra-rapid metabolizer
  - 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
  - Head injury or trauma
  - A history of drug dependence, including alcohol dependence. Caution is particularly for use in adolescents and young adults with a history of drug and/or alcohol abuse.
  - Prone to angle closure glaucoma (high pressure in the eye)
  - 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 Mersyndol during the third trimester of pregnancy.

Do not take Mersyndol during labour, especially if the baby is premature.

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

Do not take Mersyndol if you are breastfeeding or planning to breastfeed.

Use in children

• Do not give Mersyndol 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 Mersyndol even if you take it exactly as prescribed. Mersyndol 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 Mersyndol. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking Mersyndol suddenly, so it is important to take it exactly as directed by your doctor.

Tolerance

Tolerance to Mersyndol 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.

Mersyndol 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 Mersyndol with Monoamine Oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs. Tell your doctor or pharmacist if you are taking any other medicines, which contain paracetamol, codeine or doxylamine.

• Antihistamines
• Medicines used to help relax, sleep or relieve anxiety, such as sedatives, hypnotics, gabapentinoids, cannabis and centrally active anti-emetics
• Tranquillisers (medicines used for anxiety or nerves)
• Benzodiazepines (medicines used as sedatives or to treat anxiety)
• Medicines containing alcohol (ethanol), e.g. some cough syrups
• Any medicine which thins the blood
• Other opioid analgesics used to treat pain
• Monoamine oxidase inhibitors, medicine used to treat depression, taken within the last 14 days
• Antihypertensives (medicines used to help lower blood pressure)
• Medicines to treat epilepsy
• Metoclopramide or domperidone, medicines used to control nausea and vomiting
• Propantheline, a medicine used to treat stomach ulcers
• Chloramphenicol (antibiotic used to treat ear and eye infections)
• Flucloxacillin, zidovudine or rifampicin, medicines used to treat infections
• Antidepressants
• Antipsychotics (medicines used to treat mental illnesses)
• Chelating resin
• Medicines used to treat alcohol and/or opioid dependence (e.g. naltrexone, buprenorphine or methadone)

Medicines that may decrease the effect of Mersyndol 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 Mersyndol.

4. How do I use Mersyndol?

How much to take

Adults and children 12 years or over

• The usual dose is one or two tablets every 4 to 6 hours as needed for pain relief.
• Do not take more than 8 tablets in a 24-hour period.
• Mersyndol is not recommended to be used in in children under 12 years.
• Follow the instructions provided and use Mersyndol until your doctor tells you to stop. Their directions may differ from the information contained in this leaflet.

When to take Mersyndol

• Swallow the prescribed dose of Mersyndol whole with a glass of water. It can be taken with or without food.

How to take Mersyndol

• Swallow the prescribed dose of Mersyndol whole with a glass of water. It can be taken with or without food.

If you forget to use Mersyndol

If you miss your dose at the usual time, do not try to make up for missed doses. 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 take too much Mersyndol

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 Mersyndol 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 Mersyndol, you may need urgent medical attention.

You should immediately:

• phone the Australian Poisons Information Centre (by calling 13 11 26) or New Zealand 0800 POISON or 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.

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.

Large amount of paracetamol can cause liver damage. If children take too many Mersyndol they can suffer from nightmares, hallucinations, fitting or have difficulty sleeping.

Depending on your body's individual ability to break down codeine, you may experience signs of overdose even when you take Mersyndol as recommended by your doctor. If overdose symptoms occur, seek immediate medical advice.

5. What should I know while using Mersyndol?

Things you should do

Remind any doctor including surgeons, dentist or pharmacist you visit that you are taking Mersyndol.

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.
• 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.
• Are about to be started on any new medicine.

Things you should not do

• Do not give Mersyndol to anyone else, even if they have the same condition as you.
• Do not take Mersyndol 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 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 Mersyndol affects you.

Mersyndol may cause drowsiness, dizziness or light-headedness 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 feel dizzy while taking Mersyndol.

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 you are taking Mersyndol.

Drinking alcohol increases the likelihood of becoming drowsy while taking Mersyndol. Drinking alcohol and taking paracetamol at the same time can cause liver damage.

