Consumer medicine information

Chemists' Own Coldeze

Paracetamol; Chlorphenamine maleate (chlorpheniramine maleate)

BRAND INFORMATION

Brand name

Chemists' Own Coldeze Tablets

Active ingredient

Paracetamol; Chlorphenamine maleate (chlorpheniramine maleate)

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Chemists' Own Coldeze.

What is in this leaflet

This leaflet answers some common questions about Chemists’ Own Coldeze.

It does not contain all the available information and it does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits.

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

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

What Chemists’ Own Coldeze is used for

Chemists’ Own Coldeze tablets contains two ingredients, paracetamol and chlorpheniramine maleate to provide temporary relief from the following symptoms of colds & flu including:

  • Headache
  • Sneezing
  • Body aches & pains
  • Runny nose
  • Watery & itching eyes
  • Fever

Your doctor or pharmacist may recommend this medication for another use. If you want more information, ask your doctor or pharmacist.

How it works

Paracetamol
Paracetamol is an analgesic and antipyretic. It relieves the elevated body temperature, headache and joint and muscle pain associated with the common cold and influenza.

Chlorpheniramine maleate
Chlorpheniramine maleate is an antihistamine. It helps to control sneezing and relieve itchy and watery eyes. The efficacy of chlorpheniramine in this product is due to its anticholinergic effect.

There is no evidence that this medicine is addictive.

Use in children

This medicine should not be used in children under 12 years of age.

Before you take Chemists’ Own Coldeze

When you must not take it

Do not take Chemists’ Own Coldeze if:

  • you have ever had an allergic reaction with paracetamol, chlorpheniramine maleate, any other antihistamine or any other ingredients listed under ‘Product Description’. The symptoms of an allergic reaction may include shortness of breath wheezing or difficulty breathing swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
  • you are taking any other product containing paracetamol.

Do not take Chemists’ Own Coldeze if you have, or have had, any of the following medical conditions:

  • Narrow-angle glaucoma
  • Stomach or duodenal ulcer
  • Stomach problems
  • Prostate problems
  • Bladder problems

Do not take Chemists’ Own Coldeze if you are also taking monoamine oxidase inhibitors, a type of medicine used to treat depression.

Do not take Chemists’ Own Coldeze if you are breastfeeding or plan to breastfeed. It passes into the breast milk and there is a possibility that the baby may be affected.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor or pharmacist if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor or pharmacist if you have or have had any of the following medical conditions:

  • you have liver or kidney problems
  • you are having breathing problems
  • you are a heavy drinker
  • you have epilepsy

Tell your doctor or pharmacist if:

  • you are planning to have surgery or an anaesthetic.
  • you are currently receiving or are planning to receive dental treatment.

Tell your pharmacist or doctor if you are pregnant or plan to become pregnant. Your pharmacist or doctor will discuss the benefits and possible risks of taking the medicine during pregnancy.

Taking other medicines

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

Some medicines/substances and Chemists’ Own Coldeze may interfere with each other. These include:

  • anticoagulants (medicines that thin the blood such as warfarin)
  • antidepressants
  • medicines containing metoclopramide or propantheline
  • medicines for treating epilepsy or fits such as phenytoin
  • sleeping tablets
  • alcohol
  • chloramphenicol (an antibiotic)

These medicines may be affected by Chemists’ Own Coldeze or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

If you have not told your doctor or pharmacist about any of the above, tell them before you use Chemists’ Own Coldeze.

How to take Chemists’ Own Coldeze

WARNING: Keep to the recommended dose.

Adults and Children over 12 years: Do not take this medicine for longer than a few days at a time unless advised to by a doctor.

Children and adolescents 12-17 years: Do not take this medicine for longer than 48 hours at a time unless advised to by a doctor.

Do not take with other medicines containing paracetamol unless advised to do so by a doctor or pharmacist.

How much to take

Adults and Children 12 years and over: Take two tablets, every four to six hours as necessary. Do not exceed 8 tablets in 24 hours.

Not to be given to children under 12 years of age.

How to take it

Swallow the tablets whole with a glass of water.

