Paracetamol Osteo-Tab

Država: Novi Zeland

Jezik: engleski

Izvor: Medsafe (Medicines Safety Authority)

Aktivni sastojci:

Paracetamol 665mg;  

Dostupno od:

AFT Pharmaceuticals Ltd

INN (International ime):

Paracetamol 665 mg

Doziranje:

665 mg

Farmaceutski oblik:

Modified release tablet

Sastav:

Active: Paracetamol 665mg   Excipient: Croscarmellose sodium Hypromellose Opadry II white 32F58900 Magnesium stearate Microcrystalline cellulose Povidone Pregelatinised maize starch

Jedinice u paketu:

Blister pack, PVC/PvdC/AL, 48 tablets

Razred:

Pharmacy only

Tip recepta:

Restricted

Proizveden od:

Farmson Pharmaceutical Gujarat Pvt Ltd

Terapijske indikacije:

Relief of persistent pain associated with osteoarthritis

Proizvod sažetak:

Package - Contents - Shelf Life: Blister pack, PVC/PvdC/AL - 12 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PvdC/AL - 24 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PvdC/AL - 48 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PvdC/AL - 96 tablets - 36 months from date of manufacture stored at or below 25°C

Datum autorizacije:

2011-03-03

Svojstava lijeka

1
NEW ZEALAND DATA SHEET
PARACETAMOL OSTEO-TAB TABLETS 665 MG
1
NAME OF THE MEDICINE
Paracetamol Osteo-Tab
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Paracetamol 665 mg/tablet
Excipient with known effect: Lactose monohydrate (present in the film
coating Opadry II).
Excipients: For the full list of excipients, see section 6.1 List of
Excipients.
3
PHARMACEUTICAL FORM
White to off-white capsule shaped, film coated tablets. Embossed with
ML 77 on one side and plain
on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paracetamol Osteo-Tab 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
D
OSE AND METHOD OF ADMINISTRATION
Adults and children aged 12 years and over: 2 tablets swallowed whole
three times a day every 6 to
8 hours. Do not chew or suck, as it impairs the sustained release
properties. Maximum of 6 tablets in
24 hours.
Do not use for more than a few days at a time in adults except on
medical advice.
Not recommended for children under the age of 12 years.
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 tablets must
not be crushed, chewed or
sucked as it impairs the sustained release properties.
Do not exceed the stated dose.
2
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 for children 12 years of age to adults: 6 tablets.
4.3
C
ONTRAINDICATIONS
Contraindicated in patients with a previous history of
hyperse