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ENDAIN 40 MG PROLONGED-RELEASE CAPSULES HARD

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

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P1319-A

700x175mm (LSN-NAPP-04) (L) V1

Package leaflet: Information for the patient
Endain 10 mg prolonged-release capsules, hard
Endain 20 mg prolonged-release capsules, hard
Endain 40 mg prolonged-release capsules, hard
Endain 80 mg prolonged-release capsules, hard
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 Endain is and what it is used for
2. What you need to know before you take Endain
3. How to take Endain
4. Possible side effects
5. How to store Endain
6. Contents of the pack and other information
1. What Endain is and what it is used for
Endain is a strong analgesic or “painkiller” and belongs to
the group of opioids.
It is used to treat severe pain, which requires treatment
with an opioid analgesics because other painkillers have
not been effective.

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2. What you need to know before you take Endain
Do not take Endain:
• if you are allergic to oxycodone 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,
• if you suffer from elevated carbon dioxide levels in the
blood (hypercapnia),
• if you suffer from severe chronic obstructive airways
disease,
• if you have a heart problem after 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),
• if you are pregnant or breast-feeding,
• If you have acute severe stomach pain or suffer from a
delayed stomach emptying.
Warnings and precautions
Talk to your doctor or pharmacist before taking Endain
• if you are elderly or weak,
• if you have severe lung-, liver- or kidney problems,
• if you have myxoedema (a disease of the thyroid gland),
underactive thyroid gland (hypothyroidism),
• if you have adrenal insufficiency (Addison’s disease),
• if you have an enlarged prostate gland (prostate
hypertrophy),

• if you have toxic psychosis (a mental disorder as a result
of an intoxication induced by, for example, alcohol),
• if you suffer from alcoholism, delirium tremens (a
state of violent mental agitation caused by alcohol
poisoning),
• if you have known opioid dependence (any substance
that behaves in the body like an opium-derived
substance),
• if you have a history of drug or alcohol abuse,
• if you have inflammation of the pancreas (pancreatitis),
• if you have gallstones (biliary calculi),
• if you have obstructive and inflammatory intestinal
diseases; with the occurrence or suspicion of paralytic
ileus, Endain should be immediately discontinued,
• if you have conditions involving increased cerebral
pressure,
• if you have circulatory system dysfunction,
• if you have epilepsy or a predisposition to convulsions,
• if you use MAO inhibitors,
• if you are going to have an operation,
Please talk to your doctor if this information applies, or
has applied to you.
The main risk of an opioid overdose is respiratory
depression. It occurs most often in elderly or weakened
patients. Opioids may cause a severe drop in blood
pressure in vulnerable individuals.
Endain 80 mg
If you have not taken opioids before, you should not take
Endain 80 mg as such a high quantity may lead to a lifethreatening respiratory depression (breathing difficulties).
Tolerance
You may develop a tolerance with long-term use of
oxycodone. Therefore you may require higher doses of
oxycodone to achieve the desired pain control.
Dependence
Long-term use of oxycodone in chronic pain patients may
lead to physical and mental dependence. You can reduce
the risk of dependence if you use Endain as instructed.

Withdrawal symptoms
If you stop the treatment suddenly, you may suffer from
withdrawal symptoms that include yawning, mydriasis,
lacrimation, rhinorrhoea, tremor, hyperhidrosis, anxiety,
agitation, palpitations, convulsions and insomnia. When
therapy with oxycodone is no longer necessary, you
should reduce the daily dose gradually in order to prevent
withdrawal symptoms.
If you are concerned about tolerance, dependence or
withdrawal symptoms, discuss this with your doctor.
Children
Endain is not recommended in children under 12 years of
age because safety and efficacy are not established.
Other medicines and Endain
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
You may increase the side effects of Endain (particularly
respiratory depression) by taking:
• medicines acting on the central nervous system, such
as sleeping and calming medications (sedatives,
hypnotics),
• other medications which affect the nervous system
(phenothiazines, neuroleptics), antidepressants,
• medications for allergies or vomiting (antihistamines,
anti-emetics),
• other opioids and alcohol.
You may intensify specific side effects of Endain (such as
constipation, dry mouth or urinary excretion dysfunction)
by taking:
• medicines with anti-cholinergic effects, such as other
medications which act upon the nervous system
(medicines to treat psychiatric or mental disorders),
medications for allergies or vomiting (antihistamines,
antiemetics),
• medicines for Parkinson’s disease.
In individual cases where Endain and anti-coagulants of
the coumarin type were used at the same time, a clinically
relevant decrease or increase in blood coagulation
(measured as INR) has been observed.

Antiobiotics (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) and grapefruit juice as well as paroxetine and
quinidine may inhibit the metabolism of oxycodone.
Some medicines, such as rifampicin, carbamazepin,
phenytoin and St John’s Wort may induce the metabolism
of oxycodone.
These capsules must not be used together with a
monoamine oxidase inhibitor, or if you have taken this
type of medicine in the last two weeks.
Endain with food, drink and alcohol
Drinking alcohol whilst taking Endain 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 Endain.
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.
Do not take Endain if you are pregnant
You must not take Endain 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.
Do not take Endain if you are breast-feeding.
Oxycodone hydrochloride passes into breast milk.

Driving and using machines
Endain may impair your ability to drive or operate
machinery. This is particularly likely:
• when you start the treatment with Endain,
• after a dose increase or product rotation (the use of
alternative medicines, to reduce side effects)
• if Endain is combined with alcohol or with medicines,
which acting on the central nervous system.
Please discuss with your doctor whether or not, or under
which conditions you may drive.
This medicine can impair cognitive function and can affect
a patient’s ability to drive safely. This class of medicine is in
the list of drugs included in regulations under 5a of the Road
Traffic Act 1988. When prescribing this medicine, patients
should be told:
• The medicine is likely to affect your ability to drive.
• Do not drive until you know how the medicine affects
you.
• It is an offence to drive while you have this medicine in
your body over a specified limit unless you have a defence
(called the ‘statutory defence’).
• This defence applies when:
• 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 and in the information provided with the
medicine.
• Please note that it is still an offence to drive if you are
unfit because of the medicine (i.e. your ability to drive is
being affected).”
Details regarding a new driving offence concerning driving
after drugs have been taken in the UK may be found here:
https://www.gov.uk/drug-driving-law
Talk to your doctor or pharmacist if you are not sure whether
it is safe for you to drive while taking this medidine.
Endain 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 Endain
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 capsules twice a day.
Adults and adolescents (more than 12 years of age)
• Initial dosage
Initial dosage is usually 1 capsule of Endain 10 mg
prolonged-release (10 mg oxycodone hydrochloride) at
12 hour intervals.
In order to minimize the incidence of adverse reactions,
you may benefit from a starting dose of 5 mg. In this
case, your doctor will prescribe you another oxycodone
product available with this specific 5 mg strength.
Further determination of the daily dosage and dosage
adjustments which may be required in the course
of treatment is to be made by the treating doctor
depending upon the preceding dosage. If you are already
receiving opioids, you may begin Endain treatment by
taking higher doses, based upon your previous opioid
experience.
Some patients receiving Endain on a fixed time
schedule require immediate-release painkillers for fast
relief from breakthrough pain. Endain prolongedrelease capsules are not intended for the treatment of
breakthrough pain.
• Recommended dosage
If you suffer from pain not related to a cancer,
40 mg per day of the active substance oxycodone
hydrochloride is normally enough; however, higher
doses may be necessary.
If you suffer from a cancer related pain, you normally
require doses of 80 to 120 mg of the active substance
oxycodone hydrochloride, which, in exceptional cases,
may be increased up to 400 mg.

While taking Endain, you need a regular monitoring with
respect to pain relief as well as other effects, in order
to achieve the best possible pain relief treatment, rapid
treatment of any occurring side effects, and to determine
continuation of treatment.
Older people
In elderly patients without kidney and/or liver problems,
dosage adjustment is usually not necessary.
High-risk patients
If you have not received opioids before and also suffer
from kidney and/or liver problems, you 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. Therefore the lowest
recommended dose, i.e. 10 mg, may not be suitable as a
starting dose. In this case, your doctor will prescribe you
another oxycodone product available with this specific 5 mg
strength.
Please tell your doctor or pharmacist if you feel that the
effect of Endain is too strong or too weak.
Method of administration and duration of use
Endain is for oral use only. The capsules should never be
injected as this may lead to serious side effects, which may
fatal.
Swallow the capsules whole 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 Endain with or without food but not
concomitantly with alcohol.
Swallow the capsules whole and do not break, crush or
chew the capsules or their contents (granules). Taking
broken, chewed or crushed granules leads to faster release
of the active substance and to the absorption of a potentially
lethal dose of oxycodone hydrochloride (see under “If you
take more Endain than you should”).
If you take more Endain than you should
If you have taken more capsules than prescribed, you should
inform a doctor, hospital or Poison Centre immediately.

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Keep the packaging of the medicine at hand.
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.
If you have taken more Endain than you should have,
never engage in situations which need a high degree of
concentration, such as driving.
If you forget to take Endain
If you take a smaller dose of Endain than prescribed, or if
you have completely forgotten to take your dose, this will
lead to unsatisfactory and/or insufficient pain relief.
Do not take a double dose to make up for a forgotten dose.
If you have forgotten to take your dose once, you may take
it later only if the next regular dose was scheduled more
than 8 hours later. You may then continue to follow your
usual schedule.
If the interval to the next dose is shorter, take the
prolonged-release capsules, but postpone the next dose by
8 hours.
As a matter of principle, you should never take Endain
more frequently than at 8-hourly intervals.
If you stop taking Endain
Do not stop taking Endain without consulting your doctor.
If treatment with Endain is no longer necessary, you
are advised to reduce the daily dosage gradually. If you
stop the treatment abruptly, you may suffer withdrawal
symptoms e.g. agitation, palpitations, shaking and
sweating.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Call a doctor immediately if you are affected by any of
the following significant side effects.
Respiratory depression (difficulty breathing) is
the main risk of an opioid overdose and occurs most
commonly in elderly or vulnerable patients.
Opioids may cause a severe drop in blood pressure in
vulnerable individuals.
Oxycodone may cause respiratory depression, narrowing
of the pupils, cramping of the bronchial muscles and
cramping of the smooth muscles, as well as a depression
of the cough reflex.
The most common side effects are nausea (especially at
the beginning of therapy) and constipation.
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
• Lower appetite up to loss of appetite
• 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
• Skin reactions/rash, sweating (hyperhidrosis)
• Urinary retention, difficulty or pain on passing urine
(dysuria), increased urge to urinate
• Chills, general weakness
• Difficulty breathing (Dyspnoea)

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, drug
tolerance, thirst
• Accidents causing injuries
• Allergic reactions (hypersensitivity)
• Perception disturbances (e.g. hallucination,
derealisation), affect lability, decreased libido, drug
dependence
• Difficulty in concentrating, migraine, distorted sense
of taste, increased muscle tension, involuntary muscle
contractions, reduced sense of touch, poor movement
coordination, epileptic seizures (especially in persons
with epileptic disorder or predisposition to seizures),
amnesia, speech disorder
• Respiratory depression (difficulty breathing)
• Visual impairment, miosis
• Hearing difficulty, vertigo
• Increase in pulse rate, palpitations (in the context of
withdrawal syndrome)
• Vasodilatation
• Voice changes (dysphonia), cough
• 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
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):
• Exaggerated allergic reaction (Anaphylactic reaction)
• Aggression
• Hyperalgesia
• Dental caries
• Biliary colic (gallstones), cholestasis
• Amenorrhoea (abnormal lack of menstruation)
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 Endain
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 “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 to
protect the environment.

6. Contents of the pack and other information
What Endain contains
The active substance is oxycodone hydrochloride.
Endain prolonged-release capsules come in four strength
containing 10 mg, 20 mg, 40 mg or 80 mg of oxycodone
hydrochloride, corresponding respectively to 8.97 mg,
17.93 mg, 35.86 mg and 71.72 mg of oxycodone.
The other ingredients are:
• Capsule content:
Sugar spheres (containing sucrose and maize starch),
Hypromellose, Polyacrylate dispersion 30%, Talc
• Capsule shell:
Black Printing Ink: Shellac, Black iron oxide (E172)
Endain 10 (Yellow): Gelatin, Titanium dioxide (E 171),
Yellow iron oxide (E 172)
Endain 20 mg (Green): Gelatin, Indigo carmine, Black
iron oxide (E172), Titanium dioxide (E 171), Yellow
iron oxide (E 172)
Endain 40 mg (White): Gelatin, Titanium dioxide
(E 171)
Endain 80 mg (Pink): Gelatin, Titanium dioxide
(E 171), Red iron oxide (E 172)
What Endain looks like and contents of the pack
• Endain 10 mg are opaque yellow capsules with a black
inscription “OCR” on the body and “10” on the cap,
containing white spherical microgranules.
• Endain 20 mg are opaque green capsules with a black
inscription “OCR” on the body and “20” on the cap,
containing white spherical microgranules.
• Endain 40 mg are opaque white capsules with a black
inscription “OCR” on the body and “40” on the cap,
containing white spherical microgranules.
• Endain 80 mg are opaque pink capsules with a black
inscription “OCR” on the body and “80” on the cap,
containing white spherical microgranules.

Endain 10 mg, 20 mg, 40 mg and 80 mg is available in
package sizes of 20, 25, 28, 50, 56, 98 and 100 prolongedrelease capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
NAPP PHARMACEUTICALS LIMITED
Cambridge Science Park, Milton Road,
Cambridge, CB4 0GW
United Kingdom
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:
Iceland:
Oxydol 10 mg / 20 mg / 40 mg /
80 mg, forðahylki, hart
Denmark:
Oxydol 10 mg / 20 mg / 40 mg /
80 mg, depotkapsel, hård
Italy:
Endain 10 mg / 20 mg / 40 mg /
80 mg, capsula rigida a rilascio
prolungato
Sweden:
Oxylor Depot 10 mg / 20 mg /
40 mg / 80 mg, depotkapsel, hård
United Kingdom: Endain 10 mg / 20 mg / 40 mg /
80 mg, prolonged-release capsules,
hard

This leaflet is also available in large print, Braille or as an audio CD.
To request a copy, please call the RNIB Medicine Information line
(free of charge) on:

0044 1733 37 5370
You will need to give details of the product name and reference number.
These are as follows:
Product name: Endain prolonged-release capsules
Reference number: 16950/0340
This leaflet was last revised in February 2016

® ENDAIN, NAPP and the ‘napp’ logo are registered trade marks.
© 2016 Napp Pharmaceuticals Ltd.

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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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