Consumer medicine information

Pharmacy Action Sinus & Nasal Decongestant Relief

Pseudoephedrine hydrochloride

BRAND INFORMATION

Brand name

Pharmacy Action Sinus and Nasal Decongestant Relief

Active ingredient

Pseudoephedrine hydrochloride

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Pharmacy Action Sinus & Nasal Decongestant Relief.

FULL CMI

PHARMACY ACTION Sinus & Nasal Decongestant Relief

Active ingredient: pseudoephedrine hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using PHARMACY ACTION Sinus & Nasal Decongestant Relief.

You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using PHARMACY ACTION Sinus & Nasal Decongestant Relief.

Where to find information in this leaflet:

1. Why am I using PHARMACY ACTION Sinus & Nasal Decongestant Relief?
2. What should I know before I use PHARMACY ACTION Sinus & Nasal Decongestant Relief?
3. What if I am taking other medicines?
4. How do I use PHARMACY ACTION Sinus & Nasal Decongestant Relief?
5. What should I know while using PHARMACY ACTION Sinus & Nasal Decongestant Relief?
6. Are there any side effects?
7. Product details

1. Why am I using PHARMACY ACTION Sinus & Nasal Decongestant Relief?

PHARMACY ACTION Sinus & Nasal Decongestant Relief contains the active ingredient pseudoephedrine hydrochloride. PHARMACY ACTION Sinus & Nasal Decongestant Relief is a decongestant.

PHARMACY ACTION Sinus & Nasal Decongestant Relief acts to clear nasal congestion, and dry a runny nose, making breathing easier.

2. What should I know before I use PHARMACY ACTION Sinus & Nasal Decongestant Relief?

Warnings

Do not use PHARMACY ACTION Sinus & Nasal Decongestant Relief if:

  • you are allergic to pseudoephedrine, or any of the ingredients listed at the end of this leaflet.
    Always check the ingredients to make sure you can use this medicine.
    If you get an allergic reaction, you may get an asthma attack, skin rash or hayfever like symptoms.
  • you are taking or within 14 days after stopping taking monoamine oxidase inhibitors (MAOIs), a type of medicine use to treat depression.
  • you have very high blood pressure of severe blood vessel disease.

Check with your doctor or pharmacist if you:

  • have any other medical conditions such as:
    - high blood pressure
    - heart disease
    - depression
    - lung, liver, or kidney disorders
    - over-active thyroid gland
    - prostate problems such as enlarged prostate
    - bladder problems
    - diabetes mellitus (too much sugar in the blood)
    - increased pressure in the eye (glaucoma)
  • take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.

PHARMACY ACTION Sinus & Nasal Decongestant Relief is not recommended for breastfeeding mothers.

3. What if I am taking other medicines?

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

Some medicines may interfere with PHARMACY ACTION Sinus & Nasal Decongestant Relief and affect how it works. These include:

  • medicines for high blood pressure
  • medicines that suppress appetite and for slimming
  • other nasal decongestants (e.g., medicines used to treat colds and flu)
  • levodopa (a medicine used to treat Parkinson's disease)
  • medicines for depression

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect PHARMACY ACTION Sinus & Nasal Decongestant Relief.

4. How do I use PHARMACY ACTION Sinus & Nasal Decongestant Relief?

How much to take / use

  • Adults and children over 12 years of age: 1 tablet 3 to 4 times a day, when necessary.
  • Follow the instructions provided with the medicine.
  • Do not exceed the recommended dosage.

When to take / use PHARMACY ACTION Sinus & Nasal Decongestant Relief

  • The medicine should only be used when necessary.
  • PHARMACY ACTION Sinus & Nasal Decongestant Relief should be used strictly as directed. Prolonged use may be harmful.

If you use too much PHARMACY ACTION Sinus & Nasal Decongestant Relief

If you think that you have used too much PHARMACY ACTION Sinus & Nasal Decongestant Relief, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using PHARMACY ACTION Sinus & Nasal Decongestant Relief?

