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OXYCODONE HYDROCHLORIDE/NALOXONE HYDROCHLORIDE HCS BVBA 40MG/20MG PROLONGED-RELEASE TABLETS

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

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Package leaflet: Information for the patient

Oxycodone hydrochloride/
Naloxone hydrochloride
HCS bvba 10 mg/5 mg,
20 mg/10 mg, 40 mg/20 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.

86 mm ± 0,5 mm

What is in this leaflet
1. What Oxycodone hydrochloride/Naloxone hydrochloride HCS bvba is and
what it is used for
2. What you need to know before you take Oxycodone HCl/Naloxone HCl
3. How to take Oxycodone HCl/Naloxone HCl
4. Possible side effects
5. How to store Oxycodone HCl/Naloxone HCl
6. Contents of the pack and other information

1. What Oxycodone hydrochloride/Naloxone
hydrochloride HCS bvba is and what it is used for
The name of this medicine is Oxycodone hydrochloride/Naloxone
hydrochloride HCS bvba 10 mg/5 mg, 20 mg/10 mg or 40 mg/20 mg
prolonged-release tablets. This will be referred to as Oxycodone HCl/
Naloxone HCl throughout the leaflet.
Pain relief
You have been prescribed Oxycodone HCl/Naloxone HCl for the treatment
of severe pain, which can be adequately managed only with opioid
analgesics. Naloxone is added to counteract constipation.
How Oxycodone HCl/Naloxone HCl work in pain relief
Oxycodone HCl/Naloxone HCl contains oxycodone hydrochloride and
naloxone hydrochloride as active substances. Oxycodone is responsible for
the painkilling effect of Oxycodone HCl/Naloxone HCl. 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.

smer branja kode

Oxycodone hydrochloride/
Naloxone hydrochloride
HCS bvba
vizualna koda
smer branja kode

102 mm ± 0,5 mm

xxxxxx

140 mm ± 0,5 mm

2. What you need to know before you take Oxycodone
HCl/Naloxone HCl

Oxycodone hydrochloride/
Naloxone hydrochloride
HCS bvba

Do not take Oxycodone HCl/Naloxone HCl:
• if you are allergic to oxycodone or naloxone or any of the other ingredients
of this medicine (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 Oxycodone HCl/Naloxone HCl:
• 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.
Oxycodone HCl/Naloxone HCl is not recommended for use in patients with
advanced digestive or pelvic cancers where bowel obstruction may be a
problem.
How to use Oxycodone HCl/Naloxone HCl 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 Oxycodone HCl/Naloxone HCl. 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
Oxycodone HCl/Naloxone HCl.
If you have been taking Oxycodone HCl/Naloxone HCl 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 Oxycodone HCl/Naloxone HCl 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 substances will have already been released in the stomach and
gut, and absorbed into your body.
Incorrect use of Oxycodone HCl/Naloxone HCl
Oxycodone HCl/Naloxone HCl is not suitable for withdrawal treatment.
Oxycodone HCl/Naloxone HCl 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
Oxycodone HCl/Naloxone HCl because they contain the active substance
naloxone. Pre-existing withdrawal symptoms may be made worse.
You should never misuse Oxycodone HCl/Naloxone HCl 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 Oxycodone HCl/Naloxone HCl may produce positive results in
drugs tests.

