CHEMISTS? OWN COUGH, COLD & FLU RELIEF tablet blister pack

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

pseudoephedrine hydrochloride, Quantity: 30 mg; dextromethorphan hydrobromide monohydrate, Quantity: 15 mg; paracetamol, Quantity: 500 mg

Tillgänglig från:

Aspen Pharma Pty Ltd

INN (International namn):

dextromethorphan hydrobromide monohydrate,Paracetamol,Pseudoephedrine hydrochloride

Läkemedelsform:

Tablet, film coated

Sammansättning:

Excipient Ingredients: Carnauba Wax; purified water; povidone; magnesium stearate; hydrogenated vegetable oil; croscarmellose sodium; microcrystalline cellulose; pregelatinised maize starch; sodium starch glycollate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400

Administreringssätt:

Oral

Enheter i paketet:

24

Receptbelagda typ:

(S3) Pharmacist Only Medicine

Terapeutiska indikationer:

Provides temporary relief of nagging cough and discomfort associated with cold and flu: relieves blocked noses, dries runny noses, provides temporary relief of cough and headache, relieves body aches and pains, reduces fever.

Produktsammanfattning:

Visual Identification: Pale yellow film coated round plain tablet with a break bar.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Bemyndigande status:

Licence status A

Tillstånd datum:

2017-09-19

Bipacksedel

Chemists’ Own Cough, Cold & Flu Relief Tablets - CMI
Page 1 of 4
CHEMISTS’ OWN COUGH, COLD & FLU RELIEF TABLETS
_Pseudoephedrine hydrochloride _
_Paracetamol _
_Dextromethorphan hydrobromide monohydrate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Chemists’ Own Cough, Cold &
Flu Relief Tablets.
It
does
not
contain
all
of
the
available
information
about
Chemists’ Own Cough, Cold &
Flu Relief Tablets.
It does not replace talking to your
doctor or pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
or
pharmacist has weighed the risks
of
you
Chemists’
Own
Cough,
Cold & Flu Relief Tablets against
the benefits he or she expects it
will have.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
ASK YOUR DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT
ARE
CHEMISTS’
OWN COUGH, COLD &
FLU RELIEF TABLETS
The name of your medicine is
Chemists’ Own Cough, Cold &
Flu Relief Tablets.
The active ingredients in the day
tablet
are
pseudoephedrine
hydrochloride,
paracetamol
and
dextromethorphan
hydrobromide
monohydrate.
_ _
Chemists’ Own Cough, Cold &
Flu
Relief
Tablets_ _
belong
to
a
group
of
medicines
for
the
treatment of symptoms of colds
and flu.
Pseudoephedrine
hydrochloride
relieves
blocked
nose
and
sinuses.
Paracetamol
relieves
pain
and
reduces
fever.
Dextromethorphan hydrobromide
monohydrate
suppresses
coughing.
WHAT CHEMISTS’ OWN
COUGH,
COLD
&
FLU
RELIEF
TABLETS
ARE
USED FOR
Chemists’ Own Cough, Cold &
Flu
Relief
Tablets_ _
belong
to
a
group
of
medicines
for
the
treatment of symptoms of colds
and flu.
Your
doctor
or
pharmacist,
however,
may
have
recommended
Chemists’
Own
Cough, Cold & Flu Relief Tablets
for
another
purpose
not
listed
above.
Ask your doctor or pharmacist if
you
have
any
questions
about
why Chemists’ Own Cough, Cold
& Flu Relief Tablets have been
recommended you.
If you have any concerns, you
should
discuss
this
with
your
doctor or pharmacist.
This medicine is av

Produktens egenskaper

1
AUSTRALIAN PRODUCT INFORMATION – CHEMISTS’ OWN COUGH,
COLD & FLU RELIEF (PSEUDOEPHEDRINE HYDROCHLORIDE +
PARACETAMOL + DEXTROMETHORPHAN HYDROBROMIDE
MONOHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Pseudoephedrine hydrochloride + paracetamol + dextromethorphan
hydrobromide monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains the active ingredients: Paracetamol 500 mg,
Pseudoephedrine hydrochloride 30
mg and Dextromethorphan hydrobromide monohydrate 15 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Pale yellow film coated round plain tablet with a break bar on one
side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Provide temporary relief of nagging cough, fever, blocked noses, runny
noses, headaches, body aches,
pains, and discomfort associated with cold and flu.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULT AND CHILDREN 12 YEARS AND OVER:
One to two tablets three or four times a day
Duration of use: Chemists’ Own Cough, Cold & Flu Relief Tablets
should not be taken for more than
48 hours except on medical advice.
4.3
C
ONTRAINDICATIONS
Chemists’ Own Cough, Cold & Flu Relief Tablets are contraindicated
in patients:
2
•
With known sensitivity to paracetamol, pseudoephedrine,
dextromethorphan or any of the
other ingredients in the product
•
With hypersensitivity to the effects of other sympathomimetic drugs
•
With severe hypertension and/or severe coronary artery disease
•
With anaemia
•
With cardiac, renal or hepatic disease
•
With respiratory or pulmonary disease including asthma, obstructive
pulmonary disease or
breathing problems
•
Taking or within 14 days of ceasing administration of monoamine
oxidase inhibitors (MAOIs)
•
Taking anticoagulants
•
With alcohol dependence
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine should be used with caution in patients with
hypertension, hyperthyroidism,
diabetes mellitus, coronary heart disease, ischaemic heart disease,
glaucoma, p