Things you should do

  • If your symptoms do not improve within 7 days, you should contact your doctor for further advice.

Remind any doctor, dentist or pharmacist you visit that you are using PHARMACY ACTION Sinus & Nasal Decongestant Relief.

Things you should not do

  • Do not exceed 4 tablets in 24 hours.
  • Do not give to children under 12 years of age.
  • If you forget to take your medicine, do not take a double dose to make up for the dose you missed.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how PHARMACY ACTION Sinus & Nasal Decongestant Relief affects you.

PHARMACY ACTION Sinus & Nasal Decongestant Relief may cause dizziness in some people.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Looking after your medicine

  • Store below 30°C
  • Keep your tablets in the blister pack until it is time to take them. If you take them out of the blister pack, they will not keep well.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Less serious/common side effects

Less serious side effectsWhat to do
  • Sleeplessness
  • Difficulty passing urine
  • Nervousness
  • Tremor (shaking)
  • Vertigo
  • Headache
  • Fast or irregular heartbeat
  • Palpitations
  • Sweating
  • Flushing
  • Anxiety
  • Restlessness
  • Dry mouth
  • Loss of appetite
Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side-effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What PHARMACY ACTION Sinus & Nasal Decongestant Relief contains

Active ingredient
(main ingredient)		Pseudoephedrine hydrochloride
Other ingredients
(inactive ingredients)
  • Calcium hydrogen phosphate dihydrate
  • Magnesium stearate
  • Microcrystalline cellulose

Do not take this medicine if you are allergic to any of these ingredients.

What PHARMACY ACTION Sinus & Nasal Decongestant Relief looks like

PHARMACY ACTION Sinus & Nasal Decongestant Relief are white, round tablets. They come in a carton containing 12 tablets in a blister pack.

(Aust R 191938).

Who distributes PHARMACY ACTION Sinus & Nasal Decongestant Relief

Generic Health Pty Ltd
Suite 2, Level 2,
19 – 23 Prospect Street,
Box Hill, VIC 3128,
Australia

ii1286201  [email protected]

ii1286202  +61 3 9809 7900

ii1286203  www.generichealth.com.au

This leaflet was prepared in April 2023.

Published by MIMS June 2023

BRAND INFORMATION

Brand name

Pharmacy Action Sinus and Nasal Decongestant Relief

Active ingredient

Pseudoephedrine hydrochloride

Schedule

S3

 

1 Name of Medicine

Pseudoephedrine hydrochloride.

2 Qualitative and Quantitative Composition

Pseudoephedrine hydrochloride 60 mg/tablet.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

A white, round, uncoated tablet.

4 Clinical Particulars

4.1 Therapeutic Indications

Nasal and sinus decongestant for symptomatic relief of runny noses and sinus congestion.

4.2 Dose and Method of Administration

Adults and children over 12 years.

1 tablet 3 to 4 times a day, when necessary.
Do not exceed 4 tablets per day.
Do not give to children under 12 years.

4.3 Contraindications

Known hypersensitivity to pseudoephedrine or to any other ingredient in the product (see Section 6.1 List of Excipients).
Patients receiving monoamine oxidase (MAO) inhibitor antidepressants and within 14 days of ceasing treatment with a MAO inhibitor.
Patients with severe hypertension or severe coronary artery disease.
Children under 12 years.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Pharmacy Action Sinus and Nasal Decongestant Relief should be administered with caution to patients with hypertension, hyperthyroidism, heart disease, patients with diabetes mellitus, patients with prostatic enlargement, elevated intraocular pressure and bladder dysfunction.
Pseudoephedrine may cause sleeplessness if taken up to several hours before going to bed.

Use in the elderly.

No data available.

Paediatric use.

