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TARGINACT 80MG/40MG PROLONGED-RELEASE TABLETS

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

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Package leaflet: Information for the user
Targinact 60 mg/30 mg and 80 mg/40 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 is and what it is 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 is and what it is used for

How Targinact tablets work
Targinact tablets contain oxycodone hydrochloride and naloxone hydrochloride as active substances.
Oxycodone hydrochloride is responsible for the pain-killing 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.
Targinact tablets are only for use in adults.

2.

What you need to know before you take Targinact tablets

Do not take Targinact tablets

if you are allergic to oxycodone hydrochloride, naloxone hydrorochloride 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 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 also cause blood oxygen levels to
fall, resulting in possible fainting, etc.
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 tablets 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 Targinact tablets. This means you may need a
higher dose to achieve the desired pain relief. 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 tablets.

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 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 divide, break, chew or crush the tablets. Taking
divided, 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 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.
If you take Targinact tablets at the same time as you take other medicines, the effect of Targinact 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, itraconazole or
posaconazole);
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 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 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 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
Targinact tablets may affect your ability to drive or operate machines. In particular, this is likely at the start
of Targinact tablets therapy, after a dose increase or after switching from a different medication. However,
these side effects disappear once you are on a stable Targinact tablets dose.
Ask your doctor whether you may drive or operate machines.
Targinact tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicinal product.

3.

How to take Targinact tablets

Always take this medicine exactly as your doctor has told you. You should 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 much Targinact tablets 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 tablets 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 Targinact tablets to another 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 the effect of Targinact 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 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 been proven in children and adolescents. For this reason, Targinact tablets use in
children and adolescents under 18 years of age is not recommended.
Method of administration
Targinact tablets are for oral use.
Targinact tablets are a prolonged-release tablet, which means that its active substances are released over an
extended period. Their action lasts for 12 hours.
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) with sufficient liquid (½ glass of water).
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 divide, break, chew or crush the tablets. Taking
divided, 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 tablets than you should”).
You can take the tablets with or without food.
Duration of use
In general, you should not take Targinact tablets for any longer than you need to. If you are on long-term
treatmentwith 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 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 tablets
Or if you take a dose lower 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 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
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 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 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.

Common (may affect up to 1 in 10 people)
 abdominal pain
 constipation
 diarrhoea
 dry mouth
 indigestion
 vomit (be sick)
 feel sick
 flatulence (wind)
 decreased appetite up to loss of appetite
 a feeling of dizziness or 'spinning'
 headache
 hot flushes
 a feeling of unusual 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
 lack of energy
 thirst
 altered taste
 palpitations
 biliary colic
 chest pain
 generally feeling unwell
 pain
 swelling of hands, ankles or feet
 difficulties to concentrate
 impaired speaking
 shaking
 difficulties breathing
 restlessness
 chills
 hepatic enzymes increased
 rise in blood pressure
 reduced sexual drive
 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 the available data)
 euphoric mood
 severe drowsiness
 erectile dysfunction
 nightmares
 hallucinations
 shallow breathing
 difficulties in passing urine
 tingling skin (pins and needles)
 belching

The active substance oxycodone hydrochloride, if not combined with naloxone hydrochloride, is known
to have the 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 depression of the 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
 increased muscle tension
 involuntary muscle contractions
 drug dependence
 a condition where the bowel stops working properly (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)
 flushing of skin
 dehydration
 agitation
 a decrease in sex hormone levels which may affect sperm production in men or the menstrual cycle in
female
Rare:
 itching rash (urticaria)
 infections such as cold sores or herpes (which may cause blisters around the mouth or genital area)
 increased appetite
 black (tarry) stools
 bleeding gums

Not known (frequency cannot be estimated from the available data)
 acute generalized allergic reactions (anaphylactic reactions)
 an increase in sensitivity to pain
 absence of menstrual periods
 withdrawal symptoms in the newborn
 aggression
 problems with bile flow
 tooth decay
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 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, label and blister after “EXP...”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
For bottles only
Shelf life after first opening the bottle: 6 months.
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 protect the environment.

6.

Contents of the pack and other information

What Targinact tablets contain
The active substances are oxycodone hydrochloride and naloxone hydrochloride
Each prolonged-release tablet contains 60 mg of oxycodone hydrochloride equivalent to 54 mg oxycodone
and 30 mg naloxone hydrochloride as 32.7 mg of naloxone hydrochloride dihydrate, equivalent to 27 mg
naloxone.
Each prolonged-release tablet contains 80 mg of oxycodone hydrochloride equivalent to 72 mg oxycodone
and 40 mg naloxone hydrochloride as 43.6 mg of naloxone hydrochloride dihydrate, equivalent to 36 mg
naloxone.
The other ingredients are:
Targinact tablets 60 mg/30 mg
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 red (E172),
iron oxide black (E172).
Targinact tablets 80 mg/40 mg
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 yellow
(E172), iron oxide black (E172).

What Targinact tablets looks like and contents of the pack
Targinact tablets 60 mg/30 mg
Red, capsule shaped tablets, with a nominal length of 14 mm and with a film coating, embossed “OXN” on
one side and “60” on the other.
Targinact tablets 80 mg/40 mg
Brown, capsule shaped tablets, with a nominal length of 14 mm and with a film coating, embossed “OXN”
on one side and “80” on the other.

Targinact tablets are available in child-resistant blisters of 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100
prolonged-release tablets or in bottles with child-resistant closure containing 100 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Napp Pharmaceuticals Limited,
Cambridge Science Park,
Milton Road,
Cambridge, CB4 0GW,
UK
Manufacturers:
Bard Pharmaceuticals Limited
Cambridge Science, Milton Road, Cambridge
CB4 0GW, UK.
This leaflet was last revised in November 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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