TARGINACT 5 MG/2.5 MG PROLONGED RELEASE TABLETS

Active substance: OXYCODONE HYDROCHLORIDE

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7625-5

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Package leaflet: Information for the user
Targinact ® 5 mg/2.5 mg, 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.
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

TARGINACT TABS 5-2.5 - 40-20MG PIL UK 7625-5 V3.indd 2

1. What Targinact tablets are and what they are
used for
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 Targinact tablets work
These tablets contain two medicines; oxycodone
hydrochloride and naloxone hydrochloride. 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.
These are prolonged-release tablets. This means that the
active ingredients are slowly released from the tablets
over a period of 12 hours.

2. What you need to know before you take
Targinact tablets
Do not take Targinact tablets
• if you are allergic (hypersensitive) to oxycodone or
naloxone, or any of the other ingredients of the tablets
(listed in section 6);
• if you have breathing problems, such as breathing
more slowly or weakly than expected (respiratory
depression);
• if you suffer from a severe lung disease associated
with narrowing of the airways (chronic obstructive
pulmonary disease or COPD);
• if you suffer from a condition known as cor
pulmonale. In this condition, the right side of the
heart becomes enlarged, due to increased pressure
inside blood vessels in the lung etc. (e.g. as a result of
COPD – see above);
• if you suffer from severe bronchial asthma;
• if you have a type of bowel obstruction (paralytic
ileus) not caused by opioids;
• if you have moderate to severe liver problems.
Warnings and Precautions
Talk to your doctor or pharmacist before taking these
tablets:
• in the case of elderly or debilitated (weak) patients;
• if you have a type of bowel obstruction (paralytic
ileus) caused by opioids;
• if you have kidney problems;
• if you have mild liver problems;
• if you have severe lung problems (i.e. reduced
breathing capacity);
• if you have myxoedema (a thyroid disorder, with
dryness, coldness and swelling [‘puffiness’] of the
skin, affecting the face and limbs);
• if your thyroid gland is not producing enough
hormones (underactive thyroid or hypothyroidism);
• if your adrenal glands are not producing enough
hormones (adrenal insufficiency or Addison’s
disease);

• if you have a mental disorder as a result of an
intoxication (toxic psychosis);
• if you suffer from gallstone problems;
• if your prostate gland is abnormally enlarged
(prostate hypertrophy);
• if you are or ever have been addicted to alcohol or
drugs, or have previously suffered from withdrawal
symptoms such as agitation, anxiety, shaking or
sweating upon stopping alcohol or drugs;
• if your pancreas is inflamed (pancreatitis);
• if you have low blood pressure (hypotension);
• if you have high blood pressure (hypertension);
• if you have heart problems;
• if you have a head injury (due to the risk of increased
brain pressure);
• if you suffer from epilepsy or are prone to fits;
• if you are also taking a type of medicine known
as a MAO inhibitor (used to treat depression or
Parkinson’s disease) e.g. medicines containing
tranylcypromine, phenelzine, isocarboxazid,
moclobemide and linezolid.
These tablets are not recommended for use in patients
with advanced digestive or pelvic cancers where bowel
obstruction may be a problem.
Children and adolescents
These tablets must not be given to children or
adolescents under 18 years of age as the safety and
benefits have not been shown yet.
How to use Targinact tablets correctly
If you experience severe diarrhoea at the start of
treatment (within the first 3-5 days) this may be due to
the effect of naloxone. It may be a sign that your bowel
movements are returning to normal. If diarrhoea persists
after 3-5 days, or it gives you cause for concern, please
contact your doctor.
If you have been using high doses of another opioid,
withdrawal symptoms (such as restlessness, bouts
of sweating or muscle pain) may occur when you
initially switch to taking these tablets. If you experience

withdrawal symptoms, you may need to be specially
monitored by your doctor.
If you need to undergo surgery, please tell your doctor
that you are taking these tablets.
If you have been taking these tablets for a long time,
you may become tolerant. This means you may need a
higher dose to achieve the desired pain relief. Longterm use of these tablets may also lead to addiction.
Withdrawal symptoms may occur if treatment is stopped
too suddenly. If you no longer need treatment, you
should reduce your daily dose gradually, in consultation
with your doctor.
As with other strong opioid painkillers, there is a risk
that you may develop a psychological dependence to
oxycodone.
You may notice remains of the tablet in your stools.
Do not be alarmed, as the active ingredients will have
already been released in the stomach and gut, and
absorbed into your body.
Incorrect use of Targinact tablets
You must swallow these tablets whole so as not to
affect the slow release of oxycodone. Do not break,
chew or crush these tablets. Taking broken, chewed
or crushed tablets may result in your body absorbing
a potentially fatal dose of oxycodone (see under ‘If
you take more Targinact tablets than you should’).
These tablets are not suitable for withdrawal treatment.
These tablets should never be abused, particularly if you
have a drug addiction. If you are addicted to drugs such
as heroin, morphine or methadone, severe withdrawal
symptoms are likely if you abuse these tablets because
they contain the ingredient naloxone. Pre-existing
withdrawal symptoms may be made worse.
You should never misuse the tablets by dissolving
and injecting them (e.g. into a blood vessel). They
contain talc, which can cause destruction of local tissue
(necrosis) and changes in lung tissue (lung granuloma).
Misuse can also have other serious consequences which
may be fatal.

