TRUST FLUDOL DAY & NIGHT tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

chlorphenamine maleate, Quantity: 2 mg; pseudoephedrine hydrochloride, Quantity: 30 mg; paracetamol, Quantity: 500.4 mg

Available from:

NOUMED PHARMACEUTICALS PTY LTD

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: povidone; erythrosine aluminium lake; microcrystalline cellulose; purified water; crospovidone; magnesium stearate; pregelatinised maize starch; stearic acid

Administration route:

Oral

Units in package:

24 Tablets (16 DAY/ 8 NIGHT)

Prescription type:

(S3) Pharmacist Only Medicine

Therapeutic indications:

Temporary relief from the following cold & flu symptoms: nasal congestion, sinus pain, runny nose, headache, body aches & pains. Reduces fever. The night tablets also provide relief from sneezing and itchy or watery eyes, and assist rest by providing relief from these symptoms.

Product summary:

Visual Identification: Pink, round tablet with break-line.; Container Type: Multiple containers; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-02-23

Patient Information leaflet

Trust Fludol Day & Night
1
TRUST FLUDOL DAY & NIGHT
ACTIVE INGREDIENTS: _Paracetamol, Pseudoephedrine hydrochloride,
Chlorphenamine maleate_
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
Trust Fludol Day & Night. 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 FLUDOL DAY & NIGHT.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1.
Why am I using Trust Fludol Day & Night?
2.
What should I know before I use Trust Fludol Day &
Night?
3.
What if I am taking other medicines?
4.
How do I use Trust Fludol Day & Night?
5.
What should I know while using Trust Fludol Day &
Night?
6.
Are there any side effects?
7.
Product details
1.
WHY AM I USING TRUST FLUDOL DAY &
NIGHT?
TRUST FLUDOL DAY & NIGHT CONTAINS THE ACTIVE INGREDIENTS
PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE AND
CHLORPHENAMINE MALEATE. Paracetamol works to stop the
pain messages getting through to the brain. It also acts in
the brain to reduce fever. Pseudoephedrine is used to
relieve/treat nasal congestion and runny nose. It belongs
to a group of medicines called sympathomimetic
decongestants. It works by reducing congestion in the
upper respiratory tract, including the nose, nasal passages
and sinuses, making it easier to breathe. Chlorphenamine
is used to temporarily relieve runny nose, sneezing and
watery eyes. It belongs to a group of medicines called
antihistamines. Antihistamines help reduce allergic
symptoms of a cold by preventing the effects of a
substance called histamine. Histamine is produced by the
body in response to foreign substances to which the body
is allergic.
TRUST FLUDOL DAY & NIGHT IS FOR TEMPORARY RELIEF FROM THE
FOLLOWING COLD & FLU SYMPTOMS: NASAL CONGESTION, SINUS
PAIN, RUNNY NOSE, HEADACHE, BODY ACHES AND PAINS.
REDUCES FEVER. THE NIGHT TABLETS ALSO PROVIDE RELIEF FROM
SNEEZING, WATERY OR ITCHY EYES, AND ASSIST REST BY
PROVIDING RELIEF FROM THESE SYMPTOMS.
2.
WHAT SHOULD I KNOW BEFORE I USE TRUS

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
TRUST FLUDOL DAY & NIGHT
(PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE, CHLORPHENAMINE MALEATE)
1
1.
NAME OF THE MEDICINE
Paracetamol (Day & Night tablets)
Pseudoephedrine hydrochloride (Day & Night tablets)
Chlorphenamine maleate (Night tablets)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Day uncoated tablet contains the active ingredients:
•
Paracetamol 500mg
•
Pseudoephedrine hydrochloride 30mg
Each Night uncoated tablet contains the active ingredients:
•
Paracetamol 500mg
•
Pseudoephedrine hydrochloride 30mg
•
Chlorphenamine maleate 2mg
For a full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Day tablets:
Uncoated tablets.
White, round tablets with a break-line on one side.
Night tablets:
Uncoated tablets.
Pink, round tablets with a break-line on one side
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Trust Fludol Day & Night is indicated for temporary relief from the
following cold & flu symptoms: nasal
congestion, sinus pain, runny nose, headache, body aches & pains.
Reduces fever. The night tablets also
provide relief from sneezing and itchy or watery eyes, and assist rest
by providing relief from these
symptoms.
4.2.
DOSE AND METHOD OF ADMINISTRATION
Adults & Children 12 years & over:
Take 2 white Day tablets every 4 to 6 hours if required.
Take 2 pink Night tablets at bed-time if required.
Repeat dosage after 4 to 6 hours if required.
Do not take the Night tablet within 4 hours of taking a Day tablet.
Do not take more than a total of 4 doses (8 Day and Night tablets) in
a 24-hour period.
This medicine should not be taken with other medicines containing
paracetamol unless advised to do so by
a doctor or pharmacist.
Use in adults
This medicine should not be taken for more than a few days at a time
except on medical advice.
AUSTRALIAN PRODUCT INFORMATION
TRUST FLUDOL DAY & NIGHT
(PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE, CHLORPHENAMINE MALEATE)
2
Use in children
Do not give to children under 12 years of age.
This medicine s