1 Name of Medicine
Paracetamol.
Pseudoephedrine hydrochloride.
2 Qualitative and Quantitative Composition
Paracetamol is a white or almost white crystalline powder. It is sparingly soluble in water, freely soluble in alcohol and very slightly soluble in methylene chloride.
Pseudoephedrine hydrochloride is a white or almost white crystalline powder or colourless crystals. It is freely soluble in water and in ethanol (96 per cent), sparingly soluble in methylene chloride. Its melting point is at about 184°C.
Each tablet contains the active ingredients:
Paracetamol 500 mg;
Pseudoephedrine hydrochloride 30 mg.
Excipients.
For full list of excipients see Section 6.1 List of Excipients.3 Pharmaceutical Form
The tablets are white, round tablets with a break-line on one side.
4.1 Therapeutic Indications
Chemists' Own Cold and Flu Relief is indicated for temporary relief from the following cold and flu symptoms: nasal congestion, sinus pain, runny nose, headache, body aches and pains. Reduces fever.
4.2 Dose and Method of Administration
Adults and children 12 years and over.
Take 2 tablets every 4 to 6 hours if necessary.
No more than 4 doses should be taken in a 24-hour period.
This medicine should not be taken with other medicines containing paracetamol unless advised to do so by a doctor or pharmacist.
Use in adults.
This medicine should not be taken for more than a few days at a time except on medical advice.
Use in children.
Do not give to children under 12 years of age.
This medicine should not be taken for more than 48 hours except on medical advice.4.3 Contraindications
Chemists' Own Cold and Flu Relief is contraindicated for use in patients with the following conditions:
Known hypersensitivity or idiosyncratic reaction to paracetamol, pseudoephedrine, chlorphenamine (or substances of a similar chemical structure) or any of the other ingredients in this medicine.
Severe hypertension or coronary artery disease.
Taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs within the previous 14 days.
Also see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.
4.4 Special Warnings and Precautions for Use
Chemists' Own Cold and Flu Relief should be used with caution in patients with the following conditions: impaired hepatic function, impaired renal function, hypertension, hyperthyroidism, diabetes mellitus, coronary heart disease, ischaemic heart disease, glaucoma, prostatic hypertrophy.
This medicine contains pseudoephedrine which may cause sleeplessness if taken up to several hours before going to bed.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.
Paediatric use.
Do not give to children under 12 years of age.
Use in the elderly.
No data available.
Effects on laboratory tests.
No data available.4.5 Interactions with Other Medicines and Other Forms of Interactions
The following interactions with paracetamol have been noted:
Anticoagulant drugs (warfarin) - dosage may require reduction if paracetamol and anticoagulants are taken for a prolonged period of time.
Paracetamol absorption is increased by substances that increase gastric emptying, e.g. metoclopramide.
Paracetamol absorption is decreased by substances that decrease gastric emptying, e.g. propantheline, antidepressants with anticholinergic properties, and narcotic analgesics.
Paracetamol may increase chloramphenicol concentrations.
The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes such as alcohol and anticonvulsant agents.
Paracetamol excretion may be affected and plasma concentrations altered when given with probenecid.
Colestyramine reduces the absorption of paracetamol if given within 1 hour of paracetamol.
The following interactions with pseudoephedrine have been noted:
Antidepressant medication e.g. tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs) - may cause a serious increase in blood pressure or hypertensive crisis.
Other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants - may cause an increase in blood pressure and additive effects.
Methyldopa and β-blockers - may cause an increase in blood pressure.
Urinary acidifiers enhance elimination of pseudoephedrine.
Urinary alkalinisers decrease elimination of pseudoephedrine.
4.6 Fertility, Pregnancy and Lactation
Effect on fertility.
No data available.
(Category B2)
Pseudoephedrine has been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals are inadequate or may be lacking, but available data shows no evidence of an increased occurrence of foetal damage.
Chemists' Own Cold and Flu Relief should not be used in pregnancy unless the potential benefits to the patient are weighed against the possible risk to the foetus.
Paracetamol is excreted in small amounts (< 0.2%) in breast milk. Maternal ingestion of paracetamol in usual analgesic doses does not appear to present a risk to the breastfed infants.
Pseudoephedrine is excreted in breast milk in small amounts. It has been estimated that 0.5% to 0.7% of a single dose of pseudoephedrine ingested by the mother will be excreted in the breast milk over 24 hours.
