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TARGINACT 2.5 MG/1.25 MG PROLONGED-RELEASE TABLETS

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

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Package leaflet: Information for the user
Targinact 2.5 mg/1.25 mg prolonged-release tablets
Targinact 15 mg/7.5 mg prolonged-release tablets
Targinact 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 is and what it is used for
2.
What you need to know before you take Targinact
3.
How to take Targinact
4.
Possible side effects
5.
How to store Targinact
6.
Contents of the pack and other information

1.

What TARGINACT is and what it is 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.
You have been prescribed Targinact for the treatment of severe pain, which can be adequately managed
only with opioid analgesics. Naloxone hydrochloride 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 hydrochloride is responsible for the pain-killing effect of Targinact, and is a potent analgesic
(“painkiller”) of the opioid group. The second active substance of Targinact, naloxone hydrochloride, is
intended to counteract constipation. Bowel dysfunction (e.g. constipation) is a typical side effect of
treatment with opioid painkillers.

2.

What you need to know before you take TARGINACT

Do not take Targinact:
- 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:
- 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 these tablets.
The most serious result of opioid overdose is respiratory depression (slow and shallow breathing). This
may also cause blood oxygen levels to fall, resulting in possible fainting, etc.
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 tablets. Taking broken,
chewed or crushed tablets may lead to the absorption of a potentially lethal dose of oxycodone
hydrochloride (see section 3 “If you take more Targinact than you should”).
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 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 another opioid, withdrawal symptoms may occur when you initially switch to
Targinact treatment, e.g. restlessness, bouts of sweating and muscle pain. If you experience such
symptoms, you may need to be specially monitored by your doctor.
If taken over the long term, you may become tolerant to these tablets. This means you may need a higher
dose to achieve the desired effect. Also, long-term use 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.
Tell your doctor in case you have cancer associated to peritoneal metastases or beginning bowel
obstruction in advanced stages of digestive and pelvic cancers.

If you need to undergo surgery, please tell your doctors that you are taking Targinact.
You may notice remnants of the prolonged-release tablet in your stools. Do not be alarmed, as the active
substances (oxycodone hydrochloride and naloxone hydrochloride) have already been released in the
stomach and gut, and absorbed into your body.
Incorrect use of Targinact
These tablets are not suitable for withdrawal treatment.
Targinact 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
these tablets because they contain the ingredient naloxone. Pre-existing withdrawal symptoms may be
made worse.
You should never misuse these 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 may produce positive results in doping controls.
The use of Targinact as a doping agent may become a health hazard.
Other medicines and Targinact
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you take these tablets at the same time as you take other medicines, the effect of these tablets or the
other medicine may be changed. Tell your doctor if you are taking:
















other potent painkillers (opioids);
sleep medication and tranquilisers (sedatives, hypnotics);
medicines to treat depression;
medicines used to treat allergies, travel sickness or nausea (antihistamines or antiemetics)
medicines to treat psychiatric or mental disorders (phenothiazines, neuroleptics, antipsychotics);
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, erythromycin or telithromycin);
antifungal medicines of the –azole type (such as ketoconazole, voriconazole, itraconizole or
posaconizole);
a specific type of medicine known as a protease inhibitor used to treat HIV (examples include
ritonavir, indinavir, nelfinavir or saquinavir);
cimetidine (a medicine for stomach ulcers, indigestion or heartburn);
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);
a herbal remedy called St John’s Wort (also known as Hypericum perforatum);
quinidine (a medicine to treat an irregular heartbeat).

No interactions are expected between Targinact and paracetamol, acetylsalicylic acid or naltrexone.
Targinact 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 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 hydrochloride is given during childbirth, respiratory depression (slow and shallow
breathing) may occur in the newborn infant.
Breastfeeding
Breastfeeding should be discontinued during treatment with these 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.
Driving and using machines
Targinact may affect your ability to drive or operate machines. In particular, this is likely at the start of
Targinact therapy, after a dose increase or after switching from a different medication. However, these
side effects disappear once you are on a stable Targinact dose.
Ask your doctor whether you may drive or operate machines.
Targinact contains lactose
This medicine contains lactose (milk sugar). If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking these tablets.

3.

How to take TARGINACT

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure.
Targinact is a prolonged-release tablet, which means that its active substances are released over an
extended period. Their action lasts for 12 hours.
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 tablets. Taking broken,
chewed or crushed tablets may lead to the absorption of a potentially lethal dose of oxycodone
hydrochloride (see section 3 “If you take more Targinact than you should”).
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 prolongedrelease 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. 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 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 hydrochloride should not exceed 400
mg. The beneficial effect of naloxone hydrochloride on bowel activity may be affected if additional
oxycodone hydrochloride is given without additional naloxone hydrochloride.
If you are switched from these tablets to another opioid pain medication your bowel function will probably
worsen.
If you experience pain between two doses of Targinact, you may need a rapid-acting painkiller. Targinact
is not suitable for this. In this case, please talk to your doctor.
If you have the impression that the effect of these tablets is 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 impairment
If you have an impairment of your kidney function or a mild impairment of your liver function, your
attending doctor will prescribe these tablets with special caution. If you have a moderate or severe
impairment of liver function, these tablets should not be used (see also Section 2 “Do not take Targinact”
and “Warnings and precautions”).
Children and adolescents below 18 years of age
Targinact has not yet been studied in children and adolescents under 18 years of age. Its safety and
effectiveness have not 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
Oral use
Swallow these tablets whole (without chewing), with sufficient liquid (½ glass of water). You can take the
prolonged-release tablets with or without food. Take these 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 (see section 2 “Warnings and precautions”).
Duration of use
In general, you should not take these tablets for any longer than you need to. If you are on long-term
treatment, your doctor should regularly check whether you still need these tablets.
If you take more Targinact than you should
If you have taken more than the prescribed dose of these tablets, you must inform your doctor
immediately.
An overdose may result in:
 narrowed pupils
 slow and shallow breathing (respiratory depression)
 drowsiness up to loss of consciousness)
 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.
You should avoid situations which require a high level of alertness, e.g. driving.
If you forget to take Targinact
Or if you take a dose lower than the one prescribed, you may not feel any painkilling effect.

