TARGIN 2.5 / 1.25 Milligram Tablet Prolonged Release

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OXYCODONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

Available from:

Mundipharma Pharmaceuticals Limited

INN (International Name):

OXYCODONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

Dosage:

2.5 / 1.25 Milligram

Pharmaceutical form:

Tablet Prolonged Release

Prescription type:

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

Therapeutic area:

02AA55

Authorization status:

Authorised

Authorization date:

2014-01-31

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
_TARGIN_
®
2.5 MG/1.25 MG, 15 MG/7.5 MG AND 30 MG/15 MG PROLONGED-RELEASE TABLETS
Oxycodone hydrochloride and Naloxone 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.
IN THIS LEAFLET:
1.
What _TARGIN_ tablets are and what they are used for
2.
What you need to know before you take _TARGIN_ tablets
3.
How to take _TARGIN_ tablets
4.
Possible side effects
5.
How to store _TARGIN_ tablets
6.
Contents of the pack and other information
1.
WHAT _TARGIN_ TABLETS ARE AND WHAT THEY ARE USED FOR
_TARGIN_ is a prolonged-release tablet, which means that its active
substances are released over an extended
period. Their action lasts for 12 hours.
You have been prescribed _TARGIN_ tablets for the treatment of severe
pain, which can be adequately
managed only with opioid analgesics. Naloxone is added to counteract
constipation.
These tablets are only for use in adults.
HOW THESE TABLETS WORK
These tablets contain oxycodone hydrochloride and naloxone
hydrochloride as active substances.
Oxycodone is responsible for the painkilling effect of the tablets. It
is a strong analgesic (‘painkiller’) that
belongs to a group of medicines called opioids. Naloxone is intended
to bring relief from constipation.
Constipation is a typical side effect of treatment with strong
painkillers.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE _TARGIN_ TABLETS
DO NOT TAKE _TARGIN_ TABLETS

if you are allergic (hypersensitive) to oxycodone or naloxone, or any
of the other ingredients of the
tablets (liste

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Targin 2.5 mg/1.25 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 2.5 mg of oxycodone
hydrochloride equivalent to 2.25 mg oxycodone and 1.25
mg naloxone hydrochloride as 1.37 mg of naloxone hydrochloride
dihydrate equivalent to 1.13 mg naloxone.
Excipient with known effect: Each prolonged-release tablet contains
34.1 mg lactose anhydrous
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
Light yellow, round tablets, 5mm in size, with a film coating.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Severe pain, which can be adequately managed only with opioid
analgesics.
The opioid antagonist naloxone is added to counteract opioid-induced
constipation by blocking the action of oxycodone
at opioid receptors locally in the gut.
Targin is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The analgesic efficacy of_ TARGIN_ is equivalent to oxycodone
hydrochloride prolonged-release formulations.
The dosage should be adjusted to the intensity of pain and the
sensitivity of the individual
patient.
Unless otherwise
prescribed, these tablets should be administered as follows:
_Adults_
The usual starting dose for an opioid naïve patient is 10 mg/5 mg of
oxycodone hydrochloride/naloxone hydrochloride
at 12 hourly intervals.
Lower strengths are available to facilitate dose titration when
initiating opioid therapy and for individual dose
adjustment.
Patients already receiving opioids may be started on higher doses
depending on their previous opioid experience.
The maximum daily dose of these tablets is 160mg oxycodone
hydrochloride and 80 mg naloxone hydrochloride. The
maximum daily dose is reserved for patients who have previously been
maintained on a stable daily dose and who have
become in need of an increased dose. Special attention should be given
to patients with compromised renal function and
patients with mild hepatic im