Consumer medicine information

Chemists' Own Cough, Cold & Flu Day/Night Tablets

Paracetamol; Pseudoephedrine hydrochloride; Dextromethorphan hydrobromide monohydrate; Chlorphenamine maleate (chlorpheniramine maleate)

BRAND INFORMATION

Brand name

Chemists' Own Cough, Cold & Flu Day/Night

Active ingredient

Paracetamol; Pseudoephedrine hydrochloride; Dextromethorphan hydrobromide monohydrate; Chlorphenamine maleate (chlorpheniramine maleate)

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Chemists' Own Cough, Cold & Flu Day/Night Tablets.

What is in this leaflet

This leaflet answers some common questions about Chemists’ Own Cough, Cold & Flu Day /Night Tablets.

It does not contain all of the available information about Chemists’ Own Cough, Cold & Flu Day/Night Tablets.

It does not replace talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking Chemists’ Own Cough, Cold & Flu Day/Night Tablets against the benefits he or she expects it will have.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What are Chemists’ Own Cough, Cold & Flu Day/Night Tablets

The name of your medicine is Chemists’ Own Cough, Cold & Flu Day/Night Tablets.

The active ingredients in the day tablet are pseudoephedrine hydrochloride, paracetamol and dextromethorphan hydrobromide monohydrate.

The active ingredients in the night tablet are pseudoephedrine hydrochloride, paracetamol and chlorphenamine maleate.

Chemists’ Own Cough, Cold & Flu Day/Night Tablets belong to a group of medicines for the treatment of symptoms of colds and flu.

Pseudoephedrine hydrochloride relieves blocked nose and sinuses. Paracetamol relieves pain and reduces fever. Dextromethorphan hydrobromide monohydrate suppresses coughing. Chlorphenamine maleate relieves symptoms of allergies including blocked nose and sinuses.

What Chemists’ Own Cough, Cold & Flu Day/Night Tablets are used for

Chemists’ Own Cough, Cold & Flu Day/Night tablets belong to a group of medicines for the treatment of symptoms of colds and flu.

Your doctor or pharmacist, however, may have recommended Chemists’ Own Cough, Cold & Flu Day/Night Tablets for another purpose not listed above.

Ask your doctor or pharmacist if you have any questions about why Chemists’ Own Cough, Cold & Flu Day/Night Tablets have been recommended you.

If you have any concerns, you should discuss this with your doctor or pharmacist.

This medicine is available without a doctor’s prescription from your pharmacist.

Before you take it

When you must not take it

Do not take Chemists’ Own Cough, Cold & Flu Day/Night Tablets if you are allergic to:

  • Pseudoephedrine hydrochloride, paracetamol, dextromethorphan hydrobromide monohydrate or chlorphenamine maleate or any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction to Chemists’ Own Cough, Cold & Flu Day/Night Tablets may include nervousness, restlessness, dizziness, weakness, inability to sleep, nausea, vomiting, rash.

Do not take Chemists’ Own Cough, Cold & Flu Day/Night Tablets if you are pregnant or plan to become pregnant.

Do not take Chemists’ Own Cough, Cold & Flu Day/Night Tablets if you are breastfeeding or plan to breastfeed.

Do not use Chemists’ Own Cough, Cold & Flu Day/Night Tablets after the expiry date (EXP.) printed on the pack. If you take it after the expiry date has passed, it may have no effect at all, or worse, there may be an entirely unexpected effect.

Do not purchase or use Chemists’ Own Cough, Cold & Flu Day/Night Tablets if the packaging is torn or shows signs of tampering.

Do not give them to children unless your doctor has advised it.

Before you start to take it.