If you 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 within 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 8hour period.

Do not take a double dose to make up for a forgotten dose.
If you stop taking Targinact
Do not stop your treatment 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.








abdominal pain
constipation
diarrhoea
dry mouth
indigestion
vomit (be sick)

Common (may affect up to 1 in 10 people)
 feel sick
 flatulence (wind)
 decreased appetite up to loss of
appetite
 a feeling of dizziness or 'spinning'
 headache
 hot flushes

Uncommon (may affect up to 1 in 100 people)
 abdominal bloating
 palpitations
 abnormal thoughts
 biliary colic
 anxiety
 chest pain
 confusion
 generally feeling unwell
 pain
 depression
 swelling of hands, ankles or feet
 nervousness
 difficulties to concentrate
 chest tightness especially if
you already have coronary
 impaired speaking
heart disease
 shaking
 drop in blood pressure
 difficulties breathing
 withdrawal symptoms such
 restlessness
as agitation
 chills
 fainting
 hepatic enzymes increased

 a feeling of unusual
weakness
 tiredness or exhaustion
 itchy skin
 skin reactions/rash
 sweating
 vertigo
 difficulty in sleeping
 drowsiness

 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

 lack of energy
 thirst
 altered taste







increase in pulse rate
drug dependence
euphoric mood
severe drowsiness
erectile dysfunction
nightmares

 rise in blood pressure
 reduced sexual drive
Rare (may affect up to 1 in 1,000 people)
 dental changes
Not known
 hallucinations
 shallow breathing
 difficulties in passing urine

with epileptic disorder or
predisposition to
seizures)
 yawning
 weight gain
 tingling skin (pins and
needles)
 belching

The active substance oxycodone hydrochloride, if not combined with naloxone hydrochloride, is
known to have following, differing side-effects:
Oxycodone can cause breathing problems (respiratory depression), reduction in size of the pupil in the
eye, cramping of the bronchial muscles and cramping of the smooth muscles, as well as depressing the
cough reflex.
Common (may affect up to 1 in 10 people)
 altered mood and personality
 decreased activity
changes (e.g. depression,
 increased activity
feeling of extreme
happiness)
Uncommon (may affect up to 1 in 100 people)
impaired concentration
 reduced sensitivity to pain or
touch
migraines

abnormal
coordination
increased muscle tension
 vocal changes (dysphonia)
involuntary muscle
 water retention
contractions
 a condition where the bowel
 difficulties in hearing
stops working properly
 mouth ulcers
(ileus)
 difficulties in swallowing
 dry skin
 drug tolerance





Rare (may affect up to 1 in 1,000 people)
 itching rash (urticaria)
 increased appetite
 infections such as cold sores
 black (tarry) stools
or herpes (which may cause
blisters around the mouth or
genital area)

 difficulties in passing
urine
 hiccups

 sore gums
 perception disturbances
(e.g. hallucination,
derealisation)
 flushing of skin
 dehydration
 agitation
 a decrease in sex
hormone levels which
may affect sperm
production in men or
the menstrual cycle in
females
 bleeding gums

Not known (frequency cannot be estimated from the available data)
 acute generalized allergic
 absence of menstrual periods
 problems with bile flow
reactions (anaphylactic
 withdrawal symptoms in the
 tooth decay
reactions)
newborn
 an increase in sensitivity to
 aggression
pain
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 national reporting system listed in

Appendix V. By reporting side effects you can help provide more information on the safety of this
medicine.

5.

How to store TARGINACT

Keep this medicine 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 contains
The active substances are: oxycodone hydrochloride and naloxone hydrochloride.
Targinact 2.5 mg/1.25 mg
Each prolonged-release tablet contains 2.5 mg oxycodone hydrochloride, equivalent to 2.25 mg
oxycodone and 1.25 mg naloxone hydrochloride as 1.37 mg naloxone hydrochloride dihydrate, equivalent
to 1.13 mg naloxone.
Targinact 15 mg/7.5 mg
Each prolonged-release tablet contains 15 mg oxycodone hydrochloride, equivalent to 13.5 mg oxycodone
and 7.5 mg naloxone hydrochloride as 8.24 mg naloxone hydrochloride dihydrate, equivalent to 6.75 mg
naloxone.
Targinact 30 mg/15 mg
Each prolonged-release tablet contains 30 mg oxycodone hydrochloride, equivalent to 27 mg
oxycodoneand 15 mg naloxone hydrochloride as 16.48 mg naloxone hydrochloride dihydrate, equivalent
to 13.5 mg naloxone.
The other ingredients are:
Targinact 2.5 mg/1.25 mg
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
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
Tablet core:
Povidone K30, ethylcellulose, stearyl alcohol, lactose monohydrate, talc, magnesium stearate
Tablet coat:
Polyvinylalcohol, partially hydrolysed, titanium dioxide (E171), macrogol 3350, talc, iron oxide black
(E172), iron oxide red (E172), iron oxide yellow (E172)

What Targinact looks like and contents of the pack
Targinact 2.5 mg/1.25 mg
Light yellow, round tablets, 5 mm in size, with a film coating.
Targinact 15 mg/7.5 mg
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
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.
These tablets are available in blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100 prolonged-release
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
NAPP PHARMACEUTICALS LIMITED

This leaflet was last revised in 09/2016.

Expand Transcript

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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