CONTIROXIN 10 MG PROLONGED-RELEASE TABLETS

Active substance: OXYCODONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Contiroxin 5 mg Prolonged-release Tablets
Contiroxin™ 10 mg Prolonged-release Tablets


SZ00000LT000

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 Contiroxin tablets are and what they are used for
2. What you need to know before you take Contiroxin
tablets
3. How to take Contiroxin tablets
4. Possible side effects
5. How to store Contiroxin tablets
6. Contents of the pack and other information

1. WHAT CONTIROXIN TABLETS ARE AND WHAT
THEY ARE USED FOR
Contiroxin tablets are a centrally acting, strong painkiller from
the group of medicines called opioids.
Contiroxin tablets are used to treat severe pain, which can be
adequately managed only with opioid analgesics.

2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE CONTIROXIN TABLETS

Do not take Contiroxin tablets
• 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 acute, severe bronchial asthma
• if you suffer from intestinal paralysis (paralytic ileus)
• if you have an acute abdomen or suffer from delayed
(stomach) emptying
• if you suffer from elevated carbon dioxide levels.
Warnings and precautions
Talk to your doctor before taking Contiroxin tablets
• 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 Addison’s disease
• if you suffer from adrenocortical insufficiency
• 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 bowel or pancreas
(pancreatitis)
• in conditions with increased brain pressure
• if you suffer from disturbances of circulatory regulation
(e.g. low blood pressure, decreased blood volume in the
circulation)
• if you suffer from colic of the bile duct and ureter
• if you suffer from epilepsy or have a seizure tendency
• if you take MAO inhibitors (for the treatment of
depression)
• if you recently had abdominal surgery.

Contiroxin tablets have a primary dependence potential.
When used for a long time, patients can become tolerant to
the effects and progressively higher doses may be required to
maintain pain control.
Chronic use of Contiroxin 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.

An increased sensitivity for pain that will not respond to a
further dose increase of Oxycodone Hydrochloride
prolonged-release tablets may very rarely occur, particularly in
high doses. An oxycodone dose 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.
Drinking alcohol whilst taking Contiroxin 5 mg/10 mg
prolonged-release tablets 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 Contiroxin 5 mg/10 mg prolonged-release
tablets.
Contiroxin 5 mg/10 mg prolonged-release tablets should be
avoided in patients with a history of or present alcohol and
drug abuse.

• Children under 12 years of age
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.
• Older people
In elderly patients the lowest dose should be administered
with careful titration to pain control.

Athletes should be aware that this medicine, due to its active
substance, may cause a positive reaction to “anti-doping
tests”.
Use of Contiroxin as a doping agent may become a health
hazard.
Other medicines and Contiroxin tablets
Please tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. If you take
these tablets with some other medicines, the effect of these
tablets or the other medicine may be changed.
• Medicines that dampen the activity of the central nervous

system (e.g. sleeping pills or tranquillizers [sedatives,
hypnotics], other medicines that act on the nervous system
[pheno-thiazines, neuroleptics], medicines used to treat
allergies or vomiting [antihistamines, antiemetics]) 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. medicines
that dampen psychoses [neuroleptics], medicines used to
treat allergies [antihistamines] or vomiting [antiemetics]),
medicines used to treat Parkinson’s disease) can enhance
certain side effects of oxycodone (e.g. constipation, dry
mouth or urinary disturbances).

Tell your doctor or pharmacist if you are taking:
• Cimetidine (a medicine for ulcers, indigestion or heartburn)
• Antibiotics (e.g. clarithromycin, rifampicin, erythromycin
and telithromycin)
• Antifungals (e.g. ketoconazole, voriconazole, itraconazole,
and posaconazole).
• Anticonvulsants (e.g. carbamazepin, phenytoin)
• Antidepressants (e.g. paroxetine, St. John’s Wort)
• Medicines to treat HIV infections (e.g. boceprevir, ritonavir,
indinavir, nelfinavir and saquinavir)
• Quinidine (a medicine to treat a fast heart beat)
• Monoamine oxidase inhibitors (MAOIs), a medicine to treat
depression) can enhance the side effects of
oxycodone. Oxycodone should be used with caution if you
currently take MAO-inhibitors or have taken MAO-inhibitors
during the last two weeks.
• In individual cases more or less blood clotting have been
observed if medicinal products against blood clotting
(anticoagulants of the coumarin type) are taken together
with Contiroxin tablets.
Contiroxin tablets with food, drink and alcohol
Alcohol enhances the impairment of alertness and reactivity
and may enhance potential side effects such as drowsiness
and depressed breathing.
Drinking grapefruit juice whilst taking oxycodone might
increase the risk for side effects.
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 Contiroxin tablets during pregnancy.
There is 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. Use of oxycodone during
delivery can cause respiratory depression in the newborn.
Breast-feeding
You should not use Contiroxin tablets when you are
breast-feeding as oxycodone may pass into breast milk.

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. For further information on 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.
Important information about some of the ingredients of
Contiroxin 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 CONTIROXIN TABLETS

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

Adults and adolescents (over 12 years of age)

The usual initial dose is 10 mg oxycodone hydrochloride (2
prolonged-release tablets) in 12 hourly intervals. However,
your doctor will prescribe the dose required to treat pain.
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 Contiroxin tablets according to a
fixed schedule need rapidly acting painkillers as rescue
medication to control breakthrough pain. Contiroxin tablets
are not intended for the treatment of breakthrough pain.

Continued on the next page >>

For the treatment of non-cancer pain a daily dose of 40 mg
oxycodone hydrochloride (twice daily 20 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. For these
dose treatments other strengths of this medicinal product are
available.
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.