Mersyndol may be habit forming if taken at high doses for extended periods of time.

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 30° 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
• 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.

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

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 as follows:

For Australia: Therapeutic Goods Administration online at: www.tga.gov.au/reporting-problems.

New Zealand: Medsafe online at: www.medsafe.govt.nz/safety/report-a-problem.asp

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 Mersyndol contains

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

What Mersyndol looks like

Mersyndol is available in tablets and caplets:

Tablet – yellow, round, scored tablet marked “MERSYNDOL” “008” with “M” inside two concentric circles on the non-scored side.

Caplet – yellow, capsule-shaped tablets with ‘Mersyndol’ on one side and a breakline on the other side.

Mersyndol tablets and caplets are available in a blister pack of 10, 20 or 40 tablets.

Not all pack sizes may be available.

Australian Registration Number: AUST R 10110 (Tablets)
Australian Registration Number: AUST R 56535 (Caplets)

Who distributes Mersyndol

Australia:

sanofi-aventis australia pty ltd
12-24 Talavera Road Macquarie Park NSW 2113
Toll Free Number (medical information): 1800 818 806
Email: [email protected]

New Zealand:

sanofi-aventis new zealand limited
56 Cawley Street
Ellerslie, Auckland
Freecall No: 0800 283 684

This leaflet was prepared in November 2021.

Mersyndol-ccdsv2-cmiv16-19nov21.

Published by MIMS February 2022

1 Name of Medicine

Paracetamol, codeine phosphate hemihydrate and doxylamine succinate.

2 Qualitative and Quantitative Composition

Mersyndol contains paracetamol 450 mg, codeine phosphate hemihydrate 9.75 mg, doxylamine succinate 5 mg.
Mersyndol is aspirin-free.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Mersyndol is available as tablets or caplets.
The tablets are yellow, marked with 'M' inside two concentric circles on one side and 'Mersyndol 008' and a breakline on the reverse.
The caplets are yellow, capsule-shaped tablets with 'Mersyndol' on one side and a breakline on the other.

4 Clinical Particulars

4.1 Therapeutic Indications

For the relief of acute moderate pain and fever.

4.2 Dose and Method of Administration

Adults and children 12 years of age and older.

4.3 Contraindications

Known hypersensitivity to paracetamol, codeine or doxylamine succinate or to any of the excipients listed under List of Excipients; patients with severe respiratory disease, acute respiratory disease and respiratory depression/insufficiency, for example acute asthma, acute exacerbations of chronic obstructive pulmonary disease since codeine may exacerbate the condition. Patients with severe hepatocellular insufficiency. Patients with glucose-6-phosphate-dehydrogenase deficiency.
Mersyndol is contraindicated for use in patients who are:
CYP2D6 ultra-rapid metabolisers (see Section 4.4 Special Warnings and Precautions for Use, CYP2D6 metabolism);
younger than 12 years (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use);
aged between 12 - 18 years in whom respiratory function might be compromised, including post-tonsillectomy and/or adenoidectomy for obstructive sleep apnoea, obesity and pulmonary disease due to an increased risk of developing serious and life-threatening adverse reactions (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use);
breastfeeding (see Section 4.6 Fertility, Pregnancy and Lactation, Use in lactation);
using monoamine inhibitors (MAOIs) or have stopped treatment within the last 14 days. (See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Codeine is contraindicated in the event of impending childbirth or in case of risk of premature birth.

4.4 Special Warnings and Precautions for Use

Hepatotoxicity may occur with paracetamol even at therapeutic doses, after short treatment duration and in patients without pre-existing liver dysfunction.

To avoid the risk of overdose.

Severe cutaneous adverse reactions (SCARs).

Paracetamol should be used upon medical advice in patients with.

CYP2D6 metabolism.

Hazardous and harmful use.

Respiratory depression.

Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol.

Use of opioids in chronic (long-term) non-cancer pain (CNCP).

Tolerance, dependence and withdrawal.

Accidental ingestion/exposure.

Hyperalgesia.

