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TARGINACT 15 MG/7.5 MG PROLONGED-RELEASE TABLETS

Active substance(s): NALOXONE HYDROCHLORIDE DIHYDRATE / OXYCODONE HYDROCHLORIDE

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700x175mm (LSN-NAPP-04) (L) V1

7691-1
TARGINACT INTERMEDIATE TABS PIL UK 7691-1 V3.indd 1

02/06/2015 16:00

7691-1

700x175mm (LSN-NAPP-04) (L) V1

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CODE

Package leaflet: Information for the user
Targinact ® 2.5 mg/1.25 mg, 15 mg/7.5 mg, and 30 mg/15 mg
prolonged-release tablets
Oxycodone hydrochloride/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 tablets contain oxycodone hydrochloride
and naloxone hydrochloride as active substances.
Oxycodone hydrochloride is responsible for the
painkilling effect of Targinact tablets, and is a potent
analgesic (“painkiller”) of the opioid group. The
second active substance of Targinact tablets, naloxone
hydrochloride, is intended to counteract constipation.
Bowel dysfunction (e.g. constipation) is a typical side
effect of treatment with opioid painkillers.
You have been prescribed Targinact tablets for the
treatment of severe pain, which can be adequately
managed only with opioid analgesics. Naloxone
hydrochloride is added to counteract constipation.
2. What you need to know before you take
Targinact tablets
Do NOT take Targinact tablets:
• if you are allergic to oxycodone hydrochloride,
naloxone hydrochloride or any of the other
ingredients of this medicine (listed in section 6);
• if your breathing is not able to supply enough
oxygen to the blood, and to get rid of carbon dioxide
produced in the body (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 paralytic ileus (a type of bowel
obstruction) not caused by opioids;
• if you have moderate to severe liver dysfunction.
Warnings and Precautions
Talk to your doctor or pharmacist before taking
Targinact tablets:
• in the case of elderly patients or debilitated (weak)
patients;
• if you have paralytic ileus (a type of bowel
obstruction) caused by opioids;
• if you have kidney impairment;
• if you have mild liver impairment;
• if you have severe lung impairment (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 illness accompanied by a
(partial) loss of reality (psychosis), due to alcohol or
intoxication with other substances (substance-induced
psychosis);
• if you suffer from gallstone problems;
• if your prostate gland is abnormally enlarged
(prostate hypertrophy);
• if you suffer from alcoholism or delirium tremens;
• if your pancreas is inflamed (pancreatitis);
• if you have low blood pressure (hypotension);
• if you have high blood pressure (hypertension);
• if you have pre-existing cardiovascular disease;
• if you have a head injury (due to the risk of increased
brain pressure);
• if you suffer from epilepsy or are prone to seizures;
• if you are also taking MAO inhibitors (used
to treat depression or Parkinson’s disease) e.g.

medicines containing tranylcypromine, phenelzine,
isocarboxazid, moclobemide and linezolid.
Tell your doctor if any of the above has ever applied
to you in the past. Also, please tell your doctor if you
develop any of the above disorders while you are taking
Targinact tablets. The most serious result of opioid
overdose is respiratory depression (slow and shallow
breathing). This may cause blood oxygen levels to fall,
resulting in possible fainting, etc.
There is no clinical experience with Targinact tablets in
patients with cancer associated to peritoneal metastases
or with beginning bowel obstruction in advanced stages
of digestive and pelvic cancers. Therefore, the use of
Targinact tablets in these patients is not recommended.
How to use Targinact tablets correctly
If you experience severe diarrhoea at the start of
treatment this may be due to the effect of naloxone. It
may be a sign that your bowel function is returning to
normal. Such diarrhoea can occur within the first 3 - 5
days of treatment. If diarrhoea should persist after 3-5
days, or give you cause for concern, please contact your
doctor.
If you have been using high doses of another opioid,
withdrawal symptoms may occur when you initially
switch to Targinact treatment, e.g. restlessness, bouts
of sweating or muscle pain. If you experience such
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 Targinact tablets.
If used over the long term, you may become tolerant to
Targinact tablets. This means you may need a higher
dose to achieve the desired pain relief. Long-term use
of Targinact tablets may lead to physical dependence.
Withdrawal symptoms may occur if treatment is
stopped too suddenly (restlessness, bouts of sweating,
muscle pain). If you no longer need treatment, you
should reduce your daily dose gradually, in consultation
with your doctor.
The active substance oxycodone hydrochloride alone
has an abuse profile similar to other strong opioids
(strong analgesics). There is potential for development
of psychological dependence. Oxycodone hydrochloride

