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Auden Mckenzie

Auden Mckenzie Artwork Department

Morhine Sulphate Solution for Injection : 10mg/ml, 15mg/ml, 20mg/ml, 30ml/ml

Artwork Start Date: 10.02.2014






147 mm



MORPHINE SULPHATE 10mg/ml, 15mg/ml, 20mg/ml or 30mg/ml
Solution for Injection
(Morphine Sulphate)

Please read all of this leaflet carefully before taking your 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 is MORPHINE SULPHATE and what is it used for?
2. Before you are given MORPHINE SULPHATE
3. How you will be given MORPHINE SULPHATE
4. Possible side effects
6. Further information

and what is it used for?
MORPHINE SULPHATE Injection belongs to a group
of medicines called narcotic analgesics which help
relieve severe pain.

2. Before you are given MORPHINE
• 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 weak
• 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
• You have a type of adrenal gland tumour
called phaeochromocytoma
• You are at risk of having a blocked intestine
(paralytic ileus)
• You have a sudden onset of diarrhoea caused by
food poisoning or an infection
• 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 pharmacist.
Special Precautions
Your doctor may take special precautions when
giving you MORPHINE SULPHATE if any of the
points listed below applies to you:
• You have low blood pressure (hypotension)
• You have a disease that causes difficulty in
breathing such as asthma, emphysema,
cor pulmonale (high blood pressure causing
failure of the right side of the heart), abnormal
spinal shape and excessive obesity
• You have an under-active thyroid (hypothyroidism)
or adrenal gland (adrenocortical insufficiency)
• You have liver or kidney disease
• You have an inflammatory or obstructive bowel
disease such as Crohn’s disease or ulcerative
• You are in circulatory collapse (shock)
• 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 pharmacist.

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. atropine
• 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 pharmacist.
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
Morphine may reduce contractions during labour,
cause breathing problems to the infant foetus or new
born baby and affect the heart rate of the foetus.
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
The 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 if this medicine affects your
ability to drive.
• However, you would not be committing an offence if:
• 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 or in the information
provided with the medicine and
• It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure
whether it is safe for you to drive while taking this
Taking with food and drink
Taking MORPHINE SULPHATE Injection with alcohol
may cause increased sedation.
Warnings about the ingredients:
MORPHINE SULPHATE Injection contains 0.24 mg of
sodium per ml and may therefore not be suitable your
Tell for
you if you are on a controlled sodium diet.
doctor or pharmacist 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.

147 mm

3. How you will be given MORPHINE
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 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.
As this medicine can make breathing difficult, your
doctor or nurse may reduce the dose of your
MORPHINE SULPHATE Injection is not for use in

• Facial flushing (warmth and redness of the
• Restlessness
• Fits (convulsions)
• Increased sensitivity to pain
• Tiredness (fatigue)
• Stopping the drug can lead to withdrawal
symptoms such as agitation, anxiety, shaking
or sweating. This can also happen to babies
born to mothers addicted to morphine.
• Pain and irritation may occur at the site of the

Information for the Healthcare Professional
(Please detach prior to giving the leaflet to the patient)

(Morphine Sulphate)

Morphine Sulphate 10 mg/ml Solution for Injection.
Morphine Sulphate 15 mg/ml Solution for Injection.
Morphine Sulphate 20 mg/ml Solution for Injection.
Morphine Sulphate 30 mg/ml Solution for Injection.
10 mg: Each ml of Morphine Sulphate solution for
injection contains 10 mg morphine sulphate.
15 mg: Each ml of Morphine Sulphate solution for
injection contains 15 mg morphine sulphate.

Other possible side effects
• Muscle stiffness with high doses
• Pain, generally on the skin, caused by
something that would not normally cause pain
such as light touch or pressure
• Coma
• Kidney failure

20 mg: Each ml of Morphine Sulphate solution for
injection contains 20 mg morphine sulphate.
30 mg: Each ml of Morphine Sulphate solution for
injection contains 30 mg morphine sulphate.
Also contains 1.1 mg of sodium metabisulphite
(E223) in each ml of Morphine Sulphate solution for

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 pharmacist.

Symptoms of serious overdose include
breathing difficulties, low blood pressure
(hypotension) with your heart finding it difficult to
pump blood around your body (circulatory failure), a
deepening coma, feeling cold (hypothermia), fits
(convulsions) especially in infants and children and
rapid break down of muscle tissue (characterised
by dark coloured urine and muscle tenderness,
stiffness or aching) progressing to kidney failure.

Keep out of the reach and sight of children.

