Consumer medicine information

APOHealth Cold Relief

Paracetamol; Chlorphenamine maleate (chlorpheniramine maleate)

BRAND INFORMATION

Brand name

APOHealth Cold Relief Tablets

Active ingredient

Paracetamol; Chlorphenamine maleate (chlorpheniramine maleate)

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APOHealth Cold Relief.

What is in this leaflet

This leaflet answers some common questions about APOHEALTH Cold Relief tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

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

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

What this medicine is used for

APOHEALTH Cold Relief contains the active ingredients paracetamol and chlorphenamine maleate.

It is used to provide temporary relief from the following symptoms of colds & flu including:

  • headache, body aches & pains
  • sneezing and runny nose
  • watery and itching eyes
  • fever

How it works

Paracetamol
Paracetamol is a pain killer that also helps to reduce fever. It relieves the elevated body temperature, headache and joint and muscle pain associated with the common cold and influenza.

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

Ask your doctor or pharmacist if you have any questions about why this medicine has been recommended for you.

Your doctor or pharmacist may have recommended this medication for another use.

This medicine is not addictive.

There is not enough evidence to recommend the use this medicine for children under 12 years of age.

Before you take this medicine

When you must not take it

Do not take this medicine if you have an allergy to:

  • paracetamol
  • chlorphenamine maleate
  • any other antihistamines
  • any of the ingredients listed at the end of this leaflet

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue, throat or other parts of the body
  • rash, itching or hives on the skin

Do not take this medicine if you have or have had any of the following medical conditions:

  • glaucoma (high pressure in the eyes)
  • prostate problems
  • bladder problems
  • stomach or duodenal ulcer or other stomach problems
  • heavy drinking

Do not take this medicine if you are taking an antidepressant known as a monoamine oxidase inhibitors (MAOIs).

Do not take this medicine if you are pregnant, plan to become pregnant or are breastfeeding. This medicine may affect your developing baby if you take it during pregnancy. It may also pass into human breast milk. Your doctor or pharmacist can discuss with you the risks and benefits involved.

Do not take this medicine after the expiry date printed on the pack or 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 if you have or have had any of the following medical conditions:

  • liver or kidney problems
  • breathing problems
  • heavy drinking
  • epilepsy

If you have not told your doctor about any of the above, tell them before you start taking this medicine.

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 and APOHEALTH Cold Relief tablets may interfere with each other. These include:

  • other medicines containing paracetamol
  • anticoagulants (medicines that thin the blood e.g. warfarin)
  • antidepressants, including tricyclic antidepressants or MAOIs
  • medicines containing metoclopramide or propantheline
  • medicines used to treat epilepsy e.g. phenytoin
  • sleeping tablets or medicines that cause drowsiness
  • alcohol
  • chloramphenicol, an antibiotic

These medicines may be affected by this medicine 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

How to take this medicine

Follow all directions given to you by your doctor or pharmacist carefully. They may differ to the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

The usual dose for adults is two tablets every 4 to 6 hours when necessary. Do not exceed 8 tablets in 24 hours.

How to take it

Swallow the tablets whole with a full glass of water.

When to take it

It does not matter if you take this medicine before, with or after food.

If you forget to take it

If it is almost time to take 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 your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much of this medicine.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

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

While you are taking this medicine

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.

Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you are going to have surgery or an anaesthetic or are going into hospital, tell the doctor that you are taking this medicine.

This medicine is for minor and temporary ailments and should be used strictly as directed. Prolonged use without medical supervision could be harmful.

Things you must not do

Do not give this medicine to anyone else, even if they have the same condition as you.

Do not take your medicine to treat any other complaint unless your doctor or pharmacist tells you to.

Things to be careful of

Be careful when driving or operating machinery until you know how this medicine affects you. This medication may cause drowsiness 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 this medicine.

This medicine helps most people with cold symptoms, but it may have unwanted side effects in some people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

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

If you are aged 60 years and over, you may have an increased chance of getting side effects.

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

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

  • drowsiness
  • dizziness
  • nausea or vomiting
  • dry mouth
  • constipation or diarrhoea

The above list includes the more common side effects of your medicine.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • signs of an allergic reaction, such as shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue, throat or other parts of the body, rash, itching or hives on the skin

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

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.