containing products should be avoided in patients with a
present or past abuse of alcohol, drugs or medicines.
You may notice remnants of the prolonged-release
tablet in your stools. Do not be alarmed, as the active
ingredients (oxycodone hydrochloride and naloxone
hydrochloride) have already been released in the
stomach and gut, and absorbed into your body.
Incorrect use of Targinact tablets
You must swallow the prolonged-release tablet whole,
so as not to affect the slow release of oxycodone
hydrochloride from the prolonged-release tablet. Do
not break, chew or crush the prolonged-release tablet.
Taking broken, chewed or crushed prolonged-release
tablets may result in your body absorbing a potentially
lethal dose of oxycodone hydrochloride (see under ‘If
you take more Targinact tablets than you should’).
Targinact tablets are not suitable for withdrawal
treatment.
Targinact tablets should never be abused, particularly
if you have a drug addiction. If you are addicted to
substances such as heroin, morphine or methadone,
severe withdrawal symptoms are likely if you abuse
Targinact tablets because they contain the ingredient
naloxone. Pre-existing withdrawal symptoms may be
made worse.
You should never misuse Targinact tablets by
dissolving and injecting them (e.g. into a blood vessel).
In particular, they contain talc, which can cause
destruction of local tissue (necrosis) and changes in
lung tissue (lung granuloma). Such abuse can also have
other serious consequences and may even be fatal.
The use of Targinact tablets may produce positive
results in doping controls.
The use of Targinact tablets as a doping agent may
become a health hazard.
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
Targinact tablets at the same time as medicines which
affect brain function. In this case, the side effects of
Targinact tablets may be enhanced. For example,

tiredness/drowsiness may occur, or respiratory
depression (slow, shallow breathing) may get worse.
Examples of medicines which affect brain function
include:
• other potent 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).
No interactions are expected between Targinact tablets
and paracetamol, acetylsalicylic acid or naltrexone.
Targinact tablets with food, drink and alcohol
Drinking alcohol whilst taking Targinact tablets 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 tablets.
You should avoid drinking grapefruit juice while you
are taking Targinact tablets.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.

Pregnancy
Use of Targinact tablets during pregnancy should be
avoided to the extent possible during pregnancy. If used
over prolonged periods during pregnancy, oxycodone
hydrochloride may lead to withdrawal symptoms
in newborn infants. If oxycodone is given during
childbirth, respiratory depression (slow and shallow
breathing) may occur in the newborn infant.
Breastfeeding
Breastfeeding should be discontinued during treatment
with Targinact tablets. Oxycodone hydrochloride passes
into breast milk. It is not known whether naloxone
hydrochloride also passes into breast milk. Therefore,
a risk for the suckling infant cannot be excluded,
in particular following intake of multiple doses of
Targinact tablets.
Driving and using machines
This medicine can affect your ability to drive as it may
make you sleepy or dizzy. 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.
• Do not drive while taking this medicine until you
know how it affects you.
• It is an offence to drive if this medicine affects your
ability to drive.
• However, you would not be committing an offence if:
o The medicine has been prescribed to treat a
medical or dental problem and
o You have taken it according to the instructions
given by the prescriber or in the information
provided with the medicine and
o It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure
whether it is safe for you to drive while taking this
medicine.
Targinact tablets contain lactose
If you have been told that you have an intolerance
to some sugars, contact your doctor before taking
Targinact tablets.

3. How to take Targinact tablets
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
Unless otherwise prescribed by your doctor, the usual
dose is:
Adults
The usual starting dose is 10 mg oxycodone
hydrochloride / 5 mg naloxone hydrochloride as
prolonged-release tablet(s) every 12 hours.
Your doctor will decide how many Targinact tablets
you should take every day and how to divide your total
daily dose into morning and evening doses. Your doctor
will also decide on any necessary dose adjustments
during treatment. Your dose will be adjusted according
to 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, Targinact
treatment with these tablets can be started at a higher
dose.
The maximum daily dose is 160 mg oxycodone
hydrochloride and 80 mg naloxone hydrochloride.
If you need a higher dose, your doctor may give you
additional oxycodone hydrochloride without naloxone
hydrochloride. However, the maximum daily dose of
oxycodone should not exceed 400 mg. The beneficial
effect of naloxone on bowel activity may be affected if
additional oxycodone hydrochloride is given without
additional naloxone hydrochloride.
If you are switched from Targinact tablets to another
opioid pain medication, your bowel function will
probably worsen.
If you experience pain between two doses of Targinact
tablets, you may need a rapid-acting painkiller.
Targinact tablets are not suitable for this. In this case,
please talk to your doctor.
If you have the impression that Targinact tablets are
too strong or too weak, please talk to your doctor or
pharmacist.
Elderly patients
In general, no dose adjustment is necessary for elderly
patients with normal kidney and/or liver function.