Ceasing opioids.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

Uric acid and blood glucose.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The concomitant use of opioids with benzodiazepines and/or other CNS depressants (e.g. other opioid analgesics, antitussives, antihypertensives, antihistamines, antipsychotics, antianxiety, gabapentinoids, cannabis, centrally-active anti-emetics, hypnotics, sedatives, tranquillisers), including alcohol, may result in additive CNS depression and increases the risk of sedation, respiratory depression, coma and death (see Section 4.4 Special Warnings and Precautions for Use, Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol).
The concomitant use of alcohol and opioids increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. Concomitant use with alcohol is not recommended (see Section 4.4 Special Warnings and Precautions for Use).
Concomitant administration of Monoamine Oxidase Inhibitors (MAOIs) can potentiate the central nervous effects and other side effects of unpredictable severity. Codeine should not be used within 14 days after the discontinuation of MAOI treatment.
A codeine-induced respiratory depression can be potentiated by tricyclic antidepressants.
Concomitant use of codeine with antiperistaltic antidiarrhoeal drugs can increase the risk of severe constipation and CNS depression.
Morphinic agonists-antagonists - Concomitant use of codeine with a partial agonist (e.g. buprenorphine) or antagonist (e.g. naltrexone) can precipitate or delay codeine effects.
The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes, such as barbiturates and other antiepileptics (such as phenobarbital, phenytoin, carbamazepine, topiramate), rifampicin and alcohol. The induced metabolism results in an elevated production of the hepatotoxic oxidative metabolite of paracetamol. Hepatotoxicity will occur if this metabolite exceeds the normal glutathione binding capacity.
Paracetamol may increase the risk of bleeding in patients taking warfarin and other antivitamin K. Patients taking paracetamol and antivitamin K should be monitored for appropriate coagulation and bleeding complications.
Paracetamol may considerably slow down the excretion of chloramphenicol, entailing the risk of increased toxicity. When used concurrently with zidovudine, an increased tendency for neutropenia may develop. Combination of Mersyndol and zidovudine should be avoided.
Concurrent intake of drugs, which delay gastric emptying, such as propantheline, may slow down the uptake of paracetamol, thereby retarding its onset of action. Conversely, drugs which accelerate gastric emptying, such as metoclopramide or domperidone, may accelerate the absorption rate of paracetamol and its onset of action.
Chelating resin can decrease the intestinal absorption of paracetamol and potentially decrease its efficacy if taken simultaneously. In general, there must be an interval of more than 2 hours between taking the resin and taking paracetamol, if possible.
Co-administration of flucloxacillin with paracetamol may lead to metabolic acidosis, particularly in patients presenting risk factors of glutathione depletion, such as sepsis, malnutrition or chronic alcoholism.

CYP2D6 inhibitors.

CYP3A4 inducers.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Mersyndol may cause drowsiness, disturbances of visuomotor coordination and visual acuity and/or dizziness. Due to the preparation's sedative action, psychomotor impairment impacting the mental and/or physical abilities required for the performance of potentially hazardous activities may occur. Patients treated with this medicine should not drive or operate machinery or drink alcohol whilst taking this medication.

4.8 Adverse Effects (Undesirable Effects)

Side-effects with Mersyndol are infrequent. However, among those reported are: anorexia, drowsiness, depression, dizziness, sweating, anaphylactic shock, angioneurotic oedema, angioedema, difficulty in breathing, drop in blood pressure, gastrointestinal discomfort such as nausea and diarrhoea, dry mouth and, on rare occasions, erythema, urticaria, rash.
Paracetamol may occasionally cause skin reactions and isolated cases of agranulocytosis and thrombocytopenic purpura have been reported. Changes in blood picture (rarely thrombocytopenia, neutropenia, leukopenia, and, in isolated cases, pancytopenia) may occur.
Bronchospasm may be triggered in patients having a tendency of analgesic asthma.
Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalised exanthematous pustulosis, fixed drug eruption and cytolytic hepatitis, which may lead to acute hepatic failure, have also been reported.
Doxylamine succinate may cause drowsiness in some individuals, as well as paradoxical stimulation, psychomotor impairment, blurred vision, thickened respiratory secretions, gastrointestinal disorders and urinary retention. Constipation and pancreatitis may occur in association with codeine.
Haemolytic anaemia, particularly in patients with underlying glucose 6-phosphate-dehydrogenase deficiency has been reported. Kounis syndrome and bronchospasm have also been reported, as has pyroglutamic acidosis in patients with pre-disposing factors for glutathione depletion.
Adverse effects reported relating specifically to the codeine component are: hypersensitivity, confusional state, dysphoria, euphoria, seizure, headache, somnolence, dizziness, hypotension, sedation, miosis, tinnitus, respiratory depression, constipation, vomiting, nausea, dry mouth, pruritus, urinary retention, and fatigue. Long term use also entails the risk of drug dependence. Visuomotor coordination and visual acuity may be adversely affected in a dose-dependent manner at higher doses or in particularly sensitive patients.

