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CANDOX 5 MG PROLONGED-RELEASE TABLETS

Active substance(s): OXYCODONE HYDROCHLORIDE

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Candox 5 mg
Prolonged-release Tablets
oxycodone hydrochloride

PACKAGE LEAFLET: INFORMATION FOR THE USER






drugs used during surgeries (anaesthetics)
medicines used to treat depression
muscle relaxants
medicines used to treat allergies or vomiting
(antihistamines, antiemetics)
• other opioids or alcohol
can enhance the side effects of oxycodone, in
particular depressed breathing (respiratory
depression).

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
• Medicines with an anticholinergic effect, e.g.
pharmacist.
• other medicines that act against parasympathetic
• This medicine has been prescribed for you only. Do
and cholinergic nerve fibres on the central nervous
not pass it on to others. It may harm them, even if
system (psychotropic medicines)
their signs of illness are the same as yours.
• medicines used to treat allergies (antihistamines) or
• If you get any side effects, talk to your doctor or
vomiting (antiemetics)
pharmacist. This includes any possible side effects not
• medicines used to treat Parkinson’s disease
listed in this leaflet. See section 4.
can enhance certain side effects of oxycodone (e.g.
constipation, dry mouth or urinary disturbances).
What is in this leaflet:

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

1 What Candox is and what it is used for
Candox is a centrally acting, strong painkiller from the
group of opioids.

• Cimetidine (a medicine used to treat heartburn) and
quinidine (a medicine used to treat heart disease) can
inhibit the metabolism of oxycodone.
• Macrolide antibiotic, some antifungal and antiviral
medicines can increase the effect of oxycodone and
so the dose may need to be adjusted if you are taking
these medicines.
• Some antiepileptic medicines and also the herbal
remedy ‘St John Wort’ can decrease the effect of
oxycodone.

Candox is used to treat severe pain, which can be
adequately managed only with opioid analgesics.

• The influence of other medicines that can markedly
affect the metabolism of oxycodone has not been
investigated.

2 What you need to know before you take

• Monoamine oxidase inhibitors (MAOIs) can enhance
the side effects of oxycodone (e.g. excitation,
decrease or increase in blood pressure).

Candox

Do not take Candox
• if you are allergic to oxycodone hydrochloride or any
of the other ingredients of this medicine (listed in
section 6)
• 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 severe
bronchial asthma
• if you suffer from intestinal paralysis (paralytic ileus)
• if you have an acute abdomen or suffer from a
delayed gastric emptying
Warnings and precautions
Talk to your doctor or pharmacist before taking Candox
• if you are older or debilitated
• if your lung, liver or kidney function is severely
impaired (see also section 3 “Risk patients”)
• 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 and problems occur (e.g. delirium
tremens)
• if you suffer from intoxication psychosis (e.g. alcohol)
• if you suffer from known opioid-dependence
• if you suffer from inflammation of the pancreas
(pancreatitis)
• in conditions with increased brain pressure such as
head injury
• if you suffer from disturbances of circulatory
regulation
• if you suffer from diseases of the biliary tract, colic of
the bile duct and ureter
• if you suffer from low blood pressure or reduced
blood volume
• if you suffer from epilepsy or have a seizure tendency
• if you take MAO inhibitors (for the treatment of
depression)
• if you have recently undergone bowel-surgery or
abdominal surgery
• if you suffer from an inflammatory bowel disorder.

• 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.
Candox with food, drink and alcohol
Drinking alcohol whilst taking Candox 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.
Grapefruit juice can inhibit the metabolism of
oxycodone which will increase its effect. Therefore you
should avoid drinking grapefruit juice while taking
Candox.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
Pregnancy
You should not take Candox during pregnancy. There
are limited 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. Infants born
to mothers who have received opioids during the last 3
to 4 weeks before giving birth should be monitored for
respiratory depression.
Breast-feeding
You should not use Candox when you are
breast-feeding as oxycodone passes into breast milk
and may cause respiratory depression in the newborn.

Driving and using machines
Oxycodone may impair the ability to drive and use
machines.
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.
To look at the possible side effects affecting the motor
Please talk to your doctor if any of these apply to you or skills and concentration see section 4. “Possible side
effects”.
if any of these conditions applied to you in the past.
Dependence and tolerance
Candox has primary dependence potential. When used
for a long time, tolerance to the effects may develop
and progressively higher doses may be required to
maintain pain control.
Chronic use of Candox 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.
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.

Candox contains sucrose
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 you take this
medicinal product.