Liver or kidney problems
If you have an impairment of your kidney or a mild
impairment of your liver function, your attending doctor
will prescribe Targinact tablets with special caution.
If you have a moderate or severe impairment of liver
function, Targinact tablets should not be used (see also
Section 2 ‘Do not take Targinact tablets’ and ‘Warnings
and precautions’).
Children and adolescents below 18 years of age
Targinact tablets have not yet been studied in children
and adolescents under 18 years of age. Its safety and
effectiveness have not yet been proven in children
and adolescents. For this reason, Targinact use in
children and adolescents under 18 years of age is not
recommended.
Method of administration
Swallow Targinact tablets whole (without chewing),
with sufficient liquid (1/2 glass of water). You can take
the prolonged-release tablets with or without food. Take
Targinact tablets every 12 hours according to a fixed
time schedule (e.g. at 8 o’clock in the morning and 8
o’clock in the evening). Do not break, chew or crush the
prolonged-release tablets.
Duration of use
In general, you should not take Targinact tablets for
any longer than you need to. If you are on long-term
treatment with Targinact tablets, your doctor should
regularly check whether you still need Targinact tablets.
If you take more Targinact tablets than you should
If you have taken more than the prescribed dose
of Targinact tablets, you must inform your doctor
immediately.
An overdose may result in:
• narrowed pupils;
• slow and shallow breathing (respiratory depression);
• a narcotic-like state (drowsiness to the point of
unconsciousness);
• low muscle tone (hypotonia);
• reduced pulse rate; and
• a drop in blood pressure.
In severe cases, loss of consciousness (coma), fluid on the
lungs and circulatory collapse may occur, which may be
fatal in some cases.

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You should avoid situations which require a high level
of alertness, e.g. driving.
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 should forget to take your dose, please follow the
instructions below:
• If your next usual dose is due in 8 hours or more:
Take the forgotten dose immediately and continue
with your normal dosing schedule.
If your next usual dose is due in less than 8 hours: Take
the forgotten dose. Then, wait another 8 hours before
taking your next dose. Try to get back on track with
your original dosing schedule (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
dose.
If you stop taking Targinact tablets
Do not stop your treatment with Targinact tablets
without consulting your doctor.
If you do not require any further treatment, you
must reduce the daily dose gradually after talking to
your doctor. 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 this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Important side effects or signs to look out for, and
what to do if you are affected:
If you are affected by any of the following important
side effects, consult your nearest doctor immediately.
Slow and shallow breathing (respiratory depression) is
the main danger of an opioid overdose. It mostly occurs
in elderly and debilitated (weak) patients. Opioids can
also cause a severe drop in blood pressure in susceptible
patients.

TARGINACT INTERMEDIATE TABS PIL UK 7691-1 V3.indd 3

Common (may effect up to 1 in 10 people)
• abdominal pain
• constipation
• diarrhoea
• dry mouth
• indigestion
• vomit (be sick)
• feel sick
• wind
• decreased to loss of appetite
• a feeling of dizziness or ‘spinning’
• headache
• hot flushes
• general weakness
• itchy skin
• skin reactions/rash
• sweating
• vertigo
• difficulty in sleeping
• drowsiness
Uncommon (may affect up to 1 in 100 people)
• abdominal bloating
• abnormal thoughts
• anxiety
• confusion
• depression
• nervousness
• chest tightness, especially if you already have
coronary heart disease
• drop in blood pressure
• withdrawal symptoms such as agitation
• fainting
• palpitations
• biliary colic
• chest pain
• generally feeling unwell
• pain
• swelling of the hands, ankles or feet
• weight loss
• difficulties to concentrate
• impaired speaking
• shaking
• difficulties breathing
• restlessness
• chills
• hepatic enzymes increased