When to take it

Only take Chemists’ Own Coldeze when you think you need it. Leave at least 4-6 hours between each dose. The tablets can be taken with or without food.

If you take too much (overdose)

If an overdose is taken or suspected, ring the Poisons Information Centre (telephone 13 11 26), or go to a hospital straight away, even if you feel well, because of the risk of delayed, serious liver damage.

Symptoms of an overdose may include vomiting, stomach pain, hallucination and seizures.

While you are using Chemists’ Own Coldeze

Precautions while using this medicine

Chemists’ Own Coldeze is for minor and temporary ailments and should be used strictly as directed. Prolonged use without medical supervision could be harmful.

Be careful driving or operating machinery until you know how Chemists’ Own Coldeze affects you.

This medication may cause drowsiness and/or dizziness in some people. If affected do not drive a vehicle, operate machinery or do anything else that could be dangerous.

Be careful when drinking alcohol while you are taking this medicine. If you drink alcohol, drowsiness and dizziness may be worse.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Chemists’ Own Coldeze.

All medicines can have side effects. Sometimes they are serious, most of the time they are not.

If you are 60 years and over you may have an increased chance of getting side effects. Dizziness, drowsiness and a drop in blood pressure causing light-headedness are more likely to occur in elderly patients.

Do not be alarmed by the following list of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

The more common side effects of Chemists’ Own Coldeze are:

  • drowsiness
  • dizziness
  • allergic reactions
  • skin rashes
  • nausea
  • dry mouth
  • vomiting
  • constipation or diarrhoea

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After using Chemists’ Own Coldeze

Storage

Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep well.

Keep it in a cool dry place where the temperature stays below 30 degrees Celsius.

Do not store any medicines in the bathroom or in moist areas, or do not leave them in the car on hot days. Heat and dampness can destroy some medicines.

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

Disposal

If your doctor tells you to stop taking Chemists’ Own Coldeze, or the tablets have passed their expiry date, ask you pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Chemists’ Own Coldeze is an oval shaped white, film-coated tablet with a break bar on one side. Available in a blister pack containing 24 tablets.

Active ingredients

Each tablet contains:

  • Paracetamol 500 mg
  • Chlorpheniramine maleate 2 mg

Inactive ingredients

  • Microcrystalline cellulose
  • Silica colloidal anhydrous
  • Magnesium stearate
  • Croscarmellose sodium
  • Hypromellose
  • Macrogol 400
  • Carnauba wax
  • Pregelatinised maize starch
  • Povidone
  • Silicon dioxide
  • Stearic acid

This medicine does not contain sucrose, lactose, gluten, tartrazine or any other azo dyes.

Supplier

Arrow Pharma Pty Ltd
15 – 17 Chapel Street
CremorneVictoria3121.

www.chemistsown.com.au

The Australian Registration number for Chemists’ Own Coldeze is AUST R 93797.

This leaflet was prepared in May 2019.

Published by MIMS July 2019

BRAND INFORMATION

Brand name

Chemists' Own Coldeze Tablets

Active ingredient

Paracetamol; Chlorphenamine maleate (chlorpheniramine maleate)

Schedule

S3

 

1 Name of Medicine

Paracetamol, chlorphenamine maleate.

2 Qualitative and Quantitative Composition

Chemists' Own Coldeze tablets contain paracetamol 500 mg and chlorphenamine maleate 2 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

A medium sized oval shaped film-coated tablet with a break-bar on one side.

4 Clinical Particulars

4.1 Therapeutic Indications

Helps give temporary relief from the symptoms of colds and flu including: headache, sneezing, body aches and pain, runny nose, watery and itchy eyes, fever.

4.2 Dose and Method of Administration

Adults and children over 12 years.

2 tablets 3 to 4 times a day when necessary. Maximum 8 tablets in 24 hours.
Not to be used in children under 12 years of age.