3 How to take Candox
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
For doses not realisable/practicable with this medicinal
product other strengths and medicinal products are
available.
The recommended dose is

Adults and adolescents (over 12 years of age)
The usual initial dose is 10 mg of oxycodone
Increased sensitivity to pain that does not respond to
hydrochloride in 12 hourly intervals.
dose increases can rarely develop. If this happens, your Further determination of the daily dose, the division
doctor will reduce your dose or switch you to an
into the single doses and any dose adjustments during
alternative opioid painkiller.
the further course of therapy are performed by the
treating physician and depend on the previous dosage.
Candox is not recommended for use before an
Patients who have already taken opioids can start
operation or in the 12–24 hours after an operation.
treatment with higher dosages taking into account their
Candox should be used with particular care in patients
experience with opioid treatment.
with a history of or present alcohol and drug abuse.
Some patients who receive Candox according to a fixed
schedule need rapidly acting painkillers as rescue
Please refer to section 4 “Possible side effects” for
medication to control breakthrough pain. Candox is not
information on counteractive measures which may be
intended for the treatment of breakthrough pain.
used to ease certain side effects.
For the treatment of non-cancer pain a daily dose of 40
mg of oxycodone hydrochloride is generally sufficient,
Children
but higher dosages may be necessary. Patients with
Candox has not been investigated in children under
12 years. Safety and efficacy have not been established cancer pain usually require dosages from 80 to 120 mg
of oxycodone hydrochloride which may be increased up
and therefore use in children under 12 years of age is
to 400 mg in individual cases.
not recommended.
The treatment needs to be controlled regularly with
Elderly patients
regard to pain relief and other effects in order to achieve
In elderly patients without impairment of kidney and/or the best pain therapy possible as well as to be able to
liver function a dose adjustment is usually not necessary. treat any occurring side effects in good time and to
decide whether treatment should be continued.
Anti-doping warning
Athletes should be aware that this medicine may cause Risk patients
a positive reaction to “anti-doping tests”.
If you have impaired kidney and/or liver function or if
Use of Candox as a doping agent may become a health you have a low body weight your doctor may prescribe
a lower starting dose.
hazard.
Other medicines and Candox
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
• Medicines that dampen the activity of the central
nervous system, e.g.
• sleeping pills or tranquillisers (sedatives, hypnotics)
• other medicines that act on the nervous system
(phenothiazines, neuroleptics)

Method and duration of administration (oral use)
It is not recommended to take Candox with alcoholic
beverages.
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,
divided 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 leads to a rapid release and absorption of a
potentially fatal dose of oxycodone (see section “If you
take more Candox than you should”).
Candox are 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.

• pins and needles (paraesthesia)
• accelerated pulse
• sensation of irregular and forceful heartbeat (in the
context of withdrawal syndrome)
• widening of the blood vessels (vasodilatation)
• depressed breathing
• increased coughing
• pharyngitis
• runny nose
• voice changes
• difficulty swallowing
• oral ulcers
• inflammation of the gums
• inflamed mouth (stomatitis)
• flatulence
If you take more Candox than you should
• intestinal obstruction (ileus)
If you have taken more Candox than prescribed you
• belching
should inform your doctor or your local poison control • increased liver enzymes
centre immediately. The following symptoms may
• dry skin
occur: constricted pupils (miosis), depressed breathing • urinary retention
(respiratory depression), skeletal muscle flaccidity and
• injuries due to accidents
drop in blood pressure. In severe cases circulatory
• pain (e.g. chest pain)
collapse, mental and motor inactivity (torpor),
• excessive fluid in the tissues (oedema)
unconsciousness (coma), slowing of the heart rate and • drug withdrawal syndrome
accumulation of water in the lungs (non-cardiogenic
• drug tolerance
lung oedema) may occur; abuse of high doses of strong • thirst
opioids such as oxycodone can be fatal. In no case
• chills.
should you expose yourself to situations requiring
elevated concentration e.g. driving a car.
Rare (may affect up to 1 in 1,000 people)
• herpes simplex (disorder of the skin and mucosa)
If you forget to take Candox
• lymph node disease (lymphadenopathy)
If you use a smaller dose of Candox than directed or
• increased appetite
you miss the intake of the tablets, pain relief will
• lowering of blood pressure, dizziness when standing
consequently be insufficient or cease altogether.
up from a sitting or lying position
You can make up for a forgotten dose if the next regular • gum bleeding
• dark-coloured stools
intake is not due for at least another 8 hours. You can
• tooth staining and damage
then continue to take the tablets as directed.
• muscle spasms
You should also take the prolonged-release tablets if the • itchy skin rashes
time to the regular next intake is shorter, but postpone • blood in urine (haematuria)
the next intake by 8 hours. In principle, you should not • changes in body weight (loss or rise)
take Candox more than once every 8 hours.
• cellulitis.
Do not take a double dose to make up for a forgotten
tablet.

