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TARGINACT 5 MG/2.5 MG PROLONGED RELEASE TABLETS

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Targinact® 5 mg/2.5 mg Prolonged Release Tablets /
Targinact® 40 mg/20 mg Prolonged Release Tablets
(oxycodone hydrochloride / naloxone hydrochloride)
This product is available using any of the above names but will be referred to as Targinact
tablets throughout the following leaflet. Please note that the leaflet also contains
information about other strengths (Targinact® 10 mg/5 mg Prolonged Release Tablets and
Targinact® 20 mg/10 mg Prolonged Release Tablets).
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.
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 Targinact 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 severe restless legs syndrome in people who can’t be treated with dopamine
medicines. People with restless legs syndrome have unpleasant sensations in their limbs.
This can start as soon as they sit or lie down and is only relieved by an irresistible urge to
move the legs, sometimes the arms and other parts of the body. It makes sitting still and
sleeping very difficult. Naloxone hydrochloride is added to counteract constipation.
How Targinact tablets work in restless legs syndrome
These tablets help to relieve the unpleasant sensations and so reduces the urge to move
the limbs. 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 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.
Additionally for restless legs syndrome
 if you have a history of opioid abuse
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 suffer with a condition characterised by frequent breathing stops during the night
which may make you feel very sleepy during the daytime (sleep apnoea)
 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;
 if sleepiness or episodes of suddenly falling asleep occur.
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 effect. Long-term 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
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
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 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
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.
This medicine has been associated with sleepiness and episodes of suddenly falling
asleep. If you experience these side effects, you must not drive or operate machinery. You
should tell your doctor if this occurs.
 Do not drive while taking this medicine until you know how it affects you.
 It is an offence to drive while you have this medicine in your body over a specified limit
unless you have a defence (called the ‘statutory defence’).
 This defence applies when:
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 and in the
information provided with the medicine.
 Please note that it is still an offence to drive if you are unfit because of the medicine (i.e.
your ability to drive is being affected).
Details regarding a new driving offence concerning driving after drugs have been taken in
the UK may be found here:
https://www.gov.uk/drug-driving-law
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
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. Check with your doctor or
pharmacist if you are not sure.
You must swallow these prolonged-release tablets whole so as not to affect the slow
release of oxycodone from the tablets. 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’). Unless otherwise prescribed by your doctor, the usual dose is:
To treat pain
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 dosage 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 160 mg oxycodone hydrochloride and 80 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.
To treat restless legs syndrome
Adults
The usual starting dose is 5 mg oxycodone hydrochloride/ 2.5 mg naloxone hydrochloride
as prolonged-release tablet(s) every 12 hours.
Your doctor will decide how much you should take every day and how to divide your total
daily dosage into morning and evening doses. They will also decide on any necessary dose
adjustments during treatment. Your dose will be adjusted according to you individual
sensitivity. You should be given the lowest dose needed to relieve your restless legs
syndrome symptoms.
If you feel that these tablets are too strong or too weak, please talk to your doctor or
pharmacist.
The maximum daily dose is 60 mg oxycodone hydrochloride and 30 mg naloxone
hydrochloride.
To treat pain or restless legs syndrome
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 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 ‘Warnings and Precautions’).
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.
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.