Therefore, Chemists' Own Cold and Flu Relief is not recommended for breastfeeding mothers (also see Section 4.3 Contraindications).4.7 Effects on Ability to Drive and Use Machines
The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.
4.8 Adverse Effects (Undesirable Effects)
Side effects of paracetamol are rare and usually mild, although haematological reactions have been reported. Skin rashes and hypersensitivity reactions occur occasionally.
Overdosage with paracetamol if left untreated can result in severe, sometimes fatal liver damage and rarely, acute renal tubular necrosis.
Adverse effects of pseudoephedrine include:
cardiovascular stimulation - elevated blood pressure, tachycardia or arrhythmias;
central nervous system (CNS) stimulation - restlessness, insomnia, anxiety, tremors and (rarely) hallucinations;
skin rashes and urinary retention.
Children and the elderly are more likely to experience adverse effects than other age groups.
Reporting suspected adverse effects.
Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.4.9 Overdose
If an overdose is taken or suspected, immediately contact the Poisons Information Centre (in Australia, call 131 126; in New Zealand call 0800 764 766) for advice, or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage.
5 Pharmacological Properties
5.1 Pharmacodynamic Properties
Mechanism of action.
Paracetamol is a p-aminophenol derivative that exhibits analgesic and antipyretic activity. It does not possess anti-inflammatory activity. Paracetamol is thought to produce analgesia through a central inhibition of prostaglandin synthesis.
Pseudoephedrine has direct- and indirect- sympathomimetic activity and is an effective decongestant in the upper respiratory tract. It is a stereoisomer of ephedrine and has a similar action, but has been found to have less pressor activity and fewer central nervous system (CNS) effects. Sympathomimetic agents are used as nasal decongestants to provide symptomatic relief. They act by causing vasoconstriction resulting in redistribution of local blood flow to reduce oedema of the nasal mucosa, thus improving ventilation, drainage and nasal stuffiness.
Clinical trials.
Not available.
5.2 Pharmacokinetic Properties
Absorption.
Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral administration.
Pseudoephedrine is readily absorbed from the gastrointestinal tract.
Distribution.
Paracetamol is distributed into most body tissues. Plasma protein binding is negligible at usual therapeutic doses but increases with increasing doses.
Small amounts of pseudoephedrine are distributed into breast milk.
Metabolism.
Paracetamol is metabolised extensively in the liver. The metabolites of paracetamol include a minor hydroxylated intermediate which has hepatotoxic activity. This intermediate metabolite is detoxified by conjugation with glutathione, however, it can accumulate following paracetamol overdosage (more than 150 mg/kg or 10 g total paracetamol ingested) and if left untreated can cause irreversible liver damage.
Paracetamol is metabolised differently by premature infants, newborns, infants and young children compared to adults, the sulfate conjugate being predominant.
Pseudoephedrine is incompletely metabolised (less than 1%) in the liver to an inactive metabolite by N-demethylation.
Excretion.
Paracetamol is excreted in the urine mainly as inactive glucuronide and sulfate conjugates. Less than 5% is excreted unchanged. The elimination half-life varies from about 1 to 3 hours.
Pseudoephedrine is largely excreted unchanged in the urine, together with small amounts of its hepatic metabolite. It has a half-life of about 5-8 hours; elimination is enhanced and half-life reduced accordingly in acid urine.
5.3 Preclinical Safety Data
Genotoxicity.
No data available.
Carcinogenicity.
No data available.6 Pharmaceutical Particulars
6.1 List of Excipients
Crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinised maize starch, stearic acid, purified water.
6.2 Incompatibilities
Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
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
Storage.
Chemists' Own Cold and Flu Relief tablets should be stored below 30°C.
6.5 Nature and Contents of Container
Container type.
The tablets are presented in PVC/PVDC/Aluminium blister packs which are enclosed in a carton.
Pack sizes.
The pack sizes are:
24 tablets (2 x 12 tablet blister packs in a carton);
12 tablets (1 x 12 tablet blister packs in a carton).
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.
Molecular formula: C8H9NO2.
Molecular weight: 151.2.
CAS No.
103-90-2.
Pseudoephedrine hydrochloride.
Molecular formula: C10H16ClNO.
Molecular weight: 201.7.
CAS No.
345-78-8.7 Medicine Schedule (Poisons Standard)
S3 - Pharmacist Only Medicine.
Summary Table of Changes
