Skip to Content

UK Edition. Click here for US version.

SHORTEC 5 MG CAPSULES HARD

Active substance(s): OXYCODONE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
3168-3

460x148mm (LSN-NAPP-02) (L) V1

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.
• 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. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
• If any of the side effects become serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.



In this leaflet:
1. What Shortec capsules are and what
they are used for
2. Before you take Shortec capsules
3. How to take Shortec capsules
4. Possible side effects
5. How to store Shortec capsules
6. Further 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’.

SHORTEC CAPS PIL UK 3168-3 V2.indd 2

2. Before you take Shortec capsules
Do not take Shortec capsules if you:
• are allergic (hypersensitive) to
oxycodone, or any of the other
ingredients of the capsules (see
section 6 ‘Further Information’);
• have breathing problems, such as
chronic obstructive lung disease,
chronic bronchial asthma or
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 head injury that causes a
severe headache or makes you feel





sick. This is because the capsules
may make these symptoms worse or
hide the extent of the head injury;
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 severe kidney problems or
moderate to severe liver problems. If
you have other long-term kidney or
liver problems you should only take
these capsules if recommended by
your doctor;
have ongoing problems with
constipation;
are taking a type of medicine known
as a monoamine oxidase inhibitor
(examples include tranylcypromide,
phenelzine, isocarboxazid,
moclobemide and linezolid), or you
have taken this type of medicine in
the last two weeks;
are under 18 years of age.

Take special care with Shortec
capsules
Before treatment with these capsules
tell your doctor or pharmacist 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 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.
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 these capsules
with some other medicines, the effect
of these capsules or the other medicine
may be changed.
These capsules 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
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).
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 • You have taken it according to the
not to drink alcohol while you are taking
instructions given by the prescriber
Shortec capsules.
and in the information provided
with the medicine.
You should avoid drinking grapefruit
• Please note that it is still an offence to
juice during your treatment with this
drive if you are unfit because of the
medicine.
medicine (i.e. your ability to drive is
Pregnancy and breastfeeding
being affected).
Do not take these capsules if you are
Details regarding a new driving offence
pregnant or breastfeeding.
concerning driving after drugs have been
Ask your doctor or pharmacist for advice taken in the UK may be found here:
before taking any medicine.
https://www.gov.uk/drug-driving-law.
Driving and using machines
Talk to your doctor or pharmacist if you
are not sure whether it is safe for you to
These capsules may cause a number of
drive while taking this medicine.
side effects such as drowsiness which
may affect your ability to drive or use
Important information about some of
machinery (see section 4 for a full list
the ingredients of Shortec capsules
of side effects). These are usually most
noticeable when you first start taking the The 5 mg capsules contain sunset yellow
(E110) which may cause allergic reactions.
capsules, or when changing to a higher
dose. If you are affected you should not
3. How to take Shortec capsules
drive or use machinery.
This medicine can affect your ability
Always take these capsules exactly as
to drive as it may make you sleepy or
your doctor has told you. The label on
dizzy.
your medicine will tell you how many
• Do not drive while taking this
capsules to take and how often.
medicine until you know how it
Adults (over 18 years of age)
affects you.
The usual starting dose is one 5 mg
• It is an offence to drive while you
capsule every 4 to 6 hours. However,
have this medicine in your body
your doctor will prescribe the dose
over a specified limit unless you
required to treat your pain. If you find
have a defence (called the ‘statutory
that you are still in pain whilst taking
defence’).
these capsules, discuss this with your
• This defence applies when:
doctor.
• The medicine has been prescribed
to treat a medical or dental problem;
and

07/09/2015 14:47

3168-3

460x148mm (LSN-NAPP-02) (L) V1

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.
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.

SHORTEC CAPS PIL UK 3168-3 V2.indd 3

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.
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, 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.
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
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).
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 capsules
Keep out of the reach and sight 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.
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 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.

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
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 was last revised in August 2015.
® SHORTEC, QDEM and the ‘Qdem pharmaceuticals’ logo
are registered trade marks.
© 2013-2015 Qdem Pharmaceuticals Limited.

07/09/2015 14:47

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