Consumer medicine information

Boxed Warnings

Limitations of use. Because of the risks associated with the use of opioids, Dolased should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain (see Section 4.4 Special Warnings and Precautions for Use).
Hazardous and harmful use. Dolased poses risks of hazardous and harmful use which can lead to overdose and death. Assess the patient's risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment (see Section 4.4 Special Warnings and Precautions for Use).
Life threatening respiratory depression. Serious, life-threatening or fatal respiratory depression may occur with the use of Dolased. Be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk and monitor patients closely, especially on initiation or following a dose increase (see Section 4.4 Special Warnings and Precautions for Use).
Concomitant use of benzodiazepines and other central nervous system (CNS) depressants, including alcohol. Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Limit dosages and durations to the minimum required; and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patients not to drink alcohol while taking Dolased.

1 Name of Medicine

Dolased paracetamol, codeine phosphate hemihydrate and doxylamine succinate tablets.

2 Qualitative and Quantitative Composition

Each Dolased tablet contains paracetamol 500 mg, codeine phosphate hemihydrate 10 mg, doxylamine succinate 5.1 mg.
List of excipients with known effects. Contains sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Dolased tablets are white biconvex capsule-shaped tablet.

4 Clinical Particulars

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. In general, treatment should be symptomatic: re-establish adequate respiratory exchange by ensuring a clear airway and using mechanical ventilation. When treatment for paracetamol toxicity has been initiated the opioid antagonist naloxone hydrochloride is an antidote to respiratory depression; naloxone 400 microgram may be administered SC, IM or IV. Reactions associated with doxylamine overdosage may vary from CNS depression to stimulation. Stimulation is particularly likely in children; insomnia, nervousness, euphoria, irritability, tremors, nightmares, hallucinations and convulsions can occur. Atropine-like signs and symptoms such as dry mouth, fixed, dilated pupils, flushing and gastrointestinal symptoms may also occur.
Further measures will depend on the severity, nature and course of clinical symptoms of intoxication and should follow standard intensive care protocols.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data is available.
Carcinogenicity. No data is available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPARCET.gif Paracetamol. Chemical Name: N-(4-hydroxyphenyl)acetamide.
Molecular formula C₈H₉NO₂;
Molecular Weight 151.20.
Characteristics: white odourless crystalline powder.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCOPHEM.gif Codeine phosphate hemihydrate. Chemical Name: (5R,6S)-7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate hemihydrate.
Molecular formula C₁₈H₂₁NO₃.H₃PO₄.½H₂O;
Molecular Weight 406.4.
Characteristics: white crystalline powder or small, colourless crystals.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDOXSUC.gif Doxylamine succinate. Chemical Name: NN-dimethyl-2-[α-methyl- α-(2-piridyl)benzyloxy]ethylamine hydrogen succinate.
Molecular formula C₁₇H₂₂N₂O.C₄H₆O₄;
Molecular Weight 388.5.
Characteristics: white to creamy white crystalline powder with a characteristic odour.
CAS number. Paracetamol: 103-90-2.
Codeine phosphate hemihydrate: 41444-62-6.
Doxylamine succinate: 562-10-7.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/DOLASEST.gif