You must tell your doctor or pharmacist if:

  1. you are allergic to any other medicines or any foods, dyes or preservatives.
  2. you have any other medical/ health problems, including:
  • suffer from a kidney or liver disease
  • have diabetes
  • anaemia
  • asthma
  • emphysema
  • bronchitis
  • glaucoma
  • overactive thyroid
  • high blood pressure
  • heart disease
  1. you are pregnant or plan to become pregnant.
Chemists’ Own Cough, Cold & Flu Day/Night Tablets, like all medicines should not be used during pregnancy, unless your doctor tells you.
  1. you are breastfeeding or planning to breastfeed.
  2. you are taking any other medications.

If you have not told your doctor or pharmacist about any of the above, tell him/her before you take Chemists’ Own Cough, Cold & Flu Day/Night Tablets.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may interfere with Chemists’ Own Cough, Cold & Flu Day/Night Tablets. These include:

  • Stimulants such as adrenaline, dopamine and ephedrine (sympathomimetic drugs)
  • Some drugs used to treat depression (Monoamine oxidase inhibitors such as Aurorex®)
  • β-blockers
  • Drugs used to treat high blood pressure
  • CNS depressants

The above medicines may either reduce the effectiveness of Chemists’ Own Cough, Cold & Flu Day/Night Tablets, reduce its own effectiveness and/or react with each other resulting in untoward or sometimes dangerous side effects.

This list is not exhaustive. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Chemists’ Own Cough, Cold & Flu Day/Night Tablets.

How to take it

The dose for adults and children over 12 years of age is one or two daytime tablets in the morning, midday and afternoon. One or two night tablets should be taken at bedtime.

Duration of use: Chemists’ Own Cough, Cold & Flu Day/Night Tablets should not be taken for more than 48 hours except on medical advice.

Swallow the tablets with a glass of water.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.

Do not take the day tablets before going to bed as you may be unable to sleep.

Do not take the night tablet during the day, as you may feel drowsy.

Do not take a double dose to make up for the dose that you missed.

If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.

Do not try to make up for missed doses by taking more than one dose at a time. This may increase the chance of you getting an unwanted side effect.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (Overdose)

Immediately telephone your doctor or Poisons Information Centre for advice, or go to casualty at your nearest hospital, if you think that you or anyone else may have taken too many Chemists’ Own Cough, Cold & Flu Day/Night Tablets. Do this even if there are no signs of discomfort or poisoning. Also report any other medicine or alcohol which has been taken. You may need urgent medical attention.

Keep telephone numbers for these places handy.

If you take too many Chemists’ Own Cough, Cold & Flu Day/Night Tablets you may have symptoms of nausea, vomiting and diarrhoea.

While you are using it

Things you must do

Immediately stop taking Chemists’ Own Cough, Cold & Flu Day/Night Tablets if a skin rash or other allergic reaction occurs.

Use Chemists’ Own Cough, Cold & Flu Day/Night Tablets exactly as your doctor or pharmacist has advised.

Tell all doctors, dentists and pharmacists who are treating you that you are taking Chemists’ Own Cough, Cold & Flu Day/Night Tablets.

Tell your doctor (immediately) if you become pregnant while you are taking Chemists’ Own Cough, Cold & Flu Day/Night Tablets.

If your symptoms persist, visit your doctor.

Always discuss with your doctor any problems of difficulties during or after taking Chemists’ Own Cough, Cold & Flu Day/ Night Tablets.

Things you must not do

Do not take any other medicines while you are taking Chemists’ Own Cough, Cold & Flu Day/Night Tablets without first telling your doctor or pharmacist.

Do not drive or operate machinery until you know how Chemists’ Own Cough, Cold & Flu Day/Night Tablets affect you.

Chemists’ Own Cough, Cold & Flu Day/Night Tablets may cause drowsiness or dizziness and affect co-ordination in some people and therefore may affect alertness or concentration.

Do not take Chemists’ Own Cough, Cold & Flu Day/Night Tablets for a longer time than your doctor or pharmacist has advised.

Do not use this medicine to treat any other complaints unless your doctor or pharmacist says to.

Do not give this medicine to anyone else, even if his/her symptoms seem similar to yours.

