Consumer medicine information

Chemists' Own Sinus and Nasal Decongestant Tablets

Pseudoephedrine hydrochloride

BRAND INFORMATION

Brand name

Chemists' Own Sinus and Nasal Decongestant

Active ingredient

Pseudoephedrine hydrochloride

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Chemists' Own Sinus and Nasal Decongestant Tablets.

What is in this leaflet

This leaflet answers some common questions about Chemists’ Own Sinus and Nasal Decongestant. It does not contain all the available information and it does not take the place of talking to your doctor or pharmacist.

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

What Chemists’ Own Sinus and Nasal Decongestant is used for

Chemists’ Own Sinus and Nasal Decongestant provides effective relief of nasal and sinus congestion due to:

  • allergic (seasonal) rhinitis
  • vasomotor (perennial) rhinitis
  • sinusitis
  • the common cold and flu

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.

This medicine is only available from your pharmacist.

Before you use Chemists’ Own Sinus and Nasal Decongestant

When you must not take it

Do not take Chemists’ Own Sinus and Nasal Decongestant if you have an allergy to:

  • any medicine containing 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 your start to take it

Tell your pharmacist or doctor 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:

  • 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

Ask your pharmacist or doctor about taking pseudoephedrine 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 doctor or pharmacist about any of the above, tell them before you use Chemists’ Own Sinus and Nasal Decongestant.

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 and Nasal Decongestant may interfere with each other. These include:

  • 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 and Nasal Decongestant 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 will have more information on medicines to be careful with or avoid while taking this medicine.

How to take Chemists’ Own Sinus and Nasal Decongestant

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, ask your pharmacist or doctor for help.

Adults & Children over 12 years: Take 1 tablet 3 to 4 times a day when necessary (maximum 4 tablets in 24 hours).

Not recommended for children under 12 years.

How to take it

Swallow tablets with a glass of water.

When to take it

Take the recommended dose 3 to 4 times a day, as required.

How long to take it

Do not use for more than 7 days except on medical advice.

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, you may take a dose as soon as you remember if you think you need it.

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

While you are using Chemists’ Own Sinus and Nasal Decongestant

Things you must do

Talk to your pharmacist or doctor if your symptoms persist, worsen, or if new symptoms appear. 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 and Nasal Decongestant 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 and Nasal Decongestant affects you. This medicine may cause dizziness in some people. If this happens, do not drive or 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 and Nasal Decongestant.

This medicine helps most people with symptoms of sinus and nasal 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:

  • headache
  • drowsiness
  • dizziness
  • difficulty sleeping
  • nervousness
  • excitability
  • feeling of extreme happiness
  • restlessness
  • fear or anxiety
  • change in heart rate
  • rapid or irregular heart beat
  • raised blood pressure
  • tremor
  • hallucinations
  • dry mouth
  • nausea
  • vomiting

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
  • pain when passing urine
  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • skin reddening, blisters, 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.

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°C.

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 Sinus and Nasal Decongestant, or the tablets have passed their expiry date, ask you pharmacist what to do with any that are left over.

Product description

What it looks like

Chemists’ Own Sinus and Nasal Decongestant is a small white tablet with break bar & S/SH on one side.

Active ingredients

Each tablet contains Pseudoephedrine Hydrochloride 60mg

Inactive ingredients

  • Carnauba wax
  • Microcrystalline cellulose
  • Crospovidone
  • Dextrates
  • Hypromellose
  • Macrogol
  • Magnesium stearate
  • Colloidal anhydrous silica

Supplier

Chemists’ Own Sinus and Nasal Decongestant is supplied by:

Arrow Pharma Pty Ltd
15 – 17 Chapel Street
Cremorne, Victoria, 3121.
www.chemistsown.com.au

This leaflet was updated in May 2019.

The Australian Registration Number for Chemists’ Own Sinus and Nasal Decongestant is AUST R 93484

Published by MIMS November 2020

BRAND INFORMATION

Brand name

Chemists' Own Sinus and Nasal Decongestant

Active ingredient

Pseudoephedrine hydrochloride

Schedule

S3

 

1 Name of Medicine

Pseudoephedrine hydrochloride.

2 Qualitative and Quantitative Composition

Chemists' Own Sinus and Nasal Decongestant tablets contain 60 mg of pseudoephedrine hydrochloride.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Chemists' Own Sinus and Nasal Decongestant tablets are a small white tablet with break bar and S/SH on one side.

4 Clinical Particulars

4.1 Therapeutic Indications

Fast effective relief from nasal congestion without drowsiness. Dries up secretions in the nose and sinuses making breathing easier. Relieves sinus pressure.

4.2 Dose and Method of Administration

Adults and children over 12 years.

1 tablet 3 to 4 times a day when necessary.
Maximum of 4 tablets in 24 hours. Not recommended for children under 12 years.

