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ONEXILA XL 10MG PROLONGED-RELEASE TABLETS

Active substance(s): OXYCODONE HYDROCHLORIDE / OXYCODONE HYDROCHLORIDE / OXYCODONE HYDROCHLORIDE

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Package leaflet: Information for the user
Onexila XL 10 mg prolonged-release tablets
Onexila XL 20 mg prolonged-release tablets
Onexila XL 40 mg prolonged-release tablets
Onexila XL 80 mg prolonged-release tablets
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 Onexila XL is and what it is used for
2. What you need to know before you take Onexila XL
3. How to take Onexila XL
4. Possible side effects
5. How to store Onexila XL
6. Contents of the pack and other information
1. What Onexila XL is and what it is used for
Onexila XL is a centrally acting, strong painkiller from the group of
opioids.
Onexila XL is used to treat severe pain, which can be adequately
managed only with opioid analgesics.
Onexila XL is indicated in adults, and adolescents aged 12 years and
older.
2. What you need to know before you take Onexila XL
Do not take Onexila XL
- 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,
- if you suffer from cor pulmonale (cardiac changes due to chronic
overload of lung circulation),
- if you suffer from 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Onexila XL if any of
these conditions apply to you or applied to you in the past:
- 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 experience complications (e.g. delirium tremens),
- if you experience a psychosis that is caused by an intoxication
(e.g. alcohol),
- if you suffer from known opioid-dependence,
- if you suffer from inflammation of the pancreas (pancreatitis),
- if you suffer from a disease of the biliary tract,
- if you suffer from colic of the bile duct and ureter,
- in conditions with increased brain pressure,
- if you suffer from disturbances of circulatory regulation,
- if you suffer from epilepsy or have a seizure (fits) tendency,
- if you take MAO inhibitors (for the treatment of depression).
Incorrect use of Onexila XL
The prolonged-release tablet must be swallowed whole, not be
chewed or crushed as this leads to rapid oxycodone release due to
the damage of the prolonged-release properties. The administration
of chewed or crushed Onexila XL leads to a rapid release and
absorption of a potentially fatal dose of oxycodone (see section 3
“If you take more Onexila XL than you should”).
In case of abusive injection (injection in a vein) the other tablet
ingredients may lead to destruction (necrosis) of the local tissue,
change of lung tissue (granulomas of the lung) or other serious,
potentially lethal events.
Surgery
The administration of Onexila XL before surgery cannot be
recommended due to lacking safety data.
Onexila XL should only be administered after bowel surgery when the
bowel function has been restored.
Long-term treatment and abuse
Onexila XL has primary dependence potential. When used for a long
time tolerance to the effects and progressively higher doses may be
required to maintain pain control.
Chronic use of Onexila XL 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.
Children
Onexila XL should not be used in children under 12 years of age
because of safety and efficacy concerns.
Elderly patients
In elderly patients without impairment of kidney and/or liver
function a dose adjustment is usually not necessary.
Anti-doping warning
Athletes should be aware that this medicine may cause a positive
reaction to “anti-doping tests”.
Use of Onexila XL as a doping agent may become a health hazard.
Other medicines and Onexila XL
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)
• medicines used during surgery (anaesthetics)
• medicines used to treat depressions
• medicines used for muscle relaxation
• medicines used to treat allergies or vomiting
(antihistamines, antiemetics)
• other opiods 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 Parkinson’s disease can enhance
certain side effects of oxycodone (e.g. constipation, dry
mouth or urinary disturbances).
- Cimetidine and inhibitors of cytochrome P450-3A such as
ketoconazole, variconazole and erythromycin may 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 co-applied
with Onexila XL.
Onexila XL with alcohol
Drinking alcohol whilst taking Onexila XL 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 are taking
Onexila XL.
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 any medicine.
Pregnancy
Onexila XL should not be used in pregnancy unless clearly necessary.
There is insufficient experience regarding the use of oxycodone in