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The use of Oxycodone HCl/Naloxone HCl as a doping agent may become a
health hazard.
Children and adolescents
Oxycodone HCl/Naloxone HCl must not be given to children or adolescents
under 18 years of age as the safety and benefits have not been shown yet.
Other medicines and Oxycodone HCl/Naloxone HCl
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 Oxycodone HCl/Naloxone
HCl 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 medicines 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).
Oxycodone HCl/Naloxone HCl with drink and alcohol
Drinking alcohol whilst taking Oxycodone HCl/Naloxone HCl 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 Oxycodone HCl/
Naloxone HCl. You should avoid drinking grapefruit juice while you are
taking Oxycodone HCl/Naloxone HCl.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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 Oxycodone HCl/Naloxone HCl should be avoided to the extent
possible during pregnancy. If used over prolonged periods during pregnancy,
oxycodone 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 Oxycodone HCl/
Naloxone HCl. Oxycodone passes into breast milk. It is not known whether
naloxone also passes into breast milk. Therefore, a risk for the suckling
infant cannot be excluded, in particular following intake of multiple doses of
Oxycodone HCl/Naloxone HCl.
Driving and using machines
This medicine may affect your ability to drive or operate machines. This is
most likely at the start of your treatment, after a dose increase or after
switching from a different medication. These side effects should disappear
once you are on a stable dose.
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.
Ask your doctor whether you may drive or operate machines.
Oxycodone HCl/Naloxone HCl contains 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 Oxycodone HCl/Naloxone HCl
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
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. Your doctor
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 Oxycodone HCl/Naloxone HCl 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. Oxycodone HCl/Naloxone HCl is not suitable for this.
Please talk to your doctor.
If you feel that Oxycodone HCl/Naloxone HCl 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.
Hepatic or renal impairment
If you have kidney or mild liver problems your doctor may prescribe a lower
dose. You must not take Oxycodone HCl/Naloxone HCl if you have
moderate or severe liver problems, (see also Section 2 ‘Do not take
Oxycodone HCl/Naloxone HCl’ and ‘Warnings and Precautions’).
Use in children and adolescents
No studies have been carried out to show that Oxycodone HCl/Naloxone
HCl works 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
Oral use.
Swallow Oxycodone HCl/Naloxone HCl whole with a glass of water. You can
take Oxycodone HCl/Naloxone HCl 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 divide, break,
chew or crush the tablets.
Taking divided, broken, chewed or crushed tablets may result in your
body absorbing a potentially fatal dose of oxycodone (see under ‘If
you take more Oxycodone HCl/Naloxone HCl than you should’).
Oxycodone HCl/Naloxone HCl is a prolonged-release tablet, which means
that its active substances are released over an extended period. Their
action lasts for 12 hours.
Only for perforated unit dose child-resistant peel-off blister:
Oxycodone HCl/Naloxone HCl is provided in perforated unit dose childresistant peel-off blister. Remove a prolonged-release tablet from the
package as follows:

1. Hold the blister at the edges and separate one cell from the rest of the
blister by gently tearing along the perforations around it.
2. Pull up the edge of the foil and peel the foil off completely.
3. Tip the prolonged-release tablet out into your hand.
4. Swallow the whole prolonged-release tablet with sufficient liquid, with or
without food.

385 mm ± 0,5 mm

Duration of use
You should not take Oxycodone HCl/Naloxone HCl for any longer than you
need to. If you have been taking Oxycodone HCl/Naloxone HCl for a long
time your doctor should regularly check that you still need them.
If you take more Oxycodone HCl/Naloxone HCl 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 Oxycodone HCl/Naloxone HCl,
or if you take a lower dose than the one prescribed, you may not feel any
effect.
• If you forget to take your dose and 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 Oxycodone HCl/Naloxone HCl
Do not stop taking Oxycodone HCl/Naloxone HCl 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 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:
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 effect 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 substance 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

385 mm ± 0,5 mm




















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 in 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 aminotransferase increased, gammaglutamyltransferase increased)
• itchy skin
• skin reactions/rash
• chest pain
• chills
• pain
• thirst
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 or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via Yellow Card Scheme,
Website: 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 Oxycodone HCl/Naloxone HCl
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
packaging after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
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 Oxycodone HCl/Naloxone HCl contains
• The active substances are oxycodone hydrochloride and naloxone
hydrochloride.
10 mg/5 mg prolonged-release tablets:
Each prolonged-release tablet contains 10 mg of oxycodone hydrochloride
equivalent to 9 mg oxycodone and 5 mg naloxone hydrochloride as 5.45 mg
naloxone hydrochloride dihydrate, equivalent to 4.5 mg naloxone.
20 mg/10 mg prolonged-release tablets:
Each prolonged-release tablet contains 20 mg of oxycodone hydrochloride
equivalent to 18 mg oxycodone and 10 mg naloxone hydrochloride as
10.9 mg naloxone hydrochloride dihydrate, equivalent to 9 mg naloxone.
40 mg/20 mg prolonged-release tablets:
Each prolonged-release tablet contains 40 mg of oxycodone hydrochloride
equivalent to 36 mg oxycodone and 20 mg naloxone hydrochloride as
21.8 mg naloxone hydrochloride dihydrate, equivalent to 18 mg naloxone.