4.3 Contraindications

This tablet should not be given to patients with a known hypersensitivity or intolerance to paracetamol, chlorphenamine or any other antihistamines, or any excipients listed, see Section 6.1 List of Excipients.
This medicine is contraindicated for use in patients with narrow angle glaucoma, stenotic peptic ulcer, pyloroduodenal obstruction and bladder neck obstruction, symptomatic prostatic hypertrophy and in patients taking monoamine oxidase inhibitors (MAOIs).
Active alcoholism may predispose patients to paracetamol hepatotoxicity.

4.4 Special Warnings and Precautions for Use

Paracetamol should be administered with caution to patients with hepatic or renal dysfunction, epilepsy, and chronic alcohol users. Large doses of paracetamol may cause hepatic toxicity.
This medication may be dangerous when used in large amounts or for a long period.

Use in the elderly.

Dizziness, sedation and hypotension are more likely to occur in elderly patents (approximately 60 years and over).

Paediatric use.

Not recommended in children under 12 years of age.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Paracetamol.

Anticoagulant dosage may require reduction if use of the medication is prolonged.
Paracetamol absorption is increased by drugs which increase gastric emptying, e.g. metoclopramide, and decreased by drugs which decrease gastric emptying, e.g. propantheline, antidepressants with anticholinergic properties, narcotic analgesics. Paracetamol may increase chloramphenicol concentrations. The likelihood of paracetamol toxicity may be increased by the concomitant use of enzyme inducing agents such as alcohol or antiepileptic drugs.

Other possible drug interactions.

Patients who have taken liver microsomal inducing drugs including barbiturates, imipramine and alcohol show diminished ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.
Alcohol can increase the hepatotoxicity of paracetamol.

Chlorphenamine maleate.

The sedative effect may be potentiated by concomitant use with alcohol, tricyclic antidepressants, barbiturates or other CNS depressants. MAOI's prolong and intensify the effects of antihistamines.
The action of oral anticoagulants may be inhibited by antihistamines.
Chlorphenamine may have an additive antimuscarinic action with other drugs with antimuscarinic properties, such as atropine and some antidepressants (both tricyclics and MAOIs), and it may mask the warning signs of damage caused by ototoxic drugs such as aminoglycoside antibiotics.

Other possible drug interactions.

Chlorphenamine enhances the CNS depressant effects of the hypnotic sedatives such as chloral hydrate and nitrazepam.
Alcohol enhances the CNS depressant effects of chlorphenamine.
Serious adverse effects may occur when chlorphenamine is given with phenytoin.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Australian categorisation definition: 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 effect on the foetus having been observed.
 Not recommended for use by breastfeeding mothers. Paracetamol is excreted in breast milk.

4.7 Effects on Ability to Drive and Use Machines

Chlorphenamine maleate may cause drowsiness in some patients, such patients should be cautioned about operating vehicles or machinery or engaging in activities which requires them to be fully alert. Alcohol should be avoided.

4.8 Adverse Effects (Undesirable Effects)

Paracetamol.

Reports of adverse reactions are rare. Although the following reactions have been reported, a causal relationship to the administration of paracetamol has neither been confirmed nor refuted. Dyspepsia, nausea, allergic and haematological reactions, as well as hepatotoxicity.

Chlorphenamine maleate.

Antihistamines such as chlorphenamine maleate may cause disturbances of the following systems.

CNS.

Sedation, dizziness, ataxia, headache. May cause excitation in children.

Cardiovascular.

Palpitations, urinary retention, blurred vision.

Gastrointestinal.

Dry mouth, nausea, vomiting, constipation or diarrhoea.

Dermatological.

Skin rashes may occur.

Haematological.

Haematalogical disturbances.

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

Symptoms.

Paracetamol.

Toxic symptoms of paracetamol include vomiting, abdominal pain, liver damage, hypotension, sweating, central stimulation with exhilaration and convulsions in children, drowsiness, gastrointestinal haemorrhage, cerebral oedema and renal tubular necrosis, respiratory depression, cyanosis and coma.
The most serious adverse effect of acute overdosage of paracetamol is a dose dependent, potentially fatal hepatic necrosis. In adults, hepatotoxicity may occur after ingestion of a single dose of paracetamol 10 to 15 g (30 tablets); a dose of 25 g (50 tablets) or more is potentially fatal. Symptoms during the first two days of acute poisoning by paracetamol do not reflect the potential seriousness of the intoxication. Major manifestations of liver failure such as jaundice, hypoglycaemia and metabolic acidosis may take at least three days to develop.

