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CANDOX 10MG PROLONGED-RELEASE TABLETS

Active substance(s): OXYCODONE HYDROCHLORIDE

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CANDOX 10 mg
PROLONGED-RELEASE TABLETS
Oxycodone hydrochloride
PACKAGE LEAFLET:
INFORMATION FOR THE USER

Read all of this leaflet carefully before you
start taking this medicine.
s Keep this leaflet. You may need to read it
again.
s If you have any further questions, ask your
doctor or pharmacist.
s This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
s If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

s medicines used to treat Parkinson’s
disease)
can enhance certain side effects of oxycodone
(e.g. constipation, dry mouth or urinary
disturbances).
Cimetidine can inhibit the metabolism of
oxycodone. The influence of other medicines
that can markedly affect the metabolism of
oxycodone has not been investigated.
Monoamine oxidase inhibitors (MAOIs) can
enhance the side effects of oxycodone (e.g.
excitation decrease or increase in blood
pressure).
In individuals a clinically relevant increase or
decrease of blood clotting have been
observed if anticoagulants of the coumarin
type (medicinal products against blood
clotting) are taken together with Oxycodone.

IN THIS LEAFLET:

1. What Candox 10 mg prolonged-release
tablets are and what they are used for
2. Before you take Candox 10 mg
prolonged-release tablets
3. How to take Candox 10 mg
prolonged-release tablets
4. Possible side effects
5. How to store Candox 10 mg
prolonged-release tablets
6. Further information

Taking Candox 10 mg prolonged-release
tablets with food and drink
Drinking alcohol whilst taking oxycodone
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.

Pregnancy and breast-feeding
Pregnancy
Candox 10 mg prolonged-release tablets
WHAT
CANDOX
10
mg
1 PROLONGED-RELEASE TABLETS ARE should not be used in pregnancy unless clearly
necessary. There is insufficient experience
AND WHAT THEY ARE USED FOR
regarding the use of the active substance
Oxycodone Hydrochloride is a centrally acting, oxycodone hydrochloride in humans during
pregnancy. Oxycodone crosses the placenta
strong painkiller from the group of opioids.
into the blood circulation of the baby.
Candox 10 mg prolonged-release tablets are
Long-term use of oxycodone during pregnancy
used to treat severe pain, which can be
can cause withdrawal symptoms in
adequately managed only with opioid
newborns. Use of oxycodone during delivery
analgesics.
can cause breathing at an abnormally slow
rate (respiratory depression) in the newborn.
YOU TAKE CANDOX 10 mg
2 BEFORE
Breast-feeding
PROLONGED-RELEASE TABLETS
Do not take Candox 10 mg prolonged-release You should not use Candox when you are
breast-feeding as oxycodone passes into
tablets
breast milk.
s if you are allergic (hypersensitive) to
s

s

s
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oxycodone hydrochloride or any of the
other ingredients of this medicinal product
if you suffer from severely depressed
breathing (respiratory depression) with too
little oxygen in the blood (hypoxia) and/or
too much carbon dioxide (hypercapnia) in
the blood
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 have an acute abdomen or suffer
from a delayed gastric emptying.

Take special care with Candox 10 mg
prolonged-release tablets
s if you are older or debilitated
s if your lung, liver or kidney function is
severely impaired
s if you suffer from myxoedema (certain
illnesses of the thyroid gland) or impaired
function of the thyroid gland
s if you suffer from adrenal insufficiency
(Addison’s disease)
s if you suffer from intoxication psychosis
(e.g. alcohol)
s if you suffer from alcoholism or are
undergoing alcohol withdrawal
s if you suffer from known opioid-dependence
s if you suffer from enlargement of the
prostate (prostatic hypertrophy)
s if you suffer from inflammation of the
pancreas (pancreatitis)
s if you suffer from colic of the bile duct and
ureter
s if you suffer from obstructive and
inflammatory intestinal disease
s in conditions with increased brain pressure
s if you suffer from disturbances of
circulatory regulation
s if you suffer from epilepsy or have a seizure
tendency
s if you take MAO inhibitors (for the
treatment of depression).
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.
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 not be necessary. The treating
physician must assess the individual situation.
Please discuss with your doctor whether or
under what conditions you can drive a vehicle.
Important information about some of the
ingredients of Candox 10 mg
prolonged-release tablets
This medicinal product contains sucrose. 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 CANDOX 10 mg
PROLONGED-RELEASE TABLETS

