OxyNorm Dispersa 20 mg orodispersible tablets

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

OXYCODONE HYDROCHLORIDE

থেকে পাওয়া:

Mundipharma Pharmaceuticals Limited

এটিসি কোড:

N02AA; N02AA05

INN (আন্তর্জাতিক নাম):

OXYCODONE HYDROCHLORIDE

ডোজ:

20 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Orodispersible tablet

প্রেসক্রিপশন টাইপ:

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

থেরাপিউটিক এলাকা:

Natural opium alkaloids; oxycodone

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

2010-07-16

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_OXYNORM_
_DISPERSA_
®
_ _5 MG, 10 MG AND 20 MG ORODISPERSIBLE TABLETS
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_
_DISPERSA _
tablets are and what they are used for
2.
What you need to know before you take
_OXYNORM DISPERSA _
tablets
3.
How to take
_OXYNORM DISPERSA _
tablets
4.
Possible side effects
5.
How to store
_OXYNORM DISPERSA _
tablets
6.
Contents of the pack and other information
1. WHAT _OXYNORM_ _DISPERSA _TABLETS ARE AND WHAT THEY ARE USED FOR
_OXYNORM DISPERSA_
is a strong analgesic or “painkiller” and belongs to the group of
opioids.
_OXYNORM _
_DISPERSA_
is used in adults and adolescents from 12 years and older for the
relief of severe pain, which can
be adequately managed only with opioid analgesics.
Orodispersible tablets are tablets which disintegrate rapidly in the
mouth before you swallow them.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE _OXYNORM DISPERSA _TABLETS
DO NOT TAKE _OXYNORM DISPERSA _TABLETS IF YOU:
•
are allergic (hypersensitive) to oxycodone or any of the other
ingredients of the tablets (listed in
section 6 of this leaflet) or have previously had an allergic reaction
when taking other strong
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 or weakly than expected;

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
06 March 2024
CRN00F4R6
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
OxyNorm Dispersa 20 mg orodispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 18 mg of oxycodone as 20 mg of oxycodone
hydrochloride.
Excipients with known effect:
Each 20mg tablet contains 10.8 mg of aspartame (E 951) and 56.8 mg of
sucrose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet.
White to off-white round, flat, bevelled edged tablets of
approximately 12 mm in diameter marked O on one side and 20 on
the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_OXYNORM DISPERSA_ is indicated in adults andadolescents (from 12
years and older) for the treatment of severe pain, whichcan
be adequately managed only with opioid analgesics.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Prescribers should consider concomitant treatment with antiemetics and
laxatives for the prevention of nausea, vomiting and
constipation. The correct dosage per individual patient is the lowest
dose which sufficiently controls the pain with no
ortolerable side effects.
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 DISPERSA_ 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 patient's previous history
of analgesic requirements, their body weight, and sex (higher
plasma concentrations are produced in females), should also be taken
into account when determining the dose.
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 per
individual patient is that which controls the pain w