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 on the use of this
product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines MORPHINE SULPHATE Injection
can cause side effects, although not everybody gets
Seek immediate medical help if you have any of
the following symptoms:
• Breathing difficulties (respiratory depression)
• Low blood pressure (hypotension) which may
make you feel faint
• Your heart finding it difficult to pump blood
around your body (circulatory failure) causing
faintness, breathing difficulties, coughing up
blood, excessive sweating and/or pale skin
• Allergic reactions causing:
† Swelling of hands, feet, lips, mouth, tongue
or throat
† Difficulties breathing
† Itchy skin rash (hives)
• Stomach pains, bloating, vomiting and
constipation (obstructive bowel disorder)
The other side effects which have been reported
Very Common (more than 1 in 10 patients)
• Seeing or hearing things that are not there
• Morphine is an addictive substance and its use
can result in dependence
• Drowsiness and confusion
• Feeling (nausea) or being sick (vomiting)
• Constipation
• Sweating
• The drug no longer having the same effect as it
use to (drug tolerance)
Common (in less than 1 in 10, but more than 1 in
100 patients)
• Changes in your heart beat, such as slowing
(bradycardia) or quickening (tachycardia) of the
heart beat
• Low body temperature (hypothermia)
• Raised pressure in the skull (increased
intracranial pressure)
• Abdominal pain (biliary spasms)
• Constriction of the pupil (miosis)
• Blurred vision
• Involuntary eye movements (nystagmus)
• A feeling of dizziness or “spinning”(vertigo)
• Dizziness/light headedness on standing
(orthostatic hypotension)
• Difficulty passing urine
• Headaches
• Changes of mood
• Decreased libido (interest in sex) or inability to
get an erection
• Dry mouth

For a full list of excipients, see section 6.1.


Solution for injection.
A clear colourless solution.

Do not use MORPHINE SULPHATE Injection after
the expiry date on the carton or the ampoule. The
expiry date refers to the last day of that month.


Keep the ampoule in the outer carton in order to
protect from light. Do not refrigerate or freeze.
Do not use the medicine if the solution is not clear
and colourless.

6. Further Information
The active substance is MORPHINE SULPHATE 10
mg, 15 mg, 20 mg or 30 mg in each 1ml of solution.
The solution for injection also contains sodium
metabisulphite (E223), water for injections, sodium
hydroxide and sulphuric acid.
What MORPHINE SULPHATE looks like and
contents of the pack:
MORPHINE SULPHATE Injection is a sterile solution
for injection in a clear glass container called an
ampoule. It is a clear colourless solution.
MORPHINE SULPHATE Injection is supplied in
cartons of 5 or 10 ampoules containing either
10 mg/ml, 15 mg/ml, 20 mg/ml, 30 mg/ml and
60 mg/2 ml.
Not all pack sizes may be marketed.
Marketing authorisation holder:
Auden Mckenzie (Pharma Division) Ltd.,
Mckenzie House, Bury Street, Ruislip,
Middlesex, HA4 7TL, UK
SNS Pharmaceuticals Ltd., Mckenzie House,
Bury Street, Ruislip, Middlesex, HA4 7TL, UK
This leaflet was last revised in February 2014.
For information in large print, on tape, on CD or
in Braille, phone +44 (0) 1895 627 420.

147 mm
Morphine may cause the following adverse events:

MORPHINE SULPHATE 10mg/ml, 15mg/ml, 20mg/ml
or 30mg/ml Solution for Injection

Uncommon (in less than 1 in 100, but more than
1 in 1000 patients)
• Being aware that your heart is beating or the
rate has changed (palpitations)
• Abdominal pain (urethral spasms)
• An increase in liver enzymes may be noted
during blood tests

If you think you have been given more Morphine
Sulphate than you should:
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.

v2 12.02.2014

147 mm


What is MORPHINE SULPHATE used for?
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

Taking other medicines
Always tell your doctor if you are taking any other
medicines because taking some medicines together
can be harmful. Remember that the doctor at the
hospital may not have been informed if you have
recently begun a course of treatment for another
• 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.


