AMCAL STRONG PAIN RELIEF PLUS Paracetamol 500mg, codeine phosphate hemihydrate 10mg and Doxylamine succinate 5.1mg tablet bliste

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

codeine phosphate hemihydrate,doxylamine succinate,paracetamol

Available from:

Sigma Company Limited

INN (International Name):

codeine phosphate hemihydrate,doxylamine succinate,Paracetamol

Authorization status:

Registered

Patient Information leaflet

1
AMCAL STRONG PAIN RELIEF PLUS
Paracetamol 500mg and Codeine Phosphate Hemihydrate 10mg and
Doxylamine succinate 5.1mg Tablets
Consumer Medicine Information
Please read this information before you start taking this medicine
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about Amcal
Strong Pain Relief Plus Tablets.
It does not contain all the
available information. It does not
take the place of talking to your
doctor. All medicines have risks
and benefits. Your doctor has
weighed the risks of taking this
medicine against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO
YOUR DOCTOR.
Keep this leaflet with this
medicine.
You may need to read it again.
WHAT ARE AMCAL STRONG PAIN
RELIEF PLUS TABLETS USED FOR
The name of your medicine is
Amcal Strong Pain Relief Plus
Tablets.
It contains the active ingredients
paracetamol, codeine phosphate
hemihydrate & doxylamine
succinate.
Paracetamol, an analgesic with
antipyretic action also reduces
fever.
Doxylamine succinate is an
antihistamine with pronounced
sedative effects.
Codeine phosphate hemihydrate
is an analgesic, and in
combination with paracetamol
and doxylamine produces
greater analgesia than any of
these drugs alone and avoids the
side effects associated with large
doses of these components.
Amcal Strong Pain Relief Plus
Tablets are used to provide
effective temporary relief from
the pain and discomfort
associated with
•
neck and back pain,
•
headache
•
tension headache,
•
toothache,
•
backache,
•
migraine headache,
•
muscle pain,
•
nerve pain,
•
arthritis,
•
rheumatics,
•
osteoarthritis
•
period pain
•
symptoms of
-
cold,
-
sore throat,
-
flu
•
trauma
•
surgery
•
dental procedures
•
and other pain
where a combined calmative and
analgesic action is required.
It also reduces fever.
Your doctor may have
prescribed this medicine for
another reason.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
BEFORE YOU TA

Summary of Product characteristics

_Product Information _
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_Page 1 _
_Amcal Strong Pain Relief Plus Paracetamol 500mg, Codeine Phosphate
Hemihydrate 10mg and Doxylamine _
_Succinate 5.1mg _
_08/2015 _
_Sigma Company Ltd _
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_Version 03_
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PRODUCT INFORMATION
AMCAL STRONG PAIN RELIEF PLUS PARACETAMOL 500MG, CODEINE
PHOSPHATE HEMIHYDRATE 10MG AND DOXYLAMINE SUCCINATE
5.1MG TABLETS
NAME OF THE MEDICINE
Paracetamol 500mg, Codeine Phosphate Hemihydrate 10mg and Doxylamine
Succinate 5.1mg
PARACETAMOL:
CODEINE PHOSPHATE HEMIHYDRATE:
DOXYLAMINE SUCCINATE:
_Product Information _
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_Page 2 _
_Amcal Strong Pain Relief Plus Paracetamol 500mg, Codeine Phosphate
Hemihydrate 10mg and Doxylamine _
_Succinate 5.1mg _
_08/2015 _
_Sigma Company Ltd _
_ _
_Version 03_
_ _
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DESCRIPTION
Paracetamol is a white or almost white crystalline powder. It is
sparingly soluble in water, freely
soluble in alcohol, very slightly soluble in methylene chloride.
Paracetamol is an analgesic and
antipyretic.
Codeine Phosphate Hemihydrate is a white or almost white, crystalline
powder of small, colourless
crsytals. It is freely soluble in water, slightly soluble or very
slightly soluble in ethanol (96%).
Codeine Phosphate Hemihydrate is a cough suppressant and an analgesic.
Doxylamine succinate is a white or creamy white powder with a
characterisitc odour.
ACTIVES: Each tablet contains Paracetamol 500mg Codeine Phosphate
Hemihydrate 10mg and
Doxylamine Succinate 5.1mg.
EXCIPIENTS: Lactose, Starch-Maize, Povidone, Ethanol, Crospovidone,
Cellulose-microcrystalline,
Stearic acid, Magnesium Stearate.
PHARMACOLOGY
Paracetamol is an effective and fast acting analgesic that relieves
mild to moderate pain. It is
rapidly absorbed from the gastrointestinal tract with peak plasma
levels usually reached 30 to 60
minutes after oral administration. It also reduces fever by a direct
effect on the heat regulating
centres to increase dissipation of body heat.
Codeine Phosphate Hemihydrate is an effective oral analge