Contiroxin 5 mg and 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 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
Contiroxin tablets lead to a rapid release and absorption of a
potentially fatal dose of oxycodone (see section “If you take
more Contiroxin tablets than you should”). Contiroxin
tablets are for oral use only. In case of abusive injection
(injection into 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.
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.

Discontinuation of treatment
When you no longer require therapy with oxycodone, it may
be advisable to taper the dose gradually to prevent symptoms
of withdrawal.
If you take more Contiroxin tablets than you should
If you have taken more Contiroxin tablets as 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
(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 Contiroxin tablets
If you use a smaller dose of Contiroxin tablets than directed or
you forget to take a dose, 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 Contiroxin
tablets more than once every 8 hours.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Contiroxin tablets
Do not stop treatment without informing your doctor.
When a patient no longer requires therapy with Contiroxin
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

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

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
Contiroxin tablets and contact your doctor immediately.
Depressed breathing is the most significant risk induced by
opioids and is most likely to occur in elderly or debilitated
patients. As a consequence, in predisposed patients opioids
can cause severe drops in blood pressure.
Apart from this oxycodone can cause constricted pupils,
bronchial spasms and spasms in smooth muscles and
suppress the cough reflex.
Other possible side effects

Very common (may affect more than1 in 10 people):
Sedation (tiredness to drowsiness); dizziness; headache,
constipation;nausea; vomiting, itching.

(stomatitis); flatulence; decreased libido, erectile dysfunction;
injuries due to accidents; pain (e.g. chest pain); excessive
fluid in the tissues (oedema); migraine; allergic reactions; lack
of water in the body (dehydration); drug dependence; drug
tolerance; amnesia; speech disorders; seizures; fainting; pins
and needles (paraesthesia); difficulty in swallowing; belching;
ileus; increased liver enzymes; dry skin; herpes simplex
(disorder of the skin and mucosa); urinary retention; chills,
drug withdrawal syndrome; thirst

Rare (may affect up to 1 in 1,000 people):
Lymph node disease (lymphadenopathy), muscle spasms; low
blood pressure, sudden fall in blood pressure when standing
up; gum bleeding; increased appetite; tarry stool; tooth
staining and damage, itchy rash; blood in urine (haematuria),
changes in body weight (loss or rise); cellulitis.
Not known (frequency cannot be estimated from the
available data):
Severe allergic reactions (anaphylactic reactions); aggression;
increased sensitivity for pain (hyperalgesia); dental caries;
interruption in the excretion of bile, biliary colics; absence of
menstrual bleeding (amenorrhoea)
Counteractive measures
If you observe any of the above listed side effects your doctor
usually will take appropriate measures.
The side effect constipation may be prevented by fiber
enriched diet and increased drinking.
If you are suffering from sickness or vomiting your doctor will
prescribe you an appropriate medicine.

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 CONTIROXIN TABLETS

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/bottles and the carton after “EXP”. The expiry
date refers to the last day of that month.
Do not store above 30°C.

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 Contiroxin tablets contain
• The active substance is oxycodone hydrochloride.
• Each 5 mg prolonged-release tablet contains 5 mg
oxycodone hydrochloride corresponding to 4.48 mg
oxycodone.
• Each 10 mg prolonged-release tablet contains 10 mg
oxycodone hydrochloride corresponding to 8.96 mg
oxycodone.
• The other ingredients are:
Tablet core: Sugar spheres (sucrose, maize starch),
hypromellose, macrogol 6000, talc, ethyl cellulose,
hydroxypropylcellulose, propylene glycol, magnesium
stearate, microcrystalline cellulose, cellulose (10 mg only),
colloidal anhydrous silica.
5 mg tablet coating: Hypromellose, talc, macrogol 6000,
titanium dioxide (E171).
10 mg tablet coating: Hypromellose, talc, macrogol 6000,
titanium dioxide (E171), iron oxide, brown (E172), iron
oxide, red (E172).
What Contiroxin tablets look like and contents of the
pack
Contiroxin 5 mg tablets are white, round, biconvex,
prolonged-release tablets.

Contiroxin 10 mg tablets are brown-red, biconvex, oblong,
prolonged-release tablets with a breakline on both sides.

Contiroxin tablets are available in blister with child resistant
closure of 10, 20, 28, 30, 40, 50, 56, 60, 98 and 100 tablets
and HDPE bottles of 100 and 250 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
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
39179 Barleben,
Germany.

This leaflet was last approved in 08/2013.

Common (may affect up to 1 in 10 people):
Feeling weak (asthenic conditions); anxiety, confusional state,
depression, nervousness, sleep disorders, thought process
disorder; trembling (tremor), depressed breathing (dyspnoea),
bronchospasm (difficulty in breathing or wheezing), dry
mouth, bellyache; diarrhoea; upset stomach (dyspepsia);
decreased appetite,skin disorders such as rash, rarely
increased sensitivity to light (photosensitivity), in isolated
cases scaly rash (exfoliative dermatitis), increased sweating,
frequent urination,

Uncommon (may affect up to 1 in 100 people):
Agitation, emotional lability, euphoric mood, hallucinations,
change in taste, visual disturbances, constriction of the pupil
of the eye, abnormally acute sense of hearing (hyperacousis);
both increased and decreased muscle tone; tics; involuntary
contraction of the muscle; reduced sense of touch
(hypaesthesia); coordination disturbances; feeling unwell,
vertigo, accelerated pulse; pounding heartbeat; widening of
the blood vessels (vasodilatation); respiratory depression;
increased coughing; pharyngitis; runny nose; voice changes;
oral ulcers; inflammation of the gums, inflamed mouth

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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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