OxyNorm 5 mg hard capsules

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

OXYCODONE HYDROCHLORIDE

Dostępny od:

Mundipharma Pharmaceuticals Limited

Kod ATC:

N02AA; N02AA05

INN (International Nazwa):

OXYCODONE HYDROCHLORIDE

Dawkowanie:

5 milligram(s)

Forma farmaceutyczna:

Capsule, hard

Typ recepty:

Product subject to prescription which may not be renewed (A)

Dziedzina terapeutyczna:

Natural opium alkaloids; oxycodone

Status autoryzacji:

Marketed

Data autoryzacji:

2000-04-28

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
_OXYNORM_
5 MG
,
10 MG AND 20 MG HARD CAPSULES
Oxycodone hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What
_OXYNORM_
is and what it is used for
2.
What you need to know before you take
_OXYNORM_
3.
How to take
_OXYNORM_
4.
Possible side effects
5.
How to store
_OXYNORM_
6.
Contents of the pack and other information
1.
WHAT _OXYNORM_
IS AND WHAT IT IS USED FOR
These capsules have been prescribed for you by your doctor to relieve
severe pain. They contain the active
ingredient oxycodone which is a strong analgesic (‘painkiller’)
that belongs to a group of medicines
called opioids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE _OXYNORM_
DO NOT TAKE _OXYNORM_
IF YOU:
•
are allergic (hypersensitive) to oxycodone or any of the other
ingredients of the capsules (listed in section
6 ‘Further information’) or have previously had an allergic
reaction when taking other strong analgesics
or painkillers (such as morphine or other opioids);
•
have breathing problems, such as severe chronic obstructive lung
disease, severe bronchial asthma or
severe respiratory depression. Symptoms may include breathlessness,
coughing or breathing more slowly
and weakly than expected;
•
have a head injury that causes a severe headache or makes you feel
sick. This is because the capsules may
make these symptoms worse or hide the extent of the head injury;
•
have a condition where the bowel does not work properly (paralytic
ileus), your stomach empties
mo

Charakterystyka produktu

Health Products Regulatory Authority
12 December 2023
CRN00CXPJ
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
OxyNorm 5 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 5 mg of oxycodone hydrochloride (equivalent to
4.5 mg of oxycodone base).
Excipient(s) with known effect:
Each 5 mg capsule contains 0.019 mg sunset yellow FCF (E110).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
_OXYNORM_ hard capsules 5 mg are orange/beige, printed ONR 5.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_OXYNORM_ capsules is indicated in adults and adolescents (from 12
years and older) for the treatment of severe pain, which can
be adequately managed only with opioid analgesics.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
If an immediate release opioid formulation is used as rescue
medication in addition to prolonged-release, the need for more
than two "rescues" per day could be an indication that the
prolonged-release dosage requires upward titration.
_ _
_Adults:_
_OXYNORM _capsules should be taken at 4-6 hourly intervals. The dose
should be adjusted to the intensity of the pain and the
sensitivity of the individual patient. The correct dosage per
individual patient is the lowest dose which sufficiently controls the
pain with no or tolerable side effects. The patient's previous history
of analgesic requirements should also be taken into
account when determining the dose.
The usual starting dose for debilitated elderly patients, opioid
naïve patients or patients presenting with severe pain
uncontrolled with weaker opioids is 5 mg 4-6 hourly. The dose should
then be carefully titrated, every day if necessary, to
achieve pain relief. Generally, the lowest effective dose for
analgesia should be selected. If higher doses are necessary,
increases should be made in 25-50% increments where possible. The
correct dosage for any individual patient is that which
controls the pain with no or tolerable side effects throughou