OXYNORM 10MG CAPSULE,HARD

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

OXYCODONE HYDROCHLORIDE

Διαθέσιμο από:

MUNDIPHARMA PHARMACEUTICALS LTD (0000003104) 13 OTHELLOS STR, NICOSIA, 1685, 23661

Φαρμακολογική κατηγορία (ATC):

N02AA05

INN (Διεθνής Όνομα):

OXYCODONE

Δοσολογία:

10MG

Φαρμακοτεχνική μορφή:

CAPSULE,HARD

Σύνθεση:

OXYCODONE HYDROCHLORIDE (0000124903) 10MG BASE

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

OXYCODONE

Περίληψη προϊόντος:

Νομικό καθεστώς: Με Ιατρική Συνταγή σύμφωνα με την Περί Ναρκωτικών Φαρμάκων και Ψυχοτρόπων Ουσιών Νομοθεσία; PACK WITH 56 CAPS IN BLISTER(S) (260012501) 56 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή σύμφωνα με την Περί Ναρκωτικών Φαρμάκων και Ψυχοτρόπων Ουσιών Νομοθεσία

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
OxyNorm 10 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITIOIN
Each capsule contains 9 mg oxycodone as 10 mg of oxycodone
hydrochloride.
For excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsule, hard.
OxyNorm capsules 10 mg are white/beige, printed ONR 10.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of moderate to severe pain in patients with cancer
and
post-operative pain. For the treatment of severe pain requiring the
use of a strong
opioid.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration:
Oral
In common with other strong opioids, the need for continued treatment
should be
assessed at regular intervals.
Elderly and adults over 18 years:
OXYNORM capsules should be taken at 4-6 hourly intervals. The dosage
is dependent
on the severity of the pain, and the patients previous history of
analgesic requirements.
Increasing severity of pain will require an increased dosage of
OxyNorm capsules.
The correct dosage for any individual patient is that which controls
the pain and is well
tolerated throughout the dosing period. Patients should be titrated to
pain relief unless
unmanageable adverse drug reactions prevent this.
The usual starting dose for opioid naive patients or patients
presenting with severe pain
uncontrolled by weaker opioids is 5 mg, 4-6 hourly. The dose should
then be carefully
titrated, as frequently as once a day if necessary, to achieve pain
relief. The majority of
patients will not require a daily dose greater than 400 mg. However, a
few patients may
require higher doses.
SPCONC02v2.02a
Patients receiving oral morphine before oxycodone therapy should have
their daily dose based
on the following ratio: 10 mg of oral oxycodone is equivalent to 20 mg
of oral morphine. It
must be emphasised that is a quide to the dose of OXYNORM capsules
required. Inter-patient
variability requires that each patient is carefully titrated to the
appropriate dose.
Controlled pharmacokinetic studies in elderly pa