Consumer medicine information

CHEMISTS OWN SINUS RELIEF

Pseudoephedrine hydrochloride

BRAND INFORMATION

Brand name

Chemists' Own Sinus Relief Tablets

Active ingredient

Pseudoephedrine hydrochloride

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using CHEMISTS OWN SINUS RELIEF.

What is in this leaflet

This leaflet answers some common questions about Chemists’ Own Sinus Relief. 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.

Product description

What it looks like

Chemists’ Own Sinus Relief is white round, film coated tablet with S/SH embossed on one side.

Active ingredients
Each tablet contains Pseudoephedrine Hydrochloride 60mg

Inactive ingredients

  • Carnauba wax
  • Microcrystalline cellulose
  • Crospovidone
  • Dextrates
  • Hypromellose
  • Macrogol
  • Magnesium stearate
  • Silica colloidal

What Chemists’ Own Sinus Relief is used for

Chemists’ Own Sinus Relief provides effective relief of nasal and sinus congestion.

Helps to dry up secretions in the nose and sinuses thus making breathing easier.

Your doctor or pharmacist may prescribe this medication for another use. If you want more information ask your doctor or pharmacist.

Before you use Chemists’ Own Sinus Relief

When you must not take it

  • you have ever had an allergic reaction with pseudoephedrine hydrochloride or any other ingredients in the tablet (see under ‘Product description’)
  • you are taking certain types of antidepressant medications (monoamine oxidase inhibitors (MAOI’s) or – ask your doctor or pharmacist if you are unsure)
  • you are taking medicines for treating epilepsy or fits, tranquillisers, medicines for treating diabetes, high blood pressure or heart problems

Before your start to take it

Tell your doctor or pharmacist before you start to take Chemists’ Own Sinus Relief if you:

  • are taking any other medicine, particularly:
    - anti-depressant or sedative medication;
    - medicine for treating epilepsy or fits;
    - tranquilisers;
    - medicines for treating high blood pressure.
  • are taking any other medicine including any that you buy without a prescription from your pharmacy, supermarket or health food shop. These medicines may be affected by Chemists’ Own Sinus Relief or may affect the way it works.
  • are taking any other medicine, particularly antidepressant or sedative medication
  • are pregnant or breast feeding
  • are having breathing problems
  • have high blood pressure
  • have heart problems
  • have overactive thyroid
  • are diabetic
  • suffer from asthma
  • have trouble urinating due to an enlarged prostate.

If you have not told your doctor or pharmacist about any of the above, tell them before you use Chemists’ Own Sinus Relief.

How to take Chemists’ Own Sinus Relief

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.

Chemists’ Own Sinus Relief can be taken with or without food.

While you are using Chemists’ Own Sinus Relief

Precautions while using this medicine

  • Chemists’ Own Sinus Relief may cause sleeplessness if it is taken up to several hours before going to bed. Avoid taking at bedtime.
  • See your doctor before taking this product if you have high blood pressure or heart problems or are taking anti-depressant medication.

Overdose

If you take too much

Immediately telephone your doctor, or the Poisons Information Centre (telephone 131 126), or go to the nearest casualty section of a hospital, if you think you or anyone else may have taken too much Chemists’ Own Sinus Relief.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Side effects

All medicines can have side effects. Sometimes they are serious, most of the time they are mild and temporary.

The more common side effects of Chemists’ Own Sinus Relief are:

  • Chest pain that lasts more than 15 minutes
  • Very fast, pounding, or irregular heartbeat
  • Wheezing or shortness of breath
  • Sweating or flushing
  • Severe restlessness
  • Nervousness or dizziness
  • Trouble in sleeping
  • Nausea or upset stomach
  • Headache
  • Loss of appetite

Tell your doctor or pharmacist as soon as possible if you notice any of the common side effects or if you do not feel well while taking Chemists’ Own Sinus Relief.

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

Supplier

Chemists’ Own Sinus Relief is supplied by:

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

This leaflet was updated in October 2016.

The Australian Registration Number for Chemists’ Own Sinus Relief is AUST R 93484

BRAND INFORMATION

Brand name

Chemists' Own Sinus Relief Tablets

Active ingredient

Pseudoephedrine hydrochloride

Schedule

S3

 

Name of the medicine

Pseudoephedrine hydrochloride.

Excipients.

Dextrates, microcrystalline cellulose, crospovidone, colloidal anhydrous silica, hypromellose, macrogol 400, magnesium stearate and carnauba wax.

Description

Chemical name: [S-(R*,R*)]-a-[1- (methylamino)ethyl] benzenemethanol hydrochloride. Molecular formula: C10H15NO,HCl. MW: 201.70. Pseudoephedrine hydrochloride is a white or off white crystalline powder; odourless or almost odourless.

Pharmacology

Pharmacokinetics.

Pseudoephedrine has a half-life of 4-8 hours; elimination is enhanced and half-life accordingly shorter in acid urine. Pseudoephedrine is readily absorbed from the gastrointestinal tract, less than 1% is metabolised in the liver by N-demethylation to an inactive metabolite, with 55-95% of the drug is excreted unchanged in the urine, and small amounts are distributed into breast milk.

Actions.

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.

Indications

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

Contraindications

This medication should not be given to patients with the following.
Known sensitivity to pseudoephedrine or any of the excipients in this preparation.
Severe hypertension or coronary heart disease or those taking MAOIs (and for 14 days after cessation of MAOI therapy, as it may precipitate a hypertensive crisis).

Precautions

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

Use in pregnancy.

(Category B2)
Safety for use of Chemists' Own Sinus Relief during pregnancy has not yet been established.

Use in lactation.

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

Use in children

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

Interactions

Pseudoephedrine may partially reverse the hypotensive action of drugs that interfere with sympathetic activity including bretylium, bethanidine, guanethidine, debrisoquine, methyldopa and β-adrenergic blocking agents.
Concomitant use of Chemists' Own Sinus Relief with other sympathomimetic amines or tricyclic antidepressants may cause a rise in blood pressure. It should not be given to patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days after ceasing treatment with MAOI’s (see Contraindications).
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 Relief and furazolidone, they should not be taken together.

Adverse Effects

May cause sleeplessness if taken up to several hours before going to bed in sensitive people. Other adverse reactions which may occur are nervousness, tremor, vertigo, headache, tachycardia, palpitations, sweating or flushing.

Dosage and Administration

Adults, 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.

Overdosage

Symptoms.

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

Treatment.

In case of an overdose or for further information, contact the Poisons Information Centre on 131 126.

Presentation

Tablet, 60 mg (white, marked S/SH, scored): 12's (AUST R 93484).

Storage

Store below 30°C. Protect from light.

Poison Schedule

S3.