pregnant women. Oxycodone crosses the placenta into the organism
of the child. 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 Onexila XL when you are breast-feeding.
Oxycodone passes into breast milk. Therefore, a risk for the sucking
infant cannot be excluded in particular following intake of multiple
doses of Onexila XL.
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.
In these circumstances Onexila XL has moderate to major influence on
the ability to drive and use machines.
With stable therapy, a general ban on driving a vehicle may be not
necessary. In these circumstances Onexila XL has minor influence on
the ability to drive and use machines. 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 skills and
concentration see section 4. “Possible side effects”.
Onexila XL 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 Onexila XL
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 (≥12 years of age)
The usual initial dose is 10 mg of oxycodone hydrochloride once
daily, preferably taken at the same time each day. Some patients
may benefit from a starting dose of 5 mg to minimise the incidence
of side effects.
For doses not realisable/practicable with this medicinal product
other strengths and medicinal products are available.
Further determination of the daily dose and any dose adjustments
during the further course of therapy are performed by the treating
physician and depend on the previous dosage. Dose adjustments
should be made in steps of approximately one third of the daily
dose to reduce the risk of possibly occurring side effects. In general,
the lowest effective dose for the relief of pain should be chosen.
Patients who have already taken opioids can start treatment with
higher dosages taking into account their experience with opioid
treatment.
Some patients who receive Onexila XL need rapidly acting painkillers
as rescue medication to control breakthrough pain. Onexila XL is 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 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.
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.
Your doctor will adjust the dosage depending on the pain intensity
and how you respond to the treatment (see also section 2, “Warnings
and precautions”).
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.
Use in children under 12 years of age
Onexila XL should not be used in children under 12 years of age
because of safety and efficacy concerns.
Method of administration
Onexila XL is for oral use only. Take the tablets once daily as advised
by your doctor.
Swallow the prolonged-release tablets whole with a sufficient amount
of liquid (½ glass of water) with or without food, preferably at the
same time each day.
The prolonged-release tablets must be swallowed whole, not chewed
or crushed (see also section 2, “Warnings and precautions”).
Opening instruction for the blister
This medicinal product is packed in a child-resistant blister. You
cannot press out the prolonged-release tablets through 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.
If you take more Onexila XL than you should
If you have taken more Onexila XL 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), sleepiness, skeletal
muscle flaccidity and drop in blood pressure. In severe cases
circulatory collapse, drowsiness, 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 you should
expose yourself to situations requiring elevated concentration e.g.
driving a car.
If you forget to take Onexila XL
If you miss the intake of Onexila XL, pain relief will consequently be
insufficient or cease altogether.
You can make up for a forgotten dose if the next regular intake is not
due for at least another 12 hours. You can then continue to take
Onexila XL as directed. Do not take a double dose to make up for a
forgotten dose.
If you stop taking Onexila XL
Do not stop treatment without informing your doctor.
When a patient no longer requires therapy with Onexila XL, it may be
advisable to taper the dose gradually to prevent symptoms of
withdrawal.
A withdrawal syndrome may occur upon abrupt cessation of therapy.
For symptoms of the withdrawal syndrome see section 4 “Possible
side effects”.
If you have any further questions on the use of this medicine, 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
Onexila XL and contact your doctor immediately.
Depressed breathing (slowed 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, feeling or being sick
- itching
Common (may affect up to 1 in 10 people)
- loss of appetite
- several psychological side effects such as
• changes in mood (e.g. anxiety, depression, euphoria)
• changes in activity (mostly sedation, sometimes
accompanied by lethargy, occasionally increase with
restlessness, nervousness and sleep disorders)
• changes in performance (thought process disorder,
confusion, amnesia, isolated cases of speech disorders)
- pins and needles (paraesthesia)
- lowering of blood pressure, rarely accompanied by symptoms
such as pounding or racing heartbeat (palpitations), fainting
- depressed breathing (dyspnoea), bronchospasm (difficulty in
breathing or wheezing)
- dry mouth, rarely accompanied by thirst and difficulty swallowing,
- gastrointestinal disorders such as bellyache, diarrhoea, belching,
upset stomach (dyspepsia)
- skin disorders including rash, rarely increased sensitivity to light
(photosensitivity), in isolated cases itchy (urticaria) or scaly rash
(exfoliative dermatitis)
- urinary disorders (urinary retention, but also frequent urination)
- feeling weak (asthenia), sweating, chills

Uncommon (may affect up to 1 in 100 people)
- allergic reactions
- syndrome of inappropriate antidiuretic hormone secretion which
leads to frequent urination
- change in perception such as depersonalisation, hallucinations,
change in taste
- both increased and decreased muscle tone, trembling (tremor),
tics, reduced sense of touch (hypaesthesia), coordination
disturbances, dizziness
- changes in tear secretion, constriction of the pupil, visual
disturbances
- abnormally acute sense of hearing (hyperacousis)
- accelerated pulse, widening of the blood vessels (vasodilatation)
- increased coughing, pharyngitis, runny nose, voice changes
- oral ulcers, inflammation of the gums, inflamed mouth (stomatitis),
flatulence
- biliary colics, increased liver enzymes
- disturbances of sexual function (reduced sexual desire and
impotence)
- accidental injuries, pain (e.g. chest pain), feeling unwell, excessive
fluid in the tissues (oedema), migraine
- physical dependence with withdrawal symptoms
Rare (may affect up to 1 in 1,000 people)
- lymph node disease (lymphadenopathy)
- lack of water in the body (dehydration)
- fits (seizures), in particular in patients suffering from epilepsy or
with a tendency to fits
- muscle spasms (muscle cramps)
- gum bleeding, increased appetite, dark-coloured stools, tooth
staining and damage, obstruction in the gut (ileus)
-