Do not drink alcohol, as it may increase the risk hepatoxicity.

Things to be careful of

Some people may experience side effects.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Chemists’ Own Cough, Cold & Flu Day/Night Tablets.

Chemists’ Own Cough, Cold & Flu Day/Night Tablets helps most people with medical conditions listed in the beginning of this leaflet, but it may have unwanted side effects in some people.

All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist any questions you may have.

Common side effects:

Tell your doctor if you notice any of the following and they worry you:

  • nausea (feeling sick).
  • Vomiting
  • constipation
  • nervousness or anxiety
  • restlessness or the inability to sleep
  • dizziness
  • skin rash
  • drowsiness
  • sweating
  • heart flutters.

There are other side effects which occur less often.

If you develop shortness of breath, severe palpitations, confusion or vision problems tell your doctor immediately.

Some people may get other side effects of Chemists’ Own Cough, Cold & Flu Day/Night Tablets.

Check with your doctor or pharmacist as soon as possible if you have any problems while taking Chemists’ Own Cough, Cold & Flu Day/Night even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

After using it

Storage

Keep it where children cannot reach it. A locked cupboard at least one and a half meters above the floor is a good place to store medicines.

Keep Chemists’ Own Cough, Cold & Flu Day/Night Tablets in a cool dry place where the temperature stays below 25°C and protect from light.

Do not store it or any other medicines in a bathroom or near a sink.

Do not leave it in the car or on windowsills.

Heat and dampness can destroy some medicines. Do not take Chemists’ Own Cough, Cold & Flu Day/Night Tablets if they do not look quite right.

Keep your tablets in the foil tray they were provided in until it is time to take them.

Disposal

If your doctor or pharmacist tells you to stop taking the tablets OR they have passed their expiry date, ask your pharmacist what to do with any left over.

Product description

What it looks like

Chemists’ Own Cough, Cold & Flu Day Tablets are pale yellow film coated tablets with a break bar on one side.

Chemists’ Own Cough, Cold & Flu Night Tablets are pale blue film coated tablets with a break bar on one side.

Packs contain 24 tablets (24’s: 18 day tablets, 6 night tablets).

Ingredients

1. Day tablet

Active ingredients:

Each Chemists’ Own Cough, Cold & Flu Day Tablet contains pseudoephedrine hydrochloride 30 mg, paracetamol 500 mg, dextromethorphan hydrobromide monohydrate 15 mg.

Inactive ingredients:

  • microcrystalline cellulose
  • pregelatinised maize starch
  • croscarmellose sodium
  • povidone (K25)
  • hydrogenated vegetable oil
  • magnesium stearate
  • Carnauba Wax
  • sodium starch glycollate
  • Opadry Yellow OY-22920 (PI 2472).

2. Night tablet

Active ingredients:

Each Chemists’ Own Cough, Cold & Flu Night Tablet contains pseudoephedrine hydrochloride 30 mg, paracetamol 500 mg, chlorphenamine maleate 2 mg.

Inactive ingredients:

  • microcrystalline cellulose
  • pregelatinised maize starch
  • croscarmellose sodium
  • povidone (K25)
  • hydrogenated vegetable oil
  • magnesium stearate
  • Carnauba Wax
  • Opadry OY-20923 blue (PI 2452).

Sponsor

Distributed by:

Arrotex Pharmaceuticals Pty Ltd
15 – 17 Chapel Street
Cremorne VIC 3121
www.arrotex.com.au

Australian Registration Number:
AUST R 293383

This leaflet was prepared April 2022.

Published by MIMS June 2022

BRAND INFORMATION

Brand name

Chemists' Own Cough, Cold & Flu Day/Night

Active ingredient

Paracetamol; Pseudoephedrine hydrochloride; Dextromethorphan hydrobromide monohydrate; Chlorphenamine maleate (chlorpheniramine maleate)

Schedule

S3

 

Notes

Distributed by Arrotex Pharmaceuticals Pty Ltd

1 Name of Medicine

Day tablets.

