PHARMACY ACTION SINUS & NASAL DECONGESTANT RELIEF tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pseudoephedrine hydrochloride, Quantity: 60 mg

Available from:

NOUMED PHARMACEUTICALS PTY LTD

INN (International Name):

Pseudoephedrine hydrochloride

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: calcium hydrogen phosphate dihydrate; magnesium stearate; microcrystalline cellulose

Administration route:

Oral

Units in package:

12 tablets

Prescription type:

(S3) Pharmacist Only Medicine

Therapeutic indications:

Fast temporary relief from a runny nose and reduce the swollen membranes of the nose and sinuses and helping breathe freely.

Product summary:

Visual Identification: Convex white tablet; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-11-09

Patient Information leaflet

PHARMACY ACTION Sinus & Nasal Decongestant Relief
1
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:
•
hi

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
PHARMACY ACTION SINUS & NASAL DECONGESTANT RELIEF
(PSEUDOEPHEDRINE HYDROCHLORIDE)
Page 1 of 6
1.
NAME OF THE 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 (refer to
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 & 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.
AUSTRALIAN PRODUCT INFORMATION
PHARMACY ACTION SINUS & NASAL DECONGESTANT RELIEF
(PSEUDOEPHEDRINE HYDROCHLORIDE)
Page 2 of 6
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 g