4.3 Contraindications

This medication should not be given to patients with:
Known hypersensitivity or idiosyncratic reaction to pseudoephedrine.
Known hypersensitivity or idiosyncratic reaction to any of the excipients in this preparation.
Severe hypertension or coronary heart disease.
Those taking MAOI's (and for 14 days after cessation of MAOI therapy - as it may precipitate a hypertensive crisis).
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

4.4 Special Warnings and Precautions for Use

Pseudoephedrine should be used with caution in patients with hypertension, coronary heart disease, ischemic heart disease, diabetes mellitus, hyperthyroidism, glaucoma, elevated intraocular pressure, and prostatic enlargement or bladder 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.
Pseudoephedrine may cause sleeplessness if taken up to several hours before going to bed in sensitive people.

Use in hepatic impairment.

Pseudoephedrine should be used with caution in patients with severe hepatic dysfunction.

Use in renal impairment.

Pseudoephedrine should be used with caution in patients with severe renal dysfunction.

Use in the elderly.

No data available.

Paediatric use.

Not recommended for use in children under 12 years of age.

Effects on laboratory tests.

No data available.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Pseudoephedrine may partially reverse the hypotensive action of drugs that interfere with sympathetic activity including bretylium, bethanidine, guanethidine, debrisoquine, methyldopa and beta-adrenergic blocking agents.
Concomitant use of Chemists' Own Sinus and Nasal Decongestant with other sympathomimetic amines or tricyclic antidepressants may cause a rise in blood pressure or hypertensive crisis. It should not be given to patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days after ceasing treatment with MAOIs (see Section 4.3 Contraindications).
Other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants - may cause an increase in blood pressure and additive effects.
When administered with pseudoephedrine the antibacterial agent, furazolidone, is known to cause a dose related inhibition of monoamine oxidase. Although there are no reports of hypotensive action caused by the concurrent administration of Chemists' Own Sinus and Nasal Decongestant and furazolidone, they should not be taken together.
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.

No data available.
(Category B2)
Safety for use of Chemists' Own Sinus and Nasal Decongestant during pregnancy has not yet been established.

Category B2 Australian categorisation definition.

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.
Small amounts of pseudoephedrine are excreted into breast milk, and use is not recommended while breastfeeding.

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)

May cause sleeplessness if taken up to several hours before going to bed in sensitive people.
Adverse effects include:

Cardiovascular stimulation.

Elevated blood pressure, palpitations, tachycardia or arrhythmias.

CNS stimulation.

Headache, restlessness, feeling jittery, insomnia, anxiety, euphoric mood, tremor and (rarely) hallucinations, nervousness, vertigo.
Sweating or flushing; psychomotor hyperactivity (in the paediatric population); skin rashes, dysuria and urinary retention; hypersensitivity.
Children and the elderly are more likely to experience adverse effects than other age groups.

Post-marketing data.

Additional adverse drug reactions (ADRs) identified during post-marketing experience with pseudoephedrine are included in Table 1. The frequencies are provided according to the following convention:
Very common: ≥ 1/10; common: ≥ 1/100, < 1/10; uncommon ≥ 1/1,000, < 1/100; rare: ≥ 1/10,000, < 1/1,000; very rare < 1/10,000.
In Table 1, the ADRs are presented with ADR frequency categories estimated from spontaneous reporting rates where numerator represents total number of reported company AEs under given PT or medical concept and the denominator represents exposure data calculated from sales data.

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.

May include mild anxiety, hypertension, palpitations, irritability, restlessness, convulsions and difficulty with micturition, urinary retention, hallucinations or shortness of breath.
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.

Pseudoephedrine, a sympathomimetic agent is an orally effective nasal decongestant, which produces vasoconstriction of the mucosa of the upper respiratory tract and paranasal sinuses. It is about equipotent with ephedrine but has less unwanted cardiovascular or CNS effects.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Pseudoephedrine is readily absorbed from the gastrointestinal tract.

Distribution.

Small amounts are distributed into breast milk.

Metabolism.

Less than 1% is metabolised in the liver by N-demethylation to an inactive metabolite. Pseudoephedrine has a half-life of 4-8 hours; elimination is enhanced and half-life accordingly shorter in acid urine.

Excretion.

55-95% of the drug is excreted unchanged in the urine.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Dextrates, microcrystalline cellulose, crospovidone, colloidal anhydrous silica, hypromellose, macrogol 400, magnesium stearate and carnauba wax.
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 30°C. Protect from light.

6.5 Nature and Contents of Container

Blister pack 12 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

A white or off-white crystalline powder; odourless or almost odourless.

Chemical structure.


Chemical name: [S-(R*,R*)]-a-[1- (methylamino)ethyl] benzenemethanol hydrochloride.
Molecular formula: C10H15NO,HCl (MW: 201.70).

CAS number.

345-78-8.

7 Medicine Schedule (Poisons Standard)

S3 - Pharmacist only medicine.

Summary Table of Changes