产品特点
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
DHC Continus Prolonged-release Tablets 120 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Dihydrocodeine Tartrate 120 mg
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Prolonged release tablet.
White to off-white, capsule-shaped, biconvex tablet with DHC 120 on
one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an analgesic in the relief of moderate to severe pain.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Adults only
One tablet 12 hourly.
Elderly
Reduced dosage or increased intervals between doses may
be required.
Route of Administration
Oral.
4.3 CONTRAINDICATIONS
DHC CONTINUS tablets should not be used in
patients hypersensitive to the active ingredient or any
of the other
constituents of the product or in patients with respiratory
depression or obstructive airways disease. As dihydrocodeine
may cause the release of histamine it should not be given
during an attack of asthma. Patients with rare hereditary
problems of galactose intolerance, the Lapp lactase deficiency
or glucose-galactose malabsorption should not take this
medicine.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Prolonged use of high dosage may induce dependence with
a withdrawal syndrome on discontinuation. Repeated use
may result in
the development of tolerance. DHC CONTINUS tablets should
be used with great caution in patients
with a history of asthma. Opioid analgesics should be avoided in
patients with raised intracranial pressure or head
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 11/08/2005_
_CRN 2012566_
_page number: 1_
injury.
Reduced dosage or increased intervals between doses may
be required in patients with hypothyroidism and in those
with renal or hepatic dysfunction
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