CONTIROXIN 80 MG PROLONGED-RELEASE TABLETS

Active substance: OXYCODONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Contiroxin™ 20 mg Prolonged-release Tablets
Contiroxin™ 40 mg Prolonged-release Tablets
Contiroxin™ 80 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
gastric (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 glands), impaired function of the thyroid gland.
• if you suffer from Addisonʼs 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 Contiroxin tablets 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.
Drinking alcohol whilst taking Contiroxin 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 youʼre taking Contiroxin tablets.
Oxycodone Hydrochloride should be avoided in patients with
a history of, or present, alcohol and drug abuse.

• Children
Oxycodone Hydrochloride has not been investigated in
children under 18 years. Safety and efficacy have not been
established therefore use in children under 18 years of age is
not recommended.
• Older people
In elderly patients the lowest dose should be administered
with careful titration to pain control.

Other medicines and Contiroxin Tablets
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. other
medicines that act against parasympathetic and cholinergic
nerve fibres on the central nervous system [psychotropic
medicines], medicines used to treat allergies [antihistamines]
or vomiting [antiemetics], medicines used to treat Parkinsonʼs
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 Johnʼs 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 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 co-applied 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.

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.
Contiroxin tablets contain 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 (over 18 years of age)

The usual initial dose is 10 mg oxycodone hydrochloride in 12
hourly intervals. For this purpose Contiroxin 20 mg
Prolonged-release Tablets can be divided allowing the
administration of 10 mg oxycodone hydrochloride. Your doctor
will prescribe the dose required to treat pain.
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.

For the treatment of non-cancer pain a daily dose of 40 mg
oxycodone hydrochloride (twice daily Contiroxin 20 mg
Prolonged-release Tablets) 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 Contiroxin 40 mg
and 80 mg tablets 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.
Continued on the next page >>

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.

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 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
(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 than 1 in 10 people):
• sedation (tiredness to drowsiness)
• dizziness
• headache
• constipation
• nausea
• vomiting
• itching.

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
• 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 (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
• dry skin
• 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.
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.

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 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.
Medicines should not be disposed of 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 20 mg prolonged-release tablet contains 20 mg
oxycodone hydrochloride corresponding to 17.9 mg
oxycodone.
• Each 40 mg prolonged-release tablet contains 40 mg
oxycodone hydrochloride corresponding to 35.9 mg
oxycodone.
• Each 80 mg prolonged-release tablet contains 80 mg
oxycodone hydrochloride corresponding to 71.7 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, colloidal anhydrous silica.
20 mg tablet coating: Hypromellose, talc, macrogol 6000,
titanium dioxide (E171), iron oxide, red (E172).
40 mg tablet coating: Hypromellose, talc, macrogol 6000,
titanium dioxide (E171), iron oxide, yellow (E172), iron
oxide, red (E172).
80 mg tablets coating: Hypromellose, talc, macrogol 6000,
titanium dioxide (E171), iron oxide, yellow (E 172).

What Contiroxin tablets look like and contents of the pack
Contiroxin 20 mg tablets are pink, biconvex, oblong,
film-coated tablets with a breakline on both sides.
Contiroxin 40 mg tablets are orange, biconvex, oblong,
film-coated tablets with a breakline on both sides.
Contiroxin 80 mg tablets are yellow, biconvex, oblong,
film-coated tablets with a breakline on both sides.
Contiroxin tablets are available in blister packs of 10, 20, 28,
30, 40, 50, 56, 60, 100 and 112 tablets and HDPE bottles with
PP twist-off caps with 50, 100 and 250 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 revised in 08/2014.

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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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