Chlorphenamine.

Overdose with chlorphenamine is associated with antimuscarinic, extrapyramidal, gastrointestinal and CNS side effects. In infants and children CNS stimulation predominates over CNS depression, causing ataxia, excitement, tremors, psychoses, hallucinations and convulsions; hyperpyrexia may also occur. Deepening coma and cardiorespiratory collapse may follow. In adults, CNS depression is more common with drowsiness, coma and convulsions, progressing to respiratory failure or possibly cardiovascular collapse.

Treatment.

Consists primarily of management of paracetamol toxicity. In cases of overdose, methods of reducing the absorption of ingested drug are important.
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 is an analgesic and antipyretic. Paracetamol relieves the elevated body temperature, headache, and joint and muscle pain associated with the common cold and influenza.
Chlorphenamine maleate is an antihistamine. Chlorphenamine helps to control the sneezing and relieve itchy and watery eyes. The efficacy of chlorphenamine in this product is due to its anticholinergic effect.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Paracetamol.

Absorption.

After oral administration, paracetamol is absorbed rapidly and completely from the small intestine; peak plasma levels occur 30 to 120 minutes after administration.
The absorption of paracetamol is delayed by co-administration with food and anticholinergic drugs (including antihistamines).

Distribution.

Paracetamol is uniformly distributed throughout most body fluids; the apparent volume of distribution is 1 to 1.2 L/kg. Paracetamol can cross the placenta and is excreted in milk.
Plasma protein binding is negligible at usual therapeutic concentrations but increases with increased concentrations.

Metabolism.

Paracetamol is metabolised by the hepatic microsomal enzyme system. In adults, at therapeutic doses, paracetamol is mainly conjugated with glucuronide (45 to 55%) or sulfate (20 to 30%). A minor proportion (less than 20%) is metabolised to catechol derivatives and mercapturic acid compounds via oxidation. Paracetamol is metabolised differently by infants and children compared to adults, the sulfate conjugate being predominant.

Excretion.

Paracetamol is excreted in the urine mainly as the glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged paracetamol with 85 to 90% of the administered dose eliminated in the urine within 24 hours of ingestion. The elimination half-life varies from 1 to 3 hours.

Chlorphenamine.

Absorption.

Chlorphenamine is absorbed relatively slowly from the gastrointestinal tract. Peak plasma concentrations occur 2.5 to 6 hours after oral administration.

Distribution.

Chlorphenamine is approximately 70% bound to plasma proteins.

Metabolism.

It appears to undergo significant first pass metabolism resulting in low bioavailability.

Excretion.

Values of 2 to 43 hours have been reported as the half-life. It is extensively metabolised and metabolites and unchanged drug are excreted primarily in the urine. Excretion is influenced by pH and urine flow rate. The duration of action has been reported to be 4 to 6 hours. More rapid and extensive absorption, faster clearance and a shorter half-life have been reported in children.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Chemists’ Own Coldeze tablets contain cellulose microcrystalline, maize starch, silica colloidal anhydrous, povidone, croscarmellose sodium, stearic acid, magnesium stearate, hypromellose, macrogol 400 and carnauba wax.

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 30°C. Protect from moisture.

6.5 Nature and Contents of Container

Chemists' Own Coldeze tablets is available in blister pack (PVC/PVDC/Al) of 24 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

Paracetamol.

Chemical name: N-(4-hydroxyphenyl) acetamide. Molecular formula: C8H9NO2. MW: 151.2.

Chlorphenamine maleate.

Chemical name: 2-[p-chloro-α- (2-dimethylaminoethyl) benzyl] pyridine. Molecular formula: C16H19ClN2, C4H4O4. MW: 390.87.

Chemical structure.


CAS number.

Paracetamol: 103-90-2.
Chlorphenamine maleate: 113-92-8.

7 Medicine Schedule (Poisons Standard)

S3.

Summary Table of Changes