The use of these tablets may produce positive results in
drugs tests.
Other medicines and Targinact tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
The risk of side effects is increased if you take these
tablets at the same time as medicines which affect the
way the brain works. For example, you may feel very
sleepy, or breathing problems may get worse.
Examples of medicines that affect the way the brain
works include:
• other strong painkillers (opioids);
• sleep medication and tranquillisers (sedatives,
hypnotics);
• antidepressants;
• medicines used to treat allergies, travel sickness or
nausea (antihistamines or antiemetics);
• other medicines which act on the nervous system
(phenothiazines, neuroleptics).
Tell your doctor if you are taking:
• medicines that decrease the blood’s clotting ability
(coumarin derivatives), this clotting time may be
speeded up or slowed down;
• antibiotics of the macrolide type (such as
clarithromycin);
• antifungal medicines of the –azole type (e.g.
ketoconazole);
• ritonavir or other protease inhibitors (used to treat
HIV);
• rifampicin (used to treat tuberculosis);
• carbamazepine (used to treat seizures, fits or
convulsions and certain pain conditions);
• phenytoin (used to treat seizures, fits or convulsions).
Targinact tablets with food, drink and alcohol
Drinking alcohol whilst taking Targinact may make
you feel more sleepy or increase the risk of serious side
effects such as shallow breathing with a risk of stopping

breathing, and loss of consciousness. It is recommended
not to drink alcohol while you’re taking Targinact.
You should avoid drinking grapefruit juice while you
are taking these tablets.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking
any medicine.
Pregnancy
Use of these tablets during pregnancy should be
avoided unless your doctor thinks treatment with this
medicine is essential. If used over prolonged periods
during pregnancy, oxycodone may lead to withdrawal
symptoms in the newborn baby. If oxycodone is
given during childbirth, the baby may have breathing
problems (respiratory depression).
Breastfeeding
Breastfeeding should be stopped during treatment with
these tablets as oxycodone (one of the active ingredients
of your medicine) passes into breast milk.
Driving and using machines
These tablets may affect your ability to drive or
operate machines. This is most likely at the start of
your treatment, after a dose increase or after switching
from a different medication. These side effects should
disappear once you are on a stable dose.
Ask your doctor whether you may drive or operate
machines.
Targinact tablets contain lactose
These tablets contain lactose (milk sugar). If you have
been told that you have an intolerance to some sugars,
contact your doctor before taking these tablets.

3. How to take Targinact tablets
Always take these tablets exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.
Adults
The usual starting dose is 10 mg oxycodone
hydrochloride / 5 mg naloxone hydrochloride every 12
hours.
Your doctor will decide how much you should take
every day and how to divide your total daily dose into
morning and evening doses. They will also decide
on any necessary dose adjustments during treatment
depending on your level of pain and individual
sensitivity. You should be given the lowest dose needed
for pain relief. If you have already been treated with
opioids, your treatment with these tablets may be started
at a higher dose.
The maximum daily dose is 80 mg oxycodone
hydrochloride and 40 mg naloxone hydrochloride.
If you need a higher dose, your doctor may give you
additional oxycodone without naloxone. However, the
maximum daily dose of oxycodone should not exceed
400 mg. The beneficial effect of naloxone on bowel
movements may be affected if additional oxycodone is
given without additional naloxone.
If you experience pain between doses, you may need to
take an additional fast-acting painkiller. These tablets
are not suitable for this. Please talk to your doctor.
If you feel that these tablets are too strong or too weak,
please talk to your doctor or pharmacist.
Liver or kidney problems
If you have kidney or mild liver problems your doctor
may prescribe a lower dose. You must not take these
tablets if you have moderate or severe liver problems,
(see also Section 2 ‘Do not take Targinact tablets’ and
‘Take special care with Targinact tablets’).