Do not use in children under 12 years.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The effects of pseudoephedrine may be enhanced by acetazolamide, disodium hydrogen citrate, sodium acid citrotartrate and sodium bicarbonate. Acetazolamide may reduce the glomerular filtration rate in the kidney and decrease the rate of elimination of pseudoephedrine. Citrates and sodium bicarbonate could increase urinary pH and decrease the rate of elimination of pseudoephedrine.
Concurrent use of pseudoephedrine with monoamine oxidase (MAO) inhibitor antidepressants may cause severe hypertension and headaches. Pseudoephedrine should not be taken within 14 days of ceasing treatment with a MAO inhibitor (see Section 4.3 Contraindications).
Concomitant use of pseudoephedrine and other sympathomimetic agents may lead to an increase in blood pressure and increase the potential for other side effects.
Administration with tricyclic antidepressants may increase blood pressure or increase the risk of arrhythmias.
Administration with digitalis glycosides, quinidine or levodopa may increase the risk of arrhythmias.
The antibacterial agent, furazolidone, is known to cause a progressive inhibition of monoamine oxidase. Although there are no reports of a hypertensive crisis caused by the concurrent administration of pseudoephedrine and furazolidone, they should not be taken together.
Pseudoephedrine may inhibit the effects of antihypertensive medication, including methyldopa or beta-adrenergic blocking agents.
Administration with other CNS stimulants may lead to increased CNS stimulation.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
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 adequate or may be lacking, but available data show no evidence of an increased occurrence of foetal damage.
Animal reproduction studies have not been conducted with pseudoephedrine. It is also not known whether pseudoephedrine can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. Pharmacy Action Sinus and Nasal Decongestant Relief should be given to a pregnant woman only if clearly needed.
 Pseudoephedrine is excreted in breast milk in small amounts but the effect of this on breast fed infants is not known. Use of pseudoephedrine while breastfeeding is not recommended.

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)

Pseudoephedrine may cause: insomnia, urinary retention or dose-dependent CNS excitation.
Rarely, the following have been reported: sleep disturbances and hallucinations.
Other symptoms may occur, such as: nervousness, tremor, vertigo, headache, tachycardia, palpitations, sweating or flushing, anxiety, restlessness, dry mouth, anorexia and tension.

Reporting suspected adverse reactions.

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

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).
Symptoms include convulsions, irritability, palpitations, hypertension and difficulty passing urine.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Pseudoephedrine is a direct- and indirect-acting sympathomimetic agent, with similar actions to ephedrine, but with less cardiovascular or CNS effects.
Pseudoephedrine acts as a decongestant of the mucosa of the nose and sinuses to clear nasal congestion and dry nasal secretions.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Pseudoephedrine is readily absorbed from the gastrointestinal tract after oral administration. Peak concentrations are reached between 0.5 and 2 hours after administration.

Distribution.

Distribution into extravascular sites is extensive with the apparent volume of distribution between 2.6 and 5 L/kg.

Metabolism.

Pseudoephedrine is not substantially metabolised. Less than 1% of pseudoephedrine is metabolised in the liver, by N-demethylation, to norpseudoephedrine.

Excretion.

Pseudoephedrine is excreted primarily unchanged in the urine.
As pseudoephedrine is a weak base with pKa of 9.4, the elimination half-life varies from 3 - 6 hours at a urine pH of 5 to 9; 16 hours at pH of 8, with 5 - 8 hours at pH 5.8. At high urine pH (greater than 7), the drug is extensively reabsorbed in the renal tubules and the rate of excretion is therefore dependent on pH and urine flow rate. This does not appear to be the case at low urine pH.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Calcium hydrogen phosphate dihydrate, microcrystalline cellulose, and magnesium stearate.

6.2 Incompatibilities

No data available.

6.3 Shelf Life

2 years.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Container type.

PVC/PVDC-Aluminium blister packs in a carton.

Pack sizes.

12 tablets.
AUST R 191938.

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: C10H16ClNO.
Molecular weight: 201.7.
A white, crystalline powder or colourless crystals, freely soluble in water and in alcohol, sparingly soluble in methylene chloride. It melts at about 184°C.

CAS number.

345-78-8.

7 Medicine Schedule (Poisons Standard)

Schedule 3 (S3): Pharmacist Only Medicine.

Summary Table of Changes