TELFAST DECONGESTANT tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pseudoephedrine hydrochloride, Quantity: 120 mg; fexofenadine hydrochloride, Quantity: 60 mg

Available from:

Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; croscarmellose sodium; pregelatinised maize starch; Carnauba Wax; colloidal anhydrous silica; stearic acid; macrogol 8000; hypromellose; macrogol 400

Administration route:

Oral

Units in package:

2, 10, 6

Prescription type:

(S3) Pharmacist Only Medicine

Therapeutic indications:

For the relief of the symptoms of seasonal allergic rhinitis with nasal congestion when both the antiallergic properties of fexofenadine hydrochloride and the decongestant activity of pseudoephedrine hydrochloride are required.

Product summary:

Visual Identification: Bi-layer, capsule shaped, film coated tablets with one half (lengthwise) white to off-white and the other half tan. The white half of the tablet is debossed with "06/012D".; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2000-01-20

Patient Information leaflet

TELFAST DECONGESTANT
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING TELFAST DECONGESTANT?
Telfast Decongestant contains the active ingredient fexofenadine
hydrochloride and pseudoephedrine hydrochloride. Telfast
Decongestant is used to relieve the symptoms of seasonal and perennial
allergic rhinitis (including hayfever) with sinus/nasal
congestion. For more information, see Section 1. Why am I using
Telfast Decongestant? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TELFAST DECONGESTANT?
Do not use if you have ever had an allergic reaction to Telfast
Decongestant or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I use Telfast Decongestant? in the
full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Telfast Decongestant and affect how
it works. A list of these medicines is in Section 3. What if I
am taking other medicines? in the full CMI.
4.
HOW DO I USE TELFAST DECONGESTANT?
•
Your pharmacist or doctor will tell you how much Telfast Decongestant
you should take.
•
The recommended dose for adults and children over the age of 12 years,
is one tablet 12 hourly.
•
Telfast Decongestant should be swallowed whole with a full glass of
water, before a meal.
•
Do not take more than the dose your pharmacist or doctor has directed.
More instructions can be found in Section 4. How do I use Telfast
Decongestant? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TELFAST DECONGESTANT?
THINGS YOU
SHOULD DO
•
Tell any doctor, dentist or pharmacist you visit that you are using
Telfast Decongestant.
•
Tell your doctor or pharmacist if you plan to become pregnant, are
pregnant, or

Summary of Product characteristics

telfast-d-ccdsv4-piv10-08oct21
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION – TELFAST
DECONGESTANT (FEXOFENADINE AND PSEUDOEPHEDRINE)
1
NAME OF THE MEDICINE
Fexofenadine hydrochloride and pseudoephedrine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Telfast Decongestant tablet contains 60mg of fexofenadine
hydrochloride in an
immediate release formulation and 120mg of pseudoephedrine
hydrochloride in a wax matrix
for sustained release.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Telfast Decongestant tablets are bi-layer, capsule shaped, film coated
tablets with one half
(lengthwise) white to off-white and the other half tan. The white half
of the tablet is debossed
with “06/012D”.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of the symptoms of allergic rhinitis with nasal
congestion when both the
antiallergic properties of fexofenadine hydrochloride and the
decongestant activity of
pseudoephedrine hydrochloride are required.
4.2
DOSE AND METHOD OF ADMINISTRATION
For adults and children over the age of 12 years, the recommended
dosage of Telfast
Decongestant is one tablet 12 hourly. The tablet should be swallowed
whole and
administration with or after a high fat meal should be avoided.
The safety and efficacy of Telfast Decongestant in patients under the
age of 12 years has not
been established.
Dosage adjustment is not required in the elderly or in patients with
hepatic impairment.
However, for renally impaired patients, a dose of one tablet once
daily is recommended as a
starting dose (see Section 4.4 Special Warnings and Precautions for
Use).
The maximum tolerated dose of Telfast Decongestant has not been
established.
telfast-d-ccdsv4-piv10-08oct21
Page 2 of 11
4.3
CONTRAINDICATIONS
Telfast Decongestant is contraindicated in patients with a known
hypersensitivity to
fexofenadine, pseudoephedrine, terfenadine or any excipient.
Pseudoephedrine and thus Telfast Decongestant is contraindicated in
the following patients:
•
Pa