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SHORTEC 10 MG CAPSULES HARD

Active substance(s): OXYCODONE HYDROCHLORIDE

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Package leaflet: Information for the user

Shortec® 5 mg, 10 mg and 20 mg 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.
In this leaflet:
1. What Shortec capsules are and what
they are used for
2. What you need to know before you
take Shortec capsules
3. How to take Shortec capsules
4. Possible side effects
5. How to store Shortec capsules
6. Contents of the pack and other
information
1. What Shortec capsules are and
what they are used for
These capsules 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’.

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2. What you need to know before
you take Shortec capsules
Do not take Shortec capsules if you:
• are allergic to oxycodone, or any of
the other ingredients of the capsules
(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 longterm problems you should only take
these capsules 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 these capsules 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 these capsules.

Other medicines and Shortec capsules
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 capsules
with some other medicines, the effect
of these capsules 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
sezures, 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 capsules with food,
drink and alcohol
Drinking alcohol during your treatment
with these capsules 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 capsules.
You should avoid drinking grapefruit
juice during your treatment with this
medicine.
Pregnancy and breastfeeding
Do not take these capsules if you are
pregnant or breastfeeding.
Ask your doctor or pharmacist for
advice before taking any medicine.

Driving and using machines
These capsules 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
capsules, 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
• Y
ou 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.
Shortec 5 mg capsules contain sunset
yellow (E110)
The 5 mg capsules contain sunset yellow
(E110) which may cause allergic
reactions.
3. How to take Shortec capsules
Always take these capsules exactly as
your doctor has told you. The label on
your medicine will tell you how many
capsules to take and how often.
Adults (over 18 years of age)
The usual starting dose is one 5 mg
capsule 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 capsules, discuss this with your
doctor.
Children
Children and adolescents under 18 years
of age should not take the capsules.
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.

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Swallow your capsules whole with
water. Do not chew or crush them.
You must only take the capsules by
mouth. The capsules contents should
never be injected as this may lead to
serious side effects, which may be fatal.
If you take more Shortec capsules
than you should or if someone
accidentally swallows your capsules
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
capsules with you to show to the doctor.
If you forget to take Shortec capsules
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
capsules.
If you stop taking Shortec capsules
You should not suddenly stop taking
these capsules unless your doctor tells
you to. If you want to stop taking your
capsules, 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 capsules.

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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 capsules
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 capsules.
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 capsules 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 level 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 capsules 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 Shortec capsules
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 Shortec capsules
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 capsules after the expiry
date which is stated on the blister and
carton. EXP 08 2020 means that you
should not take the capsules after the
last day of that month i.e. August 2020.

Do not store your capsules above 30oC.
Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away of medicines you no longer use.
These measures will help to protect the
environment.
6. Contents of the pack and other
information
What Shortec capsules contain
The active substance is oxycodone
hydrochloride. Each capsules contains
5 mg, 10 mg or 20 mg of oxycodone
hydrochloride.
The other ingredients are:
• Cellulose, microcrystalline
• Magnesium stearate
• Titanium dioxide (E171)
• Iron oxide (E172)
• Indigo carmine (E132)
• Sodium laurilsulphate
• Gelatin
• Shellac
• Propylene glycol
In addition the 5 mg capsules contain
sunset yellow (E110).

What Shortec capsules look like and
the contents of the pack
The capsules are marked ONR and
the strength (5, 10 or 20). The capsule
colours are: 5 mg - orange/beige, 10 mg
– white/beige,
20 mg – pink/beige.
In each box there are 56 capsules.

Marketing Authorisation Holder and
Manufacturer
The capsules are made by Bard
Pharmaceuticals Limited, Cambridge
Science Park, Milton Road, Cambridge
CB4 0GW. 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 capsules
Reference number: PL 40431/0010
This leaflet was last revised in April 2016.
® SHORTEC, QDEM and the ‘Qdem pharmaceuticals’ logo
are registered trade marks.
© 2013-2016 Qdem 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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