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CANDOX 40 MG PROLONGED-RELEASE TABLETS

Active substance(s): OXYCODONE HYDROCHLORIDE

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CANDOX 20 mg, 40 mg AND 80 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.
IN THIS LEAFLET:

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 Candox
prolonged release tablets.
Taking Candox 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 prolonged-release tablets should not be
used during pregnancy unless clearly necessary.
There is insufficient experience regarding the
use of the active substance oxycodone
hydrochloride in humans during pregnancy.
Oxycodone crosses the placenta into the
blood circulation of the baby.
Long-term use of oxycodone during pregnancy
CANDOX PROLONGED1 WHAT
may cause withdrawal symptoms in
RELEASE TABLETS ARE AND WHAT
newborns. Use of oxycodone during delivery
THEY ARE USED FOR
may cause breathing at an abnormally slow
Oxycodone Hydrochloride is a centrally acting, rate (respiratory depression) in the newborn.
strong painkiller from the group of opioids.
Breast-feeding
Candox prolonged-release tablets are used to
You should not use Candox when you are breasttreat severe pain, which can be adequately
feeding as oxycodone passes into breast milk.
managed only with opioid analgesics.
Ask your doctor or pharmacist for advice
before taking any medicine.
2 BEFORE YOU TAKE CANDOX
1. What Candox prolonged-release tablets are
and what they are used for
2. Before you take Candox prolonged-release
tablets
3. How to take Candox prolonged-release tablets
4. Possible side effects
5. How to store Candox prolonged-release
tablets
6. Further information

PROLONGED-RELEASE TABLETS

Do not take Candox prolonged-release tablets
s if you are allergic (hypersensitive) to
oxycodone hydrochloride or any of the
other ingredients of this medicinal product
s 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
s 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
s if you suffer from intestinal paralysis
(paralytic ileus)
s if you have an acute abdomen or suffer
from a delayed gastric emptying.
Take special care with Candox prolongedrelease 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.

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 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
PROLONGED-RELEASE TABLETS

Always take Candox prolonged-release
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.
Some patients who receive Candox prolongedrelease tablets according to a fixed schedule
need rapidly acting painkillers as rescue
medication to control breakthrough pain.
Candox prolonged-release tablets are 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
s Dependence and tolerance
be necessary. Patients with cancer pain
Candox prolonged-release tablets has a
primary dependence potential. When used for usually require dosages from 80 mg to 120 mg
of oxycodone hydrochloride which may be
a long time tolerance to the effects and
increased up to 400 mg in individual cases.
progressively higher doses may be required
For different purpose and dose treatments
to maintain pain control.
Candox prolonged-release tablets containing
Chronic use of Candox prolonged-release
tablets may lead to physical dependence and 5 mg, 10 mg, 20 mg, 40 mg or 80 mg
oxycodone hydrochloride are available.
a withdrawal syndrome may occur upon
The treatment needs to be controlled
abrupt cessation. When a patient no longer
regularly with regard to pain relief and other
requires therapy with Candox, it may be
effects in order to achieve the best pain
advisable to taper the dose gradually to
therapy possible as well as to be able to treat
prevent symptoms of withdrawal.
any occurring side effects in good time and to
When used as directed in patients suffering
decide whether treatment should be continued.
from chronic pain the risk of developing
physical or psychological dependence is
Use in children
markedly reduced and needs to be weighed
Oxycodone is not recommended for children
against the potential benefit. Please discuss
under 12 years of age.
this with your doctor.
Elderly patients
Tablets should be avoided in patients with a
Elderly patients without clinical manifestation
history of or present alcohol and drug abuse. of impaired liver and/or kidney function
usually do not require dose adjustments.
s Children
Oxycodone Hydrochloride has not been
Risk patients
investigated in children under 12 years.
If you have impaired kidney and/or liver
Safety and efficacy have not been
function or if you have a low body weight your
established. Therefore use in children under
doctor may prescribe a lower starting dose.
12 years of age is not recommended.
Candox prolonged-release tablets should not
be taken with alcoholic beverages.
s Elderly patients
In elderly patients without impairment of
Method and duration of administration
kidney and/or liver function a dose
Swallow the prolonged-release tablets (either
adjustment is usually not necessary.
whole or divided) with a sufficient amount of
liquid (½ glass of water) with or without food
s Anti-doping warning
Athletes should be aware that this medicine, in the morning and in the evening following a
fixed schedule (e.g. at 8 a.m. and 8 p.m.).
due to its active substance, may cause a
positive reaction to “anti-doping tests”. Use of The tablets may be divided into two halves but
Oxycodone Hydrochloride as a doping agent must not be crushed or chewed as this leads to
rapid oxycodone release due to the damage
may become a health hazard.
of the prolonged release properties. The
Taking other medicines
administration of chewed or crushed Candox
Please tell your doctor or pharmacist if you
prolonged-release tablets leads to a rapid
are taking or have recently taken any other
release and absorption of a potentially fatal
medicines, including medicines obtained
dose of oxycodone (see section “If you take
without a prescription.
more Candox prolonged-release tablets than
Medicines that dampen the activity of the
you should”).
central nervous system e.g.
Candox prolonged-release tablets are for oral
s sleeping pills or tranquillizers (sedatives,
use only. In case of abusive injection
hypnotics)
(injection in a vein) the tablet excipients
s other medicines that act on the nervous
(especially talc) may lead to destruction
system (phenothiazines, neuroleptics)
(necrosis) of the local tissue, change of lung
s medicines used to treat allergies
tissue (granulomas of the lung) or other
(antihistamines) or vomiting (antiemetics)
serious, potentially fatal events.
s as well as other opioids or alcohol
can enhance the side effects of oxycodone, in This medicinal product is packed child-resistant.
You cannot press out the prolonged-release
particular depressed breathing (respiratory
tablets from the blister. Please observe the
depression).
opening instruction for the blister below.
Medicines with an anticholinergic effect e.g.
If you take more Candox prolonged-release
s other medicines that act on the central
tablets than you should
nervous system (psychotropic medicines)
If you have taken more Candox prolongeds medicines used to treat allergies
release tablets than prescribed you should
(antihistamines) or vomiting (antiemetics)
s medicines used to treat Parkinson’s disease inform your doctor or your local poison control
can enhance certain side effects of oxycodone centre immediately. The following symptoms
may occur: constricted pupils (miosis),
(e.g. constipation, dry mouth or urinary
depressed breathing (respiratory depression),
disturbances).
skeletal muscle flaccidity and drop in blood
Cimetidine can inhibit the metabolism of
pressure. In severe cases circulatory collapse,
oxycodone. The influence of other medicines
mental and motor inactivity (stupor),
that can markedly affect the metabolism of
unconsciousness (coma) slowing of the heart

s migraine
s physical dependence with withdrawal
symptoms
s allergic reactions
s changes in tear secretion
s constriction of the pupil.
Rare
s lymph node disease (lymphadenopathy)
If you forget to take Candox prolongeds lack of water in the body (dehydration)
release tablets
If you use a smaller dose of Candox prolonged- s seizures, in particular in patients suffering
from epilepsy or with a tendency to seizures
release tablets than directed or you miss the
s
involuntary contraction of the muscle
intake of the tablets, pain relief will consequently
(muscle spasms)
be insufficient or cease altogether.
s gum bleeding
You can make up for a forgotten tablet if the
s increased appetite
next regular intake is not due for at least
s tarry stool
another 8 hours. You can then continue to
s tooth staining and damage
take the tablets as directed.
s dry skin
You should also take the prolonged-release
s herpes simplex (disorder of the skin and
tablets if the time to the regular next intake is
mucosa)
shorter, but postpone the next intake by
s blood in urine (haematuria)
8 hours. In principle, you should not take
s absence of menstrual bleeding (amenorrhoea)
Candox prolonged-release tablets more than s changes in body weight (loss or rise)
once every 8 hours.
s cellulitis
Do not take a double dose to make up for a
s intestinal hypomotility (ileus).
forgotten tablet.
Tolerance and dependence may develop with
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 stop taking Candox prolonged-release
tablets
Do not stop treatment without informing your
doctor.
When a patient no longer requires therapy
with Candox prolonged-release tablets, 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

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
production of tears, runny nose, yawning,
sweating, chills, muscle pain, abnormal
dilatation of the pupil and sensation of irregular
and forceful heartbeat. Other symptoms may
also develop, including: irritability, anxiety,
backache, joint pain, weakness, belly cramps,
sleeplessness, being sick, lack of appetite,
vomiting, diarrhoea, or increased blood
pressure, breathing rate or heart rate.

Like all medicines, Candox prolonged-release
Counteractive measures
tablets can cause side effects, although not
If you observe any of the above listed side
everybody gets them.
effects your doctor usually will take
If you experience the following, stop taking
appropriate measures.
Candox and tell your doctor immediately or
The side effect constipation may be prevented
go to the casualty department of your
by fibre enriched diet and increased drinking.
nearest hospital:
If you are suffering from sickness or vomiting
s A severe allergic reaction (anaphylactic
your doctor will prescribe you an appropriate
reaction), signs and symptoms may include medicine.
rash, itching, swelling of the face, lips,
mouth or throat that may cause difficulty in If any of the side effects gets serious, or if you
notice any side effects not listed in this
swallowing or breathing.
leaflet, please tell your doctor or pharmacist.
This is a serious but rare side effect, which
affects less than 1 user in 10,000 patients. You
TO STORE CANDOX
5 HOW
may need urgent medical attention or
PROLONGED-RELEASE TABLETS
hospitalisation.
Keep out of the reach and sight of children.
Assessment of the side effects is based on
Do not use Candox prolonged-release tablets
the following frequencies:
after the expiry date which is stated on the
blister and the carton after “EXP”. The expiry
Very common: May affect more than 1
date refers to the last day of that month.
of 10 patients treated
This medicinal product does not require any
Common:
May affect up to 1 in 10
special storage conditions.
patients treated
Medicines should not be disposed of via
Uncommon:
May affect up to 1 in 100
wastewater or household waste. Ask your
patients treated
pharmacist how to dispose of medicines no
longer required. These measures will help to
Rare:
May affect up to 1 in 1,000
protect the environment.
patients treated
Very rare:

May affect up to 1 in
10,000 patients treated

6

FURTHER INFORMATION

What Candox prolonged-release tablets
contains
The active substance is oxycodone
hydrochloride.
Each prolonged-release tablet contains:
Significant side effects or signs to consider
20 mg:
and measures to be taken when these side
Each prolonged–release tablet contains
effects or signs occur:
20 mg oxycodone hydrochloride
If you experience any of the following side
effects, stop taking Candox prolonged-release corresponding to 17.9 mg oxycodone.
tablets and contact your doctor immediately. 40 mg:
Each prolonged–release tablet contains
Depressed breathing is the most significant
40 mg oxycodone hydrochloride
risk induced by opioids and is most likely to
corresponding to 35.9 mg oxycodone.
occur in elderly or debilitated patients. As a
80 mg:
consequence, in predisposed patients opioids Each prolonged–release tablet contains
can cause severe drops in blood pressure.
80 mg oxycodone hydrochloride
Apart from this oxycodone can cause
corresponding to 71.7 mg oxycodone.
constricted pupils, difficulty in breathing or
The other ingredients are:
wheezing and spasms in smooth muscles and Tablet core: Sugar spheres (sucrose; maize
suppress the cough reflex.
starch); hypromellose; macrogol 6000; talc;
ethyl cellulose; hydroxypropylcellulose;
Other possible side effects
propylene glycol; magnesium stearate;
Very common
microcrystalline cellulose; colloidal
s sedation (tiredness to drowsiness)
anhydrous silica.
s dizziness
Tablet coating:
s headache
20 mg:
s constipation
Hypromellose; talc; macrogol 6000, titanium
s nausea
dioxide (E171); iron oxide, red (E172).
s vomiting
40 mg:
s itching.
Hypromellose; talc; macrogol 6000, titanium
Common
dioxide (E171); iron oxide, yellow (E172); iron
s feeling weak (asthenia)
oxide, red (E172).
s several psychological side effects such as
80 mg:
s CHANGESINMOODEGANXIETY
Hypromellose; talc; macrogol 6000, titanium
depression, euphoria)
dioxide (E171); iron oxide, yellow (E172).
s CHANGESINACTIVITYMOSTLYSEDATION
sometimes accompanied by lethargy,
What Candox prolonged-release tablets looks
occasionally increase with restlessness,
like and contents of the pack
nervousness and sleep disorders)
Candox 20 mg prolonged-release tablets are
s CHANGESINPERFORMANCETHOUGHTPROCESS pink, biconvex, oblong, prolonged-release
disorder, confusion, amnesia, isolated
tablets with a break line on both sides.
cases of speech disorders)
Candox 40 mg prolonged-release tablets are
s pins and needles (paraesthesia)
orange, biconvex, oblong, prolonged-release
s lowering of blood pressure, rarely
tablets with a break line on both sides.
accompanied by symptoms such as
Candox 80 mg prolonged-release tablets are
pounding or racing heartbeat; fainting
yellow, biconvex, oblong, prolonged-release
s depressed breathing (dyspnoea)
tablets with a break line on both sides.
s bronchospasm (difficulty in breathing or
The tablets can be divided into equal halves.
wheezing)
Candox prolonged-release tablets are sealed
s dry mouth, rarely accompanied by thirst
in blisters with Child-resistant closure and
and difficulty swallowing
available in packages of 14 (20 mg only), 20,
s gastrointestinal disorders such as bellyache; 28, 30, 50, 56, 60, 98, 100, 100 x 1 prolonged
diarrhoea; belching; upset stomach
release tablets and HDPE bottles with PP
(dyspepsia); loss of appetite
twist-off caps of 50, 100 and 250
s skin disorders such as rash, rarely increased prolonged-release tablets.
sensitivity to light (photosensitivity), in
Not all pack sizes may be marketed.
isolated cases itchy (urticaria) or scaly rash
Not known:

Frequency cannot be
estimated from the
available data

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

Marketing Authorisation Holder and
Manufacturer
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 00289/1711, PL 00289/1712, PL 00289/1713
Opening instruction:
Dear patient,
this medicinal product is packed
child-resistant. 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.
80040-C
209082.01-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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