Skip to Content

UK Edition. Click here for US version.

SHORTEC CONCENTRATE 10 MG/ML ORAL SOLUTION

Active substance(s): OXYCODONE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
10211903

460x148mm (LSN-CON-21) (L) V1

Package leaflet: Information for the user

• have ongoing problems with constipation;
• are taking a type of medicine known as a
monoamine oxidase inhibitor (examples
®
Shortec concentrate 10 mg/ml oral solution
include tranylcypromide, phenelzine,
isocarboxazid, moclobemide and linezolid),
Oxycodone hydrochloride
or you have taken this type of medicine in
the last two weeks;
Read all of this leaflet carefully before you

are under 18 years of age.
2. Before you take Shortec concentrate
start taking this medicine.
Take special care with Shortec concentrate
• Keep this leaflet. You may need to read it
Do not take Shortec concentrate if you:
Before treatment with this medicine tell your
again.
• are allergic (hypersensitive) to oxycodone, or doctor or pharmacist if you:
• If you have any further questions, ask your
any of the other ingredients of the medicine
• are elderly or weakened;
doctor or pharmacist.
(see section 6 ‘Further information’);
• have an under-active thyroid gland
• This medicine has been prescribed for you.
• have breathing problems, such as chronic
(hypothyroidism), as you may need a lower
Do not pass it on to others. It may harm them,
obstructive lung disease, chronic bronchial
dose;
even if their symptoms are the same as yours.
asthma or respiratory depression. Your
• have myxoedema (a thyroid disorder with
• If any of the side effects become serious, or
doctor will have told you if you have any
dryness, coldness and swelling [‘puffiness’]
if you notice any side effects not listed in this
of these conditions. Symptoms may include
of the skin affecting the face and limbs);
leaflet, please tell your doctor or pharmacist.
breathlessness, coughing or breathing more
• have a severe headache or feel sick as this
In this leaflet:
slowly or weakly than expected;
may indicate that the pressure in your skull
1. What Shortec concentrate is and what it is
• have a head injury that causes a severe
is increased;
used for
headache or makes you feel sick. This is
• have low blood pressure (hypotension);
2. Before you take Shortec concentrate
because this medicine may make these
• have low blood volume (hypovolaemia);
3. How to take Shortec concentrate
symptoms worse or hide the extent of the
this can happen with severe external or
4. Possible side effects
head injury;
internal bleeding, severe burns, excessive
5. How to store Shortec concentrate
• have a condition where the small bowel does
sweating, severe diarrhoea or vomiting;
6. Further information
not work properly (paralytic ileus), your
• have a mental disorder as a result of an
stomach empties more slowly than it should
infection (toxic psychosis);
1. What Shortec concentrate is and what
(delayed gastric emptying) or you have
• have inflammation of the pancreas (which
it is used for
severe pain in your abdomen;
causes severe pain in the abdomen and
• have a heart problem after long-term lung
back);
This medicine has been prescribed for you by
disease (cor pulmonale);
• have problems with your gall bladder or
your doctor to relieve moderate to severe pain. • have severe kidney problems or moderate
bile duct;
It contains the active ingredient oxycodone
to severe liver problems. If you have
• have inflammatory bowel disease;
which belongs to a group of medicines called
other long-term kidney or liver problems
• have an enlarged prostate gland, which
strong analgesics or ‘painkillers’.
you should only take this medicine if
causes difficulty in passing urine (in men);
recommended by your doctor;

SHORTEC CON PIL 120ML UK 10211903 V2.indd 2

• 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.
Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken 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.
This medicine must not be used together with
a monoamine oxidase inhibitor, or if you have
taken this type of medicine in the last two
weeks (see section 2 “Do not take…).

Tell your doctor or pharmacist if you are
taking:
• 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).
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.

23/10/2015 10:21

10211903

460x148mm (LSN-CON-21) (L) V1

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.
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.

SHORTEC CON PIL 120ML UK 10211903 V2.indd 3

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.
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, anxiety, nervousness,
difficulty in sleeping, abnormal thoughts or
dreams.
• Difficulty in breathing or wheezing,
shortness of breath, decreased cough reflex.
• Rash.
• Sweating, chills.
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, tooth decay.
• 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.
• 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, absence of
menstrual periods.
• Fast, irregular heart beat, low blood
pressure, a feeling of ‘faintness’ especially
on standing up, flushing of the skin.
• Dehydration, thirst, swelling of the hands,
ankles or feet.
• Dry skin, severe flaking or peeling of the
skin, hives (nettle rash).
• 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).
Frequency unknown
(Frequency cannot be estimated from the
available data)
• An increased sensitivity to pain.
• Aggression.

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 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.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. Further 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 August 2015.
® QDEM and SHORTEC are registered trade marks.
™ The ‘Qdem pharmaceuticals’ logo is a trade mark.
© 2013-2015 Qdem Pharmaceuticals Limited.

23/10/2015 10:21

Expand view ⇕

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.

Hide