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LONGTEC 120 MG PROLONGED RELEASE TABLETS
Active substance(s): OXYCODONE HYDROCHLORIDE / OXYCODONE HYDROCHLORIDE / OXYCODONE HYDROCHLORIDE
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Package leaflet: Information for the user
Longtec® 5 mg, 10 mg, 15 mg, 20 mg, 30 mg,
40 mg, 60 mg, 80 mg and 120 mg
prolonged release tablets
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 illnes are the same as yours.
• If you get any of the 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 Longtec tablets are and what
they are used for
2. What you need to know before you
take Longtec tablets
3. How to take Longtec tablets
4. Possible side effects
5. How to store Longtec tablets
6. Contents of the pack and other
1. What Longtec tablets are and
what they are used for
These tablets have been prescribed for
you by your doctor to relieve moderate
to severe pain over a period of 12 hours.
They contain the active ingredient
oxycodone which belongs to a group of
medicines called strong analgesics or
LONGTEC TABS 5-120MG PIL UK 2855-4 V2.indd 2
2. What you need to know before
you take Longtec tablets
Do not take Longtec tablets if you:
• are allergic to oxycodone, or any of
the other ingredients of the tablets
(liated 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
these tablets if recommended by your
• have ongoing problems with
• are under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before
taking these tablets if you:
• are elderly or weakened;
• have an under-active thyroid gland
(hypothyroidism), as you may need a
• 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
• 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
• 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
• 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
• have an increased sensitivity to pain;
• need to take increasingly higher doses
of Longtec 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 tablets.
Other medicines and Longtec
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 tablets
with some other medicines, the effect of
these tablets or the other medicine may
These tablets 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
Tell your doctor or pharmacist if you are
• 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
• 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
• cimetidine (a medicine for stomach
ulcers, indigestion or heartburn);
• antifungal medicines (such as
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
• phenytoin (a medicine to treat
seizures, fits or convulsions);
• a herbal remedy called St. John’s
Wort (also known as Hypericum
• medicines to treat Parkinson’s disease.
Also tell your doctor if you have recently
been given an anaesthetic.
Taking Longtec tablets with food,
drink and alcohol
Drinking alcohol whilst taking Longtec
tablets may make you feel more 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
Longtec tablets. You should avoid
drinking grapefruit juice during your
treatment with this medicine.
Pregnancy and breastfeeding
Do not take these tablets if you are
pregnant or breastfeeding.
Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
These tablets 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 most
noticeable when you first start taking
the tablets, 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
• 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
• This defence applies when:
• The medicine has been prescribed
to treat a medical or dental
• 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
Details regarding a new driving offence
concerning driving after drugs have been
taken in the UK may be found here:
Talk to your doctor or pharmacist if you
are not sure whether it is safe for you to
drive while taking this medicine.
Longtec tablets contain lactose
These tablets contain lactose which is a
form of sugar. If you have been told by
your doctor that you have an intolerance
to some sugars, contact your doctor
before taking these tablets.
3. How to take Longtec tablets
Always take these tablets exactly as your
doctor has told you. The label on your
medicine will tell you how many tablets
to take and how often.
Adults (over 18 years of age)
The usual starting dose is one 10 mg
tablet every 12 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 tablets,
discuss this with your doctor.
Do not exceed the dose recommended by
your doctor. You should check with your
doctor or pharmacist if you are not sure.
Swallow your tablets whole with water.
Do not crush, dissolve or chew them.
Longtec tablets are designed to work
properly over 12 hours when swallowed
whole. If a tablet is broken, crushed,
dissolved or chewed, the entire 12-hour
dose may be absorbed rapidly into your
body. This can be dangerous, causing
serious problems such as an overdose,
which may be fatal.
You should take your tablets every
12 hours. For instance, if you take a
tablet at 8 o’clock in the morning, you
should take your next tablet at 8 o’clock
in the evening.
You must only take the tablets by mouth.
The tablets should never be crushed or
injected as this may lead to serious side
effects, which may be fatal.
