Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Chemists’ Own Sinus + 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 + 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 + Pain Relief is used for

Chemists’ Own is Sinus + Pain-Relief contains paracetamol and pseudoephedrine as active ingredients and is used to provide effective temporary relief without drowsiness from sinusitis symptoms:

• Headache
• Nasal congestion
• Sinus congestion
• Sinus pain

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

Pseudoephedrine 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.

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 + Pain Relief is only available from your pharmacist.

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

When you must not take it

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

• any medicine containing paracetamol or pseudoephedrine
• 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:

• 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 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.

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

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

• liver or kidney disease
• chronic alcoholism
• 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

Ask your pharmacist or doctor about taking this medicine if you are breastfeeding. 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 + 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 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
• 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 + Pain Relief or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

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

How to take Chemists’ Own Sinus + Pain Relief Tablets

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 and children over 12 years:
2 tablets.

Children 7 – 12 years:
1 tablet.

Keep to the recommended dose.

Not recommended to children under 7 years of age.

Do not take more than the recommended dose.

How to take it

Tablets should be swallowed with a glass of glass of water. Tablets can be taken with or without food.

When to take it

Every 6 hours as necessary.

How long to take it:

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.

If you forget to take it

If it is less than 1 hour before 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 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 (telephone 13 11 26) 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 + Pain Relief tablets. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using Chemists’ Own Sinus + Pain Relief Tablets

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

Do not take Chemists’ Own Sinus + 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

Be careful driving or operating machinery until you know how Chemists’ Own Sinus + Pain Relief affects you. This medicine may cause dizziness in some people. If this happens, do not drive or use operate machinery.

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 + 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.

Things to be careful of

Only drink small quantities of alcohol (beer, wine or spirits) while taking Chemists’ Own Sinus + Pain Relief. Drinking large quantities of alcohol while taking this medication may increase the risk of liver side effects.

Side effects

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

This medicine helps most people with the relief of sinus pain and congestion, 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:

• nervousness
• dry mouth
• nausea or dyspepsia
• dizziness
• difficulty sleeping

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

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 using Chemists’ Own Sinus + Pain Relief Tablets

Storage

Keep your medicine in the original pack until it is time to take.

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

Do not store Chemists’ Own Sinus + 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 + Pain Relief AUST R 93822 are capsule shaped, pink, uncoated tablets.

Ingredients

Chemists’ own Sinus + Pain Relief contains 500 mg of paracetamol and 30 mg of pseudoephedrine hydrochloride as the active ingredients. It also contains:

• Cellulose - microcrystalline
• Starch - maize
• Silica - colloidal anhydrous
• Povidone
• Croscarmellose sodium
• Stearic acid
• Magnesium stearate
• Sodium starch glycollate
• Glyceryl monostearate - self emulsifying
• Erythrosine ci45430 (127)

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 and pseudoephedrine hydrochloride.

2 Qualitative and Quantitative Composition

Each tablet contains paracetamol 500 mg and pseudoephedrine hydrochloride 30 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Chemists' Own Sinus + Pain Relief are capsule shaped, pink, uncoated tablets.

4 Clinical Particulars

4.1 Therapeutic Indications

For the effective temporary relief of sinus pain and congestion.

4.2 Dose and Method of Administration

Tablets should be swallowed with a glass of water. Tablets can be taken with or without food.
Take every 6 hours as necessary.

Adults and children over 12 years.

Children 7-12 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 (MAOIs) or who have taken MAOIs within the previous 14 days.
Discontinue use and see a doctor at the first sign of a skin rash or any other sign of hypersensitivity.
See Section 4.4 Special Warnings and Precautions for Use for additional information.

4.4 Special Warnings and Precautions for Use

Should be used with caution in patients with:
impaired hepatic function;
impaired renal function;
chronic alcoholism;
hypertension;
hyperthyroidism or thyroid disease;
diabetes mellitus;
coronary heart disease;
ischaemic heart disease;
glaucoma;
prostatic hypertrophy;
severe hepatic or renal dysfunction.
Pseudoephedrine should be discontinued, and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.
If signs and symptoms such as formation of small pustules occur, with or without pyrexia or erythema, then treatment with pseudoephedrine should be discontinued and a physician should be consulted.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

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.
Colestyramine reduces the absorption of paracetamol if given within 1 hour of paracetamol.
The following interactions with pseudoephedrine have been noted:
Antidepressant medication eg tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs) - may cause a serious increase in blood pressure or hypertensive crisis.
Other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants - may cause an increase in blood pressure and additive effects.
Methyldopa and β-blockers - may cause an increase in blood pressure.
Urinary acidifiers enhance elimination of pseudoephedrine.
Urinary alkalinisers decrease elimination of pseudoephedrine.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Hypersensitivity reactions occur occasionally. Overdosage with paracetamol if left untreated can result in severe, sometimes fatal liver damage and rarely, acute renal tubular necrosis.
Children and the elderly are more likely to experience adverse effects than other age groups.
The safety of pseudoephedrine, paracetamol from clinical trial data is based on data from a randomized, placebo-controlled multi-dose clinical trial in the management of symptoms attributed to the paranasal sinus associated with the common cold.
Table 1 includes adverse events that occurred where greater than one event was reported, and the incidence was greater than placebo and in 1% of patients or more. A dash represents an incidence of less than 1%.
The following additional adverse events were reported by ≥ 1% of subjects in randomized, placebo-controlled trials with single ingredient pseudoephedrine: dry mouth, nausea, dizziness and insomnia.
Adverse drug reactions identified during postmarketing experience with paracetamol, pseudoephedrine HCl or the combination appear in Table 2. The frequency category was estimated from spontaneous reporting rates according to the following convention: Very common 1/10; common 1/100 and < 1/10; uncommon 1/1,000 and < 1/100; rare 1/10,000 and < 1/1000; very rare < 1/10,000; not known (cannot be estimated from the available data).

Reporting suspected adverse effects.

4.9 Overdose

If an overdose is taken or suspected, immediately contact the Poisons Information Centre (Ph: 131 126) for advice or go to a hospital straight away even if you feel well because of the risk of delayed, serious liver damage.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

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.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

The inactive ingredients are: microcrystalline cellulose, maize starch, colloidal anhydrous silica, povidone, croscarmellose sodium, stearic acid, magnesium stearate, sodium starch glycollate, glyceryl monostearate - self emulsifying and erythrosine ci45430 (127).

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

Blister packed size of 24 tablets in cardboard boxes.

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.

Molecular formula.

CAS number.

7 Medicine Schedule (Poisons Standard)

Pharmacist Only Medicine (S3).

Summary Table of Changes