Panadol Osteo

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Paracetamol 665mg;  ;  ;  ;  ; Paracetamol 665mg; Paracetamol 665mg

Available from:

Haleon New Zealand ULC

INN (International Name):

Paracetamol 665 mg

Dosage:

665 mg

Pharmaceutical form:

Modified release tablet

Composition:

Active: Paracetamol 665mg         Excipient: Carnauba wax Croscarmellose sodium Hypromellose   glycerol triacetate Magnesium stearate Povidone Pregelatinised maize starch Stearic acid Active: Paracetamol 665mg Excipient: Carnauba wax Croscarmellose sodium Hypromellose   glycerol triacetate Magnesium stearate Povidone Pregelatinised maize starch Stearic acid Active: Paracetamol 665mg Excipient: Carnauba wax Croscarmellose sodium Hypromellose   Glycerol triacetate Magnesium stearate Povidone Pregelatinised maize starch Stearic acid

Units in package:

Blister pack, Sample pack, PVC/Al foil, 6 tablets

Class:

Pharmacy only

Prescription type:

Restricted

Manufactured by:

Novacyl (Wuxi) Pharmaceutical Co Ltd

Therapeutic indications:

PANADOL OSTEO is effective for the relief of persistent pain associated with osteoarthritis and muscle aches and pains such as backache. PANADOL OSTEO also provides effective, temporary relief of pain and discomfort associated with headache, tension headache, period pain, toothache and pain after dental procedures, and cold & flu. Reduces fever.

Product summary:

Package - Contents - Shelf Life: Blister pack, 35 gsm Glassine paper CRSF lid foil - 6 tablets - 4 years from date of manufacture stored at or below 30°C - Blister pack, Child resistant 200 ?m PVC/20 ?m Aluminium foil/8 ?m PET - 6 tablets - 4 years from date of manufacture stored at or below 30°C - Blister pack, Child resistant 200 ?m PVC/20 ?m Aluminium foil/8 ?m PET - 12 tablets - 4 years from date of manufacture stored at or below 30°C - Blister pack, 35 gsm Glassine paper CRSF lid foil - 12 tablets - 4 years from date of manufacture stored at or below 30°C - Blister pack, 35 gsm Glassine paper CRSF lid foil - 96 tablets - 4 years from date of manufacture stored at or below 30°C - Blister pack, Child resistant 200 ?m PVC/20 ?m Aluminium foil/8 ?m PET - 96 tablets - 4 years from date of manufacture stored at or below 30°C

Authorization date:

2006-09-25

Patient Information leaflet

PANADOL OSTEO
1
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 T

Summary of Product characteristics

NEW ZEALAND DATA SHEET
PANADOL OSTEO – Data Sheet
Page 1 of 9
1.
PRODUCT NAME
PANADOL OSTEO modified-release tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient_:
Paracetamol (BP) 665 mg/tablet
_Excipients_:
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated, bi-layer capsule-shaped tablets.
White to off-white tablets with flat edges. Embossed with the logo
“8” on the front face and plain
on the back face. Tablet cannot be halved.
4.
CLINICAL PARTICULARS
4.1 Therapeutic indications
PANADOL OSTEO is effective for the relief of persistent pain
associated with osteoarthritis and
muscle aches and pains such as backache. PANADOL OSTEO also provides
effective, temporary
relief of pain and discomfort associated with headache, tension
headache, period pain, toothache
and pain after dental procedures, and cold & flu. 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. 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.
Should not be used for more than 48 hours for children 12 – 17
except on medical advice.
Take with water or other fluid. Do not chew or suck, as it impairs the
sustained release properties.
Can be taken with or without food.
Doses should be equally spaced throughout the day. Minimum dosing
interval 6 hours.
The caplets must not be crushed.
Do not exceed the stated dose.
NEW ZEALAND DATA SHEET
PANADOL OSTEO – Data Sheet
Page 2 of 9
The lowest dose necessary to achieve efficacy should be used with the
shortest duration of
treatment.
Minimum dosing interval: 6 hours
Should not be used with other paracetamol-containing products.
4.3
Contraindications
This
product
is
contraindicated
in
patients
with
a
previous
history
of
hypersensitivity
to
paracetamol or any of the excipients.
4.4
Special warnings and