Panadeine Caplets

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Codeine phosphate hemihydrate 8mg;  ; Paracetamol 500mg (fine);  ;  

Dostępny od:

GlaxoSmithKline NZ Limited

INN (International Nazwa):

Codeine phosphate hemihydrate 8 mg

Dawkowanie:

500mg/8mg

Forma farmaceutyczna:

Tablet

Skład:

Active: Codeine phosphate hemihydrate 8mg   Paracetamol 500mg (fine)     Excipient: Carnauba wax Hypromellose Maize starch Methylcellulose Opadry blue 03B50817 Potassium sorbate Povidone Purified talc Starch Stearic acid Titanium dioxide Triacetin Water

Sztuk w opakowaniu:

Blister pack, 1 x 12 (not marketed), 12 tablets

Klasa:

Pharmacy only

Typ recepty:

Pharmacy only

Wyprodukowano przez:

Tasmanian Alkaloids Pty Ltd

Podsumowanie produktu:

Package - Contents - Shelf Life: Blister pack, - 12 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 16 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 24 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 48 tablets - 36 months from date of manufacture stored at or below 30°C

Data autoryzacji:

1995-01-19

Charakterystyka produktu

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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.
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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