Panadeine

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Codeine phosphate hemihydrate 8mg;  ; Paracetamol 500mg;  ;  

Disponível em:

Haleon New Zealand ULC

DCI (Denominação Comum Internacional):

Codeine phosphate hemihydrate 8 mg

Dosagem:

500mg/8mg

Forma farmacêutica:

Tablet

Composição:

Active: Codeine phosphate hemihydrate 8mg   Paracetamol 500mg     Excipient: Maize starch Potassium sorbate Povidone Pregelatinised maize starch Purified talc Stearic acid

Unidades em pacote:

Blister pack, (not marketed), 12 tablets

Classe:

Restricted

Tipo de prescrição:

Prescription

Fabricado por:

Tasmanian Alkaloids Pty Ltd

Resumo do produto:

Package - Contents - Shelf Life: Blister pack, Child resistant 200 ?m PVC/20 ?m Aluminium foil/8 ?m PET - 12 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Child resistant 200 ?m PVC/20 ?m Aluminium foil/8 ?m PET - 24 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Dispensing pack, Child resistant 200 ?m PVC/20 ?m Aluminium foil/8 ?m PET - 40 tablets - 36 months from date of manufacture stored at or below 30°C

Data de autorização:

1969-12-31

Folheto informativo - Bula

PANADEINE
®
1
PANADEINE
®
_Paracetamol 500mg and Codeine phosphate 8mg _
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 Panadeine. 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 doctor or pharmacist
has weighed the risks of you taking
Panadeine against the benefits this
medicine is expected to have for you.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS PANADEINE
USED FOR
Panadeine provides effective
temporary relief from strong pain and
discomfort associated with headache,
muscle pain, period pain, arthritis,
neuralgia, migraine headache, cold &
flu, tension headache, back pain and
toothache. Panadeine also reduces
fever.
Panadeine contains paracetamol and
codeine phosphate.
Paracetamol and codeine phosphate
are analgesics. They provide
effective temporary relief from pain.
Other uses
Panadeine is only registered for the
uses listed above. However, your
doctor or pharmacist may
recommend this medicine for another
use.
IF YOU WANT MORE INFORMATION, ASK
YOUR DOCTOR OR PHARMACIST.
DO NOT USE PANADEINE
IF
•
YOU ARE ALLERGIC TO PARACETAMOL
CODEINE OR OTHER OPIOID PAIN
KILLERS OR ANY OF THE INGREDIENTS
LISTED UNDER "PRODUCT
DESCRIPTION". THE SYMPTOMS OF
AN ALLERGIC REACTION MAY INCLUDE
A RASH, ASTHMA ATTACK OR HAY
FEVER.
•
YOU ARE UNDER 18 YEARS OF AGE
BECAUSE OF THE RISK OF OPIOID
TOXICITY DUE TO THE
UNPREDICTABLE METABOLISM OF
CODEINE TO MORPHINE
•
YOU ARE TAKING ANY OTHER
MEDICINES CONTAINING
PARACETAMOL OR CODEINE.
•
YOU ARE PREGNANT UNLESS
ADVISED BY YOUR DOCTORYOU ARE
BREASTFEEDING, UNLESS ON YOUR
DOCTOR'S ADVICE. THE USE OF
CODEINE CONTAINING PRODUCTS
WHILST BREASTFEEDING MAY HARM
YOUR BABY.
•
YOU HAVE BEEN TOLD BY YOUR
DOCTOR THAT YOU BREAKDOWN
CODEINE RAPIDLY SINCE THE
FOLLOWING SIDE EFFECTS MAY
DEVELOP: FEELING SICK, VOMITTING,
CONS

Características técnicas

Page
1
of
9
NEW ZEALAND DATA SHEET
1. NAME OF MEDICINE
Panadeine
®
Tablets / Caplets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol 500mg, Codeine Phosphate 8mg
3. PHARMACEUTICAL FORM
ACTIVE INGREDIENTS
CHEMICAL STRUCTURE
CAS REGISTRY
NUMBER
Paracetamol
103-90-2
Codeine Phosphate
41444-62-6
TABLETS: Flat, round white 1.27cm tablet with bevelled edges. Front
face marking
“PANADEINE” with a break bar on the back face
CAPLETS: white, uncoated capsule-shaped tablets, marked Panadeine with
break-bar
on the back face
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the temporary relief of pain and discomfort associated with
•
Headache
•
Arthritis
•
Migraine headache
•
Toothache
•
Tension headache
•
Neuralgia
•
Period pain
•
Cold & flu symptoms
•
Back pain
•
Dental procedures
•
Muscle pain
•
Sore throat
Reduces fever.
Page
2
of
9
4.2 DOSAGE AND ADMINISTRATION
18 YEARS - ADULTS:
2 tablets/caplets – to be taken with water four to six hours if
necessary. Maximum 8
tablets/caplets in 24 hours. Do not use in children aged below 18
years.
Do not exceed the stated dose or take for more than three days without
a doctors
advice.
If symptoms persist or worsen medical advice must be sought.
Should not be used with other paracetamol or codeine-containing
products.
Must not be used in children under 18 years.
4.3 CONTRAINDICATIONS
•
Previous history of hypersensitivity to paracetamol, codeine, opioid
analgesics, or excipients.
•
Active alcoholism
•
Acute respiratory depression
•
In mothers who are breastfeeding.
•
Under the age of 18 years.
•
Those who are known to be CYP2D6 ultra-rapid metabolisers. If the
patient is an extensive or ultra-rapid CYP2D6 metaboliser there is an
increased risk of developing symptoms of opioid toxicity, even at
commonly prescribed doses. General symptoms of opioid toxicity include
confusion, somnolence, shallow breathing, small pupils, nausea,
vomiting,
constipation and lack of appetite. In severe cases this may include
symptoms of circulatory a