Storage and disposal

Storage

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

Keep your medicine in a cool dry place where the temperature stays below 30°C.

Do not store your medicine or any other medicines in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

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

Disposal

If your doctor or pharmacist tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with the medicine that is left over.

Product description

What it looks like

Oval shaped white, film-coated tablet with a break bar on one side.

Available in a blister pack containing 24 tablets. AUST R 254172

Ingredients

Each tablet contains 500 mg of Paracetamol & 2 mg of Chlorphenamine maleate as active ingredients.

It also contains the following:

  • microcrystalline cellulose
  • colloidal anhydrous silica
  • magnesium stearate
  • maize starch
  • povidone
  • sodium starch glycollate
  • Opadry 04F58804 White

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

Sponsor

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

This leaflet was prepared in April 2024.

Published by MIMS June 2024

BRAND INFORMATION

Brand name

APOHealth Cold Relief Tablets

Active ingredient

Paracetamol; Chlorphenamine maleate (chlorpheniramine maleate)

Schedule

S3

 

1 Name of Medicine

Paracetamol, chlorphenamine maleate.

2 Qualitative and Quantitative Composition

Paracetamol is a white odourless crystalline powder.
Chlorphenamine maleate is a white odourless crystalline powder.
Each tablet contains paracetamol 500 mg and chlorphenamine maleate 2 mg. In addition, each tablet also contains microcrystalline cellulose, maize starch, sodium starch glycollate, povidone, colloidal anhydrous silica, magnesium stearate, Opadry 04F58804 white.

3 Pharmaceutical Form

Paracetamol 500 mg and chlorphenamine maleate 2 mg.

Tablets (oval, film coated, scored 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 pains, runny nose, watery and itching eyes, fever.

4.2 Dose and Method of Administration

Adults, children > 12 years.

2 tablets every 4 to 6 hours when necessary (maximum 8 tablets in 24 hours).
Not to be used in children under 12 years of age.

4.3 Contraindications

Known hypersensitivity or intolerance to paracetamol, chlorphenamine or any other antihistamines, or any of the excipients (see Section 2 Qualitative and Quantitative Composition; Section 3 Pharmaceutical Form).
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

Identified precautions.

This medicine should be administered with caution to patients with epilepsy, and chronic alcohol users.
This medication may be dangerous when used in large amounts or for a long period.

Use in hepatic impairment.

This medicine should be administered with caution to patients with hepatic dysfunction. Large doses of paracetamol may cause hepatic toxicity.

Use in renal impairment.

This medicine should be administered with caution to patients with renal dysfunction.

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. Monoamine oxidase inhibitors (MAOIs) prolong and intensify the effects of antihistamines.
The action of oral anticoagulants maybe 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.
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)
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 fetus having been observed.
 Not recommended for use by breastfeeding mothers. Paracetamol and chlorphenamine 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 require 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.

Central nervous system.

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.

Haematological disturbances.
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 http://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 overdosage, methods of reducing the absorption of ingested drug are important. For the latest treatment, contact the Poisons Information Centre; phone 13 11 26.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

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.

Chlorphenamine maleate.

Chlorphenamine maleate is an antihistamine. It helps to control 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 coadministration 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 one to three hours.

Chlorphenamine.

Absorption.

Chlorphenamine is absorbed relatively slowly from the gastrointestinal tract. Peak plasma concentrations occur 2.5 to 6 hours after oral administration. It appears to undergo significant first-pass metabolism resulting in low bioavailability.

Distribution.

Chlorphenamine is approximately 70% bound to plasma proteins. Values of 2 to 43 hours have been reported as the half-life.

Metabolism.

More rapid and extensive absorption, faster clearance and a shorter half-life have been reported in children.

Excretion.

Excretion is influenced by pH and urine flow rate. The duration of action has been reported to be four to six 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

See Section 2 Qualitative and Quantitative Composition; Section 3 Pharmaceutical Form.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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

Blister packs 24s.

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 structure.


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

CAS number.

103-90-2.

Chlorphenamine maleate.

Chemical structure.


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

CAS number.

113-92-8.

7 Medicine Schedule (Poisons Standard)

S3 - Pharmacist Only Medicine.

Summary Table of Changes