Reporting suspected adverse effects.

4.9 Overdose

Elderly persons, small children, patients with liver disorders, chronic alcohol consumption or chronic malnutrition, as well as patients concomitantly treated with enzyme-inducing drugs are at an increased risk of intoxication, including fatal outcome.
It has been reported that paracetamol may produce symptoms of acute toxicity in adults, following the ingestion of more than 15 g. Hepatotoxicity may develop after the ingestion of a single dose of 10 to 15 g (200 to 250 mg/kg) and a dose of more than 25 g is potentially fatal. Nausea, vomiting, anorexia, pallor and abdominal pain generally appear during the first 24 hours of overdosage with paracetamol. Overdosage with paracetamol may cause hepatic cytolysis which can lead to hepatocellular insufficiency, gastrointestinal bleeding, metabolic acidosis, encephalopathy, disseminated intravascular coagulation, coma and death. Increased levels of hepatic transaminases, lactate dehydrogenase and bilirubin with a reduction in prothrombin level can appear 12 to 48 hours after acute overdosage. It can also lead to pancreatitis, acute renal failure and pancytopenia. Patients may be asymptomatic for several days following ingestion of large doses of paracetamol and laboratory evidence of hepatotoxicity may be delayed for up to one week. Non-fatal hepatic damage is usually reversible. The antidote, N-acetylcysteine, should be administered as early as possible.
Despite lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention.
Determinations of the plasma concentration of paracetamol are recommended.
Plasma concentration of paracetamol should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable).
Where paracetamol intoxication is suspected, intravenous administration of SH group donators such as acetylcysteine within the first 10 hours after ingestion is indicated. Although acetylcysteine is most effective if initiated within this period, it can still offer some degree of protection if given as late as 48 hours after ingestion; in this case it is taken for longer.
In an evaluation of codeine intoxication in children, symptoms ranked by decreasing order of frequency included sedation, rash, miosis, vomiting, itching, ataxia and swelling of the skin. Respiratory failure may occur. Blood concentrations of codeine ranged from 1.4 to 5.6 microgram/mL in eight adults whose deaths were attributed primarily to codeine overdosage.
The ingestion of very high doses of codeine can cause initial excitation, anxiety, insomnia followed by drowsiness in certain cases, areflexia progressing to stupor or coma, headache, miosis, alterations in blood pressure, arrhythmias, dry mouth, hypersensitivity reactions, cold clammy skin, bradycardia, tachycardia, convulsions, gastrointestinal disorders, nausea, vomiting and respiratory depression.
Severe intoxication can lead to apnoea, circulatory collapse, cardiac arrest and death.

Relating to codeine component.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Mersyndol also contains sodium starch glycollate, purified talc, magnesium stearate, microcrystalline cellulose, quinoline yellow (CI 47005) and sunset yellow FCF (CI 15985).

6.2 Incompatibilities

No data available.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Mersyndol is available in packs of 10, 20 and 40 tablets.
Mersyndol Caplets is available in packs of 10, 20 and 40 caplets.
Not all pack sizes are marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Paracetamol is an odourless, crystalline powder or crystals with a bitter taste. Codeine phosphate hemihydrate is an odourless, crystalline powder or small colourless crystals with a bitter taste. Doxylamine succinate is a powder with a characteristic odour.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes