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CAREXIL 10MG PROLONGED-RELEASE TABLETS

Active substance(s): OXYCODONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Carexil® 5 mg Prolonged-release Tablets
Carexil® 10 mg Prolonged-release Tablets
Carexil® 20 mg Prolonged-release Tablets

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Oxycodone 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 Carexil is and what it is used for
2. What you need to know before you take Carexil
3. How to take Carexil
4. Possible side effects
5. How to store Carexil
6. Contents of the pack and other information

1

What Carexil is and what it is
used for

Carexil is a centrally acting, strong painkiller
from the group of opioids.
Carexil is used to treat severe pain, which
can be adequately managed only with
opioid analgesics.

2

What you need to know before
you take Carexil

Do not take Carexil
• if you are allergic to oxycodone hydrochloride
or any of the other ingredients this
medicine (listed in section 6)
• if you suffer from severely depressed
breathing (respiratory depression)
• if you suffer from severe chronic
obstructive lung disease, cor pulmonale
(cardiac changes due to chronic overload
of lung circulation) or acute, severe
bronchial asthma
• if you suffer from intestinal paralysis
(paralytic ileus)
• if you suffer from elevated carbon dioxide
levels

Warnings and precautions
Talk to your doctor or pharmacist before
taking Carexil
• if you are older or debilitated
• if your lung, liver or kidney function is
severely impaired
• if you suffer from myxoedema (certain
illnesses of the thyroid gland), impaired
function of the thyroid gland
• if you suffer from adrenal insufficiency
(Addisonʼs disease)
• if you suffer from enlargement of the
prostate (prostatic hypertrophy)
• if you suffer from alcoholism or are
undergoing alcohol withdrawal
• if you suffer from known opioid-dependence
• if you suffer from inflammation of the
pancreas (pancreatitis) or if you have
problems with your gall bladder
• if you have difficulty or pain passing urine
• if you have inflammatory bowel disease
• in conditions with increased brain pressure
• if you suffer from disturbances of
circulatory regulation
• if you suffer from epilepsy or have a
seizure tendency
• if you take MAO inhibitors (for the
treatment of depression) or within 2
weeks of discontinuation of their use
• if you are also taking a medicine called
naltrexone (see also “Other medicines
and Carexil”)
• if you recently had abdominal surgery.
Please talk to your doctor if any of these
apply to you or if any of these conditions
applied to you in the past.

Carexil has a primary dependence potential.
When used for a long time tolerance to the
effects and progressively higher doses may
be required to maintain pain control.

Chronic use of Carexil may lead to physical
dependence and withdrawal syndrome may
occur upon abrupt cessation. When a patient
no longer requires therapy with Carexil, it
may be advisable to taper the dose gradually
to prevent symptoms of withdrawal.
Withdrawal symptoms may include yawning,
dilation of the pupil of the eye, abnormal or
excessive secretion of tears, running nose,
trembling or shaking, increased sweating,
anxiety, agitation, fits and sleeplessness.
An increased sensitivity to pain
(hyperalgesia) that will not respond to a
further dose increase of oxycodone may
very rarely occur, particularly in high doses.
An oxycodone dose reduction or change to
an alternative opioid may be required.

When used as directed in patients suffering
from chronic pain the risk of developing
physical or psychological dependence is
markedly reduced and needs to be weighed
against the potential benefit. Please discuss
this with your doctor.
The prolonged-release tablets should be
used with particular care in patients with a
history of or present alcohol and drug abuse.

In case of abusive injection (injection in a
vein) the tablet excipients may lead to
destruction (necrosis) of the local tissue,
change of lung tissue (granulomas of the
lung) or other serious, potentially fatal events.
Athletes should be aware that this medicine
may cause a positive reaction to
“anti-doping tests”.
Use of Carexil as a doping agent may
become a health hazard.

Children
Carexil has not been studied in children under
12 years. The safety and efficacy have not been
demonstrated and therefore use in children
under 12 years of age is not recommended.

Older people
In elderly patients the lowest dose should be
administered with careful titration to pain control.
Other medicines and Carexil
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.

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Medicines inducing severe breathing
problems such as sleeping pills and strong

pain killers can enhance the risk of stopping
breathing, especially in the case of
overdose and in the elderly.
Taking Carexil at the same time as
medicines which affect the way the brain
works can enhance the sedative effect of
Carexil (you may feel very sleepy).

Medicines that affect the way the brain
works include:
• other strong pain killers (opioids),
• sleeping pills and tranquillisers,
• certain antidepressants,
• medicines used to treat allergies, travel
sickness or nausea (antihistamines or
antiemetics),
• other medicines which act on the nervous
system (antipsychotics),
• medicines used to treat Parkinsonʼs disease.

Further interactions may occur with
• certain strong pain killers (so-called mixed
agonists-antagonists such as buprenorphine,
pentazocine, and nalbuphine).
• medicines against blood clotting (e.g.
warfarin). Carexil may influence their effects.
• naltrexone, a medicine used in the
management of alcohol and opioid
dependence.
• certain antibiotics (e.g. clarithromycin,
erythromycin, telithromycin and rifampicin)
• certain antifungals (e.g. ketoconazole,
voriconazole, itraconazole, and posaconazole)
• certain medicines to treat HIV infection
(e.g. boceprevir, ritonavir, indinavir,
nelfinavir and saquinavir)
• cimetidine, a medicine to treat heartburn
• phenytoin, a medicine to treat seizures
• St. Johnʼs Wort, a medicine to treat
depression

Taking Carexil with food, drink and alcohol
Drinking alcohol whilst taking Carexil 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 youʼre taking Carexil.
Drinking grapefruit juice whilst taking
Carexil may increase the risk for side
effects. It is recommended not to drink
grapefruit juice while youʼre taking Carexil.
Pregnancy and breast-feeding
Pregnancy
You should not take Carexil during
pregnancy. There are no adequate data
from the use of oxycodone in pregnant
women. Oxycodone crosses the placenta
into the blood circulation of the baby.

Prolonged use of oxycodone during pregnancy
can cause withdrawal symptoms in newborns.
Use of oxycodone during delivery can cause
respiratory depression in the newborn.
Breast-feeding
You should not use Carexil when you are
breast-feeding as oxycodone may pass into
breast milk.
Ask your doctor or pharmacist for advice
before taking any medicine.

Driving and using machines
Oxycodone impairs alertness and reactivity
to such an extent that the ability to drive
and operate machinery is affected or
ceases altogether. To look at the possible
side effects affecting the motor skills and
concentration see section 4 “Possible side
effects”. With stable therapy, a general ban
on driving a vehicle may be not necessary.
The treating physician must assess the
individual situation. Please discuss with
your doctor whether or under what
conditions you can drive a vehicle.

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.
• It is an offence to drive if this medicine
affects your ability to drive.
• However, you would not be committing an
offence if:
- The medicine has been prescribed to
treat a medical or dental problem and
- You have taken it according to the
instructions given by the prescriber or in
the information provided with the
medicine and
- It was not affecting your ability to drive
safely
Talk to your doctor or pharmacist if you are
not sure whether it is safe for you to drive
while taking this medicine.

Important information about some of the
ingredients of Carexil
Carexil Prolonged-release 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 Carexil

Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.
For dose adjustment other strengths of this
medicinal product are available.

The recommended dose is
Adults and children (over 12 years of age)
The usual initial dose is 10 mg of oxycodone
hydrochloride in 12 hourly intervals.

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Further determination of the daily dose, the
division into the single doses and any dose
adjustments during the further course of
therapy are performed by the treating physician
and depend on the previous dosage.
Patients who have already taken opioids
can start treatment with higher dosages
taking into account their experience with
opioid treatment.

Some patients who receive Carexil according
to a fixed schedule need rapidly acting
painkillers as rescue medication to control
breakthrough pain. Carexil is not intended
for the treatment of breakthrough pain.
For the treatment of non-cancer pain a daily
dose of 20 mg of oxycodone hydrochloride
twice daily is generally sufficient, but higher
dosages may be necessary. Patients with
cancer pain usually require dosages from
80 to 120 mg of oxycodone hydrochloride
which may be increased up to 400 mg in
individual cases.
The treatment needs to be controlled
regularly with regard to pain relief and other
effects in order to achieve the best pain
therapy possible as well as to be able to
treat any occurring side effects in good time
and to decide whether treatment should be
continued.
Patients with impaired kidney and/or liver
function
Your doctor may prescribe a lower starting
dose.
Other risk patients
If you have a low body weight your doctor
may prescribe a lower starting dose.
Method and duration of administration
For oral use only.

Swallow the prolonged-release tablets
whole with a sufficient amount of liquid (½
glass of water) with or without food in the
morning and in the evening following a fixed
schedule (e.g. at 8 a.m. and 8 p.m.).
The prolonged-release tablets must not be
crushed or chewed as this leads to rapid
oxycodone release due to the damage of
the prolonged-release properties. The
administration of chewed or crushed Carexil
leads to a rapid release and absorption of a
potentially fatal dose of oxycodone (see section
“If you take more Carexil than you should”).

Carexil is for oral use only. In case of
abusive injection (injection in a vein) the
tablet excipients may lead to destruction
(necrosis) of the local tissue, change of lung
tissue (granulomas of the lung) or other
serious, potentially fatal events.
Your doctor will adjust the dosage
depending on the pain intensity and how
you respond to the treatment. Take the
number of prolonged-release tablets
determined by your doctor twice daily.

If you take more Carexil than you should
If you have taken more Carexil than prescribed
you should inform your doctor or your local
poison control center immediately. The
following symptoms may occur: constricted
pupils (miosis), depressed breathing
(respiratory depression), skeletal muscle
flaccidity and drop in blood pressure. In
severe cases circulatory collapse, mental
and motor inactivity (torpor), unconsciousness
(coma), slowing of the heart rate and
accumulation of water in the lungs
(non-cardiogenic lung oedema) may occur;
abuse of high doses of strong opioids such
as oxycodone can be fatal. In no case
should you expose yourself to situations
requiring high levels of concentration e.g.
driving a car or using machines.
If you forget to take Carexil
If you use a smaller dose of Carexil than
directed or you miss the intake of a dose,
pain relief will consequently be insufficient
or cease altogether.

You can make up for a forgotten dose if the
next regular intake is not due for at least
another 8 hours. You can then continue to
take the next dose as directed.
You should also take your dose if the time
to the regular next intake is shorter, but
postpone the next intake by 8 hours. In
principle, you should not take Carexil more
than once every 8 hours.

Do not take a double dose to make up for a
forgotten dose.
If you stop taking Carexil
Do not stop treatment without informing
your doctor.

When a patient no longer requires therapy
with Carexil, it may be advisable to taper
the dose gradually to prevent symptoms of
withdrawal.

If you have any further questions on the use
of this product, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause
side effects, although not everybody gets them.
Contact a doctor immediately if any of
the following symptoms occur:
• Very slow or weak breathing
(respiratory depression). This is the most
serious risk in connection with medicines
such as Carexil (opioids), and may even
be fatal after high doses of this medicine.
OTHER SIDE EFFECTS

Very common (may affect more than 1 in
10 people)
• drowsiness, dizziness, headache.
• constipation, feeling or being sick. Your
doctor will prescribe an appropriate
medicine to treat these symptoms.
• itching.

Common (may affect up to 1 in 10 people)
• anxiety, depression, nervousness, sleep
disorders, abnormal thoughts, confusion,
trembling
• feeling weak
• shortness of breath
• dry mouth, general symptoms of
indigestion such as stomach ache,
diarrhoea, loss of appetite.
• rash, increased sweating, frequent urination.

