Ibucode Plus

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Codeine phosphate hemihydrate 12.8mg; Ibuprofen 200mg

Available from:

Teva Pharma (New Zealand) Limited

INN (International Name):

Codeine phosphate hemihydrate 12.8 mg

Dosage:

200mg/12.8mg

Pharmaceutical form:

Film coated tablet

Composition:

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

Units in package:

Blister pack, Alu-PVC/PVdC, 12 tablets

Class:

Restricted

Prescription type:

Prescription

Manufactured by:

GlaxoSmithKline Australia Pty Ltd

Product summary:

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

Authorization date:

2010-03-10

Summary of Product characteristics

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