Oxycodone hydrochloride Rowex 10 mg Hard capsules

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

OXYCODONE HYDROCHLORIDE

제공처:

Rowex Ltd

ATC 코드:

N02AA; N02AA05

INN (International Name):

OXYCODONE HYDROCHLORIDE

복용량:

10 milligram(s)

약제 형태:

Capsule, hard

처방전 유형:

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

치료 영역:

Natural opium alkaloids; oxycodone

승인 상태:

Not marketed

승인 날짜:

2017-12-08

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OXYCODONE HYDROCHLORIDE ROWEX 5 MG HARD CAPSULES
OXYCODONE HYDROCHLORIDE ROWEX 10 MG HARD CAPSULES
OXYCODONE HYDROCHLORIDE ROWEX 20 MG HARD CAPSULES
oxycodone hydrochloride
For use in adults and adolescents aged 12 years and older
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 Oxycodone hydrochloride Rowex is and what it is used for
2.
What you need to know before you take Oxycodone hydrochloride Rowex
3.
How to take Oxycodone hydrochloride Rowex
4.
Possible side effects
5.
How to store Oxycodone hydrochloride Rowex
6.
Contents of the pack and other information
1.
WHAT OXYCODONE HYDROCHLORIDE ROWEX IS AND WHAT IT IS USED FOR
Oxycodone hydrochloride Rowex contains the active substance oxycodone
hydrochloride which is a
strong painkiller of the group of opioids.
Oxycodone hydrochloride Rowex is used in adults and adolescents aged
12 years and older to treat severe
pain which can be adequately managed only with opioid analgesics.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OXYCODONE HYDROCHLORIDE ROWEX
DO NOT TAKE OXYCODONE HYDROCHLORIDE ROWEX IF YOU
•
are allergic to oxycodone hydrochloride or any of the other
ingredients of this medicine (listed in
section 6)
•
have breathing problems, such as severely depressed breathing
(respiratory depression), severe
chronic obstructive lung disease, or severe bronchial asthma. Symptoms
may include breathlessness,
coughing or breathing more slowly or weakly than expected.
•
have elevated carbon dioxide

제품 특성 요약

Health Products Regulatory Authority
25 March 2024
CRN00F50W
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxycodone hydrochloride Rowex 10 mg Hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 10 mg oxycodone hydrochloride, equivalent
to 8.96 mg oxycodone.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Hard capsules of 14.4 mm in length with a white body imprinted with 10
and a brown cap imprinted with OXY.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Severe pain, which can be adequately managed only with opioid
analgesics.
Oxycodone hydrochloride Rowex is indicated in adults and adolescents
of 12 years and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose depends on the intensity of pain and the patient's individual
response to the treatment. In general, the lowest
effective analgesic dose should be chosen. The following general dose
recommendations apply:
_Adults and adolescents (12 years of age and older)_
_Starting dose_
In general, the initial dose for opioid naïve patients is 5 mg
oxycodone hydrochloride at intervals of 6 hours. Patients already
receiving opioids may start treatment with higher doses (under
consideration of their experience with former opioid therapies).
In patients who have received oral morphine prior to oxycodone
therapy, the daily dose is based on the fact that 10 to 13 mg
of oral oxycodone hydrochloride are equivalent to approximately 20 mg
of oral morphine sulphate. It should be noted that this
is a guideline value for the required dose of hard capsules containing
oxycodone hydrochloride. Treatment should be titrated
to the adequate dose on an individual basis for each patient due to
the inter-individual variability.
_Dose adjustment_
The dose should be increased with increasing pain intensity. If
necessary, it should be carefully titrated, as frequent as once a
day if necessary, to achieve adequate pain relief. The dose interval
can simultaneously be redu