Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Chemists’ Own Sinus + Allergy & Pain Relief.

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

All medicines have risks and benefits. Your pharmacist or doctor has weighed the risks of you taking Chemists’ Own Sinus + Allergy & Pain Relief against the benefits they expect it will have for you.

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

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

What Chemists’ Own Sinus + Allergy & Pain Relief is used for

Chemists’ Own Sinus + Allergy & Pain Relief contains three active ingredients paracetamol, pseudoephedrine and chlorpheniramine and they provide effective temporary relief of the symptoms and discomfort associated with:

• Hayfever
• Relieves blocked noses
• Dries runny noses
• Reduce sneezing
• Pains and Sinus Pain
• Runny Nose
• Sneezing
• Sinus Congestion
• Watery eyes.

Chlorpheniramine belongs to a group of medicines called 'antihistamines'. Antihistamines help reduce allergic symptoms by preventing the effects of a substance called histamine. Histamine is produced by the body in response to foreign substances that the body is allergic to.

Pseudoephedrine hydrochloride belongs to a group of medicines called sympathomimetic decongestants. It works by reducing congestion in the upper respiratory tract, including the nose, nasal passages and sinuses, and making it easier to breathe.

Paracetamol works to stop the pain messages from getting through to the brain. It also acts in the brain to reduce fever.

Ask your pharmacist or doctor if you have any questions about this medicine. Your pharmacist or doctor may have given it for another reason.

Chemists’ Own Sinus + Allergy & Pain Relief are only available from your pharmacist.

Before you take/give Chemists’ Own Sinus + Allergy & Pain Relief

When you must not take it

Do not take Chemists’ Own Sinus + Allergy & Pain Relief if you have an allergy to:

• any medicine containing chlorpheniramine, pseudoephedrine, paracetamol or 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 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)
• stomach or duodenal ulcer, or other stomach problems
• prostate problems
• bladder problems
• high blood pressure
• overactive thyroid gland
• diabetes
• heart disease and poor blood flow in the blood vessels of the heart
• glaucoma (high pressure in the eyes)
• prostate problems
• liver or kidney disease

Do not take this medicine if you have:

• very high blood pressure
• severe coronary artery disease (heart disease caused by poor blood flow or narrowing of the blood vessels of the heart)
• taken monoamine oxidase inhibitors, medicines used to treat depression, in the last 14 days

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

Do not take this medicine if you are pregnant or plan to become pregnant. It may affect your developing baby if you take it during pregnancy.

Your pharmacist or doctor will discuss the benefits and possible risks of taking the medicine during pregnancy.

Ask your pharmacist or doctor about taking this product if you are breastfeeding or plain to breastfeed. Your pharmacist or doctor will discuss the potential benefits and risks of taking the medicine if you are breastfeeding.

Do not give this medicine to newborn or premature babies.

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 pharmacist or doctor.

Before you start to take it

Tell your doctor 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:

• high blood pressure
• overactive thyroid gland
• diabetes
• heart disease and poor blood flow in the blood vessels of the heart
• glaucoma (high pressure in the eyes)
• prostate problems
• liver or kidney disease
• epilepsy

Tell your pharmacist or doctor if you take sedatives.

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.

Ask your pharmacist or doctor about taking this medicine if you are breastfeeding. Small amounts of pseudoephedrine pass into the breast milk. Your pharmacist or doctor will discuss the potential benefits and risks of taking the medicine if you are breastfeeding.

If you have not told your pharmacist or doctor about any of the above, tell him/her before you start taking Chemists’ Own Sinus + Allergy & Pain Relief.

Taking other medicines

Tell your pharmacist or doctor 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 Chemists’ Own Sinus + Allergy & Pain Relief may interfere with each other.

These include:

• warfarin, a medicine used to prevent blood clots
• metoclopramide, a medicine used to control nausea and vomiting
• medicines used to treat epilepsy or fits
• chloramphenicol, an antibiotic used to treat ear and eye infections
• alcohol
• medicines used to treat depression, especially monoamine oxidase inhibitors and tricyclic antidepressants
• medicines used to help you sleep or relax (sedatives and hypnotics)
• opioid analgesics, medicines used to treat pain
• phenytoin, a medicine used to treat epilepsy (for chlorpheniramine-containing products only)
• medicines used to treat heart conditions
• medicines used to treat high blood pressure
• medicines used to treat urinary tract infections and bladder problems
• medicines used to treat behavioural disorders
• phenylephrine, a medicine used to treat congestion
• appetite suppressants

These medicines may be affected by Chemists’ Own Sinus + Allergy & Pain Relief or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

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

How to take Chemists’ Own Sinus + Allergy & Pain Relief

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

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

How much to take

Adults: Only take paracetamol for a few days at a time unless your doctor tells you to take it for longer.