Pseudoephedrine hydrochloride + paracetamol + dextromethorphan hydrobromide monohydrate.

Night tablets.

Chlorphenamine maleate + pseudoephedrine hydrochloride + paracetamol.

2 Qualitative and Quantitative Composition

Each day tablet contains the active ingredients: Paracetamol 500 mg, Pseudoephedrine hydrochloride 30 mg and Dextromethorphan hydrobromide monohydrate 15 mg.
Each night-time tablet contains the active ingredients: Paracetamol 500 mg, Pseudoephedrine hydrochloride 30 mg and Chlorphenamine maleate 2 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Day tablet.

Pale yellow film coated round plain tablet with a break bar on one side.

Night tablet.

Pale blue film coated round plain tablet with a break bar on one side.

4 Clinical Particulars

4.1 Therapeutic Indications

Provides fast and effective relief from the symptoms of cold and flu.
The non-drowsy "Day" tablet temporarily relieves blocked noses, runny noses, nagging cough, headaches, body aches, pains, and fever.
The "Night" tablet contains an antihistamine and temporarily relieves blocked noses, headaches, body aches, pains, and fever.

4.2 Dose and Method of Administration

Adults and children 12 years and over.

Daytime.

One to two pale yellow 'Day' tablets in the morning, at midday and again in the afternoon.

Night-time.

Take one to two pale blue 'Night' tablets at bedtime.
Maximum of 8 tablets in 24 hours.

Duration of use.

Chemists' Own Cough, Cold & Flu Day/Night tablets should not be taken for more than 48 hours except on medical advice.

4.3 Contraindications

Chemists' Own Cough, Cold & Flu Day/Night tablets are contraindicated in patients:
With known sensitivity to paracetamol, pseudoephedrine, dextromethorphan, chlorphenamine or any of the other ingredients in the product.
With hypersensitivity to the effects of other sympathomimetic drugs.
With severe hypertension and/or severe coronary artery disease.
With anaemia.
With cardiac, renal or hepatic disease.
With respiratory or pulmonary disease including asthma, obstructive pulmonary disease or breathing problems.
With closed angle glaucoma, hyperthyroidism or prostatic hypertrophy.
Taking or within 14 days of ceasing administration of monoamine oxidase inhibitors (MAOIs).
Taking anticoagulants.
With alcohol dependence.

4.4 Special Warnings and Precautions for Use

Pseudoephedrine hydrochloride.

Pseudoephedrine should be used with caution in patients with hypertension, hyperthyroidism, diabetes mellitus, coronary heart disease, ischaemic heart disease, glaucoma, prostatic hypertrophy, severe hepatic or renal dysfunction.

Ischaemic colitis.

Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.

Paracetamol.

Paracetamol should be used with caution in patients with impaired hepatic function, impaired renal function.

Dextromethorphan hydrobromide monohydrate.

Dextromethorphan should not be used for chronic persistent cough accompanying a disease state, or for cough associated with excessive secretions.
Dextromethorphan should not be given to patients with or at risk of developing respiratory failure, e.g. asthma, chronic obstructive airways disease and pneumonia. Caution is needed in patients with a history of asthma and it should not be given during an acute attack.

Chlorphenamine maleate.

Chlorphenamine maleate may cause drowsiness and may increase the effects of alcohol. Drowsiness may continue the following day. Those affected should not drive or operate machinery; alcohol should be avoided.

Epilepsy.

Use with caution in patients with epilepsy (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Use in hepatic impairment.

Use with caution in patients with hepatic impairment.

Use in renal impairment.

Use with caution in patients with renal impairment.

Use in the elderly.

Chemists' Own Cough, Cold & Flu Day/Night tablets should be used with caution in elderly patients, who are more likely to have age-related renal impairment and are more likely to experience adverse effects from therapeutic doses of pseudoephedrine hydrochloride. More severe effects are likely to be experienced in elderly patients after overdosage than in younger patients.

