Panafen Plus

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Codeine phosphate hemihydrate 12.8mg;  ; Ibuprofen 200mg

Available from:

Haleon New Zealand ULC

INN (International Name):

Codeine phosphate hemihydrate 12.8 mg

Dosage:

200mg, 12.8mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Codeine phosphate hemihydrate 12.8mg   Ibuprofen 200mg Excipient: Cellactose 80 Colloidal silicon dioxide Hydrogenated vegetable oil Hypromellose Macrogol 400 Microcrystalline cellulose Sodium starch glycolate

Units in package:

Blister pack, PVC/Al foil,, 15 tablets

Class:

Restricted

Prescription type:

Prescription

Manufactured by:

GlaxoSmithKline Australia Pty Ltd

Therapeutic indications:

Panafen Plus is indicated for the temporary relief of strong pain and discomfort associated with migraine headache, tension headache, period pain, toothache, cold & flu symptoms, back or muscular pain, arthritis and neuralgia. Reduces fever.

Product summary:

Package - Contents - Shelf Life: Blister pack, child resistant senior friendly 200 ?m PVC/20 ?m aluminium foil/8 ?m PET - 15 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, child resistant senior friendly 200 ?m PVC/20 ?m aluminium foil/8 ?m PET - 30 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2004-01-08

Patient Information leaflet

PANAFEN
® PLUS
_Ibuprofen 200 mg and Codeine Phosphate 12.8 mg _
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 PANAFEN PLUS.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your pharmacist or doctor
has weighed the risks of you taking
PANAFEN PLUS against the
benefits this medicine is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
PHARMACIST OR DOCTOR.
KEEP THIS LEAFLET WITH THE MEDICINE.
YOU MAY NEED TO READ IT AGAIN.
WHAT PANAFEN PLUS
IS USED FOR
This medicine is for the short term
treatment of acute moderate pain
when other pain killers have not
worked.
You should only take this product for
a
MAXIMUM OF 3 DAYS
at a time. If
you need to take it for longer than 3
days, you should see
YOUR DOCTOR
for
advice.
This medicine
CONTAINS CODEINE
which
CAN CAUSE ADDICTION
if you
take it continuously for
MORE THAN 3
DAYS
.
PANAFEN PLUS caplets contain the
active ingredients ibuprofen and
codeine phosphate. Ibuprofen
belongs to a family of medicines
called non-steroidal anti-
inflammatory drugs (NSAIDS).
These medicines work by relieving
pain, inflammation (swelling,
redness, soreness) and fever.
Codeine is an opioid analgesic that
works in the brain and spinal cord to
relieve pain.
PANAFEN PLUS relieves strong
pain and discomfort associated with
migraine or tension headache, period
pain, toothache, cold & flu
symptoms, back or muscular pain,
arthritis and neuralgia. It also
reduces any fever associated with
these pain conditions.
PANAFEN PLUS should not be used
in children under the age of 18 years.
Your doctor or pharmacist may have
given you this medicine for another
use.
IF YOU NEED MORE INFORMATION ASK
YOUR DOCTOR OR PHARMACIST.
DO NOT USE USE
PANAFEN PLUS IF
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE PANAFEN PLUS IF
YOU ARE UNDER THE AGE OF 18 YE

Summary of Product characteristics

PANAFEN
® PLUS – Data Sheet
Page 1 of 14
NEW ZEALAND DATASHEET
1.
NAME OF MEDICINE
PANAFEN ®
PLUS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients:
Ibuprofen 200 mg, codeine phosphate 12.8 mg
3.
PHARMACEUTICAL FORM
Ibuprofen
Chemical name: 2-(4-isobutylphenyl) propionic acid
Molecular formula: C
13
H
18
O
2
MW: 206.3
CAS: 15687-27-1
Ibuprofen is a white or almost white powder or crystals with a
characteristic odour.
Practically insoluble in water, soluble 1 in 1.5 of alcohol, 1 in 1 of
chloroform, 1 in 2 of
ether and 1 in 1.5 of acetone; soluble in aqueous solutions of alkali
hydroxides and
carbonates.
Codeine phosphate.
Chemical name: (5R,6S)-7, 8-didehydro-4,5- epoxy-3-methoxy-N-
methylmorphinan-
6-ol dihydrogen orthophosphate hemihydrate
Molecular formula: C
18
H
21
NO
3
H
3
PO
4.
½H
2
O MW: 406.4
CAS: 41444-62-6
Codeine phosphate is a small, colourless, odourless crystal or a
white, odourless
crystalline powder. It is soluble in four parts water, slightly
soluble in ethanol (96%),
practically insoluble in chloroform and ether.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The temporary relief of strong pain and discomfort associated with
migraine headache,
tension headache, period pain, toothache, cold & flu symptoms, back or
muscular pain,
PANAFEN
® PLUS – Data Sheet
Page 2 of 14
arthritis and neuralgia. Reduces fever.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
18 years - Adults
Initial dose: 2 caplets taken with fluid, then 1 or 2 caplets every
four hours when
necessary. Maximum: 6 caplets in a 24 hour period.
Children (under 18 years)
Must not be used in patients under 18 years.
Do not exceed the stated dose.
Should not be used with other ibuprofen, NSAID or codeine-containing
products.
Minimum dosing interval: 4 hours
Maximum duration of continued use without medical advice: 3 days
If symptoms persist or worsen, medical advice must be sought.
Panafen Plus should not be used for more than 3 days at a time unless
on medical
advice, in which case the patient should be reviewed regula