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CAREXIL 40MG PROLONGED-RELEASE TABLETS

Active substance(s): OXYCODONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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

SZ03809LT02A

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

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).

What Carexil is and what it is
used for

Carexil is a centrally acting, strong painkiller
from the group of opioids.

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),

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

• other medicines which act on the nervous
system (antipsychotics),
• medicines used to treat Parkinson’s disease.

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.

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. John’s Wort, a medicine to treat depression

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
(Addison’s 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.

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 you’re taking Carexil.
Drinking grapefruit juice whilst taking Carexil
may increase the risk for side effects. It is
recommended not to drink grapefruit juice
while you’re 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.

Please talk to your doctor if any of these apply
to you or if any of these conditions applied to
you in the past.

Ask your doctor or pharmacist for advice
before taking any medicine.

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.

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.

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.

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.

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.

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.

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.

3

H
H

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

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

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.

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.

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.
46148734

draft: 44040720, 44040721
laetus code: 11645
mat.no.: 46148734

How to take Carexil

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 >>

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• increased or decreased muscle tension,
tics, epileptic seizures (fits), reduced
sensitivity to pain or touch, problems with
coordination or with keeping one’s 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

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.

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.

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.).

Very rare (may affect up to 1 in 10,000 people)
• scaly rash.

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”).

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

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.

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”).

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.

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

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.

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.

This medicinal product does not require any
special storage conditions.

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.

In use HDPE bottles
Shelf life after first opening of the bottle: 6
months.

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 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

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.

Each prolonged-release tablet contains 40 mg
or 80 mg oxycodone hydrochloride equivalent
to 35.9 mg or 71.8 mg oxycodone.

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

The other ingredients are:
Tablet core: hydrogenated castor oil,
copovidone, behenoyl polyoxylglycerides,
lactose monohydrate, magnesium stearate,
maize starch, colloidal anhydrous silica,
medium-chain triglycerides.

Possible side effects

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).

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.

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.

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.

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

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.

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.

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

draft: 44040720, 44040721
laetus code: 11645
mat.no.: 46148734

Contents of the pack and other
information

What Carexil contains
The active substance is oxycodone hydrochloride.

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

4

How to store Carexil

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.

46148734
SZ03809LT02A

Artwork Proof Box
Ref: N001: SPC & PIL update to add driving warning, keylines
Proof no.
003.1

Date prepared:
04/12/2014

Colours:
Black
Dimensions: 148 x 620 mm

Font size:
8.5pt
Fonts:
Helvetica

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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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