Children: Only give paracetamol to children for up to 48 hours unless a doctor has told you to give it longer.

Adults and children over 12 years: Take 2 tablets 3 to 4 times a day as necessary. Keep to the recommended dose.

Not recommended for children under 12 years of age.

Do not take more than the recommended dose.

If you are over 65 years of age, talk to you pharmacist or doctor about how much to take. Elderly patients are more likely to have side effects from taking these medicines.

How to take it

Should be swallowed with a glass of glass of water.

Tablets can be taken with or without food.

When to take it

Take 3 to 4 times a day as necessary.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and give the 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 pharmacist or doctor.

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

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (in Australia, call 13 11 26; in New Zealand, call 0800 764 766) for advice or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Chemists’ Own Sinus + Allergy & Pain Relief.

Do this even if there are no signs of discomfort or poisoning.

While you are using Chemists’ Own Sinus + Allergy & Pain Relief

Things you must do

Talk to your pharmacist or doctor if your symptoms do not improve. Your pharmacist or doctor will assess your condition and decide if you should continue to take the medicine.

Things you must not do

Children: Do not give paracetamol for more than 48 hours unless a doctor has told you to.

Adults: Do not take for more than a few days at a time unless your doctor tells you to.

Do not take more than the recommended dose unless your doctor tells you to.

Do not take Chemists’ Own Sinus + Allergy & Pain Relief to treat any other complaints unless your pharmacist or doctor tells you to. Do not give your medicine to anyone else, even if they have the same condition as you.

Do not drink alcohol while taking this medicine. The sedation effects of alcohol may be increased.

Do not take Chemists’ Own Sinus + Allergy & Pain Relief to treat any other complaints unless your pharmacist or doctor tells you to.

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

Do not take more than the recommended dose unless your pharmacist or doctor tells you to.

Things to be careful of

Only drink small quantities of alcohol (beer, wine or spirits) while taking paracetamol. Drinking large quantities of alcohol while taking paracetamol may increase the risk of liver side effects.

Be careful driving or operating machinery until you know how the medicine affects you.

This medicine may cause sleepiness and/or dizziness in some people. If this happens, do not drive or use operate machinery.

Side effects

Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking Chemists’ Own Sinus + Allergy & Pain Relief. This medicine helps most people with hayfever, nasal congestion, sinus congestion, runny nose, sneezing and watery eyes, but it may have unwanted side effects in a few 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 lists of side effects. You may not experience any of them.

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

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

• nausea or dyspepsia
• difficulty sleeping
• nervousness
• excitability
• restlessness
• dizziness
• fear or anxiety
• rapid heart beat
• tremor
• drowsiness or sleepiness
• dry mouth, nose and throat
• constipation
• nervousness and irritability
• anxiety
• hallucinations
• twitching or jerking muscles
• fast heart beat

The above list includes the more common side effects of your medicine. They are usually mild and short-lived.

Children and people over 65 years of age may have an increased chance of getting side effects.

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

• urine retention
• 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
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• skin rashes
• seizures (fits)

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

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

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

After taking Chemists’ Own Sinus + Allergy & Pain Relief

Storage

Keep your medicine in the original pack until it is time to take it. Keep your medicine in a cool dry place where the temperature stays below 30°C.

Do not store Chemists’ Own Sinus + Allergy & Pain Relief or any other medicine 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 it 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

Ask your pharmacist what to do with any medicine that is left over, or if the expiry date has passed.

Product description

What it looks like

Chemists’ Own Sinus + Allergy & Pain Relief are blue film coated oval tablets with a break-bar on one side and plain on the other.

Ingredients

Chemists’ Own Sinus + Allergy & Pain Relief (AUST R 93809) contains the following active ingredients:

• Paracetamol 500mg
• Pseudoephedrine hydrochloride 30mg
• Chlorpheniramine maleate 2mg

It also contains:

• Starch - maize
• Cellulose - microcrystalline
• Silica - colloidal anhydrous
• Povidone
• Croscarmellose sodium
• Stearic acid
• Magnesium stearate
• Carnauba wax
• Brilliant blue FCF ci42090 (133)
• Titanium Dioxide ci77891 (171)

This medicine does not contain lactose, sucrose, gluten and tartrazine.

Supplier

Arrotex Pharmaceuticals Pty Ltd
15 – 17 Chapel Street
Cremorne Victoria 3121

This leaflet was updated in August 2023.

Published by MIMS September 2023

1 Name of Medicine

Paracetamol, pseudoephedrine hydrochloride and chlorphenamine maleate.

