Ibucode Plus

Држава: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Codeine phosphate hemihydrate 12.8mg; Ibuprofen 200mg

Доступно од:

Teva Pharma (New Zealand) Limited

INN (Међународно име):

Codeine phosphate hemihydrate 12.8 mg

Дозирање:

200mg/12.8mg

Фармацеутски облик:

Film coated tablet

Састав:

Active: Codeine phosphate hemihydrate 12.8mg Ibuprofen 200mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Microcrystalline cellulose Opadry white OY-58900 Purified water Starch

Јединице у пакету:

Blister pack, Alu-PVC/PVdC, 12 tablets

Класа:

Restricted

Тип рецептора:

Prescription

Произведен од:

GlaxoSmithKline Australia Pty Ltd

Резиме производа:

Package - Contents - Shelf Life: Blister pack, Alu-PVC/PVdC - 12 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Alu-PVC/PVdC - 20 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Alu-PVC/PVdC - 24 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, Alu-PVC/PVdC - 30 tablets - 36 months from date of manufacture stored at or below 30°C

Датум одобрења:

2010-03-10

Карактеристике производа

Version 1.2
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Ibucode Plus, film coated tablets, 200 mg/12.8 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 200 mg of ibuprofen and 12.8 mg
codeine phosphate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White to off white caplet-shaped, film coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The
temporary
relief
of
strong
pain
and/or
inflammation
associated
with
headache
(including
migraine and tension headache), period pain, dental pain, back pain,
neuralgia, rheumatic and arthritic
pain, muscular pain.
4.2
DOSE AND METHOD OF ADMINISTRATION
_Adults and children 12 years and over: _
Initial dose two tablets taken with fluid, then one or two tablets
every 4 to 6 hours as necessary.
Maximum 6 tablets in a 24-hour period.
_Children aged less than 12 years: _
Ibucode Plus is not indicated for use in children under 12 years of
age.
SPECIAL POPULATIONS
_Elderly _
No specific dosage recommendations are required unless renal or
hepatic function is impaired, in
which case dosage should be assessed individually.
Do not use for more than 3 days at a time, except on doctor’s
advice. The recommended dose should
not be exceeded. Excessive use can be harmful. Codeine use can cause
addiction.
4.3
CONTRAINDICATIONS
Ibucode Plus is contraindicated in the following conditions:
Known hypersensitivity to ibuprofen, codeine or other opioid
analgesics, or any of the excipients.
Patients who have previously shown hypersensitivity reactions (eg,
asthma, rhinitis, angioedema,
bronchospasm or urticaria) in response to ibuprofen, acetylsalicylic
acid (aspirin) or other non-
steroidal anti-inflammatory drugs (NSAIDs).
Active, or a history of recurrent peptic ulcer/haemorrhage (two or
more distinct episodes of proven
ulceration or bleeding). As with other NSAIDs, ibuprofen should not be
used in active
gastrointestinal bleeding or in the presence of peptic ulceration.
Respiratory depression, chronic constipation and active alc