If you forget to take Targinact tablets,
or if you take a lower dose than the one prescribed, you may not feel any 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 routine.
 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 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 dose.
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.
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.
The following side effects have been seen in patients being treated for pain
Common (may affect up to 1 in 10 people)
 abdominal pain
 constipation
 diarrhoea
 dry mouth
 indigestion
 vomit (be sick)
 feel sick
 wind
 decreased appetite up to loss of appetite
 a feeling of dizziness or ‘spinning’
 headache
 hot flushes
 general weakness
 tiredness or exhaustion
 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
 difficulties to concentrate
 impaired speaking
 shaking
 difficulties breathing
 restlessness
 chills
 hepatic enzymes increased
 rise in blood pressure
 runny nose
 cough
 hypersensitivity/allergic reactions
 weight loss
 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
 weight gain
 yawning
Not known (frequency cannot be estimated from available data)
 euphoric mood
 severe drowsiness
 erectile dysfunction
 nightmares
 hallucinations
 shallow breathing
 difficulty 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
 difficulty 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
The following side effects have been seen in patients being treated for restless legs
syndrome
Very common (may affect 1 in 10 people or more)
 headache
 drowsiness
 constipation
 feel sick
 sweating
 tiredness or exhaustion
Common (may affect up to 1 in 10 people)
 decreased appetite to loss of appetite
 difficulty sleeping
 depression
 a feeling of dizziness or ‘spinning
 difficulty in concentrating
 shaking
 tingling in hands or feet
 vision impairment
 vertigo
 hot flushes
 drop in blood pressure
 rise in blood pressure
 abdominal pain
 dry mouth
 vomit (be sick)
 hepatic enzymes increased (alanine
glutamyltransferase increased)
 itchy skin
 skin reactions/rash
 chest pain
 chills
 pain
 thirst

aminotransferase

increased,

gamma-

Uncommon (may affect up to 1 in 100 people)
 reduced sexual drive
 episodes of suddenly falling asleep
 altered taste
 difficulties breathing
 wind
 erectile dysfunction
 withdrawal symptoms such as agitation
 swelling of hands, ankles or feet
 injuries from accidents
Not known (frequency cannot be estimated from available data)
 hypersensitivity/ allergic reactions
 abnormal thoughts
 anxiety
 confusion
 nervousness
 restlessness
 euphoric mood
 hallucinations
 nightmares
 epileptic seizures (especially in persons with epileptic disorder or predisposition to
seizures)
 severe drowsiness
 impaired speaking
 fainting
 chest tightness especially if you already have coronary heart disease
 palpitations
 increase in pulse rate
 shallow breathing
 cough
 runny nose
 yawning
 abdominal bloating
 diarrhoea
 indigestion
 belching
 dental changes
 biliary colic
 muscle cramps
 muscle twitches
 muscle pain
 difficulties in passing urine
 increased urge to urinate
 generally feeling unwell
 weight loss
 weight increase
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any
possibe 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 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 that month.
Do not store above 25°C. Store in the original package in order to protect from light.
If your medicine becomes discoloured, or shows any signs of deterioration, consult your
pharmacist who will tell you what to do.
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 prolonged release tablet contains 5 mg oxycodone hydrochloride
equivalent to 4.5 mg oxycodone / 2.73 mg naloxone hydrochloride dihydrate equivalent to
2.5 mg naloxone hydrochloride and 2.25 mg naloxone.
Each 40 mg/20 mg prolonged release tablet contains 40 mg oxycodone hydrochloride
equivalent to 36.0 mg oxycodone / 21.8 mg naloxone hydrochloride dihydrate equivalent to
20.0 mg naloxone hydrochloride and 18.0 mg naloxone.
The other ingredients are:
Tablet core:
 hydroxypropylcellulose (5 mg/2.5 mg strength tablet only), povidone K30 (40 mg/20 mg
strength tablet 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 FCF aluminium lake (E133) and the 40
mg/20 mg tablets contain yellow iron oxide (E172).
What Targinact tablets look like and the contents of the pack
Targinact 5 mg/2.5 mg Prolonged Release tablets are blue, oblong, film coated tablets,
marked ‘OXN’ on one side and ‘5’ on the other.
Targinact 40 mg/20 mg Prolonged Release tablets are yellow, oblong, film coated tablets,
marked ‘OXN’ on one side and ‘40’ on the other
Targinact tablets are available in blister packs of 28 and 56 tablets.
PLPI 15814/1087 Targinact® 5 mg/2.5 mg Prolonged Release Tablets POM
PLPI 15814/1090 Targinact® 40 mg/20 mg Prolonged Release Tablets

CD

This product is manufactured by BARD Pharmaceuticals Ltd., Cambridge, UK OR
Mundipharma GmbH, Limburg, Germany.
Procured from within the EU and repackaged by the Product Licence holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.) 12.10.2015.
Targinact and Targin are registered trademarks of Mundipharma AG, Switzerland.
To request a copy of this in Braille, large print or audio please call 01923 332 796.

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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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