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CAREXIL 80MG PROLONGED-RELEASE TABLETS

Active substance(s): OXYCODONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Carexil® 40 mg Prolonged-release Tablets
Carexil® 80 mg Prolonged-release Tablets

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.

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

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.

Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you are
not sure.

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.

The recommended dose is
Adults and adolescents (12 years of age and older)
The usual initial dose is 10 mg of oxycodone
hydrochloride in 12 hourly intervals. Your doctor will
prescribe the dose required to treat pain.

Older people
In elderly patients the lowest dose should be
administered with careful titration to pain control.

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.

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For dose adjustment other strengths of this medicinal
product are available.

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.

Continued on the next page >>

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
40 mg of oxycodone hydrochloride 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, confusiontrembling
• 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.
This medicinal product does not require any special
storage conditions.
In use HDPE bottles
Shelf life after first opening of 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 Carexil contains
The active substance is oxycodone hydrochloride.

Each prolonged-release tablet contains 40 mg or 80 mg
oxycodone hydrochloride equivalent to 35.9 mg or
71.8 mg oxycodone.
The other ingredients are:
Tablet core: hydrogenated castor oil, copovidone,
behenoyl polyoxylglycerides, lactose monohydrate,
magnesium stearate, maize starch, colloidal anhydrous
silica, medium-chain triglycerides.

Tablet coating: microcrystalline cellulose, hypromellose,
stearic acid, titanium dioxide (E171) Carexil 40 mg
Prolonged-release Tablets also contain: iron oxide
yellow (E172).
Carexil 80 mg Prolonged-release Tablets also contain:
iron oxide black (E172), hydrated aluminium oxide,
indigo carmine (E132), quinoline yellow (E104).
What Carexil looks like and contents of the pack
Carexil 40 mg Prolonged-release Tablets are yellow,
round, biconvex film coated prolonged-release tablets,
diameter: 6.8 mm - 7.4 mm.
Carexil 80 mg Prolonged-release Tablets are green,
round, biconvex film coated prolonged-release tablets,
diameter: 9.8 mm - 10.4 mm.

Carexil is available in blisters
Pack sizes: 10, 20, 28, 30, 40, 50, 56, 60, 100 and 112
prolonged-release tablets

Carexil is also available in HDPE–bottles closed with
child resistant cap, with or without a desiccant capsule,
containing silica gel as desiccant.
Pack sizes: 50 and 100 prolonged-release tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz Ltd, Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR, UK.
Manufacturer
Lek Pharmaceuticals d.d., Verovškova 57, 1526
Ljubljana, Slovenia or 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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