PHARMACY ACTION PARACETAMOL OSTEO 665 paracetamol 665 mg modified release tablet blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

paracetamol, Quantity: 665 mg

から入手可能:

Lupin Australia Pty Limited

医薬品形態:

Tablet, modified release

構図:

Excipient Ingredients: hypromellose; magnesium stearate; microcrystalline cellulose; silicon dioxide; povidone; pregelatinised maize starch; purified water; croscarmellose sodium; titanium dioxide; macrogol 6000

投与経路:

Oral

パッケージ内のユニット:

96

処方タイプ:

(S3) Pharmacist Only Medicine

適応症:

Pharmacy Action Paracetamol Osteo provides effective relief from persistent pain for up to 8 hours. Effective for the relief of persistent pain associated with osteoarthritis and muscular aches and pains such as backache. Provides effective temporary relief of pain and discomfort associated with: headache, tension headache, cold and flu, period pain, toothache and pain after dental procedures. Reduces fever.

製品概要:

Visual Identification: White to off-white film coated capsule shaped biconvex tablets debossed with ?PT? on one side and ?665? on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

認証ステータス:

Registered

承認日:

2018-05-09

情報リーフレット

CONSUMER MEDICINE INFORMATION
PHARMACY ACTION PARACETAMOL
OSTEO 665
(PARACETAMOL) MODIFIED RELEASE TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
PHARMACY ACTION
Paracetamol Osteo 665. 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.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE,
ASK YOUR PHARMACIST OR
DOCTOR.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to
read it again.
WHAT PHARMACY
ACTION OSTEO 665 IS
USED FOR
PHARMACY ACTION
Paracetamol Osteo 665 is
effective for the relief of
persistent pain associated with:
•
Osteoarthritis.
•
Muscle aches and pains such
as backache.
Paracetamol, the active
ingredient in this medicine, is
also used for the fast-effective
temporary relief of pain and
discomfort associated with:
•
headache;
•
tension headache;
•
period pain;
•
toothache and pain after
dental procedures;
•
colds and flu.
Paracetamol also reduces fever.
Paracetamol works to stop the
pain messages from getting
through to the brain. It also acts
in the brain to reduce fever.
ASK YOUR PHARMACIST OR
DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT THIS
MEDICINE. Your pharmacist or
doctor may have recommended
it for another reason.
BEFORE YOU TAKE
PHARMACY ACTION
OSTEO 665
Do not take more than the
recommended dose as it may
cause serious harm to your liver.
_WHEN YOU MUST NOT TAKE IT _
DO NOT USE PHARMACY
ACTION PARACETAMOL OSTEO
665 IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
paracetamol;
•
any of the ingredients listed
at the end of this leaflet.
Do not take this medicine if you
are taking other prescription or
non- prescription medicines
containing paracetamol to treat
pain, fever, symptoms of cold
and flu, or to aid sleep.
ALWAYS READ AND FOLLOW THE
LABEL.
DO NOT USE THIS MEDICINE AFTER
THE EXPIRY DATE PRINTED ON THE
PACK OR IF THE PACKAGING IS
TORN OR SHOWS SIGNS OF
TAMPERING.
If it has expired or is damaged,
return it to your pharmacist for
d

製品の特徴

AUSTRALIAN PRODUCT INFORMATION – PHARMACY ACTION
PARACETAMOL OSTEO 665
(PARACETAMOL) MODIFIED RELEASE TABLETS
1
NAME OF THE MEDICINE
Paracetamol.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pharmacy Action Paracetamol Osteo 665 modified release tablets contain
665 mg of paracetamol. _ _
_ _
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Pharmacy Action Paracetamol 665 modified release tablets are white to
off-white film coated capsule
shaped biconvex tablets debossed with “PT” on one side and
“665” on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pharmacy Action Paracetamol Osteo provides effective relief from
persistent pain for up to 8 hours.
Effective for the relief of persistent pain associated with
osteoarthritis and muscular aches and pains
such as backache. Provides effective temporary relief of pain and
discomfort associated with: headache,
tension headache, cold and flu, period pain, toothache and pain after
dental procedures. Reduces fever.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN AGED 12 YEARS AND OVER: Two tablets swallowed
whole 3 times a day every 6 to 8
hours. Do not chew or suck, as it impairs the sustained release
properties. Maximum of 6 tablets in 24
hours.
Do not use for more than a few days at a time in adults except on
medical advice.
CHILDREN UNDER 12 YEARS: Not recommended for children under the age of
12 years.
Should not be used for more than 48 hours for children aged 12–17
years except on medical advice.
Take with water or other fluid. Can be taken with or without food.
Doses should be equally spaced throughout the day. The tablets must
not be crushed.
Do not exceed the stated dose.
PA Paracetamol Osteo 665 PI v 3.0
(paracetamol) modified release tablets
Page 2 of 10
The lowest dose necessary to achieve efficacy should be used for the
shortest duration of treatment.
Should not be used with other paracetamol-containing products.
MINIMUM DOSING INTERVAL: 6 hours.
MAXIMUM DAILY DOSE: 4000 mg.
4.3