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OXYNORM CONCENTRATE 10MG/ML ORAL SOLUTION

Active substance(s): OXYCODONE HYDROCHLORIDE

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10210604

• 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 this
OxyNorm® concentrate 10 mg/ml oral solution
medicine if recommended by your
Oxycodone hydrochloride
doctor;
• have ongoing problems with
constipation;
Read all of this leaflet carefully before
1. What OxyNorm concentrate is and what • are under 18 years of age.
you start taking this medicine because it
it is used for
Warnings and precautions
contains important information for you.
Talk to your doctor or pharmacist before
This medicine has been prescribed for you by
• Keep this leaflet. You may need to read it
taking this medicine if you:
doctor
to
relieve
moderate
to
severe
pain.
your
again.
• are elderly or weakened;
It contains the active ingredient oxycodone
• If you have any further questions, ask your
• have an under-active thyroid gland
which belongs to a group of medicines called
doctor or pharmacist.
(hypothyroidism), as you may need a
strong analgesics or ‘painkillers’.
• This medicine has been prescribed for you
lower dose;
only. Do not pass it on to others. It may

have
myxoedema (a thyroid disorder
harm them, even if their signs of illness are
2. What you need to know before you take
with dryness, coldness and swelling
the same as yours.
OxyNorm concentrate
[‘puffiness’] of the skin affecting the face
• If you get any side effects, talk to your
and limbs;
Do not take OxyNorm concentrate if you:
doctor or pharmacist. This includes any

have
a head injury, severe headache or

are
allergic
(hypersensitive)
to
oxycodone,
possible side effects not listed in this leaflet.
feel sick as this may indicate that the
or any of the other ingredients of the
See section 4.
pressure in your skull is increased;
medicine (listed in section 6);
In this leaflet:
• have low blood pressure (hypotension);
• have breathing problems, such as severe
1. What OxyNorm concentrate is and what it
• have low blood volume (hypovolaemia);
chronic obstructive lung disease, severe
is used for
this can happen with severe external or
bronchial asthma or severe respiratory
2. What you need to know before you take
internal bleeding, severe burns, excessive
depression. Your doctor will have told you if
OxyNorm concentrate
sweating, severe diarrhoea or vomiting;
you have any of these conditions. Symptoms
3. How to take OxyNorm concentrate
• have a mental disorder as a result of an
may include breathlessness, coughing or
4. Possible side effects
infection (toxic psychosis);
breathing more slowly or weakly than
5. How to store OxyNorm concentrate
• have inflammation of the pancreas
expected;
6. Contents of the pack and other information
(which causes severe pain in the
• have a condition where the small bowel does
abdomen and back);
not work properly (paralytic ileus), your
• have problems with your gall bladder or
stomach empties more slowly than it should
bile duct;
(delayed gastric emptying) or you have
• have inflammatory bowel disease;
severe pain in your abdomen;

Package leaflet: Information for the user

• 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
OxyNorm 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 this
medicine.
Other medicines and OxyNorm concentrate
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 this medicine
with some other medicines, the effect of this
medicine 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 concentrate with food,
drink and alcohol
Drinking alcohol during your treatment
with this medicine 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’re taking OxyNorm concentrate.
You should avoid drinking grapefruit juice
during your treatment with this medicine.
Pregnancy and breastfeeding
Do not take this medicine if you are
pregnant or breastfeeding.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
This medicine may cause a number of side
effects such as drowsiness which could
affect your ability to drive or use machinery
(see section 4 for a full list of side effects).
These are usually more noticeable when
you first start taking this medicine, 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 concentrate contains sunset yellow
(E110)
This medicine contains sunset yellow (E110)
which may cause allergic reactions.
3. How to take OxyNorm concentrate


Always take this medicine exactly as your
doctor has told you. The label on your medicine
will tell you how much to take and how often.
Adults (over 18 years of age)
The usual starting dose is 0.5 ml 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 this medicine
discuss this with your doctor.
Children
Children and adolescents under 18 years of age
should not take the medicine.

10210604

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.
Do not exceed the dose recommended by
your doctor. You should check with your
doctor or pharmacist if you are not sure.
You must only take this medicine by mouth.
This medicine should never be injected as
this may lead to serious side effects, which
may be fatal.
If you take more OxyNorm concentrate
than you should or if someone accidentally
swallows your medicine.
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
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 medicine
with you to show to the doctor.
If you forget to take OxyNorm concentrate
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 a forgotten dose.
If you stop taking OxyNorm concentrate
You should not suddenly stop taking this
medicine unless your doctor tells you to.
If you want to stop taking your medicine,
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 this medicine.
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.
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 this
medicine.
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 medicine 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
this medicine 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 during pregnancy
may cause life-threatening 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 concentrate
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 this medicine after the expiry
date which is stated on the label and carton.
EXP 08 2020 means that you should not take
any of this medicine after the last day of that
month i.e. August 2020.
Do not store your medicine 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 OxyNorm concentrate contains
The active substance is oxycodone
hydrochloride. Each 1 ml contains 10 mg
of oxycodone hydrochloride.
The other ingredients are:
• Saccharin sodium
• Sodium benzoate
• Citric acid
• Sodium citrate
• Hydrochloric acid
• Sodium hydroxide
• Purified water
• Sunset yellow (E110)

What OxyNorm concentrate looks like and
contents of the pack
This medicine is a clear orange solution.
Each bottle contains 120 ml of solution.
An oral syringe is also supplied.
Marketing Authorisation Holder and
Manufacturer
This medicine is made by Mundipharma
Pharmaceuticals Limited, 13 Othellos Street,
Dhali Industrial Zone, 2540-Nicosia, Cyprus.
The marketing authorisation holder is Napp
Pharmaceuticals Limited, both at Cambridge
Science Park, Milton Road, Cambridge
CB4 0GW, UK.

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 concentrate
Reference number: 16950/0004
This leaflet was last revised in November2015.
® OxyNorm, NAPP and NAPP logo are registered trade marks.
© 2009-2015 Napp Pharmaceuticals Limited.

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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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