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ELENOXY 40 MG PROLONGED-RELEASE TABLETS

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Package leaflet: Information for the user
Elenoxy 5 mg prolonged-release tablets
Elenoxy 10 mg prolonged-release tablets
Elenoxy 20 mg prolonged-release tablets
Elenoxy 40 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.
2.
3.
4.
5.
6.

What Elenoxy is and what it is used for
What you need to know before you take Elenoxy
How to take Elenoxy
Possible side effects
How to store Elenoxy
Contents of the pack and other information

1.

What Elenoxy is and what it is used for

Elenoxy is indicated in adults and adolescents (from 12 years of age).
Elenoxy contains the active ingredient oxycodone hydrochloride, which is a strong analgesic or
“painkiller” and belongs to a group of medicines called opioids.
It is used for the relief of severe pain, which can be adequately managed only with opioid analgesics.
Do not take this medicine other than prescribed by your doctor. It is not for use on an “as-needed”
basis for relief of mild pain, ordinary aches, or the symptoms of colds or the flu.

2.

What you need to know before you take Elenoxy

Do not take Elenoxy:








if you are allergic to oxycodone hydrochloride or any of the other ingredients of this medicine
(listed in section 6),
if you suffer from severe breathing problems, such as severe respiratory depression (where you
breathe more slowly or weakly than expected),
if you suffer from elevated carbon dioxide levels in the blood (hypercapnia),
if you suffer from a severe lung disease associated with narrowing of the airways (chronic
obstructive airways disease),
if you have a heart problem caused by long-term lung disease (cor pulmonale),
if you suffer from severe bronchial asthma,
if you have a condition where the small bowel does not work properly (paralytic ileus),
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Warnings and precautions
Talk to your doctor or pharmacist before taking Elenoxy:

if you are elderly or weak,

if you have severe lung-, liver- or kidney problems,

if you have a disease of the thyroid gland (myxoedema) or underactive thyroid gland
(hypothyroidism),

if your adrenal glands are not producing enough hormones (adrenal insufficiency, Addison’s
disease),

if you have an enlarged prostate gland (prostate hypertrophy),

if you have a mental disorder as a result of an intoxication caused by, for example, alcohol (toxic
psychosis),

if you suffer from a state of violent mental agitation caused by alcohol poisoning (alcoholism,
delirium tremens),

if you have known opioid dependence,

if you have inflammation of the pancreas (pancreatitis),

if you have gallstones (biliary calculi),

if you have obstructive and inflammatory intestinal diseases. Stop taking Elenoxy immediately if
you think your intestines have stopped working properly (paralytic ileus),

if you have conditions involving increased brain (cerebral) pressure,

if you have problems with your circulatory system, if you have epilepsy or are prone to fits
(convulsions),

if you use MAO inhibitors.
If any of the above applies to you or has in the past, talk to your doctor.
The most serious side effect of an opioid overdose is a condition where you breathe more slowly or
weakly than expected (respiratory depression). This occurs most commonly in elderly or vulnerable
patients.
Opioids may also cause a severe drop in blood pressure in susceptible individuals. If you are affected
by these side effects, consult a doctor immediately.
If you are going to have an operation, make sure you tell your doctor that you are taking Elenoxy
This medicine should be avoided in patients with a history of, or present alcohol and drug abuse.
Long term use / Dependence
Patients may develop a tolerance with long-term use of Elenoxy. Therefore they may require higher
doses of Elenoxy to achieve the desired pain control. Prolonged use of Elenoxy in chronic pain
patients may lead to physical dependence. If treatment is stopped abruptly withdrawal symptoms that
include yawning, mydriasis, lacrimation, rhinorrhoea, tremor, hyperhidrosis, anxiety, agitation,
palpitations, convulsions and insomnia may occur. When therapy with Elenoxy is no longer necessary,
it may be advisable to reduce the daily dose gradually in order to prevent withdrawal symptoms.
Elenoxy has a primary dependence potential. When used as instructed in chronic pain patients, the risk
of physical and mental dependence is clearly reduced and must be assessed correspondingly relative to
the benefits. Please discuss this with your doctor.
Athletes should be aware that this medicine may cause a positive reaction to “anti-doping tests”. Use
of Elenoxy as a doping agent may become a health hazard.
Children

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Elenoxy has not been tested in children under 12 years of age. Therefore safety and efficacy are not
established and Elenoxy is not recommended in children under 12 years of age.
Other medicines and Elenoxy
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Taking Elenoxy at the same time as the following medicines may increase the side effects of Elenoxy
(particularly breathing problems):

medicines acting on the central nervous system, such as sleeping and calming medicines
(sedatives, hypnotics),

other medicines which affect the nervous system (phenothiazines, neuroleptics),

antidepressants,

medicines for allergies or vomiting (antihistamines, anti-emetics),

other strong painkillers (opioids),

alcohol.
Taking Elenoxy at the same time as the following medicines may intensify specific side effects of
Elenoxy (such as constipation, dry mouth or problems urinating):

medicines with anti-cholinergic effects, such as other medicines which act upon the nervous
system (medicines to treat psychiatric or mental disorders), medicines for allergies or vomiting
(antihistamines, antiemetics),

medicines for Parkinson’s disease.
If you are taking Elenoxy at the same time as medicines that thin your blood (coumarin-type anticoagulants), your blood clotting time may be speed up or slowed down. This is measured by a test
called the INR that checks how long it takes for your blood to clot.
Antibiotics (such as clarithromycin, erythromycin and telithromycin), antifungal medicines (such as
ketoconazole, voriconazole, itraconazole and posaconazole), protease inhibitors (such as boceprevir,
ritonavir, indinavir, nelfinavir and saquinavir), cimetidine (gastric acid inhibitor - a medicine for
stomach ulcers, indigestion or heartburn) and grapefruit juice as well as paroxetine and quinidine may
prevent the metabolism of oxycodone hydrochloride.
Some medicines, such as rifampicin, carbamazepin, phenytoin and St John’s Wort may induce the
metabolism of oxycodone hydrochloride.
These tablets must not be used together with a monoamine oxidase inhibitor, or if you have taken this
type of medicine in the last two weeks.
Elenoxy with food, drink and alcohol
You can take Elenoxy with or without food.
Drinking alcohol whilst taking Elenoxy 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 Elenoxy.
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.
Elenoxy should not be taken during pregnancy unless clearly necessary. There are only limited data
from the use of oxycodone hydrochloride in pregnant women. Oxycodone hydrochloridecrosses the
placenta into the blood circulation of the unborn child. The long-term use of Elenoxy during
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pregnancy may lead to withdrawal symptoms in newborn infants. If taken during birth, breathing
problems (respiratory depression) may occur in the child.
You should not take Elenoxy if you are breast-feeding as oxycodone passes into breast milk.
Driving and using machines
Elenoxy may impair your ability to drive or operate machinery. This is particularly likely:

when you start the treatment with Elenoxy,

after a dose increase or product rotation (the use of alternative medicines, to reduce side
effects),

if Elenoxy is combined with alcohol or with medicines, which act on the central nervous
system.
General driving restrictions may not apply during stable treatment; your doctor makes this decision
based upon the individual situation. Please discuss with your doctor whether or not, or under which
conditions you may drive.

3.

How to take Elenoxy

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Your doctor will adjust the dosage to the intensity of the pain and to your personal sensitivity. Take
the prescribed number of prolonged-release tablets twice daily.
Use in adults and adolescents (from 12 years of age)
The usual starting dose is 10 mg oxycodone hydrochloride every 12 hours. Take 1 prolonged-release
tablet in the morning and 1 prolonged-release tablet in the evening.
While symmetric (same dose in the morning and in the evening), around-the-clock, 12 hourly dosing
is appropriate for the majority of patients, some patients may benefit from asymmetric dosing
(different dose in the morning and in the evening) tailored to their pain pattern. Your doctor will
decide on the best treatment schedule to suit your needs.
Your doctor will decide on any necessary dose adjustments during treatment depending on your
previous dosage. If you have already been treated with opioids, your treatment with Elenoxy may be
started at a higher dose.
Some patients taking Elenoxy on a fixed time schedule require a fast-acting painkiller for quick relief
from breakthrough pain. Elenoxy prolonged-release tablets are not intended for the treatment of
breakthrough pain.
Your doctor will monitor you regularly to ensure you receive the best possible pain relief treatment.
Treatment of side effects and the need to continue treatment will also be monitored.
Please speak to your doctor or pharmacist if you feel that the effect of Elenoxy is too strong or too
weak.
Tumour and no-tumour related pain
For the treatment of non-tumour related pain, 40 mg of oxycodone hydrochloride is normally a
sufficient daily dose; however, higher doses may be necessary. Patients with tumour related pain
normally require doses of 80 to 120 mg of oxycodone hydrochloride, which, in exceptional cases, may
be increased up to 400 mg of oxycodone hydrochloride.
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Older people
In elderly patients without kidney and/or liver problems, dosage adjustment is usually not necessary.
High-risk patients
Patients with kidney and/or liver problems who have not received opioids before should initially take
half of the recommended adult dose. This also applies to patients with low body weight and patients
who metabolise medications at slower rates.
Children
Elenoxy has not been tested in children under 12 years of age. Therefore safety and efficacy are not
established and Elenoxy is not recommended in children under 12 years of age.
Method of administration and duration of use
Elenoxy is for oral use only. The tablets should never be injected as this may lead to serious side
effects, which may be fatal.
Swallow the prolonged-release tablets with sufficient liquid (half a glass of water) in the morning and
evening in accordance to a fixed time schedule (e.g. in the morning at 8 a.m., in the evening at 8 p.m.).
You can take your tablets with or without food.
Elenoxy should not be taken with alcoholic beverages.
Swallow the tablets whole, and do not cut, break, chew, crush, or dissolve the tablets. Taking cut,
broken, chewed, crushed or dissolved tablets leads to speedier release of the active substance and to
the absorption of a potentially lethal dose of the active substance oxycodone hydrochloride (see under
“If you take more Elenoxy than you should”).
Oxycodone should not to be administered for longer than absolutely necessary. If long-term pain
treatment is necessary in view of the nature and severity of the illness, careful and regular monitoring
should be carried out to establish whether and to what extent further treatment is necessary. When the
patient no longer requires opioid therapy, it may be advisable to taper the dose gradually to prevent
symptoms of withdrawal.
If you take more Elenoxy than you should
If you have taken more medicine than prescribed, you should inform your doctor immediately.
The following may occur:

narrowed pupils,

respiratory depression,

somnolence progressing up to stupor or loss of consciousness (coma),

decreased tension of skeletal muscles,

slowed pulse rate and drop in blood pressure,

loss of consciousness (coma), water retention in the lung and circulatory collapse may occur in
more severe cases and may lead to death.
Never engage in situations which require a high degree of concentration, such as driving.
Accidental overdose by a child is dangerous and may be fatal.
If you forget to take Elenoxy

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If you take a smaller dose of Elenoxy than prescribed, or if you have completely forgotten to take your
dose, this will lead to unsatisfactory and/or insufficient pain relief.
If you have forgotten to take your dose, and your next usual dose is scheduled more than 8 hours later:
Take the forgotten dose. You may then continue to follow your usual schedule.
If the time until your next dose is less than 8 hours, take your dose but postpone the next dose by
8 hours.
As a matter of principle, you should never take more than one dose of Elenoxy within any 8 hour
period.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Elenoxy
Do not stop taking Elenoxy without consulting your doctor.
If treatment with Elenoxy is no longer necessary, gradual reduction of the daily dosage may be
advisable. If treatment is stop abruptly, withdrawal symptoms may occur.
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.
The most common side effects are nausea (especially at the beginning of therapy) and constipation.
Constipation may be countered by preventive measures (such as drinking plenty of fluids, nutrition,
rich in fibre); your doctor may prescribe a treatment to overcome this problem.
If you experience nausea or vomiting, your doctor may prescribe medication for you.
Important side effects or signs to look out for. If you are affected by these side effects, consult a
doctor immediately:
• The most serious side effect is a condition where you breathe more slowly or weakly than expected
(respiratory depression). It can occur most commonly in elderly or vulnerable patients. Opioids
may cause a severe drop in blood pressure in susceptible individuals.
• The active substance oxycodone hydrochloride can cause respiratory depression, narrowing of the
pupils, cramping of the bronchial muscles, as well as a depression of the cough reflex.
Other possible side effects:
Very Common (may affect more than 1 in 10 people):




Constipation, vomiting, nausea
Fatigue and/or drowsiness (sedation), dizziness, headache
Itching (pruritus)

Common (may affect up to 1 in 10 people):



Abdominal pain, diarrhoea, dry mouth, hiccups, indigestion (dyspepsia)
Decreased appetite up to loss of appetite

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Altered mood and personality changes (e.g. anxiety, depression, euphoric mood), decreased
activity, restlessness, increased activity, agitation, nervousness, insomnia, abnormal thinking,
confusion
Loss of consciousness (syncope), tingling or numbness in the hands or feet (paraesthesia), shaking
(tremor)
Drop in blood pressure (hypotension)
Difficulty breathing (dyspnoea, bronchospasm)
Skin reactions/rash
Urinary retention, difficulty or pain on passing urine (dysuria), increased urge to urinate
Chills, general weakness, sweating, hyperhidrosis

Uncommon (may affect up to 1 in 100 people):


















Physical dependence including withdrawal symptoms, pain (e.g. chest pain), a general feeling of
unease or lack of health (malaise), swelling from excessive accumulation of fluid (edema),
peripheral edema, thirst
Injuries from accidents
Allergic reactions (hypersensitivity)
Perception disturbances (e.g. hallucination, derealisation ), reduced libido, affect lability, drug
dependence
Difficulty in concentrating, migraine, distorted sense of taste (dysgeusia), increased muscle
tension (hypermyotonia), involuntary muscle contractions, reduced sense of touch
(hypoaesthesia), abnormal coordination, epileptic seizures (especially in persons with epileptic
disorder or predisposition to seizures), amnesia, speech disorder
Visual impairment, miosis
Hearing difficulty, vertigo
Increase in pulse rate (tachycardia), palpitations (in the context of withdrawal syndrome)
Vasodilatation
Vocal changes (dysphonia), cough, respiratory depression
Oral ulcers, inflammation in the mouth (stomatitis), flatulence, difficult swallowing (dysphagia),
eructation, blockage of the intestine (ileus)
Erectile dysfunction
Dehydration
Increase of liver enzymes levels
Dry skin
A need to take increasingly higher doses to obtain the same level of pain relief (tolerance)

Rare (may affect up to 1 in 1,000 people):







Melaena (abnormally dark tarry feces containing blood), dental changes, gum bleeding
Herpes simplex
Increased appetite
Weight increase, weight decrease
Orthostatic hypotension
Itching rash (urticaria)

Not known (frequency cannot be estimated from the available data):







Suppression of cough reflex
Biliary colic (gallstones), cholestasis
Amenorrhoea (abnormal lack of menstruation)
Exaggerated allergic reaction (anaphylactic reaction)
Aggression
Hyperalgesia
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Dental caries

As with all strong painkillers, there is a risk that you may become addicted or reliant on these tablets.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet.
You can also report side effects directly (see details below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
5.

How to store Elenoxy

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 carton after “Expiry
date”. The expiry date refers to the last day of that month.
This medicine 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 Elenoxy contains


The active substance is oxycodone hydrochloride.
Elenoxy 5 mg prolonged-release tablets
Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride equivalent to 4.5 mg of
oxycodone
Elenoxy 10 mg prolonged-release tablets
Each prolonged-release tablet contains 10 mg of oxycodone hydrochloride equivalent to 9.0 mg of
oxycodone.
Elenoxy 20 mg prolonged-release tablets
Each prolonged-release tablet contains 20 mg of oxycodone hydrochloride equivalent to 17.9 mg of
oxycodone
Elenoxy 40 mg prolonged-release tablets
Each prolonged-release tablet contains 40 mg of oxycodone hydrochloride equivalent to 35.9 mg of
oxycodone.


The other ingredients are:
Hypromellose, polyvinyl acetate, povidone K30, sodium lauryl sulphate, silica, microcrystalline
cellulose, silicon dioxide, magnesium stearate, dibutyl sebacate, ethylcellulose, cetyl alcohol, talc.
What Elenoxy looks like and contents of the pack
Elenoxy 5 mg prolonged-release tablets

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Elenoxy 5 mg prolonged-release tablets are white to off-white, 9.6 x 4.8 mm, elliptic, biconvex, coated
tablet, embossed with “5” on one side and “LT” on the other side.
Elenoxy 10 mg prolonged-release tablets
Elenoxy 10 mg prolonged-release tablets are white to off-white, 9.6 x 4.8 mm, elliptic, biconvex,
coated tablet, embossed with “10” on one side and “LT” on the other side.
Elenoxy 20 mg prolonged-release tablets
Elenoxy 20 mg prolonged-release tablets are white to off-white, 11 x 5.5 mm, elliptic, biconvex,
coated tablet, embossed with “20” on one side and “LT” on the other side.
Elenoxy 40 mg prolonged-release tablets
Elenoxy 40 mg prolonged-release tablets are white to off-white, 11 x 5.5 mm, elliptic, biconvex,
coated tablet, embossed with “40” on one side and “LT” on the other side.
Elenoxy prolonged release tablets is available in pack sizes of 10, 20, 28, 30, 40, 50, 56, 60, 100 and
112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
ETHYPHARM
194 Bureaux de la Colline - Bâtiment D
92213 Saint Cloud cedex
France
Manufacturer
ETHYPHARM
Chemin de la Poudrière
76120 Grand Quevilly
France
This medicinal product is authorised in the Member States of the EEA under the following
names:
Germany:
UK:

Oxylene 5 mg / 10 mg / 20 mg / 40mg Retardtabletten
Elenoxy 5 mg / 10 mg / 20 mg / 40mg prolonged release tablet

This leaflet was last revised in 01/2014.

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Expand Transcript

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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