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• The other ingredients are:
10 mg/5 mg prolonged-release tablets:
hydroxypropylcellulose, ethylcellulose, glyceryol distearate, lactose
monohydrate, talc (E553b), magnesium stearate (E470b) in the tablet core
and poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc
(E553b) in film coating. See section 2 “Oxycodone HCl/Naloxone HCl
contains lactose”.
20 mg/10 mg prolonged-release tablets:
hydroxypropylcellulose, ethylcellulose, glyceryol distearate, lactose
monohydrate, talc (E553b), magnesium stearate (E470b) in the tablet core
and poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc
(E553b), red iron oxide (E172) in film coating. See section 2 “Oxycodone
HCl/Naloxone HCl contains lactose”.
40 mg/20 mg prolonged-release tablets:
hydroxypropylcellulose, ethylcellulose, glyceryol distearate, lactose
monohydrate, talc (E553b), magnesium stearate (E470b) in the tablet core
and poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc
(E553b), yellow iron oxide (E172) in film coating. See section 2
“Oxycodone HCl/Naloxone HCl contains lactose”.
What Oxycodone HCl/Naloxone HCl looks like and contents of the pack
10 mg/5 mg prolonged-release tablets:
White, oval, slightly biconvex, film coated prolonged-release tablets
engraved with “10” on one side of the tablet (dimensions: 9.5 mm x 4.5 mm).
20 mg/10 mg prolonged-release tablets:
Light pink, oval, slightly biconvex, film coated prolonged-release tablets
engraved with “20” on one side of the tablet (dimensions: 9.5 mm x 4.5 mm).
40 mg/20 mg prolonged-release tablets:
Brownish yellow, capsule shaped, slightly biconvex, film coated
prolonged-release tablets engraved with “40” on one side of the tablet
(dimensions: 14.0 mm x 6.0 mm).
Oxycodone hydrochloride/Naloxone hydrochloride HCS bvba 10 mg/5 mg is
available in packs containing 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100 or
112 prolonged-release tablets in child-resistant blisters.
Oxycodone hydrochloride/Naloxone hydrochloride HCS bvba 20 mg/10 mg
is available in packs containing 10, 20, 28, 30, 50, 56, 60, 90, 98, 100 or
112 prolonged-release tablets in child-resistant blisters.
Oxycodone hydrochloride/Naloxone hydrochloride HCS bvba 40 mg/20 mg
is available in packs containing 10, 20, 28, 30, 50, 56, 60, 90, 98, 100 or
112 prolonged-release tablets in child-resistant blisters.
Only for perforated unit dose child-resistant peel-off blisters:
Oxycodone hydrochloride/Naloxone hydrochloride HCS bvba 10 mg/5 mg is
available in packs containing 10x1, 14x1, 20x1, 28x1, 30x1, 50x1, 56x1,
60x1, 90x1, 98x1, 100x1 or 112x1 prolonged-release tablets in perforated
unit dose child-resistant peel-off blisters.
Oxycodone hydrochloride/Naloxone hydrochloride HCS bvba 20 mg/10 mg
is available in packs containing 10x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1,
90x1, 98x1, 100x1 or 112x1 prolonged-release tablets in perforated unit
dose child-resistant peel-off blisters.
Oxycodone hydrochloride/Naloxone hydrochloride HCS bvba 40 mg/20 mg
is available in packs containing 10x1, 20x1, 28x1, 30x1, 50x1, 56x1, 60x1,
90x1, 98x1, 100x1 or 112x1 prolonged-release tablets in perforated unit
dose child-resistant peel-off blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
HCS bvba
H. Kennisstraat 53
Edegem
2650
Belgium
Manufacturer(s)
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This leaflet was last revised in 04/2017

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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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