Children and adolescents below 18 years of age
No studies have been carried out to show that these
tablets work properly in children and adolescents,
or are safe for them to take. They are therefore not
recommended for use in patients under 18 years of age.
Elderly patients
In general, no dose adjustment is necessary for elderly
patients with normal kidney and/or liver function.
Method of administration
Swallow your tablets whole with a glass of water. You
can take these tablets with or without food. Take them
every 12 hours. For instance, if you take a tablet at
8 o’clock in the morning, you should take your next
tablet at 8 o’clock in the evening. Do not break, chew or
crush the tablets.
Duration of use
You should not take these tablets for any longer than
you need to. If you have been taking them for a long
time your doctor should regularly check that you still
need them.
If you take more Targinact tablets than you should
If you have taken more than the prescribed dose, you
must inform your doctor immediately.
An overdose may result in:
• a reduction in size of pupils in the eye;
• breathing more slowly or weakly than expected
(respiratory depression);
• drowsiness or loss of consciousness;
• low muscle tone (hypotonia);
• reduced pulse rate;
• a fall in blood pressure.
In severe cases, loss of consciousness (coma), fluid on
the lungs and circulatory collapse may occur, which
may be fatal.
You should avoid situations which require you to be
alert, e.g. driving.

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If you forget to take Targinact tablets,
or if you take a lower dose than the one prescribed, you
may not feel any painkilling effect.
• If you forget to take your tablets and your next
usual dose is due in 8 hours time or more: Take the
forgotten tablet immediately and continue with your
normal dosing routine.
• If your next usual dose is due in less than 8 hours
time: Take the forgotten tablet, then, wait another 8
hours before taking your next tablet. Try to get back
in your normal dosing routine (e.g. 8 o’clock in the
morning and 8 o’clock in the evening).
Do not take more than one dose within any 8 hour
period.
Do not take a double dose to make up for a forgotten
tablet.
If you stop taking Targinact tablets
Do not stop taking these tablets without first speaking
with your doctor. If you do not require any further
treatment, your doctor will advise you how to reduce
the daily dose gradually. In this way, you will avoid
withdrawal symptoms, such as restlessness, bouts of
sweating and muscle pain.
If you have any further questions on the use of these
tablets, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, these tablets can cause side effects,
although not everybody gets them.
The following terms are used to explain how frequently
patients experience side effects:
Very common: may affect more than 1 in 10 people

taking these tablets
Common:
may affect up to 1 in 10 people taking

these tablets
Uncommon: may affect up to 1 in 100 people taking

these tablets
Rare:
may affect up to 1 in 1,000 people

taking these tablets
Very rare:
may affect up to 1 in 10,000 people

taking these tablets
Not known: frequency cannot be estimated from the

available data
Important side effects or signs to look out for, and
what to do if you are affected:
The most serious side effect is a condition where
you breathe more slowly or weakly than expected
(respiratory depression). It mostly occurs in elderly and
weak patients. Opioids can also cause a severe drop
in blood pressure in susceptible patients. If you are
affected by these important side effects, consult a doctor
immediately.
Other important side effects are:
Common
• abdominal pain
• constipation
• diarrhoea
• sweating
• hot flushes
• dry mouth
• indigestion
• wind
• feeling or being sick

TARGINACT TABS 5-2.5 - 40-20MG PIL UK 7625-5 V3.indd 3










difficulty in sleeping
loss of appetite
general weakness
headache
itchy skin
skin reactions/rash
a feeling of dizziness or ‘spinning’
drowsiness

Uncommon
• abdominal bloating
• difficulty in concentrating
• withdrawal symptoms such as agitation
• difficulties with speech
• fall in blood pressure
• rise in blood pressure
• chest pain
• restlessness
• generally feeling unwell
• chills
• swelling of the hands, ankles or feet
• abnormal thoughts
• anxiety
• confusion
• depression
• nervousness
• colicky abdominal pain or discomfort
• pain
• weight loss
• shaking
• shortness of breath
• palpitations
• vision impairment
• hypersensitivity/allergic reactions
• an increased risk of accidental injuries
• chest tightness (especially if you already have heart
problems)
• runny nose
• cough
• a sudden urge to pass urine
• muscle pain, cramps or twitches

• changes in the results of blood tests that show how
well your liver is working
• fainting
• epileptic fits (especially in people with epilepsy or a
predisposition to fits)
Rare
• increase in pulse rate
• dental changes
• yawning
• weight gain
Not known
• a feeling of extreme happiness
• severe drowsiness
• impotence
• nightmares
• hallucinations
• breathing more slowly or weakly than expected
• difficulty in passing urine
• tingling or numbness in the hands or feet
• belching




















flushing of the skin
migraines
changes in taste
increased muscle tension
involuntary muscle contractions
reduced sensitivity to pain or touch
problems with coordination
water retention
perception disturbances (e.g. hallucinations,
feeling detached)
decreased sexual drive
drug dependence
dry skin
a condition where the small bowel (part of your
gut) does not work properly (ileus)
a need to take increasingly higher doses to gain the
same level of pain relief (tolerance)
difficulty in swallowing
dehydration
agitation
thirst

The active ingredient oxycodone hydrochloride,
if not combined with naloxone hydrochloride, is
known to have the following differing side effects:
Breathing problems, such as breathing more slowly
or weakly than expected (respiratory depression),
reduction in size of the pupils in the eye, muscle
cramps and decreased cough reflex.