Paediatric use.

Chemists' Own Cough, Cold & Flu Day/Night tablets is not recommended for children under 12 years.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Sympathomimetic agents.

Concurrent use with other sympathomimetics should be avoided because of the possibility of additive effects and increased toxicity.

Monoamine oxidase inhibitors.

Concurrent use of pseudoephedrine, chlorphenamine maleate, or dextromethorphan hydrobromide monohydrate and monoamine oxidase inhibitors increases the quantities of noradrenaline available in nervous tissue and can lead to hypertensive crisis. Anticholinergic effects of chlorphenamine maleate are accentuated. Avoid MAOIs with this drug.

Anticoagulants.

Chronic ingestion of large doses of paracetamol has been reported to potentiate the effects of coumarin- and indandione derivative anticoagulants. Some studies have found an increased risk of bleeding in patients taking regular doses of paracetamol while on an oral anticoagulant.

Other drugs.

β-blockers may increase the pressor effects of pseudoephedrine. Pseudoephedrine may reduce the antihypertensive effects of reserpine, methyldopa, mecamylamine hydrochloride and veratrum alkaloids.

Phenothiazines.

Possibility of severe hypothermia in patients receiving concomitant phenothiazine and antipyretic (e.g. paracetamol) therapy.

Alcohol.

Chronic alcoholics should be cautioned to avoid regular or excessive use of paracetamol as alcohol may increase the risk of paracetamol-induced hepatotoxicity.
Chlorphenamine maleate may also enhance the sedative effects of alcohol.

Anticonvulsants.

Phenytoin, barbiturates, carbamazepine all induce hepatic microsomal enzymes so may increase paracetamol induced liver toxicity because of the increased conversion of the drug to hepatotoxic metabolites. No dosage reduction is indicated but patients should be warned to limit their intake of paracetamol.

Isoniazid.

Isoniazid also increases the risks of paracetamol induced hepatotoxicity.

CNS depressants.

Chlorphenamine maleate may enhance the sedating effects of CNS depressants including alcohol, opioid analgesic, anxiolytic sedatives, and antipsychotics.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Chlorphenamine maleate.

Impaired fertility has been reported in female rats receiving chlorphenamine maleate dosages approximately 67 times the usual human dosage. However, more recent studies in rabbits and rats using more appropriate methodology and dosages up to 50 and 85 times the usual human dosage, respectively, have no revealed evidence of impaired fertility.

Paracetamol, pseudoephedrine hydrochloride and dextromethorphan hydrobromide monohydrate.

No data available.

Paracetamol, chlorphenamine maleate, and dextromethorphan hydrobromide monohydrate are categorised as "A".

The Australian definition of Category A is: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.

Pseudoephedrine hydrochloride is categorised as "B2".

The Australian definition of category B2 is: This category indicates drugs which have 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 show no evidence of an increased occurrence of foetal damage.
Chemists' Own Cough, Cold & Flu Day/Night tablets should only be used in pregnant women under medical supervision.
 Pseudoephedrine passes into breast milk. Approximately 0.5% of the maternal dose will appear in the breast milk within 24 hours. Paracetamol also passed into breast milk. There is no published information on the excretion of dextromethorphan or chlorphenamine into breast milk, but other antihistamines have been detected in breast milk. Therefore, the use of Chemists' Own Cough, Cold & Flu Day/Night tablets during breastfeeding is not recommended.

4.7 Effects on Ability to Drive and Use Machines

This medicine may affect mental alertness and drowsiness. Patients should determine if they are affected before attempting to drive or operate machinery.

4.8 Adverse Effects (Undesirable Effects)

The following adverse reactions may occur after administration of Chemists' Own Cough, Cold & Flu Day/Night tablets:

CNS.

