RELTEBON 80 Milligram Tablet Prolonged Release

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:

80 Milligram

Pharmaceutical form:

Tablet Prolonged Release

Prescription type:

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

Therapeutic area:

Natural opium alkaloids

Authorization status:

Authorised

Authorization date:

2014-08-08

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Reltebon 5 mg prolonged-release tablets
Reltebon 10 mg prolonged-release tablets
Reltebon 20 mg prolonged-release tablets
Reltebon 40 mg prolonged-release tablets
Reltebon 80 mg prolonged-release 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 Reltebon is and what it is used for
2.
What you need to know before you take Reltebon
3.
How to take Reltebon
4.
Possible side effects
5.
How to store Reltebon
6.
Contents of the pack and other information
1.
WHAT RELTEBON IS AND WHAT IT IS USED FOR
Reltebon contains the active ingredient oxycodone hydrochloride which
belongs to a group of medicines
called opioids. These are strong painkillers.
Reltebon is used to relieve severe pain, which can only be controlled
by opioid analgesics in adults and
adolescents 12 years of age and older.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RELTEBON
DO NOT TAKE RELTEBON
-
if you are allergic to oxycodone hydrochloride or any of the other
ingredients of this medicine (listed
in section 6).
-
if you have severe problems breathing, low amounts of oxygen in your
blood (hypoxia) or too much
carbon dioxide in your blood.
-
if you suffer from severe chronic obstructive lung disease, cor
pulmonale (cardiac changes due to
chronic overload of lung circulation) or acute, severe bronchial
asthma.
-
if you suffer from intestinal paralysis.
-
if you have an acute abdomen or suffer from a delayed gastric
emptying.
WARNINGS AND PRECAUTIONS
Talk to your doctor

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Reltebon 80 mg Prolonged-release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 80 mg oxycodone hydrochloride
corresponding to 72 mg of oxycodone.
Excipient with known effect:
The prolonged-release tablets contain lactose monohydrate.
Each prolonged-release tablet contains 63.2 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
Green, round, biconvex tablets, 9 mm in diameter, with ‘OX 80’
debossed on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Severe pain, which can be adequately managed only with opioid
analgesics.
Reltebon is indicated in adults and adolescents aged 12 years and
older.
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
following general dosage recommendations apply:
_Adults and adolescents 12 years of age and older_
_Dose titration and adjustment_
In general, the initial dose for opioid naïve patients is 10 mg
oxycodone hydrochloride given at intervals of 12
hours. Some patients may benefit from a starting dose of 5 mg to
minimize the incidence of side effects.
Patients already receiving opioids may start treatment with higher
dosages taking into account their experience
with former opioid therapies.
For doses not realisable/practicable with these strengths, other
strengths are available.
According to well-controlled clinical studies 10-13 mg oxycodone
hydrochloride correspond to approximately
20 mg morphine sulphate, both in the prolonged-release formulation.
Because of individual differences in sensitivity for different
opioids, it is recommended that patients should start
conservatively with Reltebon prolonged-release tablets after
conversion from other opioids, with 50-75% of the
calculated oxycodone dose.
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