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Uncommon (may affects up to 1 in 100
people)
• allergic reactions
• increase in the amount of a certain hormone
(ADH = antidiuretic hormone) in the blood
with symptoms such as headache,

















irritability, lethargy, nausea, vomiting,
confusion and disturbance of consciousness.
lack of water in the body (dehydration).
restlessness, emotional lability, feeling elated
hallucinations, drug dependence, vision
disturbances, unusual acuteness of
hearing, change in taste
increased or decreased muscle tension,
tics, epileptic seizures (fits), reduced
sensitivity to pain or touch, problems with
coordination or with keeping oneʼs balance.
loss of memory, speech disorders
fainting
changes in tear secretion, reduction in the
size of the pupils.
increased pulse rate, palpitation of the heart
(in the context of withdrawal syndrome).
widening of the blood vessels causing low
blood pressure, increased coughing, sore
throat, runny nose, voice changes,
difficulty in breathing or wheezing.
mouth ulcers, sore gums, flatulence
(excessive gas in the stomach or bowel),
difficulty in swallowing, belching,
obstruction of the bowel (ileus).
decreased sexual desire and impotence.
injuries due to accidents resulting from
decreased alertness, pain (e.g. chest
pain), fluid retention (oedema), migraine,
withdrawal symptoms, drug tolerance.
dry skin, thirst
problems passing urine
chills

Rare (may affect up to 1 in 1,000 people)
• lymph node disease.
• muscle spasms, low blood pressure,
sudden drop in blood pressure when
standing up
• bleeding gums, increased appetite,
dark-coloured stools, tooth staining and
other changes of the teeth.
• blisters on the skin and the mucous
membranes (cold sores or herpes),
increased sensitivity to light, itchy rash.
• blood in urine.
• changes in body weight (loss or rise), skin
inflammation.
Very rare (may affect up to 1 in 10,000
people)
• scaly rash.

Frequency not known (frequency cannot
be estimated from the available data)
• absence of menstrual bleeding.
• serious allergic reaction which causes
breathing difficulty or dizziness.
• aggression
• increased sensitivity to pain (hyperalgesia)
• caries
• biliary colic (which causes stomach pain),
biliary congestion
Prolonged use of Carexil may lead to
dependence and a withdrawal syndrome
may occur, if treatment is abruptly stopped.
If you no longer require treatment with
Carexil your doctor will gradually decrease
the dose to prevent withdrawal symptoms
(see also “Warnings and precautions”.

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
(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 Carexil

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 blister/bottle and
the carton after “EXP”. The expiry date
refers to the last day of that month.
HDPE-Twist-off containers
Shelf life after first opening: 6 months

This medicinal product 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 Carexil contains
The active substance is oxycodone
hydrochloride.

Each prolonged-release tablet contains 5
mg/10 mg/20 mg oxycodone hydrochloride
equivalent to 4.5 mg/9.0 mg/17.9 mg
oxycodone.

The other ingredients are:
Tablet core: hydrogenated castor oil,
copovidone, behenoyl polyoxyglycerides,
lactose monohydrate, magnesium stearate,
maize starch, colloidal anhydrous silica,
triglycerides, medium-chain.
Tablet coating: microcrystalline cellulose,
hypromellose, stearic acid, titanium dioxide
(E171), (Carexil 5 mg: indigo carmine
aluminium salt; Carexil 20 mg: iron oxide
red (E172).

What Carexil looks like and contents of
the pack
Carexil 5 mg Prolonged-release Tablets are
blue, round, biconvex prolonged-release
tablets.
Carexil 10 mg Prolonged-release Tablets
are white, round, biconvex
prolonged-release tablets.
Carexil 20 mg Prolonged-release Tablets
are pink, round, biconvex prolonged-release
tablets.

Carexil is available in packs of 7, 10, 14, 20,
28, 30, 50, 56, 60, 98, 100, 100x1 and 112
prolonged-release tablets in blisters and
100 and 250 prolonged-release tablets in
HDPE bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Ltd, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR, UK.
Manufacturer
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
39179 Barleben, Germany.

This leaflet was last revised in 08/2014.
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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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