Nervousness, excitability, restlessness, insomnia, weakness, headache, drowsiness, dizziness, confusion, incoordination. Lightheadedness, fear, anxiety, tenseness, tremor, hallucination, confusion and/or seizures have generally only been reported after large doses.

Cardiovascular.

Tachycardia, palpitation, and hypotension. Increased irritability of heart muscle and/or altered rhythmic function of ventricles may occur after large doses or in patients hypersensitive to the myocardial effects of sympathomimetic drugs.

Blood.

Neutropenia, thrombocytopenia purpura. Other blood disorders, including pancytopenia and leukopenia may occur rarely or after large doses.

GIT.

Nausea, vomiting and/or other gastrointestinal disturbances, increased gastric reflux. Ischaemic colitis (frequency unknown).

Renal.

Urinary difficulty or urinary retention.

Dermatological.

Fixed dermatological eruptions (erythematous nummular patches), pruritic maculopapular rash, and urticaria.

Other.

Dry mouth, blurred vision, sweating, myalgia, tinnitus, hair loss.
Hypersensitivity reactions including laryngeal oedema, angioedema, bronchospasm and anaphylaxis may occur.

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

The following symptoms may occur after overdosage of Chemists' Own Cough, Cold & Flu Day/Night tablets: nausea, vomiting, lethargy, sweating, liver damage, acidosis, cerebral oedema, haemorrhage hypotension, hypoglycaemia, blurred vision, nystagmus, ataxia, irritability, psychoses, tremor, tachycardia, palpitation, difficulty with micturition, vertigo, hallucination, convulsions, progressing to respiratory failure and cardiovascular collapse.
Elderly patients may be more susceptible to the effects of overdosage.

Treatment of overdosage.

Medical advice should be sought as soon as an overdose of Chemists' Own Cough, Cold & Flu Day/Night tablets is suspected.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Paracetamol.

Paracetamol is a synthetic non-opiate derivative of p-aminophenol, which produces analgesia and antipyresis, by a mechanism similar to that of salicylates.
The mechanism of analgesic action appears to be due to the inhibition of prostaglandin synthesis both centrally and peripherally.
Paracetamol is used for the relief of mild to moderate pain and minor febrile conditions. It has no uricosuric activity but has weak anti-inflammatory activity in some non-rheumatoid conditions (e.g. in-patients who have had oral surgery). In equal doses paracetamol produces the same levels of analgesia and antipyresis as aspirin.
Paracetamol lowers body temperature in-patients with fever but rarely lowers normal body temperature. The drug acts on the hypothalamus to produce antipyresis; heat dissipation is increased as a result of vasodilatation and increased peripheral blood flow.

Pseudoephedrine hydrochloride.

Pseudoephedrine acts directly on both α- and, to a lesser degree, β- adrenergic receptors. It is believed that α-adrenergic effects result from the inhibition of the production of cyclic adenosine-3',5'-monophosphate (AMP) by inhibition of the enzyme adenyl cyclase, whereas β-adrenergic effects result from stimulation of adenyl cyclase activity. Like ephedrine, pseudoephedrine also has an indirect effect by releasing noradrenaline from its storage sites.
Pseudoephedrine acts directly on α-adrenergic receptors in the mucosa of the respiratory tract producing vasoconstriction which results in shrinkage of swollen nasal mucous membranes, reduction of tissue hyperaemia, oedema and nasal congestion, and an increase in nasal airway patency. Drainage of sinus secretions is increased and obstructed eustachian ostia may be opened. Pseudoephedrine may relax bronchial smooth muscle by stimulation of β-adrenergic receptors; however, substantial bronchodilation has not been demonstrated consistently following oral administration of the drug.

Dextromethorphan hydrobromide monohydrate.

Dextromethorphan causes depression of the cough reflex by a direct effect on the cough centre in the medulla of the brain. It retains only the antitussive activity of the other morphinan derivatives. The drug is equivalent to codeine in depressing the cough reflex and has no expectorant action. At therapeutic doses, dextromethorphan does not inhibit ciliary activity.