Unknown frequency (cannot be estimated from the
available data)
• severe hypersensitivity reactions (anaphylactic
If you stop taking Candox
reactions)
Do not stop treatment without informing your doctor.

aggression
When a patient no longer requires therapy with Candox,

increased sensitivity to pain which cannot be
it may be advisable to taper the dose gradually to
improved increasing the dose
prevent symptoms of withdrawal.
• tooth decay
• pain on the right side of abdomen, biliary colic
If you have any further questions on the use of this
• absence of menstrual periods (amenorrhoea).
medicine, ask your doctor or pharmacist.
Tolerance and dependence may develop with chronic
use and a withdrawal syndrome may occur upon abrupt
cessation of therapy. The withdrawal syndrome is
Like all medicines, this medicine can cause side effects,
characterised by some or all of the following:
although not everybody gets them.
restlessness, increased production of tears, runny nose,
If you experience the following, stop taking Candox and yawning, sweating, chills, muscle pain, abnormal
dilatation of the pupil and sensation of irregular and
tell your doctor immediately or go to the casualty
forceful heartbeat. Other symptoms may also develop,
department of your nearest hospital:
including: irritability, anxiety, backache, joint pain,
• A severe allergic reaction (anaphylactic reaction),
weakness, belly cramps, sleeplessness, being sick, lack
signs and symptoms may include rash, itching,
of appetite, vomiting, diarrhoea, or increased blood
swelling of the face, lips, mouth or throat that may
pressure, breathing rate or heart rate.
cause difficulty in swallowing or breathing.
This is a serious but rare side effect, which affects less
Counteractive measures
than 1 user in 10,000 patients. You may need urgent
If you observe any of the above listed side effects your
medical attention or hospitalisation.
doctor usually will take appropriate measures. The side
effect constipation may be prevented by fibre enriched
Significant side effects or signs to consider and
diet and increased drinking. If you are suffering from
measures to be taken when these side effects of signs
sickness or vomiting your doctor will prescribe you an
occur
If you experience any of the following side effects, stop appropriate medicine.
taking Candox and contact your doctor immediately.
Reporting of side effects
Depressed breathing is the most significant risk induced
If you get any side effects, talk to your doctor or
by opioids and is most likely to occur in elderly or
pharmacist. This includes any possible side effects not
debilitated patients. As a consequence, in predisposed
listed in this leaflet. You can also report side effects
patients opioids can cause severe drops in blood
directly via the Yellow Card Scheme at:
pressure.
www.mhra.gov.uk/yellowcard
Apart from this oxycodone can cause constricted pupils,
By reporting side effects you can help provide more
difficulty in breathing or wheezing and spasms in
information on the safety of this medicine.
smooth muscles and suppress the cough reflex.

4 Possible side effects

Other possible side effects
Very common (may affect more than 1 in 10 people)
• sedation (tiredness to drowsiness)
• dizziness
• headache
• constipation
• feeling or being sick
• vomiting
• itching
Common (may affect up to 1 in 10 people)
• feeling weak (asthenia)
• several psychological side effects such as
• changes in mood (e.g. anxiety, depression)
• changes in activity (mostly sedation, sometimes
accompanied by lethargy, occasionally increase
with nervousness and sleep disorders)
• changes in performance (thought process disorder,
confusion)
• breathing difficult (dyspnoea)
• bronchospasm (difficulty in breathing or wheezing)
• dry mouth
• gastrointestinal disorders such as bellyache,
diarrhoea, upset stomach (dyspepsia), loss of appetite
up to complete absence of appetite
• skin disorders such as rash, rarely increased
sensitivity to light (photosensitivity), in isolated cases
scaly rash (exfoliative dermatitis)
• frequent urination
• increased sweating
• trembling (tremor)
Uncommon (may affect up to 1 in 100 people)
• abnormal production of antidiuretic hormone
• lack of water in the body (dehydration)
• change in perception such as depersonalisation,
hallucinations
• restlessness
• extreme emotional behavior
• a feeling of extreme happiness
• disturbances of sexual function (reduced sexual
desire)
• impotence
• drug dependence
• change in taste
• visual disturbances
• changes in tear secretion
• constriction of the pupil
• abnormally acute sense of hearing (hyperacousis)
• feeling of dizziness or spinning (vertigo)
• both increased and decreased muscle tone
• involuntary muscle contractions
• seizures, (in particular in patients suffering from
epilepsy or with a tendency to seizures)
• reduced sense of touch (hypoaesthesia)
• coordination disturbances
• migraine
• feeling unwell
• speech disorder
• loss of memory
• syncope

5 How to store Candox
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.
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 Candox contains
The active substance is oxycodone hydrochloride.
Each prolonged-release tablet contains 5 mg oxycodone
hydrochloride equivalent to 4.5 mg oxycodone.
The other ingredients are:
Tablet core: Sugar spheres (sucrose, maize starch),
hypromellose, talc, ethylcellulose, hyprolose, propylene
glycol, carmellose sodium, cellulose, microcrystalline,
magnesium stearate, silica, colloidal anhydrous.
Tablet coating: Polyvinyl alcohol, macrogol 3350, talc,
titanium dioxide (E171).
What Candox looks like and contents of the pack
Candox are white, round, biconvex prolonged-release
tablets with a diameter of 5-5.5 mm.
Pack sizes:
20, 25, 28, 30, 50, 56, 98, 100 prolonged-release tablets
in blisters.
100, 250 prolonged-release tablets in HDPE bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
This leaflet was last revised in 02/2015
PL 00289/1709

80031-I

210 x 600

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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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