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Active substance(s): MORPHINE SULPHATE

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

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Sevredol Tablets PIL
Datamatrix 5966-8
460x148mm (LSN-NAPP-02) V1 (L)

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Charlotte Grant

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

Package leaflet: Information for the user

2. Before you take Sevredol tablets

• 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
• you have recent onset liver disease;
• you are taking a type of medicine
known as a monoamine oxidase
inhibitor (examples include
tranylcypromine, phenelzine,
isocarboxazid, moclobemide and
linezolid), or you have taken this type
of medicine in the last two weeks;
• the patient is under three years of age.

Do not take Sevredol tablets if:
• you are allergic (hypersensitive)
to morphine or any of the other
ingredients of the tablets (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 tablets may
make these symptoms worse or hide
the extent of the head injury;

Take special care with Sevredol
Before treatment with these tablets tell
your doctor or pharmacist if you:
• have breathing problems, such as
impaired lung function or severe
bronchial asthma. 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;

Sevredol® 10 mg, 20 mg and 50 mg tablets
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.
In this leaflet:
1. What Sevredol tablets are and what
they are used for
2. Before you take Sevredol tablets
3. How to take Sevredol tablets
4. Possible side effects
5. How to store Sevredol tablets
6. Further information
1. What Sevredol tablets are and
what they are used for
These tablets have been prescribed for
you by your doctor to relieve severe
pain. They contain the active ingredient
morphine which belongs to a group of
medicines called strong analgesics or


• suffer from, or have ever suffered
from epilepsy, seizures, fits or
• have low blood pressure;
• have a severe heart problem after
long-term lung disease (severe cor
• 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.
If you are going to have an operation,
please tell the doctor at the hospital that
you are taking these tablets.
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 tablets
with some other medicines, the effect of
these tablets or the other medicine may
be changed.
Sevredol 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 not take…’).
Tell your doctor or pharmacist if you
are taking:
• medicines to help you sleep (for
example tranquillisers, hypnotics or
• medicines to treat psychiatric
or mental disorders (such as
• muscle relaxants;
• medicines to treat high blood
• cimetidine to treat stomach ulcers,
indigestion or heartburn;
• certain types of medicines to stop
you feeling or being sick;
• medicines used to prevent or
relieve the symptoms of an allergy
• other strong analgesics or
‘painkillers’(such as buprenorphine,
nalbuphine or pentazocine);
• rifampicin to treat tuberculosis;
• ritonavir to treat HIV;

• medicines to treat Parkinson’s
• gabapentin to treat epilepsy or
neuropathic pain (pain due to nerve
Also tell your doctor if you have
recently been given a general
Taking Sevredol tablets with alcohol
Drinking alcohol during your treatment
with these tablets may make you sleepy.
If you are affected you should avoid
drinking alcohol.
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

to some sugars, contact your doctor
before taking these tablets.
The 20 mg strength tablets contain
sunset yellow (E110) which may
cause allergic reactions.

• 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
• 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
Talk to your doctor or pharmacist if you
are not sure whether it is safe for you to
drive while taking this medicine.

Always take the tablets exactly as
your doctor has told you. The label on
your medicine will tell you how many
tablets to take and how often.
Swallow your tablets whole with a
glass of water.
You must only take the tablets by
mouth. The tablets should never be
crushed and injected as this may lead
to serious side effects, which may be

Important information about some of
the ingredients of Sevredol tablets
These tablets contain lactose which is a
form of sugar. If you have been told by
your doctor that you have an intolerance

Children 3 to 5 years of age
The usual dose is 5 mg every four

3. How to take Sevredol tablets

The usual starting dose is one tablet
every 4 hours. Your doctor will decide
how many tablets you should take.
Only the 10 mg and 20 mg strength
tablets are suitable for children.
Children should not be given the
50 mg tablets.

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

Children 6 to 12 years of age
The usual dose is 5 – 10 mg every four
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
If you take more Sevredol 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. 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 doctor.
If you forget to take Sevredol tablets
If you miss a dose you should take it as
soon as you remember and then carry on
as before. Do not take two doses within
4 hours. Do not take a double dose to
make up for a forgotten tablet.
If you stop taking Sevredol 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. 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 tablets.
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.
This medicine 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, although
uncommon, 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 tablets.

In patients treated with Sevredol tablets,
the following side effects have been
Very common (probably affecting more
than 1 in 10 people taking these tablets)
• Feeling sick.
• Constipation (your doctor can
prescribe a laxative to overcome this
Common (probably affecting between
1 in 10 and 1 in 100 people taking these
• 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).
• Drowsiness (this is most likely when
you start taking your tablets or when
your dose is increased but should
wear off after a few days).
• Dizziness, headache, confusion,
difficulty in sleeping.
• A feeling of unusual weakness.
• Involuntary muscle contractions.
• Rash or itchy skin.
• Sweating.

Uncommon (probably affecting
between 1 in 100 and 1 in 1000 people
taking these tablets)
• Indigestion, changes in taste.
• A condition where the bowel does not
work properly (ileus).
• Vertigo, (a feeling of dizziness or
‘spinning’), fainting, seizures, fits or
• Agitation, mood changes,
hallucinations, a feeling of extreme
• Unusual muscle stiffness.
• Difficulty in breathing (possibly due
to fluid on the lungs) or wheezing.
• 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 the available data):
• Unpleasant or uncomfortable mood,
abnormal thoughts.
• An increased sensitivity to pain.
• Reduction in size of the pupils in the
• 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
• Absence of menstrual periods, decreased
sexual drive, impotence.
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:
By reporting side effects you can help
provide more information on the safety of
this medicine.
5. How to store Sevredol tablets
Keep out of the reach and sight of children.
Do not use any tablets after the expiry date
which is stated on the blister and carton.
EXP 08 2010 means that you should not
take the tablets after the last day of that
month i.e. August 2010.
Do not store your tablets 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 Sevredol tablets contain
The active ingredient is morphine
sulphate. Each tablet contains 10 mg,
20 mg or 50 mg of morphine sulphate.
The other ingredients are:
• Lactose
• Pregelatinised maize starch
• Povidone
• Magnesium stearate
• Talc
• Macrogol
• Hypromellose (E464) (10 mg and
50 mg tablets only)
• Titanium dioxide (E171)
• Polyvinyl alcohol (E1203) (20 mg
tablet only)
The tablets also contain the following
10 mg – Brilliant blue (E133)
20 mg – Erythrosine (E127) and sunset
yellow (E110)
50 mg – Quinoline yellow (E104),
indigo carmine (E132) and iron
oxide (E172)

What Sevredol tablets look like and
the contents of the pack
The tablets have a score line on one
side. ‘IR’ and the strength (e.g. 10,
20 etc) are on either side of the score
line. The tablets are coloured as
follows: 10 mg - blue, 20 mg - pink,
50 mg – pale green.
In each box there are 56 tablets.

Marketing Authorisation Holder and
The tablets 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: Sevredol tablets
Reference number: 16950/0063
This leaflet was last revised in January 2014
® Sevredol, NAPP and the NAPP device (logo) are Registered
Trade Marks.
© 2010 - 2014 Napp Pharmaceuticals Limited.

07/04/2014 16:04

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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.