Targinact 5mg/2.5mg modified-release tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Oxycodone hydrochloride; Naloxone hydrochloride

Available from:

Napp Pharmaceuticals Ltd

ATC code:

N02AA55

INN (International Name):

Oxycodone hydrochloride; Naloxone hydrochloride

Dosage:

5mg ; 2.5mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5012854029156

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
_TARGINACT_
®
5 MG/2.5MG, 10 MG/5_ _MG, 20 MG/ 10 MG AND 40 MG/20_ _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.
WHAT IS IN THIS LEAFLET:
1.
What _TARGINACT_ tablets are and what they are used for
2.
What you need to know before you take _TARGINACT_ tablets
3.
How to take _TARGINACT_ tablets
4.
Possible side effects
5.
How to store _TARGINACT_ tablets
6.
Contents of the pack and other information
1.
WHAT _TARGINACT_ TABLETS ARE AND WHAT THEY ARE USED FOR
_ _
_TARGINACT_ is a prolonged-release tablet, which means that its active
substances are released over an
extended period. Their action lasts for 12 hours.
These tablets are only for use in adults.
PAIN RELIEF
You have been prescribed _TARGINACT_ tablets for the treatment of
severe pain, which can be adequately
managed only with opioid analgesics. Naloxone is added to counteract
constipation.
HOW THESE TABLETS WORK IN PAIN RELIEF
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.
RESTLESS LEGS SYNDROME
You have been prescribed _TARGINACT _tablets for the second line
symptomatic treatment of severe to very
seve

Summary of Product characteristics

OBJECT 1
TARGINACT 5 MG/2.5 MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 02-Jan-2018 | Napp
Pharmaceuticals Limited
1. Name of the medicinal product
_TARGINACT_
_®_
_ _5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg and 40 mg/20 mg
prolonged-release tablets
2. Qualitative and quantitative composition
_TARGINACT _5 mg/2.5 mg
Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride
equivalent to 4.5 mg oxycodone
and 2.5 mg naloxone hydrochloride as 2.73 mg of naloxone hydrochloride
dihydrate equivalent to 2.25
mg naloxone.
_TARGINACT_ 10 mg/5 mg
Each prolonged-release tablet contains 10 mg of oxycodone
hydrochloride equivalent to 9.0 mg
oxycodone and 5 mg naloxone hydrochloride as 5.45 mg of naloxone
hydrochloride dihydrate equivalent
to 4.5 mg naloxone.
_TARGINACT_ 20 mg/10 mg
Each prolonged-release tablet contains 20 mg of oxycodone
hydrochloride equivalent to 18 mg
oxycodone and 10 mg of naloxone hydrochloride as 10.9 mg of naloxone
hydrochloride dihydrate
equivalent to 9 mg naloxone.
_TARGINACT _40 mg/20 mg
Each prolonged-release tablet contains 40 mg of oxycodone
hydrochloride equivalent to 36 mg
oxycodone and 20 mg of naloxone hydrochloride as 21.8 mg of naloxone
hydrochloride dihydrate
equivalent to 18 mg naloxone
Excipient with known effect:
_TARGINACT _5 mg/2.5 mg
Each prolonged-release tablet contains 68.2 mg lactose anhydrous.
_TARGINACT_ 10 mg/5 mg
Each prolonged-release tablet contains 61.0 mg lactose anhydrous.
_TARGINACT_ 20 mg/10 mg
Each prolonged-release tablet contains 51.8 mg lactose anhydrous.
_TARGINACT _40 mg/20 mg
Each prolonged-release tablet contains 103.6 mg lactose anhydrous.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Prolonged-release tablet
_TARGINACT _5 mg/2.5 mg
Blue, oblong tablets, with a nominal length of 9.5 mm and with a film
coating, embossed “OXN” on one
side and “5” on the other side.
_TARGINACT_ 10 mg/5 mg
White, oblong tablets, with a nominal length of 9.5 mm and with a film
coating, embossed “OXN” on on