2 Qualitative and Quantitative Composition

Each tablet contains paracetamol 500 mg, pseudoephedrine hydrochloride 30 mg and chlorphenamine maleate 2 mg as the active ingredients.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Chemists' Own Sinus + Allergy and Pain Relief are blue film coated oval tablets with a break-bar on one side and plain on the other.

4 Clinical Particulars

4.1 Therapeutic Indications

Chemists' Own Sinus + Allergy and Pain Relief tablets provide effective temporary relief from hayfever, nasal congestion, sinus pain, runny nose, sneezing sinus congestion and watery eyes.

4.2 Dose and Method of Administration

Adults and children over 12 years.

Use in adults.

Use in children.

4.3 Contraindications

Paracetamol is contraindicated for use in patients with known hypersensitivity or idiosyncratic reaction to paracetamol (or any of the other ingredients in the product).
Pseudoephedrine is contraindicated for use in patients:
with known hypersensitivity or idiosyncratic reaction to pseudoephedrine (or any of the other ingredients in the product);
with severe hypertension or coronary artery disease;
taking monoamine oxidase inhibitors (MAOls) or who have taken MAOls within the previous 14 days.
Chlorphenamine is contraindicated for use in patients with:
a history of hypersensitivity to the substance or substances of similar chemical structure (or any of the other ingredients in the product);
narrow angle glaucoma;
stenosing peptic ulcer;
symptomatic prostatic hypertrophy;
bladder neck obstruction;
pyloroduodenal obstruction.
Chlorphenamine is contraindicated for use in:
newborns or premature infants;
lactating women;
patients taking monoamine oxidase inhibitors (MAOls).
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

4.4 Special Warnings and Precautions for Use

Paracetamol should be used with caution in patients with:
impaired hepatic function;
impaired renal function.
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.
Chlorphenamine 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.
Use with caution in patients with epilepsy.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

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.
Cholestyramine 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 (MAOls), 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.
The following interactions with chlorphenamine have been noted:
Central nervous system (CNS) depressants (alcohol, sedatives, opioid analgesics, hypnotics) may cause an increase in sedation effects.
Monoamine oxidase inhibitors (MAOls) and tricyclic antidepressants (TCAs) may prolong and intensify the anticholinergic and CNS depressive effects.
Chlorphenamine when taken concomitantly with phenytoin may cause a decrease in phenytoin elimination.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

CNS depressive effects of chlorphenamine include sedation and impaired performance (impaired driving performance, poor work performance, incoordination, reduced motor skills, and impaired information processing). Performance may be impaired in the absence of sedation and may persist the morning after a night-time dose.

4.8 Adverse Effects (Undesirable Effects)

Pseudoephedrine.

Paracetamol.

Chlorphenamine.

Central nervous system (CNS) effects.

Anticholinergic effects.

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia), 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.

Clinical trials.

5.2 Pharmacokinetic Properties

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral administration. Paracetamol is distributed into most body tissues. Plasma protein binding is negligible at usual therapeutic doses but increases with increasing doses. The elimination half-life varies from about 1 to 3 hours.
Paracetamol is metabolised extensively in the liver and excreted in the urine mainly as inactive glucuronide and sulfate conjugates. Less than 5% is excreted unchanged. 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 readily absorbed from the gastrointestinal tract. It 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. Small amounts are distributed into breast milk.
Chlorphenamine maleate is absorbed relatively slowly from the gastrointestinal tract, with peak plasma concentrations occurring about 2.5 to 6 hours after oral administration.
Chlorphenamine appears to undergo considerable first-pass metabolism. Bioavailability is low, values of 25 to 50% having been reported. About 70% of chlorphenamine in the circulation is bound to plasma proteins. There is wide interindividual variation in the pharmacokinetics of chlorphenamine; half-life values ranging from 2 to 43 hours have been reported. Chlorphenamine is widely distributed in the body and enters the CNS.
Chlorphenamine maleate is metabolised extensively. Metabolites include desmethyl and didesmethylchlorphenamine. Unchanged drug and metabolites are excreted primarily in the urine; excretion is dependent on urinary pH and flow rate. Only trace amounts have been found in the faeces.
A duration of action of 4 to 6 hours has been reported; this is shorter than may be predicted from pharmacokinetic parameters.
More rapid and extensive absorption, faster clearance, and a shorter half-life have been reported in children compared to adults.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each tablet contains maize starch, microcrystalline cellulose, colloidal anhydrous silica, povidone, croscarmellose sodium, stearic acid, magnesium stearate, carnauba wax, brilliant blue FCF, titanium dioxide.

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 Sinus + Allergy and Pain Relief tablets are available in PVC/PVDC/Al blister packs containing 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

Chemical structure.

Paracetamol.

Pseudoephedrine hydrochloride.

Chlorphenamine maleate.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 3 - Pharmacist Only Medicine.

Summary Table of Changes