MXL 120MG PROLONGED RELEASE CAPSULES

Active substance: MORPHINE SULPHATE

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7642-5

Package leaflet: Information for the user
MXL® 30 mg, 60 mg, 90 mg, 120 mg, 150 mg
and 200 mg prolonged-release capsules
Morphine sulphate
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.

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In this leaflet:
1. What MXL capsules are and what
they are used for
2. Before you take MXL capsules
3. How to take MXL capsules
4. Possible side effects
5. How to store MXL capsules
6. Further information
1. What MXL capsules are and
what they are used for
These capsules have been prescribed
for you by your doctor to relieve severe
pain over a period of 24 hours. They
contain the active ingredient morphine
which belongs to a group of medicines
called strong analgesics or ‘painkillers’.

2. Before you take MXL capsules
Do not take MXL capsules if:
• you are allergic (hypersensitive) to morphine
or any of the other ingredients of the capsules
(see section 6 ‘Further Information’);
• you have breathing problems, such as
obstructive airways disease or respiratory
depression. Your doctor will have told you if
you have these conditions. Symptoms may
include breathlessness, coughing or breathing
more slowly or weakly than expected;
• you 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;
• you have a condition where the small bowel
(part of your gut) 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;
• you have recent onset liver disease;
• you 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;
• the patient is under one year of age.
If you are going to have an operation, please
tell the doctor at the hospital that you are taking
these capsules.

Take special care with MXL capsules
Before treatment with these capsules
tell your doctor or pharmacist if you:
• have breathing problems, such as
severe bronchial asthma or impaired
lung function. Your doctor will
have told you if you have these
conditions. Symptoms may include
breathlessness and coughing;
• have an under-active thyroid gland
(hypothyroidism), kidney or longterm liver problems as you may need
a lower dose;
• have a severe headache or feel sick as
this may indicate that the pressure in
your skull is increased;
• suffer from seizures, fits or
convulsions;
• have low blood pressure;
• have a severe heart problem after
long-term lung disease (severe cor
pulmonale);
• have inflammation of the pancreas
(which causes severe pain in the
abdomen and back) or problems with
your gall bladder;
• have an inflammatory bowel disorder;
• have prostate problems;
• 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);

• are or have ever been addicted to
alcohol or drugs;
• have previously suffered from
withdrawal symptoms such as
agitation, anxiety, shaking or
sweating, upon stopping taking
alcohol or drugs.
Very rarely you may experience
increased sensitivity to pain despite
the fact that you are taking increasing
doses of these capsules (hyperalgesia).
Your doctor will decide whether you
need a change in dose or a change in
strong analgesic (‘painkiller’).
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 the 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 (for
example tranquillisers, hypnotics or
sedatives);
• medicines to treat psychiatric
or mental disorders (such as
phenothiazines);
• muscle relaxants;
• medicines to treat high blood
pressure;
• cimetidine to treat stomach ulcers,
indigestion or heartburn;
• other strong analgesics
or ‘painkillers’ (such as
buprenorphine, nalbuphine or
pentazocine);
• rifampicin to treat tuberculosis;
• ritonavir to treat HIV;
• gabapentin to treat epilepsy or
neuropathic pain (pain due to nerve
problems).
Also tell your doctor if you have
recently been given an anaesthetic.
Taking MXL capsules with alcohol
Drinking alcohol whilst taking MXL
capsules 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’re taking MXL capsules.

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
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 capsules, or when changing to a
higher dose. If you are affected you
should not drive or use machinery.
3. How to take MXL capsules
Always take the capsules exactly as
your doctor has told you. The label on
your medicine will tell you how many
capsules to take and how often.
Swallow your capsules whole with a
glass of water. If you prefer, you can
open your capsules and sprinkle the
contents on to cold soft food, such as
yogurt. Do not crush, dissolve or chew
the capsule contents.

MXL capsules are designed to work
properly over 24 hours. If the capsule
contents are crushed, dissolved or
chewed, the entire 24‑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 capsules every
24 hours. For instance, if you take a
capsule at 8 o’clock in the morning,
you should take your next capsule at
8 o’clock the next morning.
You must only take the capsules by
mouth.
Adults
The usual starting dose is one 60 mg
capsule every 24 hours. However, the
dose will depend on your age, weight
and the severity of your pain. If you are
elderly or weigh less than 70 kg your
doctor may suggest a starting dose of
one 30 mg capsule every 24 hours. Your
doctor will decide how many capsules
you should take.