Chlorphenamine maleate.

Chlorphenamine maleate, an alkylamine derivative, is a sedating antihistamine that causes a moderate degree of sedation; it also has antimuscarinic activity. It is used for the symptomatic relief of allergic conditions including urticaria and angioedema, and in pruritic skin disorders.
It is also used in rhinitis, conjunctivitis, and in preparations for symptomatic treatment of coughs and common cold.
Chlorphenamine maleate acts by blocking the activity of histamine on H1 receptors.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Paracetamol.

Paracetamol is readily absorbed from the GIT with peak plasma concentrations occurring about 10-60 minutes after oral administration.

Pseudoephedrine hydrochloride.

Pseudoephedrine is readily and almost completely absorbed from the GIT and there is no evidence of first pass metabolism. Plasma concentration after oral administration of 60 mg of pseudoephedrine as tablets will occur within 30 minutes and persists for 4-6 hours.

Dextromethorphan hydrobromide monohydrate.

Dextromethorphan is readily absorbed and onset of action is usually within 15-30 minutes and persists for 3-6 hours. It is rapidly absorbed from the gastrointestinal tract.

Chlorphenamine maleate.

Chlorphenamine maleate is absorbed relatively slowly from the gastrointestinal tract, peak plasma concentration occurring about 2.5-6 hours after administration by mouth. Bioavailability is low, values of 25-50% having been reported.
Chlorphenamine maleate appears to undergo considerable first-pass metabolism.

Distribution.

Paracetamol.

Following oral administration of 500 mg conventional tablet, the average plasma concentration of 2.1 or 1.8 microgram/mL will occur at 6 or 8 hours respectively. Food may delay slightly the absorption of tablets.
Paracetamol is distributed into most body tissues; about 25% of paracetamol in blood is bound to plasma proteins. It crosses the placenta and is present in breast milk.

Pseudoephedrine hydrochloride.

Although specific information is lacking, pseudoephedrine is presumed to cross the placenta and to enter CSF. Pseudoephedrine distributes into breast milk; about 0.5% of an oral dose is distributed into breast milk over 24 hours.

Chlorphenamine maleate.

About 70% of it in the circulation is bound to plasma proteins.

Metabolism.

Paracetamol.

Paracetamol is metabolised predominantly in the liver and excreted in the urine mainly as the glucuronide and sulfate conjugates. A small amount of paracetamol is also conjugated with cysteine, and small amount is de-acetylated, probably to p-aminophenol, which can cause methemoglobinemia.
A minor hydroxylated metabolite (N-acetyl-p-benzoquinoneimine), which is usually produced in very small amounts by mixed functions oxidases in the liver and the kidney and which is usually detoxified by conjugation with glutathione, may accumulate following paracetamol overdosage and cause tissues damage.

Pseudoephedrine hydrochloride.

Pseudoephedrine is incompletely metabolized (< 1%) in the liver by N-demethylation to an inactive metabolite. The drug and its metabolite are excreted in urine - 55-96% of a dose is excreted unchanged.

Dextromethorphan hydrobromide monohydrate.

Dextromethorphan is metabolised by the liver.

Chlorphenamine maleate.

In adults with normal renal and hepatic function, the terminal elimination half-life of chlorphenamine maleate reportedly ranges from 12-43 hours. In children the terminal elimination half-life is 9.6-13.1 hours. Patients with chronic renal failure undergoing hemodialysis, the elimination half-life of chlorphenamine maleate reportedly ranged from 280-330 hours.

Excretion.

Paracetamol.

The elimination half-life of paracetamol varies from 1-3 hours. Plasma half-life may be prolonged following toxic doses or in patients with liver damage.
Approximately 85% of a dose of paracetamol is excreted in urine as free and conjugated paracetamol within 24 hours after ingestion. Administration of paracetamol to patients with moderate to severe renal impairment may result in accumulation of paracetamol conjugates.

