TRUST SINUS & NASAL DECONGESTANT pseudoephedrine hydrochloride 60 mg tablet blister pack

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

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Bipacksedel Bipacksedel (PIL)
21-01-2015
Produktens egenskaper Produktens egenskaper (SPC)
21-01-2015

Aktiva substanser:

pseudoephedrine hydrochloride, Quantity: 60 mg

Tillgänglig från:

NOUMED PHARMACEUTICALS PTY LTD

INN (International namn):

Pseudoephedrine hydrochloride

Läkemedelsform:

Tablet, uncoated

Sammansättning:

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

Administreringssätt:

Oral

Enheter i paketet:

12

Receptbelagda typ:

(S3) Pharmacist Only Medicine

Terapeutiska indikationer:

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

Produktsammanfattning:

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

Bemyndigande status:

Licence status A

Tillstånd datum:

2015-01-21

Bipacksedel

                                Trust Sinus & Nasal Decongestant
1
TRUST SINUS & NASAL DECONGESTANT
ACTIVE INGREDIENT: _pseudoephedrine hydrochloride_
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
Trust Sinus & Nasal Decongestant. 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 TRUST SINUS & NASAL DECONGESTANT.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1.
Why am I using Trust Sinus & Nasal Decongestant?
2.
What should I know before I use Trust Sinus & Nasal
Decongestant?
3.
What if I am taking other medicines?
4.
How do I use Trust Sinus & Nasal Decongestant?
5.
What should I know while using Trust Sinus & Nasal
Decongestant?
6.
Are there any side effects?
7.
Product details
1.
WHY AM I USING TRUST SINUS & NASAL
DECONGESTANT?
TRUST SINUS & NASAL DECONGESTANT CONTAIN THE ACTIVE
INGREDIENT PSEUDOEPHEDRINE HYDROCHLORIDE. TRUST SINUS &
NASAL DECONGESTANT is a decongestant.
TRUST SINUS & NASAL DECONGESTANT ACT TO CLEAR NASAL
CONGESTION, AND DRY A RUNNY NOSE, MAKING BREATHING
EASIER.
2.
WHAT SHOULD I KNOW BEFORE I USE TRUST
SINUS & NASAL DECONGESTANT?
WARNINGS
DO NOT USE TRUST SINUS & NASAL DECONGESTANT 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)

                                
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Produktens egenskaper

                                AUSTRALIAN PRODUCT INFORMATION
TRUST SINUS & NASAL DECONGESTANT
(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
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.
AUSTRALIAN PRODUCT INFORMATION
TRUST SINUS & NASAL DECONGESTANT
(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 glomerular
filtration rate in the kidney and decrea
                                
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