Rare
• increased appetite
• infections such as cold sores or herpes (which may
cause blisters around the mouth or genitals)
• dark coloured, tarry stools
• bleeding gums
• itchy rash (urticaria)

Common
• altered mood and personality changes (e.g.
depression, a feeling of extreme happiness)
• decreased or increased activity
• difficulty in passing urine
• hiccups

Not known
• serious allergic reactions
• absence of menstrual periods
• problems with bile flow
If you get any side effects talk to your doctor or
pharmacist. This includes any side effects not listed
in this leaflet.

Uncommon
• difficulty in concentrating
• voice alteration
• difficulty in hearing
• mouth ulcers
• sore gums

5. How to store Targinact tablets
Keep out of the sight and reach of children.
Do not use any tablets after the expiry date which is
stated on the carton and blister, after ‘EXP…’ The
expiry date refers to the last day of the month.
Do not store above 25°C. Store in the original package
in order to protect from light.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.
6. Contents of the pack and other information
What Targinact tablets contain
The active ingredients are oxycodone hydrochloride
and naloxone hydrochloride.
Each 5 mg/2.5 mg tablet contains 5 mg of oxycodone
hydrochloride (equivalent to 4.5 mg oxycodone), and
2.73 mg naloxone hydrochloride dihydrate (equivalent
to 2.5 mg naloxone hydrochloride and 2.25 mg
naloxone).
Each 10 mg/5 mg tablet contains 10 mg of oxycodone
hydrochloride (equivalent to 9 mg oxycodone), and
5.45 mg naloxone hydrochloride dihydrate (equivalent
to 5 mg naloxone hydrochloride and 4.5 mg naloxone).
Each 20 mg/10 mg tablet contains 20 mg of
oxycodone hydrochloride (equivalent to 18 mg
oxycodone) and 10.9 mg naloxone hydrochloride
dihydrate (equivalent to 10 mg naloxone
hydrochloride and 9 mg naloxone).
Each 40 mg/20 mg tablet contains 40 mg of
oxycodone hydrochloride (equivalent to 36 mg
oxycodone) and 21.8 mg naloxone hydrochloride
dihydrate (equivalent to 20 mg of naloxone
hydrochloride and 18 mg naloxone).

The other ingredients are:
Tablet core:
hydroxypropylcellulose (5 mg/2.5 mg strength
tablet only), povidone K30 (10 mg/5 mg, 20 mg/10
mg and 40 mg/20 mg strength tablets only), ethyl
cellulose, stearyl alcohol, lactose monohydrate, talc,
magnesium stearate
Tablet coat:
polyvinyl alcohol, titanium dioxide (E171), macrogol
3350, talc
The 5 mg/2.5 mg tablets also contain brilliant blue
(E133), the 20 mg/10 mg tablets also contain iron
(III) oxide red (E172) and the 40 mg/20 mg tablets
contain iron oxide yellow (E172).
What Targinact tablets look like and the contents
of the pack
Targinact 5 mg/2.5 mg tablets are blue, oblong, film
coated tablets, marked ‘OXN’ on one side and ‘5’ on
the other.
Targinact 10 mg/5 mg tablets are white, oblong, film
coated tablets, marked ‘OXN’ on one side and ‘10’
on the other.
Targinact 20 mg/10 mg tablets are pink, oblong, film
coated tablets, marked ‘OXN’ on one side and ‘20’
on the other.
Targinact 40 mg/20 mg tablets are yellow, oblong,
film coated tablets, marked ‘OXN’ on one side and
‘40’ on the other.
In each box there are 28 or 56 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Napp Pharmaceuticals Limited
Cambridge Science Park, Milton Road, Cambridge
CB4 0GW, UK.
Manufacturers:
Mundipharma GmbH
Mundipharma Straße 2, 65549 Limburg/Lahn, Germany
Bard Pharmaceuticals Limited
Cambridge Science, Milton Road, Cambridge
CB4 0GW, UK.

This leaflet is also available in large print, Braille or as an audio CD.
To request a copy, please call the RNIB Medicine Information
line (free of charge) on:

0800 198 5000
You will need to give details of the product name and reference
number.
These are as follows:
Product name: Targinact
Reference number: 16950/0161

This leaflet was last revised in December 2012
® Targinact, NAPP and the NAPP device (logo) are Registered Trade Marks.
© 2009-2012 Napp Pharmaceuticals Limited

14/12/2012 14:33

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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