dry skin, herpes simplex (disorder of the skin and mucosa)
blood in urine (haematuria)
absence of menstrual bleeding (amenorrhoea)
changes in body weight (loss or rise), cellulitis

Very rare (may affect up to 1 in 10,000 people)
- severe allergic reactions (anaphylactic reactions)
- speech disorders
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 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.
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 fibre enriched diet and increased drinking. If you are
suffering from sickness or vomiting your doctor will prescribe you an
appropriate medicine.
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
at 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 Onexila XL
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.
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 Onexila XL contains
The active substance is oxycodone hydrochloride.
Onexila XL 10 mg prolonged-release tablets:
Each prolonged-release tablet contains 10 mg oxycodone
hydrochloride equivalent to 8.97 mg oxycodone.
Onexila XL 20 mg prolonged-release tablets:
Each prolonged-release tablet contains 20 mg oxycodone
hydrochloride equivalent to 17.94 mg oxycodone.
Onexila XL 40 mg prolonged-release tablets:
Each prolonged-release tablet contains 40 mg oxycodone
hydrochloride equivalent to 35.87 mg oxycodone.
Onexila XL 80 mg prolonged-release tablets:
Each prolonged-release tablet contains 80 mg oxycodone
hydrochloride equivalent to 71.75 mg oxycodone.
The other ingredients are:
Tablet core:
Sugar spheres (sucrose, maize starch), hypromellose, talc, ethylcellulose,
hydroxypropylcellulose, propylene glycol, carmellose sodium,
cellulose, microcrystalline, magnesium stearate (Ph. Eur.), silica,
colloidal anhydrous.
Onexila XL 10 mg prolonged-release tablets:
Tablet coating: Opadry® II White (consisting of polyvinyl alcohol,
talc, titanium dioxide (E171), macrogol 3350).
Onexila XL 20 mg prolonged-release tablets:
Tablet coating: Opadry® II White (consisting of polyvinyl alcohol,
talc, titanium dioxide (E171), macrogol 3350) and Opadry® II
Yellow (consisting of polyvinyl alcohol, talc, macrogol 3350, iron
oxide, yellow (E172)).
Onexila XL 40 mg prolonged-release tablets:
Tablet coating: Opadry® II White (consisting of polyvinyl alcohol,
talc, titanium dioxide (E171), macrogol 3350) and Opadry® II Red
(consisting of polyvinyl alcohol, talc, macrogol 3350 iron oxide, red
(E172)).
Onexila XL 80 mg prolonged-release tablets:
Tablet coating: Opadry® II White (consisting of polyvinyl alcohol,
talc, titanium dioxide (E171), macrogol 3350).
What Onexila XL looks like and contents of the pack
Onexila XL 10 mg prolonged-release tablets:
White, round, biconvex prolonged-release tablets with a diameter of
6.16 mm.
Onexila XL 20 mg prolonged-release tablets:
Yellowish to yellow, oblonged, biconvex prolonged-release tablets
with a diameter of 10.2 mm x 4.7 mm and with a breakline on both
sides. The tablet can be divided into equal doses.
Onexila XL 40 mg prolonged-release tablets:
Pink, oblonged, biconvex prolonged-release tablets with a diameter
of 12.3 mm x 5.8 mm and with a breakline on both sides.
The tablet can be divided into equal doses.
Onexila XL 80 mg prolonged-release tablets:
White, oblonged, biconvex prolonged-release tablets with a diameter
of 16.3 mm x 7.8 mm and with a breakline on both sides.
The tablet can be divided into equal doses.
Pack sizes:
10, 14, 20, 28, 30, 50, 56, 60, 98 and 100 prolonged-release tablets in
child-resistant perforated unit dose blister.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Rivopharm UK Ltd
30th Floor
40 Bank Street
Canary Wharf
London
E14 5NR
United Kingdom
Manufacturer
Develco Pharma GmbH
Grienmatt 27
Schopfheim
79650
Germany

This leaflet was last revised in 07/2016

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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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