PANADOL OSTEO paracetamol 665mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

paracetamol, Quantity: 665 mg

Available from:

Haleon Australia Pty Ltd

INN (International Name):

Paracetamol

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: hypromellose; pregelatinised maize starch; triacetin; Carnauba Wax; magnesium stearate; croscarmellose sodium; povidone; stearic acid

Administration route:

Oral

Units in package:

96 tablets, 48 tablets, 6 tablets, 36 tablets, 18 tablets, 24 tablets, 12 tablets

Prescription type:

(S2) Pharmacy Medicine

Therapeutic indications:

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.

Product summary:

Visual Identification: White to off-white film coated capsule shaped tablets with flat edges. Embossed with the logo "8" on the front face and plain on the back face.; Container Type: Blister Pack; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2005-02-17

Patient Information leaflet

PANADOL
® OSTEO
_665 mg Paracetamol_
CONSUMER MEDICINE INFORMATION
_PLEASE READ THIS INFORMATION BEFORE YOU START USING THIS MEDICINE._
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PANADOL OSTEO.
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 PANADOL
OSTEO IS USED FOR
PANADOL OSTEO 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 USE
PANADOL OSTEO
Do not take more than the
recommended dose as it may cause
serious harm to your liver.
_WHEN YOU MUST NOT USE IT_
DO NOT USE PANADOL OSTEO 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 disposal.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START USING THIS MEDICINE,
TA

Summary of Product characteristics

PRODUCT INFORMATION
PANADOL OSTEO
1.
NAME OF THE MEDICINE
Paracetamol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _
_Paracetamol 665 mg _
_ _
Chemical structure:
ACTIVE INGREDIENTS
CHEMICAL STRUCTURE
CAS REGISTRY
NUMBER
Paracetamol
103-90-2
_Excipients: _
For the full list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
White to off-white film coated capsule shaped tablets with flat edges.
Embossed
with the logo “8” on the front face and plain on the back face.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PANADOL 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: 2 caplets swallowed whole
three times a
day every 6 to 8 hours. Do not chew or suck, as it impairs the
sustained relese
properties. Maximum of 6 caplets 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.
Page 1 of 9
PANADOL OSTEO – Product Information
Page 2 of 9
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 caplets must not be crushed.
Do not exceed the stated dose.
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
CONTRAINDICATIONS
Contraindicated in patients with a previous history of
hypersensitivity to paraceta