Երկիր: Նոր Զելանդիա
Լեզու: անգլերեն
Աղբյուրը: Medsafe (Medicines Safety Authority)
Paracetamol 665mg;
AFT Pharmaceuticals Ltd
Paracetamol 665 mg
665 mg
Modified release tablet
Active: Paracetamol 665mg Excipient: Croscarmellose sodium Hypromellose Opadry II white 32F58900 Magnesium stearate Microcrystalline cellulose Povidone Pregelatinised maize starch
Blister pack, PVC/PvdC/AL, 48 tablets
Pharmacy only
Restricted
Farmson Pharmaceutical Gujarat Pvt Ltd
Relief of persistent pain associated with osteoarthritis
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
2011-03-03
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 Կարդացեք ամբողջական փաստաթուղթը