Always take Candox 10 mg prolongedrelease tablets exactly as your doctor has told
you. You should check with your doctor or
pharmacist if you are not sure.
The usual dose is:
Adults and adolescents (over 12 years of
age)
The usual initial dose is 10 mg oxycodone
hydrochloride in 12 hourly intervals.
However, your doctor will prescribe the dose
required. Your doctor will adjust the dosage
depending on the pain intensity and how you
respond to the treatment.
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.

s Dependence and Tolerance
Candox 10 mg prolonged-release tablets have
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.

Some patients who receive Candox 10 mg
prolonged-release tablets according to a fixed
schedule need rapidly acting painkillers as
rescue medication to control breakthrough
pain. Candox 10 mg prolonged-release tablets
is not intended for the treatment of
breakthrough pain.

Chronic use of Candox 10 mg prolongedrelease tablets may lead to physical dependence
and a withdrawal syndrome may occur upon
abrupt cessation. When a patient no longer
requires therapy with oxycodone hydrochloride,
it may be advisable to taper the dose
gradually to prevent symptoms of withdrawal.

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 mg to 120 mg
of oxycodone hydrochloride which may be
increased up to 400 mg in individual cases.

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.

For different purpose and dose treatments
Candox prolonged-release tablets containing
5 mg, 10 mg, 20 mg, 40 mg or 80 mg
Oxycodone Hydrochloride are available.

Tablets should be avoided in patients with a
history of or present alcohol and drug abuse.
s Children
Oxycodone Hydrochloride has not been
investigated in children under 12 years.
Safety and efficacy have not been
established. Therefore use in children under
12 years of age is not recommended.
s Elderly patients
In elderly patients without impairment of
kidney and/or liver function a dose
adjustment is usually not necessary.
s Anti-doping warning
Athletes should be aware that this medicine,
due to its active substance, may cause a
positive reaction to “anti-doping tests”.
Use of Oxycodone Hydrochloride as a doping
agent may become a health hazard.
Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicine, including medicines obtained
without a prescription.
Medicines that dampen the activity of the
central nervous system, e.g.
s sleeping pills or tranquillizers (sedatives,
hypnotics)
s other medicines that act on the nervous
system (phenothiazines, neuroleptics)
s medicines used to treat allergies
(antihistamines) or vomiting (antiemetics)
s as well as other opioids or alcohol
can enhance the side effects of oxycodone, in
particular depressed breathing (respiratory
depression).
Medicines with an anticholinergic effect, e.g.
s other medicines that act on the central
nervous system (psychotropic medicines)
s medicines used to treat allergies
(antihistamines) or vomiting (antiemetics)

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.
Use in children
Oxycodone is not recommended for children
under 12 years of age.
Elderly patients
Elderly patients without clinical manifestation
of impaired liver and/or kidney function
usually do not require dose adjustments.
Risk patients
If you have impaired kidney and/or liver
function or if you have a low body weight your
doctor may prescribe a lower starting dose.
Candox 10 mg prolonged-release tablets
should not be taken with alcoholic beverages.
Method and duration of administration
Swallow the prolonged-release tablets (either
whole or divided) 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 tablets may be divided into two halves
but 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
Candox 10 mg prolonged-release tablets leads to
a rapid release and absorption of a potentially
fatal dose of oxycodone (see section “If you
take more Candox 10 mg prolonged-release
tablets than you should”).
Candox 10 mg prolonged-release tablets are
for oral use only. In case of abusive injection
(injection in a vein) the tablet excipients
(especially talc) may lead to destruction
(necrosis) of the local tissue, change of lung
tissue (granulomas of the lung) or other
serious, potentially fatal events.

This medicinal product is packed child-resistant.
You cannot press out the prolonged-release
tablets from the blister. Please observe the
opening instruction for the blister below.
If you take more Candox 10 mg
prolonged-release tablets than you should
If you have taken more Candox 10 mg
prolonged-release tablets than prescribed
you should inform your doctor or your local
poison control centre 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 (stupor), unconsciousness
(coma) slowing of the heart rate (bradycardia)
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
elevated concentration e.g. driving a car.
If you forget to take Candox 10 mg
prolonged-release tablets
If you use a smaller dose of Candox 10 mg
prolonged-release tablets than directed or
you miss the intake of the tablets, pain relief
will consequently be insufficient or cease
altogether.
You can make up for a forgotten tablet if the
next regular intake is not due for at least
another 8 hours. You can then continue to
take the tablets as directed.
You should also take the prolonged-release
tablets if the time to the regular next intake is
shorter, but postpone the next intake by
8 hours. In principle, you should not take
Candox 10 mg prolonged-release tablets
more than once every 8 hours.

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trembling (tremor)
tics
reduced sense of touch (hypaesthesia)
coordination disturbances
feeling unwell
vertigo
accelerated pulse
widening of the blood vessels
(vasodilatation)
increased coughing
pharyngitis
runny nose
voice changes
biliary colics
oral ulcers
inflammation of the gums
inflamed mouth (stomatitis)
flatulence
disturbances of sexual function
injuries due to accidents
pain (e.g. chest pain)
excessive fluid in the tissues (oedema)
migraine
physical dependence with withdrawal
symptoms
allergic reactions
changes in tear secretion
constriction of the pupil.

Rare
s lymph node disease (lymphadenopathy)
s lack of water in the body (dehydration)
s seizures, in particular in patients suffering
from epilepsy or with a tendency to seizures
s involuntary contraction of the muscle
(muscle spasms)
s gum bleeding
s increased appetite
s tarry stool
s tooth staining and damage
s intestinal hypomotility (ileus)
s dry skin
s herpes simplex (disorder of the skin and
Do not take a double dose to make up for a
mucosa)
forgotten tablet.
s blood in urine (haematuria)
s absence of menstrual bleeding
If you stop taking Candox 10 mg
(amenorrhoea)
prolonged-release tablets
Do not stop treatment without informing your s changes in body weight (loss or rise)
s cellulitis.
doctor.
Tolerance and dependence may develop with
chronic use and a withdrawal syndrome may
occur upon abrupt cessation of therapy. The
withdrawal syndrome is characterised by some
or all of the following: restlessness, increased
If you have any further questions on the use
production of tears, runny nose, yawning,
of this product, ask your doctor or pharmacist.
sweating, chills, muscle pain, abnormal
dilatation of the pupil and sensation of irregular
4 POSSIBLE SIDE EFFECTS
and forceful heartbeat. Other symptoms may
also develop, including: irritability, anxiety,
Like all medicines, Candox 10 mg
backache, joint pain, weakness, belly cramps,
prolonged-release tablets can cause side
sleeplessness, being sick, lack of appetite,
effects, although not everybody gets them.
vomiting, diarrhoea, or increased blood
If you experience the following, stop taking
pressure, breathing rate or heart rate.
Candox and tell your doctor immediately or
Counteractive measures
go to the casualty department of your
If you observe any of the above listed side
nearest hospital:
effects your doctor will usually take
s A severe allergic reaction (anaphylactic
reaction), signs and symptoms may include appropriate measures.
The side effect constipation may be
rash, itching, swelling of the face, lips,
mouth or throat that may cause difficulty in prevented by fibre enriched diet and
increased drinking.
swallowing or breathing.
If you are suffering from sickness or vomiting
This is a serious but rare side effect, which
affects less than 1 user in 10,000 patients. You your doctor will prescribe you an appropriate
medicine.
may need urgent medical attention or
hospitalisation.
If any of the side effects gets serious, or if you
notice any side effects not listed in this
Assessment of the side effects is based on
leaflet, please tell your doctor or pharmacist.
the following frequencies:
When a patient no longer requires therapy
with Candox 10 mg prolonged-release tablets,
it may be advisable to taper the dose
gradually to prevent symptoms of withdrawal.