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Children over one year of age
Children over one year of age can take these
capsules. The required dose will depend on
their weight and severity of pain. This should
be discussed with your doctor or pharmacist.
If you find that you are still in pain whilst
taking these capsules 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.
If you take more MXL 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 MXL capsules
If you remember within 16 hours of the time
your capsule was due, take your capsule
straight away. Take your next capsule at your
normal time. If you are more than 16 hours late,
please call your doctor for advice. Do not take a
double dose to make up for a forgotten capsule.

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If you stop taking MXL 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, 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 uncommon. 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).

As with all strong painkillers, there
is a risk that you may become
addicted or reliant on these
capsules.
Very common side effects
(probably affecting more than 1 in
10 people taking these capsules)
• Constipation (your doctor can
prescribe a laxative to overcome
this problem).
• Feeling sick.
Common side effects (probably
affecting between 1 and 10 in
100 people taking these capsules)
• Drowsiness (this is most likely
when you first start taking your
capsules or when your dose is
increased, but it should wear off
after a few days).
• Dry mouth, loss of appetite,
abdominal pain or discomfort.
• Vomiting (being sick). (This
should normally wear off after a
few days. However your doctor
can prescribe an anti-vomiting
medicine if it continues to be a
problem).
• Dizziness, headache, confusion,
difficulty in sleeping.
• A feeling of unusual weakness.
• Involuntary muscle contractions.
• Rash or itchy skin.
• Sweating.

Uncommon side effects (probably
affecting between 1 and 10 in 1,000
people taking these capsules)
• Difficulty in breathing (possibly due
to fluid on the lungs) or wheezing.
• A condition where the bowel does not
work properly (ileus).
• Changes in taste, indigestion.
• A feeling of dizziness or ‘spinning’,
fainting, seizures, fits or convulsions.
• Agitation, mood changes,
hallucinations, a feeling of extreme
happiness.
• Generally feeling unwell.
• Unusual muscle stiffness.
• Tingling or numbness.
• Difficulty in passing urine.
• Low blood pressure, facial flushing
(redness of the face).
• Palpitations.
• Swelling of the hands, ankles or feet.
• Hives.
• A worsening in liver function tests
(seen in a blood test).
• Blurred vision.
• Muscle spasms.
Frequency unknown (cannot be
estimated from available data)
• Unpleasant or uncomfortable mood,
abnormal thoughts.
• An increased sensitivity to pain.
• Reduction in size of the pupils in the
eye.






A fast or slow heartbeat.
High blood pressure.
Decreased cough reflex.
Colicky abdominal pain or
discomfort, an increase in the
severity of symptoms associated with
inflammation of the pancreas (severe
pain in the abdomen and back).
• Impotence, decreased sexual drive,
absence of menstrual periods.
• Withdrawal symptoms (See section 3
“If you stop taking MXL capsules”).
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.
5. How to store MXL capsules
Keep out of the reach and sight of
children.
Do not use any capsules after the expiry
date which is stated on the blister and
carton. EXP 08 2010 means that you
should not take the capsules after the
last day of that month i.e. August 2010.
Do not store your capsules above 25ºC.
Do not take your capsules if they
are broken or crushed as this can
be dangerous and can cause serious
problems such as overdose.

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 MXL capsules contain
The active ingredient is morphine
sulphate. Each capsule contains 30 mg,
60 mg, 90 mg, 120 mg, 150 mg or
200 mg of morphine sulphate.
The other ingredients are:
• Hydrogenated vegetable oil
• Macrogol
• Talc
• Magnesium stearate
• Gelatin
• Sodium dodecyl sulphate
• Shellac
• Iron oxide (E172)
• Propylene glycol
• Titanium dioxide (E171)
The capsules also contain the following
colourants:
30 mg, 60 mg & 120 mg – Indigo
carmine (E132)
90 mg – Erythrosine (E127)
150 mg – Erythrosine (E127) and indigo
carmine (E132)

What MXL capsules look like and the
contents of the pack
The capsules are marked MS OD
followed by the strength (e.g. 30,
60 etc).
The capsules are coloured as follows:
30 mg – light blue, 60 mg – brown,
90 mg – pink, 120 mg – olive,
150 mg – blue, 200 mg – rust.
In each box there are 28 capsules.

Marketing Authorisation Holder
and Manufacturer
The capsules are made by
Bard Pharmaceuticals Limited for the
marketing authorisation holder
Napp Pharmaceuticals Limited, both
at Cambridge Science Park,
Milton Road, Cambridge CB4 0GW,
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: MXL prolonged-release capsules
Reference number: 16950/0042
This leaflet was last revised in August 2012
MXL® capsules are protected by European Patent (UK) Nos. 0636370 and
0654263.
® MXL and the NAPP device (logo) are
Registered Trade Marks.
© 2009 - 2011 Napp Pharmaceuticals Limited

06/08/2012 12:22

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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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