OXYCODONE ACTAVIS 10 Milligram Capsules Hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OXYCODONE HYDROCHLORIDE

Available from:

Actavis Group PTC ehf

ATC code:

N02AA05

INN (International Name):

OXYCODONE HYDROCHLORIDE

Dosage:

10 Milligram

Pharmaceutical form:

Capsules Hard

Prescription type:

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

Therapeutic area:

Natural opium alkaloids

Authorization status:

Authorised

Authorization date:

2013-02-01

Patient Information leaflet

AAAI5210
Oxycodone 5mg, 10mg, 20mg capsules, hard PIL - Ireland
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print proof no: 
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approved for print/date
Non Printing Colours
1. Black
2.
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6.
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2.
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date sent:
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TECHNICAL APPROVAL
AAAI5210
2
23.11.15
DR
16.06.16
DR
Dupnitsa
145x600
9pt
25.11.15
25.11.15 
OXYCODONE ACTAVIS 5 MG CAPSULES, HARD
OXYCODONE ACTAVIS 10 MG CAPSULES, HARD
OXYCODONE ACTAVIS 20 MG CAPSULES, HARD
Oxycodone hydrochloride
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 ACTAVIS IS 
AND WHAT IT IS USED FOR
2
  WHAT YOU NEED TO KNOW 
BEFORE YOU TAKE OXYCODONE 
ACTAVIS
3
  HOW TO TAKE OXYCODONE 
ACTAVIS
4
  POSSIBLE SIDE EFFECTS
5
  HOW TO STORE OXYCODONE 
ACTAVIS
6
  CONTENTS OF THE PACK AND 
OTHER INFORMATION
1

WHAT OXYCODONE ACTAVIS IS 
AND WHAT IT IS USED FOR
Oxycodone Actavis is a centrally acting,
strong painkiller from the group of
opioids.
Oxycodone Actavis is used to treat severe
pain, which can only be adequately
managed with opioid analgesics.
2

WHAT YOU NEED TO KNOW BEFORE 
YOU TAKE OXYCODONE ACTAVIS
DO NOT TAKE OXYCODONE ACTAVIS
•   if you are allergic to oxycodone
hydrochloride or any of the other
ingredients of this medicine (listed in
section 6).
•   if you suffer from severely depressed
breathing (respiratory depression)

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxycodone Actavis 10 mg capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10.0 mg oxycodone hydrochloride corresponding to
8.96 mg oxycodone.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard (capsule)
Hard capsules, 14.4 mm in length, with a white body marked with
‘10’ and a brown cap marked with ‘OXY’.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Severe pain, which can only be adequately managed with opioid
analgesics.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage depends on the intensity of pain and the patient’s
individual susceptibility to the treatment. The
followinggeneral dose recommendations apply:
Adults and adolescents over 12 years of age
_Dose initiation_
In general, the initial dose for opioid naïve patients is 5 mg
oxycodone hydrochloride given at intervals of 6
hours.Patients already receiving opioids may start treatment with
higher doses taking into account their experience
withformer opioid therapies.
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
should be noted that this is a guide to the dose
ofoxycodone hydrochloride capsules required. Inter-patient variability
requires that each patient is carefully titrated
tothe appropriate dose.
_Dose adjustment_
Increasing severity of pain will require an increased dose of
Oxycodone Actavis. The dose should be carefully titrated,
as frequently as once a day if necessary, to achieve pain relief. In
doing so, the dosing interval may be reduced to 4
hours.
The correct dose for any individual patient is that which controls the
pain and is well tolerated throughout the
dosingperiod.
The majority of patients will not require a daily dose greater than
400 mg. However, a few patients may require higher
doses.
In patients receiving a prolonged-release formulation o