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ARISTIGA 20 MG/10MG PROLONGED-RELEASE TABLETS

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

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Package leaflet: Information for the user
Aristiga 20 mg/10 mg prolonged-release tablets
oxycodone hydrochloride / naloxone hydrochloride
Read all of this leaflet carefully before you start
Incorrect use of Aristiga
taking this medicine because it contains important
These tablets are not suitable for withdrawal treatment.
information for you.
Aristiga should never be abused, particularly if you have
- Keep this leaflet. You may need to read it again.
a drug addiction. If you are addicted to substances such
- If you have any further questions, ask your doctor or
as heroin, morphine or methadone, severe withdrawal
pharmacist.
symptoms are likely if you abuse these tablets because
- This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs they contain the ingredient naloxone. Pre-existing
withdrawal symptoms may be made worse.
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 Aristiga is and what it is used for
2. What you need to know before you take Aristiga
3. How to take Aristiga
4. Possible side effects
5. How to store Aristiga
6. Contents of the pack and other information
1. What Aristiga is and what it is used for
Aristiga is a prolonged-release tablet, which means that its
active substances are released over an extended period.
Their action lasts for 12 hours.
These tablets are only for use in adults.
Pain relief
You have been prescribed Aristiga for the treatment of
severe pain, which can be adequately managed only with
opioid analgesics. Naloxone hydrochloride is added to
counteract constipation.
How these tablets work in pain relief
These tablets contain oxycodone hydrochloride and
naloxone hydrochloride as active substances. Oxycodone
hydrochloride is responsible for the pain-killing effect of
Aristiga, and is a potent analgesic (“painkiller”) of the opioid
group. The second active substance of Aristiga, 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 Aristiga
Do not take Aristiga:
• 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

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.

The use of Aristiga may produce positive results in doping
controls.
The use of Aristiga as a doping agent may become a health
hazard.
Other medicines and Aristiga
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 (e.g.
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 Aristiga and
paracetamol, acetylsalicylic acid or naltrexone.
Aristiga with food, drink and alcohol
Drinking alcohol whilst taking Aristiga 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 Aristiga.



Talk to your doctor or pharmacist before taking Aristiga:
• 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.

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.

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 Aristiga.
Driving and using machines
Aristiga may affect your ability to drive or operate machines.
In particular, this is likely at the start of Aristiga, after a dose
increase or after switching from a different medication.
However, these side effects disappear once you are on a
stable Aristiga dose.
Ask your doctor whether you may drive or operate
machines.

The medicine can affect your ability to drive as it may make
you sleepy or dizzy.
• Do not drive while taking this medicine until you know
how it affects you.
You must swallow the prolonged-release tablet whole, so as
• It is an offence to drive if this medicine affects your ability
not to affect the slow release of oxycodone hydrochloride
to drive.
from the prolonged-release tablet. Do not break, chew or
• However, you would not be committing an offence if:
crush the tablets. Taking broken, chewed or crushed tablets
o The medicine has been prescribed to treat a medical or
may lead to the absorption of a potentially lethal dose of
dental problem and
oxycodone hydrochloride (see section 3 “If you take more
o You have taken it according to the instructions given by
Aristiga than you should”).
the prescriber or in the information provided with the
medicine and
If you experience severe diarrhoea at the start of treatment,
o It was not affecting your ability to drive safely
this may be due to the effect of naloxone. It may be a sign
that bowel function is returning to normal. Such diarrhoea
Talk to your doctor or pharmacist if you are not sure
can occur within the first 3-5 days of treatment. If diarrhoea
whether it is safe for you to drive while taking this medicine.
should persist after 3-5 days, or give you cause for concern,
please contact your doctor.
3. How to take Aristiga
If you have been using another opioid, withdrawal
symptoms may occur when you initially switch to Aristiga
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 Aristiga.
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.

Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
Aristiga 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
Aristiga 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 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. 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, Aristiga 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 Aristiga, you may
need a rapid-acting painkiller. Aristiga 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
In general, no dose adjustment is necessary for elderly patients
with normal kidney and/or liver function.
Hepatic or renal 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 Aristiga…”
and “Warnings and precautions”).
Children and adolescents below 18 years of age
Aristiga 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,
Aristiga 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 the 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”).
Opening instructions:
This medicinal product is available in peelable, child resistant
perforated unit dose blisters.

• withdrawal
symptoms such
as agitation
• fainting
• lack of energy
• thirst
• altered taste

• restlessness
• chills
• hepatic enzymes
increased
• rise in blood
pressure
• reduced sexual
drive

Rare (may affect up to 1 in 1,000 people)
• increase in
pulse rate

• dental changes

If you take more Aristiga 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 Aristiga
Or if you take a dose lower 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 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 Aristiga
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.

• 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

Pull off a single dose by tearing along the perforated line on the
blister and peel back the foil on the blister to expose the tablet.
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.

• epileptic
seizures
(especially
in persons
with epileptic
disorder or
predisposition
to seizures)

• 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

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

• bleeding gums

Not known
(frequency cannot be estimated from the available data)
• acute generalized • absence of
allergic reactions
menstrual periods
(anaphylactic
• withdrawal
reactions)
symptoms in the
• an increase in
newborn
sensitivity to pain • aggression

• problems with
bile flow
• tooth decay

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme
at 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 Aristiga
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.
This medicine does not require any special storage conditions.
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 Aristiga contains
The active substances are oxycodone hydrochloride and
naloxone hydrochloride.

Each prolonged-release tablet contains 20 mg oxycodone hydrochloride, equivalent to 18 mg oxycodone, and 10 mg naloxone
If you have any further questions on the use of this medicine, ask hydrochloride as 11.0 mg naloxone hydrochloride dihydrate,
your doctor or pharmacist.
equivalent to 9.01 mg naloxone.

4. Possible side effects
The other ingredients are:
Like all medicines, this medicine can cause side effects, although Tablet core:
hypromellose, polyvinyl acetate, povidone, sodium laurilsulfate,
not everybody gets them.
cellulose microcrystalline, silicon dioxide, colloidal anhydrous
silica, magnesium stearate.
Important side effects to look out for, and what to do if you
are affected:
Tablet coat:
If you are affected by any of the following important side effects, polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, red iron
oxide (E172), yellow iron oxide (E172)
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












palpitations
biliary colic
chest pain
generally
feeling unwell
pain
swelling of
hands, ankles
or feet
difficulties to
concentrate
impaired
speaking
shaking
difficulties
breathing

• runny nose
• cough
• hypersensitivity/
allergic reactions
• injuries from
accidents
• increased urge to
urinate
• muscle cramps
• muscle twitches
• muscle pain
• vision impairment

What Aristiga looks like and contents of the pack
Prolonged-release tablet.
Pink, 9.6x4.8mm, elliptic, biconvex coated tablet, engraved with
“20” on one side.
Aristiga prolonged release tablets are available in peelable, child
resistant perforated unit dose blisters of: 10x1, 14x1, 20x1, 28x1,
30x1, 50x1, 56x1, 60x1, 98x1, 100x1, 100x1 (Hospital pack)
tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ethypharm
194 Bureaux de la Colline, Bâtiment D
92213 Saint Cloud cedex
France
Manufacturer
Ethypharm
Chemin de la Poudrière
76120 Le Grand Quevilly
France
For any information about this medicine, please contact the
local representative of the Marketing Authorisation Holder:
United Kingdom: Ethypharm UK Ltd
Medical information tel: + 44 (0)1277 266 600

This medicinal product is authorised in the Member States
of the EEA under the following names:
Germany :

Oxycodon-HCl/Naloxon-HCl Ethypharm
20 mg/10 mg Retardtabletten
Ireland:
Aristiga 20 mg/10 mg prolonged release tablets
United Kingdom: Aristiga 20 mg/10 mg prolonged release tablets
This leaflet was last revised in 09/2017.

88xxxx0

+ 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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