rise in blood pressure
runny nose
cough
hypersensitivity/allergic reactions
injuries from accidents
increased urge to urinate
muscle cramps
muscle twitches
muscle pain
vision impairment
epileptic seizures (especially in persons with epileptic
disorder or predisposition to seizures)
Rare (may affect up to 1 in 1,000 people)
• increase in pulse rate
• dental changes
• yawning
• weight change
Not known (frequency cannot be estimated from
available data)
• euphoric mood
• severe drowsiness
• erectile dysfunction
• nightmares
• hallucinations
• shallow breathing
• difficulties in passing urine
• tingling in hands or feet
• belching
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.
Common (may affect up to 1 in 10 people)
• altered mood and personality changes (e.g.
depression, feeling of extreme happiness)
• decreased activity
• increased activity
• difficulties in passing urine
• hiccups
Uncommon (may affect up to 1 in 100 people)
• impaired concentration
• migraines
• taste anomalies

















increased muscle tension
involuntary muscle contractions
drug dependence
ileus
dry skin
drug tolerance
reduced sensitivity to pain or touch
abnormal coordination
vocal changes (dysphonia)
water retention
difficulties in hearing
mouth ulcers
difficulties in swallowing
sore gums
perception disturbances (e.g. hallucination,
derealisation)
• reduced sexual drive
• flushing of skin
• dehydration
• agitation
• thirst
Rare (may affect up to 1 in 1,000 people)
• itching rash (urticaria)
• herpes simplex
• increased appetite
• black (tarry) stools
• gingival bleeding
Not known (frequency cannot be estimated from the
available data)
• acute generalized allergic reactions (anaphylactic
reactions)
• absence of menstrual periods
• problems with bile flow
Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme
(www.mhra.gov.uk/yellowcard). By reporting side
effects you can help provide more information on the
safety of this medicine.

5. How to store Targinact tablets
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton and blister, after “EXP…”
The expiry date refers to the last day of that month.
Do not store above 25°C.
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.
Targinact 2.5 mg/1.25 mg tablets
One prolonged-release tablet contains 2.5 mg of
oxycodone hydrochloride, equivalent to 2.25 mg
oxycodone, and 1.37 mg naloxone hydrochloride
dihydrate equivalent to 1.25 mg naloxone hydrochloride
and 1.13 mg naloxone.
Targinact 15 mg/7.5 mg tablets
One prolonged-release tablet contains 15 mg of
oxycodone hydrochloride, equivalent to 13.5 mg
oxycodone, and 8.24 mg naloxone hydrochloride
dihydrate equivalent to 7.5 mg naloxone hydrochloride
and 6.75 mg naloxone.
Targinact 30 mg/15 mg tablets
One prolonged-release tablet contains 30 mg of
oxycodone hydrochloride, equivalent to 27 mg
oxycodone, and 16.48 mg naloxone hydrochloride
dihydrate equivalent to 15 mg naloxone hydrochloride
or 13.5 mg naloxone.
The other ingredients are:
Targinact 2.5 mg/1.25 mg tablets
Tablet core:
Hydroxypropylcellulose, ethylcellulose, stearyl alcohol,
lactose monohydrate, talc, magnesium stearate

Tablet coat:
polyvinyl alcohol, partially hydrolysed, titanium dioxide
(E171), macrogol 3350, talc, iron oxide red (E172), iron
oxide yellow (E172)
Targinact 15 mg/7.5 mg tablets
Tablet core:
hydroxypropylcellulose, ethylcellulose, stearyl alcohol,
lactose monohydrate, talc, magnesium stearate
Tablet coat:
polyvinyl alcohol, partially hydrolysed, titanium dioxide
(E171), macrogol 3350, talc, iron oxide black (E172),
iron oxide red (E172), iron oxide yellow (E172)
Targinact 30 mg/15 mg tablets
Tablet core:
Povidone K30, ethylcellulose, stearyl alcohol, lactose
monohydrate, talc, magnesium stearate
Tablet coat:
polyvinyl alcohol, partially hydrolysed, titanium dioxide
(E171), macrogol 3350, talc, iron oxide black (E172),
iron oxide red (E172), iron oxide yellow (E172)
What Targinact tablets look like and the contents of
the pack
Targinact 2.5 mg/1.25 mg tablets
Light yellow, round tablets, 5 mm in size, with a film
coating.
Targinact 15 mg/7.5 mg tablets
Grey, oblong tablets, with a nominal length of 9.5 mm
and with a film-coating, embossed ‘OXN’ on one side
and ‘15’ on the other.
Targinact 30 mg/15 mg tablets
Brown, oblong tablets, with a nominal length of 9.5 mm
and with a film-coating, embossed ‘OXN’ on one side
and ‘30’ on the other.
In each box there are 14, 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:  16950/0191
This leaflet was last revised in May 2015
® Targinact, NAPP and the NAPP device (logo) are
registered trade marks.
© 2009-2014 Napp Pharmaceuticals Limited

02/06/2015 16:00

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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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