460x148mm (LSN-NAPP-02) (L) V1
Children and adolescents under 18 years
of age should not take the tablets.
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
If you take more Longtec tablets than
you should or if someone accidentally
swallows your tablets
Call your doctor or hospital straight
away. People who have taken an
overdose may feel very sleepy, sick or
dizzy, or have hallucinations. 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 tablets with you to show to the
If you forget to take your Longtec
If you remember within 4 hours of the
time your tablet was due, take your tablet
straight away. Take your next tablet at
your normal time. If you are more than
4 hours late, please call your doctor or
pharmacist for advice. Do not take a
double dose to make up for a forgotten
If you stop taking Longtec tablets
You should not suddenly stop taking
these tablets unless your doctor tells
you to. If you want to stop taking your
tablets, discuss this with your doctor first.
LONGTEC TABS 5-120MG PIL UK 2855-4 V2.indd 3
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
If you have any further questions on the
use of this medicine, ask your doctor or
4. Possible side effects
Like all medicines, these tablets
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 tablets.
Very common side effects
(May affect more than 1 in 10 people)
• Constipation (your doctor can
prescribe a laxative to overcome this
• 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 tablets or when
your dose is increased, but it should
wear off after a few days).
• Itchy skin.
Common side effects
(May affect up to 1 in 10 people)
• Dry mouth, loss of appetite,
indigestion, abdominal pain or
• 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
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
• 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, low blood
pressure, a feeling of ‘faintness’
especially on standing up, flushing of
• Dehydration, thirst, chills, 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,
• A need to take increasingly higher
doses of the tablets 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
• Hives (nettle rash).
Frequency not known
(Frequency cannot be estimated from the
• An increased sensitivity to pain.
• 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 Longtec 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.
You may see the remains of the tablets in
your faeces. This should not affect how
the tablets work.
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/
By reporting side effects you can help
provide more information on the safety
of this medicine.
5. How to store Longtec tablets
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 tablets after the expiry
date which is stated on the blister and
carton. EXP 08 2020 means that you
should not take the tablets after the last
day of that month i.e. August 2020.
Do not store your tablets above 25ºC.
Do not take your tablets if they are
broken or crushed as this can be
dangerous and can cause serious
problems such as overdose.
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
6. Contents of the pack and other
What Longtec tablets contain
The active ingredient is oxycodone
hydrochloride. Each tablet contains
5 mg, 10 mg, 15 mg, 20 mg, 30 mg,
40 mg, 60 mg, 80 mg or 120 mg of
The other ingredients are:
• Lactose monohydrate
• Ammoniomethacrylate polymer
• Sorbic acid
• Stearyl alcohol
• Magnesium stearate
• Hypromellose (E464)
• Titanium dioxide (E171)
In addition, the tablet coatings contain
5 mg - brilliant blue (E133)
10 mg – hydroxypropylcellulose
15 mg – iron oxide (E172)
20 mg, 30 mg, 40 mg, 60 mg and
120 mg - polysorbate 80 (E433), and iron
80 mg - hydroxypropylcellulose, iron
oxide (E172), and indigo carmine (E132)
What Longtec tablets look like and the
contents of the pack
The tablets are marked OC on one side
and the strength on the other (5, 10, etc).
All strengths are round, bi-convex, film
The tablets are all film coated in the
following colours: 5 mg - light blue,
10 mg - white, 15 mg – grey,
20 mg - pink, 30 mg – brown,
40 mg - yellow, 60 mg – red,
80 mg – green, 120 mg – purple.
In each box there are 28, 56 or
112 tablets. Not all pack sizes may be
Marketing Authorisation Holder and
The tablets are made by Bard
Pharmaceuticals Limited for the
marketing authorisation holder Qdem
Pharmaceuticals Limited, both at
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: Longtec
Reference number: 40431/0006
This leaflet was last revised in April 2016.
® QDEM and LONGTEC and the ‘Qdem pharmaceuticals’ logo
are registered trade marks.
© 2012-2016 Qdem Pharmaceuticals Limited.
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.