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Active substance(s): MORPHINE SULPHATE

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Patient Information Leaflet Morphine Sulphate Injection BP
10 mg/ml, 15 mg/ml or 30 mg/ml. Solution for Injection Morphine Sulphate

Read all of this leaflet carefully before
you are given this medicine.
• Keep this leaflet. You may need to
read it again.
• If you have any further questions, ask
your doctor or nurse
• 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.
• In this leaflet, Morphine Sulphate
Injection BP 10 mg/ml, 15 mg/ml or
30 mg/ml Solution for Injection will
be called Morphine Sulphate
In this leaflet:
1. What Morphine Sulphate Injection is
2. Before you are given Morphine
Sulphate Injection
3. How Morphine Sulphate Injection
will be given to you
4. Possible side effects
5. How to store Morphine Sulphate
6 Further information.

1. What Morphine Sulphate
Injection is for

Morphine Sulphate Injection belongs to
a group of medicines called narcotic
analgesics which help relieve severe pain.
Morphine Sulphate Injection is for the
treatment of severe pain, to help with
breathing which becomes difficult
because fluid has collected in the lungs
(pulmonary oedema) due to heart
failure. It can also be given prior to
having an operation.

2. Before you are given
Morphine Sulphate Injection
You must not be given Morphine
Sulphate Injection if:
• You are allergic to morphine sulphate
• You are allergic to any of the other
ingredients of Morphine Sulphate
Injection (see section 6)
• You have conditions that make
breathing difficult, such as obstructive
airways disease, or your breathing is
• You are taking, or have recently taken
(in the past two weeks) any drugs for
depression known as Monoamine
Oxidase Inhibitors (MAOIs) e.g.

• You have head injuries, headaches or
have increased pressure in the skull
(raised intracranial pressure)
• You have problems related to fluid on
the brain (cerebral oedema)
• You suffer from convulsions (fits)
• You have severe stomach cramps
(biliary colic)
• You have been drinking heavily or
suffer from alcoholism
• You have a type of adrenal gland
cancer called phaeochromocytoma
• You are at risk of having a blocked
intestine (paralytic ileus)
• You have diarrhoea caused by
poisoning or infection
• You are taking an antibiotic called
• You are pregnant or breast feeding
• You are a child.
Morphine sulphate is never given to
patients in a coma.
If any of the above applies to you, do
not use this medicine and talk to your
doctor or nurse.

Check with your doctor before you are
given Morphine Sulphate Injection if:
• You have low blood pressure
• You have an abnormally curved spine
• You are excessively over weight
• You have poor blood supply to the
heart muscle or other heart problems
• You have asthma or other breathing
problems such as emphysema
• You have sleep apnoea where your
breathing is interrupted during sleep
• You have an under-active thyroid
(hypothyroidism) or adrenal gland
(adrenocortical insufficiency)
• You have liver or kidney disease
• You have a inflammatory or
obstructive bowel disease such as
Crohn’s disease or ulcerative colitis
• You are in circulatory collapse (shock)
• You have difficulty passing water due
to a narrowing of the tube that urine
flows through from the bladder
(urethral stricture)
• You are male and have an enlarged
prostate or have difficulty passing
water (prostatic hypertrophy)

• You have muscle weakness
(myasthenia gravis)
• You have a tendency to abuse drugs
or have ever suffered from drug abuse
• You are on a controlled sodium diet
• You are elderly.
If any of the above applies to you talk
to your doctor or nurse.
Taking other medicines
• You must not be given Morphine
Sulphate Injection if you are taking,
or have recently taken (in the past
two weeks) any drugs for depression
known as Monoamine Oxidase
Inhibitors (MAOIs), e.g. phenelzine
Tell your doctor if you are taking any
of the following medicines:
• Drugs to help you sleep or reduce your
anxiety (hypnotics and anxiolytics)
e.g. diazepam
• Anticholinergic drugs to relax smooth
muscle and regulate the heart rate e.g.
• An antibiotic called ciprofloxacin
• Any other medicine, including medicines
obtained without a prescription.
If any of the above applies to you talk
to your doctor or nurse.

Pregnancy and breast-feeding
If you are pregnant, in labour or
breastfeeding, Morphine Sulphate
Injection will only be given to you if
your doctor considers the benefit of
treatment outweighs the risk to the
infant foetus or new born baby.
If you are breastfeeding, your doctor or
nurse will observe your baby for any
side effects.
Driving and using machines
Morphine Sulphate Injection may cause
drowsiness. If this happens to you, do
not drive or use machinery.
Warnings about the ingredients
Morphine Sulphate Injection contains
0.24 mg of sodium per ml and may
therefore not be suitable for you if you
are on a controlled sodium diet. Tell
your doctor or nurse before you are
given Morphine Sulphate Injection if
this applies to you.
Morphine Sulphate Injection contains
sodium metabisulphite (E223) which
may rarely cause severe allergic
reactions and bronchospasm which can
lead to difficulty in breathing.

3. How Morphine Sulphate
Injection will be given to you
Morphine Sulphate Injection will be given
to you by a doctor or nurse in hospital.
Your doctor will choose the dose that is
right for you.
• If this medicine is injected into a muscle
or under the skin, the usual dose is 10
mg/ml every 4 hours.
• However, the amount may range from 5
mg to 20 mg depending on how severe
your pain is and how you respond to
the drug.
• If the drug is injected into a vein, the
usual dose for an adult is 2.5 mg to 15
mg with at least 4 hours between doses.
• Your doctor or nurse may adjust the
dose of your medicine and the number
of injections you are given each day
until your pain is relieved.
Because this medicine can make breathing
difficult, your doctor or nurse may reduce
the dose of your medicine.
Morphine Sulphate Injection is not for
use in children.

If you think you have been given more
Morphine Sulphate Injection than you
As this medicine will be given to you
whilst you are in hospital, it is unlikely
that you will be given too little or too
much, however, tell your doctor or nurse
if you have any concerns.
Symptoms of serious overdose include
breathing difficulties, low blood pressure
with your heart finding it difficult to
pump blood around your body, a
deepening coma, feeling cold, fits
especially in infants and children and
rapid break down of muscle tissue
progressing to kidney failure.
If you have these symptoms, you will be
given another medicine called Naloxone
to reverse the effects of Morphine
Sulphate Injection.
If you have any further questions about
the use of this medicine, ask your doctor
or nurse.

4. Possible side effects

Like all medicines Morphine Sulphate
Injection can cause side effects, although
not everybody gets them.
Seek immediate medical help if you have
any of the following symptoms:
• Breathing difficulties
• Low blood pressure which may make
you feel faint
• Your heart finding it difficult to pump
blood around your body
• Allergic reactions causing:
- Swelling of hands, feet, lips, mouth,
tongue or throat
- Difficulties breathing
- Itchy skin rash
- Diarrhoea or stomach pains.
The other side effects which have been
reported are:
• Morphine is an addictive substance and
its use can result in dependence,
tolerance (reduced effect) and
withdrawal symptoms (including
moodiness and sleep disturbance)
• Changes in your heart beat, such as
slowing or quickening of the heart beat.
Also being aware that your heart is
beating or the rate has changed.
• Low body temperature
• Raised pressure in the skull
• Seeing or hearing things that are not there

• Abdominal pain
• Very sensitive skin where you feel pain
from a light touch
• Constriction of the pupil
• Blurred vision or uncontrolled eye
• A feeling of dizziness or “spinning”
• Head rush or dizzy spell
• Drowsiness and confusion
• An increase in liver enzymes
• Muscle twitching or rigidity with high
• Feeling sick or being sick
• Difficulty passing urine
• Headaches
• Constipation
• Changes of mood
• Decreased interest in sex or impotence
• Dry mouth
• Sweating
• Facial flushing (warmth and redness of
the skin)
• Restlessness or fatigue
• Fits
• Rapid breakdown of muscle tissue
• Pain and irritation may occur at the site
of the injection.
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or nurse.

5. How to store Morphine
Sulphate Injection
Keep out of the reach and sight of children.
Do not use Morphine Sulphate Injection
after the expiry date on the carton. The
expiry date refers to the last day of that
Do not store above 25°C. Keep the
ampoule in the outer carton to protect
from light.
Your doctor or nurse will make sure your
medicine is correctly stored and disposed of.

Morphine Sulphate Injection comes in
cartons of 5 or 10 ampoules containing
either 10 mg/ml, 15 mg/ml, 30 mg/ml
and 60 mg/2 ml. Morphine Sulphate
Injection also comes in ampoules attached
to an adhesive vinyl label packed in
cartons of 5 or 10 ampoules containing
10 mg/ml, 15 mg/ml or 300 mg/10ml
packed in a carton of 1 ampoule. Not all
pack sizes may be marketed.
Marketing Authorisation Holder
Bristol Laboratories Ltd.,
Unit 3, Canalside, Northbridge Road,

6. Further information

Berkhamsted, Hertfordshire,

What Morphine Sulphate Injection contains
The active substance is morphine sulphate
10 mg, 15 mg or 30 mg in each 1ml of
The other ingredients are sodium
metabisulphite (E223), sodium hydroxide,
sulphuric acid and water for injections.

HP4 1EG, United Kingdom

What Morphine Sulphate Injection looks like
Morphine Sulphate Injection is a sterile
solution for injection in a clear glass
container called an ampoule.

Recipharm Limited, Vale of Bardsley
Ashton-under-Lyne, OL7 9RR, UK
This leaflet was last updated 03/2016

If this leaflet is difficult to see or
read or you would like it in a
different format, please contact
Bristol Laboratories Ltd..

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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.