Pseudoephedrine hydrochloride.

The elimination half-life of the drug ranges from 3-6 or 9-16 hours, when urinary pH is 5 or 8 respectively. Renal clearance of pseudoephedrine is about 7.3-7.6 mL/minute per kg in adult.

Dextromethorphan hydrobromide monohydrate.

Dextromethorphan is excreted in the urine as unchanged dextromethorphan and demethylated metabolites including dextrorphan.

Chlorphenamine maleate.

Chlorphenamine maleate and its metabolites (monodesmethylchlorpheniramine and didesmethylchlorpheniramine) are apparently excreted almost completely in urine. Excretion is dependent on urinary pH and flow rate. Only small amounts have been found in the faeces.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

The Day Tablets contain the following inactive ingredients: microcrystalline cellulose, pregelatinised maize starch, croscarmellose sodium, povidone, sodium starch glycollate, hydrogenated vegetable oil, carnauba wax, magnesium stearate and PI 2472 (Opadry yellow).
The Night Tablets contain the following inactive ingredients: microcrystalline cellulose, pregelatinised maize starch, croscarmellose sodium, povidone, hydrogenated vegetable oil, carnauba wax, magnesium stearate and PI 2452 (Opadry Blue).
Chemists' Own Cough, Cold & Flu Day/Night tablets are free of gluten, lactose and sucrose.
See Section 2 Qualitative and Quantitative Composition.

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

Store below 25°C in a dry place.

6.5 Nature and Contents of Container

Both tablets are available blister packs containing 24 tablets (18 Day Tablets and 6 Night Tablets).

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

Chemical structure.

Paracetamol is 4'-hydroxyacetanilide. It is a synthetic non-opiate analgesic with the following chemical structure:
The molecular formula is C8H9NO2. The molecular weight is 151.2. Paracetamol is a white, odourless, crystalline powder.
Pseudoephedrine hydrochloride is (1S, 2R)-2-methylamino-1-phenylpropan-1-ol hydrochloride. It is a sympathomimetic amine with the following chemical structure:
The molecular formula is C10H15NO3HCl. The molecular weight is 201.7. Pseudoephedrine hydrochloride is a white, crystalline powder; odourless or almost odourless. Pseudoephedrine hydrochloride is soluble in 1.6 parts of water, 1 in 4 parts of ethanol (96%) and 1 in 60 parts of chloroform.
Dextromethorphan hydrobromide monohydrate is (+)-3-methoxy-9a-methylmorphinan hydrobromide monohydrate. It is an antitussive agent with the following chemical structure:
The molecular formula is C18H25NO, HBr, H2O. The relative molecular mass is 370.3. Dextromethorphan hydrobromide monohydrate is a white or almost white odourless, crystalline powder. Dextromethorphan hydrobromide monohydrate is soluble in 60 parts of water, 1 in 10 parts of ethanol (96%) and freely soluble in chloroform with the separation of water; practically insoluble in ether.
Chlorphenamine maleate is 3-(4-chlorophenol)-3-(2-pyridyl) propyldimethylamine hydrogen maleate. It is an antihistamine with the following chemical structure:
The molecular formula is C16H19ClN2,C4H4O4. The molecular weight is 390.9. Chlorphenamine maleate is a white, odourless, crystalline powder. It is soluble 1 in 4 parts of water, 1 in 10 parts of ethanol (96%) and 1 in 10 parts of chloroform, slightly soluble in ether.

CAS number.

Paracetamol: CAS - 103-90-2.
Pseudoephedrine hydrochloride: CAS - 345-78-8.
Dextromethorphan hydrobromide monohydrate: CAS - 6700-34-1.
Chlorphenamine maleate: CAS - 113-92-8.

7 Medicine Schedule (Poisons Standard)

Pharmacist Only Medicine (S3).

Summary Table of Changes