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


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

SEVREDOL TABS PIL UK 5966-10 V2.indd 1

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12/01/2017 16:20


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

Package leaflet: Information for the user
Sevredol® 10 mg, 20 mg and 50 mg tablets
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.
In this leaflet:
1. What Sevredol tablets are and what
they are used for
2. What you need to know before you
take Sevredol tablets
3. How to take Sevredol tablets
4. Possible side effects
5. How to store Sevredol tablets
6. Contents of the pack and other

SEVREDOL TABS PIL UK 5966-10 V2.indd 2

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

2. What you need to know before
you take Sevredol tablets
Do not take Sevredol tablets if:
• you are allergic to morphine or any
of the other ingredients of the tablets
(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 tablets 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
• 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.

Warnings and precautions
Tell your doctor or pharmacist before
taking these tablets 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;
• 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.
Other medicines and Sevredol tablets
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
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
• 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 here:
Talk to your doctor or pharmacist if
you are not sure whether it is safe
for you to drive while taking this
Sevredol tablets contain lactose and
sunset yellow (E110)
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
The 20 mg tablets contain sunset
yellow (E110) which may cause
allergic reactions.
3. How to take Sevredol tablets
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

12/01/2017 16:20


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

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
Children 3 to 5 years of age
The usual dose is 5 mg every four
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 as you may need emergency
treatment in a 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,

SEVREDOL TABS PIL UK 5966-10 V2.indd 3

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 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). Tell
you 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.
In patients treated with Sevredol tablets,
the following side effects have been
Very common (may affect more than 1
in 10 people)
• Feeling sick.
• Constipation (your doctor can
prescribe a laxative to overcome this

Common (may affect up to 1 in 10
• 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 (may affect up to 1 in 100
• 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 not known (Frequency
cannot be estimated from the available
• 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 pancreas.
• 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 this medicine out of the sight and
reach of children.
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 30oC.
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
6. Contents of the pack and other
What Sevredol tablets contain
The active ingredient is morphine
sulfate. Each tablet contains 10 mg,
20 mg or 50 mg of morphine sulfate.
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.

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
Marketing Authorisation Holder and Manufacturer
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 was last revised in November 2016
® Sevredol, NAPP and the NAPP logo are registered trade marks.
© 2010 - 2015 Napp Pharmaceuticals Limited.

12/01/2017 16:20

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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.