Skip to Content

UK Edition. Click here for US version.

SEVREDOL TABLETS 10MG

Active substance(s): MORPHINE SULFATE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

5966-11

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
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
‘painkillers’.

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
abdomen;
• 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 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.
If you are going to have an operation,
please tell the doctor at the hospital that
you are taking these tablets.
You may experience hormonal changes
while taking these tablets. Your doctor
may want to monitor these changes.
Other medicines and Sevredol tablets
Concomitant use of opioids and
benzodiazepines increases the risk of
drowsiness, difficulties in breathing
(respiratory depression), coma and
may be life-threatening. Because of
this, concomitant use should only be
considered when other treatment options
are not possible.

However if your doctor does prescribe
benzodiazepines or related drugs
with opioids the dosage and duration
of concomitant treatment should be
limited by your doctor.
Please follow your doctor’s dosage
recommendation closely. It could be
helpful to inform friends or relatives
to be aware of sign and symptoms
stated above. Contact your doctor when
experiencing such symptoms.
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 benzodiazepines,
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;

• certain types of medicines to stop you
feeling or being sick;
• medicines used to prevent or
relieve the symptoms of an allergy
(antihistamines);
• other strong analgesics or
‘painkillers’(such as buprenorphine,
nalbuphine or pentazocine);
• rifampicin to treat tuberculosis;
• ritonavir to treat HIV;
• medicines to treat Parkinson’s disease;
• gabapentin to treat epilepsy or
neuropathic pain (pain due to nerve
problems).
Also tell your doctor if you have recently
been given a general anaesthetic.
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.
Prolonged use of morphine during
pregnancy may cause withdrawal
symptoms in newborns. Withdrawal
symptoms in babies born to mothers
who have used Sevredol tablets in
pregnancy may include high-pitched
crying, irritability and restlessness,
shaking (tremor), feeding difficulties
and sweating.

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

5966-11

Children 3 to 5 years of age
The usual dose is 5 mg every four
hours.
Children 6 to 12 years of age
The usual dose is 5 – 10 mg every
four hours.
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 sure.
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, 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
pharmacist.
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
reported
Very common (may affect more than 1
in 10 people)
• Feeling sick.
• Constipation (your doctor can
prescribe a laxative to overcome this
problem).
Common (may affect up to 1 in 10
people)
• 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.
• Generally feeling unwell, tiredness.
• Involuntary muscle contractions.
• Rash or itchy skin.
• Sweating.
Uncommon (may affect up to 1 in
100 people)
• 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 convulsions.
• Agitation, mood changes,
hallucinations, a feeling of extreme
happiness.
• 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
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.
• Absence of menstrual periods,
decreased sexual drive, impotence.
• Withdrawal symptoms (See section 3
“If you stop taking Sevredol tablets”).
• Withdrawal symptoms in babies born
to mothers who have used Sevredol
tablets 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 or search
for MHRA Yellow Card in the Google
Play or Apple App Store.
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 30°C.
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.
6. Contents of the pack and other
information
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
colourants:
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 Feburary 2018
® Sevredol, NAPP and the NAPP logo are registered trade marks.
© 2010 - 2015 Napp Pharmaceuticals Limited.

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide