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SHORTEC CONCENTRATE 10 MG/ML ORAL SOLUTION

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

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10211904

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Package leaflet: Information for the user

Shortec® concentrate 10 mg/ml oral solution
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 symptoms are the same as yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any side effects not
listed in this leaflet. See section 4.
In this leaflet:
1. What Shortec concentrate is and what it is used
for
2. What you need to know before you take
Shortec concentrate
3. How to take Shortec concentrate
4. Possible side effects
5. How to store Shortec concentrate
6. Contents of the pack and other information
1. What Shortec concentrate is and what it
is used for
This medicine has been prescribed for you by
your doctor to relieve moderate to severe pain. It
contains the active ingredient oxycodone which
belongs to a group of medicines called strong
analgesics or ‘painkillers’.

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2. What you need to know before you take
Shortec concentrate
Do not take Shortec concentrate if you:
• are allergic to oxycodone, or any of the other
ingredients of the medicine (listed in section 6 );
• have breathing problems, such as severe
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 small 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 this medicine 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
infection (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
Shortec 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 Shortec 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 Shortec 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 are taking Shortec
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.

Important information about some of the
ingredients of Shortec concentrate
This medicine contains sunset yellow (E110)
which may cause allergic reactions.
3. How to take Shortec 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.
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.

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If you take more Shortec 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 Shortec 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 Shortec 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.

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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 Shortec 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 30ºC.
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 if the pack and other
information
What Shortec 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 Shortec 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
Qdem Pharmaceuticals Limited,
Cambridge Science Park, Milton Road,
Cambridge CB4 0AB, 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: Shortec concentrate
Reference number: 40431/014
This leaflet was last revised in April 2016.
® QDEM, SHORTEC and the ‘Qdem pharmaceuticals’ logo are
registered trade marks.
© 2013-2016 Qdem Pharmaceuticals Limited.

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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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