PANADOL SINUS RELIEF ORIGINAL FORMULA capsule-shaped tablet blister pack

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

paracetamol, Quantity: 500 mg; pseudoephedrine hydrochloride, Quantity: 30 mg

Dostępny od:

Haleon Australia Pty Ltd

Forma farmaceutyczna:

Tablet, uncoated

Skład:

Excipient Ingredients: stearic acid; povidone; purified talc; sodium benzoate; pregelatinised maize starch; maize starch

Droga podania:

Oral

Sztuk w opakowaniu:

24

Typ recepty:

(S3) Pharmacist Only Medicine

Wskazania:

For the temporary relief of sinus congestion and pain, nasal congestion and runny nose.

Podsumowanie produktu:

Visual Identification: White capsule shaped tablet with flat edges 17.5mm x 7mm. One face marking PANADOL, SINUS on the other side.; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Status autoryzacji:

Registered

Data autoryzacji:

1992-02-18

Ulotka dla pacjenta

PANADOL
® SINUS
RELIEF
_ORIGINAL FORMULA_
_Paracetamol 500 mg and Pseudoephedrine Hydrochloride 30 mg_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PANADOL SINUS
RELIEF ORIGINAL FORMULA.
It does not contain all the available
information.
It does not take the place of talking to
your pharmacist or doctor.
All medicines have risks and
benefits. Your pharmacist or doctor
has weighed the risks of you taking
PANADOL SINUS RELIEF
ORIGINAL FORMULA against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
PHARMACIST OR DOCTOR.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PANADOL
SINUS RELIEF
ORIGINAL FORMULA
IS USED FOR
PANADOL SINUS RELIEF
ORIGINAL FORMULA is used for
the temporary relief of sinus
congestion and pain, nasal
congestion and runny nose.
PANADOL SINUS RELIEF
ORIGINAL FORMULA caplets
®
contain the active ingredients
paracetamol and pseudoephedrine
hydrochloride
Paracetamol works to stop the pain
messages from getting through to the
brain. It also acts in the brain to
reduce fever.
Pseudoephedrine hydrochloride
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,
and making it easier to breathe.
ASK YOUR PHARMACIST OR DOCTOR IF
YOU HAVE ANY QUESTIONS ABOUT THIS
MEDICINE.
Your pharmacist or doctor may have
given it for another reason.
This medicine is not addictive.
It is only available from your
pharmacist.
BEFORE YOU TAKE/GIVE
PANADOL SINUS
RELIEF ORIGINAL
FORMULA
Taking too much paracetamol can
cause serious harm to your liver.
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE PANADOL SINUS
RELIEF ORIGINAL FORMULA
IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
paracetamol or pseudoephedrine
hydrochloride
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of

Charakterystyka produktu

a
1
AUSTRALIAN PRODUCT INFORMATION
PANADOL SINUS RELIEF ORIGINAL FORMULA TABLETS
1
NAME OF THE MEDICINE
Paracetamol
Pseudoephedrine Hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Panadol Sinus Relief Original Formula Tablets contain pseudoephedrine
hydrochloride 30 mg and paracetamol 500 mg.
Excipient with known effect: sodium benzoate as a preservative.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Panadol Sinus Relief Original Formula Tablets are white,
capsule-shaped tablets
with flat edges debossed with I – I on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Panadol Sinus Relief Original Formula Tablets are used for the
temporary relief of
sinus congestion and pain, nasal congestion and runny nose.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN 12 YEARS AND OVER:
2 capsule-shaped tablets (caplets) taken with water every 6 hours as
necessary,
maximum 8 caplets within 24 hours.
USE IN ADULTS
Paracetamol should not be taken for more than a few days at a time
except on
medical advice.
USE IN CHILDREN AGED 12 TO 17 YEARS
Paracetamol should not be taken for more than 48 hours except on
medical advice.
Do not use in children below 12 years of age.
a
2
Do not exceed the stated dose or frequency of dosing. Minimum dosage
interval: 6
hours.
Do not use with other paracetamol-containing or decongestant products
including
cough and cold preparations.
Seek medical advice if symptoms persist for more than 7 days.
4.3
C
ONTRAINDICATIONS
This product is contraindicated for use in patients:
•
with known hypersensitivity or idiosyncratic reaction to paracetamol,
pseudoephedrine or any of the other ingredients in the product;
•
with severe hypertension or severe coronary artery disease;
•
who are receiving other sympathomimetics (such as decongestants,
appetite suppressants and amphetamine-like psycho-stimulants)
•
who are receiving monoamine oxidase inhibitors (MAOIs) or for two
weeks
after stopping a MAOI drug
•
with severe renal impa