Consumer medicine information

TRUST SINUS AND NASAL DECONGESTANT

Pseudoephedrine hydrochloride

BRAND INFORMATION

Brand name

Trust Sinus & Nasal Decongestant

Active ingredient

Pseudoephedrine hydrochloride

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using TRUST SINUS AND NASAL DECONGESTANT.

1. What is in this leaflet

This information answers some common questions about Trust Sinus & Nasal Decongestant tablets. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist who has detailed information.

Keep this information with the medicine as you may want to read it again.

2. What is Trust Sinus & Nasal Decongestant used for

Trust Sinus & Nasal Decongestant tablets contain a decongestant, pseudoephedrine hydrochloride which acts to clear nasal congestion and dry a runny nose, making breathing easier.

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

3. Before you take Trust Sinus & Nasal Decongestant Tablets

3a. When you must not take it

  • Do not use this product after the expiry date printed on the carton and foil.
  • Do not use this product if the packaging is torn or shows signs of tampering.
  • Do not give to children under 12 years.
  • Do not take if you are taking, or within 14 days after stopping taking, monoamine oxidase inhibitors (MAOIs), a type of medicine used to treat depression.
  • Do not take if you have very high blood pressure or severe blood vessel disease.
  • Do not use if you are allergic to pseudoephedrine or any of the ingredients mentioned under “Product Description” of this Consumer Medicine Information.

If you have an allergic reaction, you may get an asthma attack, skin rash, or hay fever-like symptoms.

If you are not sure whether you should take this medicine, talk to your doctor or pharmacist.

3b. Before you start to take it

You must tell your doctor or pharmacist if you are suffering from any of these conditions:

  • 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)
  • any other medical problem

It may not be safe for you to take Trust Sinus & Nasal Decongestant if you have any of these conditions.

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

In particular, you should tell your doctor or pharmacist if you are using any of these substances:

  • Medicines for high blood pressure
  • Medicines that suppress appetite and for slimming
  • Other nasal decongestant (e.g. Medicines used to treat symptoms of colds and flu)
  • Levodopa (a medicine used to treat Parkinson’s disease)
  • Medicines for depression

These medicines may affect the way Trust Sinus & Nasal Decongestant work or Trust Sinus & Nasal Decongestant may affect the way they work. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

3c. Pregnancy

Tell your doctor if you are pregnant or are planning to become pregnant.

Women who are pregnant should check with their doctor before using Trust Sinus & Nasal Decongestant tablets.

3d. Breastfeeding

Tell your doctor or pharmacist if you are breastfeeding.

Trust Sinus & Nasal Decongestant is not recommended for breastfeeding mothers.

4. How to take Trust Sinus & Nasal Decongestant

4a. Recommended dose

Adults and children over 12 years of age: 1 tablet 3 to 4 times a day, when necessary. Do not exceed 4 tablets in 24 hours.

Not suitable for use in children under 12 years.

If you are unsure what dose to take, ask your pharmacist.

This preparation is for the relief of minor and temporary ailments and should be used strictly as directed. Prolonged use may be harmful. If symptoms persist, seek medical advice.

4b. If you miss a dose

If you miss a dose, do not take a double dose to make up. This medicine should only be used when necessary.

4c. If you take too much (in case of overdose)

Immediately telephone your doctor, Poisons Information Centre (Telephone: 13 11 26) or go to the Emergency Department at your nearest hospital if you think that you or anyone else may have taken too many Trust Sinus & Nasal Decongestant tablets even if there are no signs of discomfort or poisoning.

5. While you are taking Trust Sinus & Nasal Decongestant

5a. Things you must do

Take Trust Sinus & Nasal Decongestant as described on the label and in this leaflet.

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

Tell your doctor or pharmacist if you become pregnant while taking Trust Sinus & Nasal Decongestant.

6. Side Effects

Trust Sinus & Nasal Decongestant provides relief from nasal congestion, but it may have unwanted side effects in a few people. You may need medical treatment if you get some of these side effects.

Tell your doctor or pharmacist if you notice and become worried about any of the following:

  • Sleeplessness,
  • Difficulty passing urine,
  • Nervousness,
  • Tremor (shaking),
  • Vertigo,
  • Headache,
  • Fast or irregular heartbeat,
  • Palpitations,
  • Sweating,
  • Flushing,
  • Anxiety,
  • Restlessness,
  • Dry mouth or loss of appetite.

Some people my get other side effects not mentioned in this leaflet.

Tell your doctor or pharmacist if you notice anything else which makes you feel unwell.

7. After using Trust Sinus & Nasal Decongestant

7a. Storage

Trust Sinus & Nasal Decongestant should be stored below 30°C until the expiry date shown on the label.

Do not leave Trust Sinus & Nasal Decongestant in the car on hot days.

Store away from direct sunlight or heat.

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 will not keep well.

7b. Disposal

Return any unused medicines to your pharmacist.

7c. Where to go for further information

If you have any questions about this, or any other medication, discuss with your pharmacist.

8. Product Description

Trust Sinus & Nasal Decongestant tablets come as white round-shaped tablets.

Active Ingredients

Each tablet contains:

  • Pseudoephedrine hydrochloride 60mg

Other ingredients:

  • Cellulose - microcrystalline
  • Magnesium stearate
  • Calcium hydrogen phosphate

Contains no lactose, sugar, gluten, yeast, artificial colouring, preservatives, starch, dairy products, glucose or alcohol.

9. Sponsor

Pharmacor Pty Ltd
Suite 401, 7 Oaks Avenue
Dee Why NSW 2099
www.pharmacor.com.au

The Australian Registration Number for Trust Sinus & Decongestant tablets is AUST R 233000.

Available in pack sizes 12s.

February 2015

Published by MIMS July 2015

BRAND INFORMATION

Brand name

Trust Sinus & Nasal Decongestant

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.

Trust Sinus & Nasal Decongestant 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)

Australian categorisation definition.

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. Trust Sinus & Nasal Decongestant 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, dose dependent CNS excitation.
Rarely, the following have been reported: sleep disturbances, hallucinations.
Other symptoms may occur, such as: nervousness, tremor, vertigo, headache, tachycardia, palpitations, sweating or flushing, anxiety, restlessness, dry mouth, anorexia, 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, 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 (blister pack of 12 tablets in a carton).

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.

CAS number.

345-78-8.
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.

7 Medicine Schedule (Poisons Standard)

Schedule 3 (S3): Pharmacist Only Medicine.

Summary Table of Changes