Oxycodone Lannacher SR 80 mg prolonged release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OXYCODONE HYDROCHLORIDE

Available from:

Lannacher Heilmittel Ges.m.b.H

ATC code:

N02AA; N02AA05

INN (International Name):

OXYCODONE HYDROCHLORIDE

Dosage:

80 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

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

Therapeutic area:

Natural opium alkaloids; oxycodone

Authorization status:

Not marketed

Authorization date:

2010-09-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
OXYCODONE LANNACHER SR 5 MG PROLONGED-RELEASE TABLETS
OXYCODONE LANNACHER SR 10 MG PROLONGED-RELEASE TABLETS
OXYCODONE LANNACHER SR 20 MG PROLONGED-RELEASE TABLETS
OXYCODONE LANNACHER SR 40 MG PROLONGED-RELEASE TABLETS
OXYCODONE LANNACHER SR 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 side effects not
listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Oxycodone Lannacher SR is and what it is used for
2.
What you need to know before you take Oxycodone Lannacher SR
3.
How to take Oxycodone Lannacher SR
4.
Possible side effects
5.
How to store Oxycodone Lannacher SR
6.
Contents of the pack and other information
1.
WHAT OXYCODONE LANNACHER SR IS AND WHAT IT IS USED FOR
Oxycodone hydrochloride Lanancher is a strong painkiller from the
group of opioids.
Oxycodone Lannacher SR is used to treat SEVERE PAIN, which requires
treatment with opioid
analgesics because other painkillers have not been effective.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OXYCODONE LANNACHER SR
DO NOT TAKE OXYCODONE LANNACHER SR

if you are ALLERGIC to oxycodone hydrochloride, soya, peanut, or any
of the other ingredients of
this medicine (listed in section 6).

if you have breathing problems, such as breathing more slowly or more
weakly than expected
(RESPIRATORY DEPRESSION).

If you have too much CARBON DIOXIDE in your blood.

if you suffer from a severe chronic LUNG DISEASE associated with
narrowing of the airways
(COPD = chronic obstructive pulmonary disease),

if you have a certain HEART CONDITION known

Summary of Product characteristics

Health Products Regulatory Authority
02 September 2020
CRN009WV9
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxycodone Lannacher SR 80 mg prolonged release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains 80 mg oxycodone hydrochloride
corresponding to 71.72 mg oxycodone.
Excipient with known effect:
Soya lecithin.................... 0.525 mg per tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged - release tablet
Pale green, round and biconvex film-coated tablets.
Diameter: 11.1 mm
Thickness: 4.4 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Severe pain, which requires opioid analgesics to be adequately
managed.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
The dosage depends on the pain intensity and the patient’s
individual susceptibility to the treatment.
For doses not realisable/practicable with this strength, other
strengths of this medicinal product are available.
The following general dosage recommendations apply:
PAEDIATRIC POPULATION
Oxycodone Lannacher SR is not recommended for children under 12 years
of age.
ADULTS AND ADOLESCENTS 12 YEARS 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 adverse reactions.
Patients already receiving opioids may start treatment with higher
dosages taking into account their experience with former
opioid therapies.
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 Oxycodone hydrochloride prolonged-release tablets after
conversion from other opioids, with 50-75% of the calculated
oxycodone dose.
Some patie