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OXYNORM DISPERSA 10MG ORODISPERSIBLE TABLETS

Active substance(s): OXYCODONE HYDROCHLORIDE

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9962-4

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Package leaflet: Information for the user
OxyNorm Dispersa® 5 mg, 10 mg and 20 mg
orodispersible 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.

OXYNORM DISPERSA TABS PIL UK 9962-4 V2.indd 2

In this leaflet:
1. What OxyNorm Dispersa tablets are and
what they are used for
2. What you need to know before you take
OxyNorm Dispersa tablets
3. How to take OxyNorm Dispersa tablets
4. Possible side effects
5. How to store OxyNorm Dispersa tablets
6. Contents of the pack and other
information
1. What OxyNorm Dispersa tablets are
and what they are used for
These tablets have been prescribed for
you by your doctor to relieve moderate
to severe pain. They contain the active
ingredient oxycodone which belongs
to a group of medicines called strong
analgesics or ‘painkillers’.

2. What you need to know before you
take OxyNorm Dispersa tablets
Do not take OxyNorm Dispersa tablets
if you:
• are allergic to oxycodone or any of the
other ingredients of the tablets (listed in
section 6);
• have breathing problems, such as severe
chronic obstructive lung disease, severe
bronchial asthma or severe respiratory
depression. Your doctor will have told
you if you have any of these conditions.
Symptoms may include breathlessness,
coughing or breathing more slowly or
weakly than expected;
• have a condition where the bowel does
not work properly (paralytic ileus), your
stomach empties more slowly than it
should (delayed gastric emptying) or
you have severe pain in your abdomen;
• have a heart problem after long-term
lung disease (cor pulmonale);
• have moderate to severe liver problems.
If you have other long-term liver
problems you should only take these
tablets if recommended by your doctor;
• have ongoing problems with
constipation;
• are under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before
taking this medicine if you:
• are elderly or weakened;
• have an under-active thyroid gland
(hypothyroidism), as you may need a
lower dose;
• have myxoedema (a thyroid disorder
with dryness, coldness and swelling
[‘puffiness’] of the skin affecting the
face and limbs;
• have a head injury, severe headache or
feel sick as this may indicate that the
pressure in your skull is increased;
• have low blood pressure (hypotension);
• have low blood volume (hypovolaemia);
this can happen with severe external
or internal bleeding, severe burns,
excessive sweating, severe diarrhoea or
vomiting;
• have a mental disorder as a result of an
intoxication (toxic psychosis);
• have inflammation of the pancreas
(which causes severe pain in the
abdomen and back);
• have problems with your gall bladder or
bile duct;
• have inflammatory bowel disease;
• have an enlarged prostate gland, which
causes difficulty in passing urine (in
men);
• have poor adrenal gland function (your
adrenal gland is not working properly

which may cause symptoms including
weakness, weight loss, dizziness, feeling
or being sick), e.g. Addison’s disease;
• have breathing problems such as severe
pulmonary disease. Your doctor will
have told you if you have this condition.
Symptoms may include breathlessness
and coughing;
• have kidney or liver problems;
• have previously suffered from
withdrawal symptoms such as agitation,
anxiety, shaking or sweating, upon
stopping taking alcohol or drugs;
• are or have ever been addicted to
alcohol or drugs or have a known opioid
dependence;
• have an increased sensitivity to pain;
• need to take increasingly higher doses of
the tablets to gain the same level of pain
relief (tolerance).
If you are going to have an operation,
please tell the doctor at the hospital that
you are taking these tablets.
Other medicines and OxyNorm Dispersa
tablets
Please tell your doctor or pharmacist if
you are taking, have recently taken or
might take any other medicines, including
medicines obtained without a prescription.
If you take these tablets with some other
medicines, the effect of these tablets or the
other medicine may be changed.

Tell your doctor or pharmacist if you are
taking:
• a type of medicine known as a
monoamine oxidase inhibitor or you
have taken this type of medicine in the
last two weeks;
• medicines to help you sleep or stay calm
(for example tranquillisers, hypnotics or
sedatives);
• medicines to treat depression (such as
paroxetine);
• medicines to treat psychiatric or mental
disorders (such as phenothiazines or
neuroleptic drugs);
• other strong analgesics (‘painkillers’);
• muscle relaxants;
• medicines to treat high blood pressure;
• quinidine (a medicine to treat a fast heart
beat);
• cimetidine (a medicine for stomach
ulcers, indigestion or heartburn);
• antifungal medicines (such as
ketoconazole, voriconazole, itraconazole
and posaconazole);
• antibiotics (such as clarithromycin,
erythromycin or telithromycin);
• medicines known as ‘protease inhibitors’
to treat HIV (e.g. boceprevir, ritonavir,
indinavir, nelfinavir or saquinavir);
• rifampicin (to treat tuberculosis);
• carbamazepine (a medicine to treat
seizures, fits or convulsions and certain
pain conditions);
• phenytoin (a medicine to treat seizures,
fits or convulsions);

• a herbal remedy called St. John’s Wort
(also known as Hypericum perforatum);
• antihistamines;
• medicines to treat Parkinson’s disease.
Also tell your doctor if you have recently
been given an anaesthetic.
Taking OxyNorm Dispersa tablets with
food, drink and alcohol
Drinking alcohol during your treatment
with these tablets may make you 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
OxyNorm Dispersa tablets.
You should avoid drinking grapefruit juice
during your treatment with this medicine.
Pregnancy and breastfeeding
Do not take these tablets if you are
pregnant or breastfeeding.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
These tablets may cause a number of
side effects such as drowsiness which
may affect your ability to drive or use
machinery (see section 4 for a full list
of side effects). These are usually most
noticeable when you first start taking the
tablets, or when changing to a higher dose.

If you are affected you should not drive or
use machinery.
This 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 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 medicine.
OxyNorm Dispersa tablets contain
sucrose, maltodextrin and aspartame
• These tablets contain sucrose and
maltodextrin. Maltodextrin is a form of
glucose. Both sucrose and glucose are

forms of sugar and may be harmful to
your teeth. If you have been told by your
doctor that you have an intolerance to
some sugars, contact your doctor before
taking these tablets.
• These tablets contain aspartame.
Aspartame contains a source of
phenylalanine which may be harmful to
people with phenylketonuria.
3. How to take OxyNorm Dispersa
tablets
Always take these tablets exactly as your
doctor has told you. The label on your
medicine will tell you how many tablets to
take and how often.
Adults (over 18 years of age)
The usual starting dose is one 5 mg tablet
every 4 to 6 hours. However, your doctor
will prescribe the dose required to treat
your pain. If you find that you are still in
pain whilst taking these tablets discuss this
with your doctor.
Children
Children and adolescents under 18 years of
age should not take the tablets.
Patients with kidney or liver problems
Please tell your doctor if you suffer from
kidney or liver problems as they may
prescribe a lower dose depending on your
condition.

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Do not exceed the dose recommended by
your doctor. You should check with your
doctor or pharmacist if you are not sure.
To remove a tablet from the blister strip:
Diagram 1: Do not press your tablet
through the foil as this may damage it.
Diagram 2: Detach a pocket containing
one tablet from the blister strip by
carefully tearing along the perforations.
Diagram 3: Peel back the corner of the foil
where indicated with the arrow and gently
remove the tablet.
Place the tablet in
your mouth and allow
to dissolve before
swallowing.
You must only take the
tablets by mouth. The
tablets should never be
crushed and injected as
this may lead to serious
side effects, which may
be fatal.
If you take more
OxyNorm Dispersa
tablets than you
should or if someone
accidentally swallows your tablets
Call your doctor or hospital straight away.
People who have taken an overdose may
feel very sleepy, sick or dizzy. They may
also have breathing difficulties leading to

OXYNORM DISPERSA TABS PIL UK 9962-4 V2.indd 3

unconsciousness or even death and may
need emergency treatment in hospital.
When seeking medical attention make sure
that you take this leaflet and any remaining
tablets with you to show to the doctor.
If you forget to take your OxyNorm
Dispersa tablets
If you miss a dose you should take the next
dose as soon as you remember, then carry
on as before. Do not take two doses within
4 hours. Do not take a double dose to make
up for forgotten tablets.
If you stop taking OxyNorm Dispersa
tablets
You should not suddenly stop taking these
tablets unless your doctor tells you to.
If you want to stop taking your tablets,
discuss this with your doctor first. They
will tell you how to do this, usually by
reducing the dose gradually so you do not
experience unpleasant effects. Withdrawal
symptoms such as agitation, anxiety,
palpitations, shaking or sweating may
occur if you suddenly stop taking these
tablets.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, these tablets can cause
side effects, although not everybody gets
them.
All medicines can cause allergic reactions,
although serious allergic reactions are
rare. Tell your doctor immediately if you
get any sudden wheeziness, difficulties
in breathing, swelling of the eyelids, face
or lips, rash or itching especially those
covering your whole body.
The most serious side effect is a condition
where you breathe more slowly or weakly
than expected (respiratory depression). Tell
your doctor immediately if this happens
to you.
As with all strong painkillers, there is a risk
that you may become addicted or reliant on
these tablets.
Very common side effects
(May affect more than 1 in 10 people)
• Constipation (your doctor can prescribe
a laxative to overcome this problem).
• Feeling or being sick (this should
normally wear off after a few days,
however your doctor can prescribe an
anti-sickness medicine if it continues to
be a problem).
• Drowsiness (this is most likely when
you start taking your tablets or when
your dose is increased, but it should
wear off after a few days).

• Dizziness.
• Headache.
• Itchy skin.
Common side effects
(May affect up to 1 in 10 people)
• Dry mouth, loss of appetite, indigestion,
abdominal pain or discomfort, diarrhoea.
• Confusion, depression, a feeling of
unusual weakness, shaking, lack of
energy, tiredness, anxiety, nervousness,
difficulty in sleeping, abnormal thoughts
or dreams.
• Difficulty in breathing or wheezing,
shortness of breath, decreased cough
reflex.
• Rash.
• Sweating.
Uncommon side effects
(May affect up to 1 in 100 people)
• Difficulty in swallowing, belching,
hiccups, wind, a condition where the
bowel does not work properly (ileus),
inflammation of the stomach, changes in
taste.
• A feeling of dizziness or ‘spinning’,
hallucinations, mood changes,
unpleasant or uncomfortable mood,
a feeling of extreme happiness,
restlessness, agitation, generally feeling
unwell, loss of memory, difficulty in
speaking, reduced sensitivity to pain or
touch, tingling or numbness, seizures,
fits or convulsions, blurred vision,
fainting, unusual muscle stiffness











or slackness, involuntary muscle
contractions.
Difficulty in passing urine, impotence,
decreased sexual drive, low levels of sex
hormones in the blood (‘hypogonadism’,
seen in a blood test).
Fast, irregular heart beat, flushing of the
skin.
Dehydration, thirst, chills, swelling of
the hands, ankles or feet.
Dry skin, severe flaking or peeling of the
skin.
Redness of the face, reduction in size of
the pupils in the eye, muscle spasm, high
temperature.
A need to take increasingly higher doses
of the tablets to obtain the same level of
pain relief (tolerance).
Colicky abdominal pain or discomfort.
A worsening of liver function tests (seen
in a blood test).

Rare side effects
(May affect up to 1 in 1,000 people)
• Low blood pressure.
• A feeling of ‘faintness’ especially on
standing up.
• Hives (nettle rash).
Frequency not known
(Frequency cannot be estimated from the
available data)
• An increased sensitivity to pain.
• Aggression.
• Tooth decay.
• Absence of menstrual periods.

• A blockage in the flow of bile from the
liver (cholestasis). This can cause itchy
skin, yellow skin, very dark urine and
very pale stools.
• Long term use of OxyNorm Dispersa
tablets during pregnancy may cause lifethreatening withdrawal symptoms in the
newborn. Symptoms to look for in the
baby include irritability, hyperactivity
and abnormal sleep pattern, high pitched
cry, shaking, being sick, diarrhoea and
not putting on weight.
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. 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 OxyNorm Dispersa
tablets
Keep this medicine out of the sight and
reach of children. Accidental overdose by
a child is dangerous and may be fatal.
Do not use any tablets after the expiry date
which is stated on the blister and carton.
EXP 08 2020 means that you should not
take the tablets after the last day of that
month i.e. August 2020.

Do not store above 25°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 OxyNorm Dispersa tablets contain
The active ingredient is oxycodone
hydrochloride. Each tablet contains
5 mg, 10 mg or 20 mg of oxycodone
hydrochloride.
The other ingredients are:
• Sucrose
• Maize starch
• Polyacrylate dispersion 30 %
• Hypromellose
• Mannitol
• Silicon dioxide
• Microcrystalline cellulose
• Crospovidone
• Aspartame
• Spearmint flavour (containing
maltodextrin)
• Magnesium stearate

What OxyNorm Dispersa tablets look
like and the contents of the pack
The tablets are white to off-white, round,
flat, bevel edged, marked with O on one
side and with the strength (5, 10 or 20) on
the other.
In each box there are 14, 28 or 56 tablets.
Not all pack sizes may be marketed.

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:

0800 198 5000
You will need to give details of the product name and
reference number. These are as follows:
Product name: OxyNorm Dispersa orodispersible tablets
Reference number: 16950/0142
Marketing Authorisation Holder and Manufacturer
The tablets are made by Bard Pharmaceuticals Limited for the
marketing authorisation holder Napp Pharmaceuticals Limited,
both at Cambridge Science Park, Milton Road, Cambridge
CB4 0GW, UK.
This leaflet was last revised in November 2015.
® OxyNorm and OXYNORM DISPERSA are registered trade marks of
Mundipharma AG.
NAPP and the ‘NAPP’ logo are registered trade marks of the Napp
Pharmaceutical Group.
FLASHTAB and the ‘FLASHTAB TECHNOLOGY’ logo are registered
trade marks of Ethypharm S.A. and are used under licence.
© 2013-2015 Napp Pharmaceuticals Limited.

05/01/2016 11:10

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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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