MXL 120MG PROLONGED RELEASE CAPSULES

Active substance: MORPHINE SULPHATE

View full screen / Print PDF » Download PDF ⇩

Transcript
7642-6

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

2. Before you take MXL capsules

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.

MXL CAPS PIL UK 7642-6 V2.indd 2

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’.

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.
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 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.

20/03/2014 12:39

7642-6

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

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. 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

MXL CAPS PIL UK 7642-6 V2.indd 3

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.
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”).
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 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.

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
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 January 2014
MXL capsules are protected by European Patent (UK) Nos. 0636370 and 0654263.
® MXL and the NAPP device (logo) are Registered Trade Marks.
© 2009 - 2014 Napp Pharmaceuticals Limited
®

20/03/2014 12:39

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
(web4)