PHARMACY ACTION HAYFEVER & SINUS PAIN RELIEF PSE tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

NOUMED PHARMACEUTICALS PTY LTD

INN (International Name):

chlorphenamine maleate,Paracetamol,Pseudoephedrine hydrochloride

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

24 tablets

Prescription type:

(S3) Pharmacist Only Medicine

Therapeutic indications:

Temporary relief of the symptoms of sinus headache, pain and nasal congestion (including fever) and hay fever.

Product summary:

Visual Identification: A pink, round tablet with breakline.; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2011-09-26

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
PHARMACY ACTION
HAYFEVER & SINUS PAIN RELIEF PSE
(PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENAMINE
MALEATE) TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
PHARMACY ACTION Hayfever
& Sinus Pain Relief PSE tablets.
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 PHARMACY
ACTION Hayfever & Sinus Pain
Relief PSE 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 PHARMACY
ACTION HAYFEVER &
SINUS PAIN RELIEF PSE IS
USED FOR
This product is used for
temporary relief of symptoms of:
•
Sinus headache;
•
Pain and nasal congestion
(including fever) and
hayfever.
PARACETAMOL works to stop the
pain messages from getting
through to the brain. It also acts
in the brain to reduce fever.
PSEUDOEPHEDRINE 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.
CHLORPHENAMINE belongs to a
group of medicines called
‘antihistamines’. Antihistamines
help reduce allergic symptoms
by preventing the effects of a
substance called histamine.
Histamine is produced by the
body in response to foreign
substances that the body is
allergic to.
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 only available
from a pharmacist.
BEFORE YOU TAKE
PHARMACY ACTION
HAYFEVER & SINUS PAIN
RELIEF PSE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PHARMACY
ACTION HAYFEVER & SINUS
PAIN RELIEF PSE TABLETS IF YOU
HAVE AN ALLERGY TO:
•
Any medicine containing
paracetamol,
pseudoephedrine, or
ch

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – PHARMACY ACTION HAYFEVER
& SINUS PAIN RELIEF PSE
(PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE, CHLORPHENAMINE
MALEATE) UNCOATED TABLET
1
NAME OF THE MEDICINE
Paracetamol, pseudoephedrine hydrochloride, chlorphenamine maleate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PHARMACY
ACTION
Hayfever
&
Sinus
Pain
Relief
PSE
contains
500 mg
paracetamol;
30 mg
pseudoephedrine hydrochloride and 2 mg chlorphenamine maleate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
PHARMACY ACTION Hayfever & Sinus Pain Relief PSE: Pink, round tablet
with breakline.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Temporary relief of symptoms of sinus headache, pain and nasal
congestion (including fever) and
hayfever.
4.2 DOSE AND METHOD OF ADMINISTRATION
DIRECTION:
Do not give to children under 12 years of age.
ADULTS AND CHILDREN OVER 12 YEARS: Two tablets every 4 to 6 hours when
necessary. No more than
4 doses should be taken in 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: Paracetamol should not be taken for more than 48
hours except on medical advice.
Pharmacy Action Hayfever & Sinus Pain Relief PSE v2.0
Page 2 of 10
(paracetamol, pseudoephedrine hydrochloride, chlorphenamine maleate)
uncoated tablet
4.3 CONTRAINDICATIONS
PARACETAMOL
Paracetamol is contraindicated for use in patients with known
hypersensitivity or idiosyncratic reaction
to paracetamol (or any of the other ingredients in the product).
Refer to SECTION 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS
OF INTERACTION for additional
information.
PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine is contraindicated for use in patients:
•
with known hypersensitivity or idiosyncratic reaction to
pseudoephedrine (or any of the other
ingredients in the product);
•
with severe hypertension or coronary artery disease;
•
taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs
within the previous