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MXL 60MG PROLONGED RELEASE CAPSULES

Active substance(s): MORPHINE ANHYDROUS / MORPHINE SULPHATE / MORPHINE ANHYDROUS / MORPHINE SULPHATE / MORPHINE ANHYDROUS / MORPHINE SULPHATE

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

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.

What is in this leaflet:
1. What MXL capsules are and what
they are used for
2. What you need to know before you
take MXL capsules
3. How to take MXL capsules
4. Possible side effects
5. How to store MXL capsules
6. Contents of the pack and other
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. What you need to know before
you take MXL capsules
Do not take MXL capsules if:
• you are allergic to morphine or any of
the other ingredients of the capsules
(see section 6);
• 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.
Warnings and precautions
Talk to your doctor or pharmacist before
taking these capsules 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.
• have an 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”).
Other medicines and MXL capsules
If you are taking or have recently taken
any other medicines, or might take any
other medicines please tell your doctor
or pharmacist. 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, breastfeeding and fertility
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your doctor
or pharmacist for advice before taking
this medicine.
Prolonged use of morphine during
pregnancy may cause withdrawal
symptoms in newborns. Withdrawal
symptoms in babies born to mothers
who have used MXL capsules in
pregnancy may include high-pitched
crying, irritability and restlessness,

shaking (tremor), feeding difficulties
and sweating.
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.
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.
3. How to take MXL capsules
Always take the capsules exactly as
your doctor or phamacist has told you.
The label on your medicine will tell
you how many capsules to take and
how often. Check with your doctor or
pharmacist if you are not sure.
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.

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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.
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 as you may need emergency
treatment in hospital. People who
have taken an overdose may feel very
sleepy, sick, dizzy or get pneumonia
from inhaling vomit or foreign matter
(symptoms may include breathlessness,
cough and fever). They may also
have breathing difficulties leading to
unconsciousness, or even death. 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.
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, this medicine
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). 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.
The following side effects may also
occur:
Very common side effects (May affect
more than 1 in 10 people)
• Constipation (your doctor can
prescribe a laxative to overcome this
problem).
• Feeling sick.
Common side effects (May affect up to
1 in 10 people)
• 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.
• Generally feeling unwell, tiredness.
• Involuntary muscle contractions.
• Rash or itchy skin.
• Sweating.
Uncommon side effects (may affect up
to 1 in 100 people)
• 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.
• 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.
Not known (frequency 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”).
• Withdrawal symptoms in babies
born to mothers who have used
MXL capsules in pregnancy (See
section 2 ‘Pregnancy, breastfeeding
and fertility’).
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 MXL capsules
Keep this medicine out of sight and
reach of children.
Do not use any capsules after the expiry
date which is stated on the blister and
carton. The expiry date refers to the last
day of that month.
Do not store your capsules above 25°C.
Do not take your capsules if they
are broken or crushed as this can
be dangerous and can cause serious
problems such as overdose.
Do not throw away 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
environment.

• 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)

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

6. Contents of the pack and other
information
What MXL capsules contain
The active ingredient is morphine
sulfate. Each capsule contains 30 mg,
60 mg, 90 mg, 120 mg, 150 mg or
200 mg of morphine sulfate.
The other ingredients are:
• Hydrogenated vegetable oil
• Macrogol
• Talc
• Magnesium stearate
• Gelatin
• Sodium dodecyl sulfate

What MXL capsules look like and
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 was last revised in March 2017.
MXL capsules are protected by European Patent (UK) Nos. 0636370 and 0654263.
® MXL and the NAPP logo are registered trade marks.
© 2009 - 2017 Napp Pharmaceuticals Limited.
®

Expand Transcript

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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