Very common: May affect more than 1
of 10 patients treated
Common:

May affect up to 1 in 10
patients treated

Uncommon:

May affect up to 1 in 100
patients treated

Rare:

May affect up to 1 in 1,000
patients treated

Very rare:

May affect up to 1 in
10,000 patients treated

Not known:

Frequency cannot be
estimated from the
available data

5

HOW TO STORE CANDOX 10 mg
PROLONGED-RELEASE TABLETS

Keep out of the reach and sight of children.
Do not use Candox 10 mg prolonged-release
tablets after the expiry date which is stated on
the blister and the carton after “EXP”.The
expiry date refers to the last day of that month.
Do not store above 30°C.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6

FURTHER INFORMATION

Significant side effects or signs to consider
and measures to be taken when these side
effects or signs occur:
If you experience any of the following side
effects, stop taking Candox 10 mg
prolonged-release tablets and contact your
doctor immediately.

What Candox 10 mg prolonged-release
tablets contains
The active substance is oxycodone
hydrochloride. Each prolonged-release tablet
contains 10 mg oxycodone hydrochloride
corresponding to 8.96 mg oxycodone.
The other ingredients are:
Depressed breathing is the most significant
Tablet core: Sugar spheres (sucrose, maize
risk induced by opioids and is most likely to
starch), hypromellose, macrogol 6000, talc,
occur in elderly or debilitated patients. As a
ethyl cellulose, hydroxypropylcellulose,
consequence, in predisposed patients opioids propylene glycol, magnesium stearate,
can cause severe drops in blood pressure.
microcrystalline cellulose, colloidal
anhydrous silica, cellulose, powdered.
Apart from this oxycodone can cause
Tablet coating: Hypromellose, talc, macrogol
constricted pupils, difficulty in breathing or
6000, titanium dioxide (E171), Iron oxide
wheezing and spasms in smooth muscles and
brown (E172), Iron oxide red (E172).
suppress the cough reflex.
Other possible side effects
Very common
s sedation (tiredness to drowsiness)
s dizziness
s headache
s constipation
s nausea
s vomiting
s itching.
Common
s feeling weak (asthenia)
s several psychological side effects such as
s CHANGESINMOODEGANXIETY
depression, euphoria)
s CHANGESINACTIVITYMOSTLYSEDATION
sometimes accompanied by lethargy,
occasionally increase with restlessness,
nervousness and sleep disorders)
s CHANGESINPERFORMANCETHOUGHTPROCESS
disorder, confusion, amnesia, isolated
cases of speech disorders)
s pins and needles (paraesthesia)
s lowering of blood pressure, rarely
accompanied by symptoms such as
pounding or racing heartbeat; fainting
s depressed breathing (dyspnoea)
s bronchospasm (difficulty in breathing or
wheezing)
s dry mouth, rarely accompanied by thirst
and difficulty swallowing
s gastrointestinal disorders such as bellyache;
diarrhoea; belching; upset stomach
(dyspepsia); loss of appetite, anorexia
s skin disorders such as rash, rarely increased
sensitivity to light (photosensitivity), in
isolated cases itchy (urticaria) or scaly rash
(exfoliative dermatitis)
s urinary disorders (urinary retention, but
also frequent urination)
s sweating
s chills.
Uncommon
s change in perception such as
depersonalisation, hallucinations
s change in taste
s visual disturbances
s abnormally acute sense of hearing
(hyperacousis)
s both increased and decreased muscle tone

What Candox 10 mg prolonged-release
tablets look like and contents of the pack
Candox 10 mg prolonged-release tablets are
brown-red, biconvex, oblong, prolonged-release
tablets with a breakline on both sides.
The tablet can be divided into equal halves.
Candox 10 mg prolonged-release tablets are
sealed in blisters with child resistant closure and
available in packs of 14, 20, 25, 28, 30, 50, 56,
60, 98 and 100 prolonged-release tablets and in
HDPE bottles with PP child resistant twist-off
caps of 100 and 250 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK.
Manufacturer
Merckle GmbH, Ludwig-Merckle-Str. 3,
89143 Blaubeuren, Germany.
This leaflet was last revised in 07/2012
PL 00289/1710
Opening instruction:
Dear patient,
this medicinal product is packed childresistant. You cannot press out the
prolonged-release tablets from the blister.
Please observe the following opening
instruction for the blister:

1. Tear off a single dose along the
perforation line of the blister.
2. Hereby an unsealed area is accessible
which is located at the position, where
the perforation lines have crossed.
3. Pull at the unsealed “strap” to peel off
the cover seal.

80035-C
209079.01-GB

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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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