For Drug Driving Variation

4.1 Therapeutic indications
Morphine is used for the symptomatic relief of
severe pain; relief of dyspnoea of left ventricular
failure and pulmonary oedema; pre-operative use.
4.2 Posology and method of administration
The injection may be given by the intravenous,
intramuscular or subcutaneous route.
Adults: The dosage should be based on the
severity of the pain and the response and tolerance
of the patient. The usual adult subcutaneous or
intramuscular dose is 10mg every 4 hours if
necessary, but may range from 5mg to 20mg.
The usual adult intravenous dose is 2.5mg to 15mg
not more than 4 hourly, where necessary, but
dosage and dosing interval must be titrated against
the patient's response and adjustments made until
analgesia is achieved.
Elderly: Because of the depressant effect on
respiration, caution is necessary when giving
morphine to the elderly and reduced doses may be
Children: Use in children is not recommended.
4.3 Contraindications
Respiratory depression, obstructive airways
disease, concurrent treatment with monoamine
oxidase inhibitors or within two weeks of their
discontinuation of treatment with them.
Known morphine sensitivity, or sensitivity to any of
the ingredients. Cerebral oedema, head injuries,
coma, convulsive disorders and raised intracranial
pressure, biliary colic and acute alcoholism.
Administration of morphine is contra-indicated in
patients with phaeochromocytoma , those at risk of
paralytic ileus and in patients with acute diarrhoea
caused by poisoning or invasive pathogens.
4.4 Special warnings and special precautions for
Morphine is a potent medicine but with considerable
potential for harmful effect, including addiction. It
should be used only if other drugs with fewer
hazards are inadequate, and with the recognition
that it may possibly mask significant manifestations
of disease which should be identified for proper
diagnosis and treatment. It should be used with
special caution in patients with a history of drug
abuse. Dependence may occur after 1-2 weeks of
Morphine should be given with caution where there
is a reduced respiratory reserve as in emphysema
and asthma, chronic cor pulmonale, kyphoscoliosis
and excessive obesity. Opiates should also be used
cautiously in patients with cardiac arrhythmias,
myasthenia gravis or inflammatory or obstructive
bowel disorders.
Morphine should be administered with caution or in
reduced doses to patients with hypotension,
hypothyroidism, adrenocortical insufficiency,
impaired kidney or liver function, prostatic
hypertrophy, urethral stricture or shock.
Morphine should be given with great care to
infants, especially neonates. Dosage should be
reduced in elderly and debilitated patients.

Disappearance of opioid analgesic effects,
particularly when associated with an unexplained
increase in pain, may indicate the development of
tolerance or opioid-induced hyperalgesia.
An unexplained increase in abdominal pain
associated with disturbed intestinal motility,
symptoms of constipation, bloating, abdominal
distension and increased gastroesophageal reflux
during treatment with morphine sulphate, may
indicate the development of opioid-induced bowel
dysfunction or narcotic bowel syndrome. In such
situations consider the use of alternative analge
sics and a morphine detoxification.

4.5 Interaction with other medicinal products
and other forms of interaction
Concurrent administration of other CNS depres
sants, including hypnotics and anxiolytics, may
potentiate the sedative effects.
Morphine should not be administered to patients
receiving monoamine oxidase inhibitors (see
section 4.3).
Anticholinergic agents such as atropine antagonise
morphine-induced respiratory depression and can
partially reverse biliary spasm but are additive to
the gastro-intestinal and urinary tract effects.
Consequently, severe constipation and urinary
retention may occur during intensive
anticholinergic-analgesic therapy.
Morphine sulphate should not be used for
premedication when ciprofloxacin is given for
surgical prophylaxis as serum levels of ciprofloxa
cin are reduced and adequate cover may not be
obtained during surgery.
Taking alcohol with morphine sulphate can cause
enhanced sedative and hypertensive effects.
4.6 Pregnancy and lactation
Pregnancy: Since morphine rapidly crosses the
placental barrier, it is not advised to administer
morphine during pregnancy and labour. It may
reduce uterine contractions, cause respiratory
depression in the foetus and new born infant, and
may have significant effects on foetal heart rate.
Lactation: The amount of morphine secreted in
breast milk after a single-dose administration
seems to be compatible with breast feeding and
insufficient to cause major problems or depend
ence. However long-term treatment with morphine
in high doses may cause significant plasma
concentration. That is why caution is advised on
the use of morphine in breast-feeding patient and
the benefit must outweigh the risk to the infant. If
breast feeding is continued, the infant should be
observed for possible adverse effects.
4.7 Effects on ability to drive and use machines
Morphine may cause drowsiness. If this occurs the
patient should not be allowed to drive or operate
This medicine can impair cognitive function and
can affect a patient’s ability to drive safely. This
class of medicine is in the list of drugs included in
regulations under 5a of the Road Traffic Act 1988.
When prescribing this medicine, patients should
be told:
• The medicine is likely to affect your ability to drive
• Do not drive until you know how the medicine
affects you
• It is an offence to drive while under the influence
of this medicine
• However, you would not be committing an
offence (called ‘statutory defence’) if:
• 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 and
• It was not affecting your ability to drive safely.
4.8 Undesirable effects
In routine clinical practice, the commonest side
effects of morphine sulphate are nausea, vomiting,
constipation, drowsiness and confusion.
If constipation occurs, this may be treated with
appropriate laxatives.
Adverse effects can be listed in terms of their
frequency of occurrence:
- Very common (≥1/10)
- Common (≥1/100 to <1/10)
- Uncommon (≥1/1,000 to <1/100)
- Not known (cannot be estimated from the
available data)

Common: Convulsion,
headache, increased intracranial
pressure, myoclonus,
opioid-induced hyperalgesia
(or hyperaesthesia), vertigo
Not Known: Allodynia, coma


Very Common: Confusional
state, hallucinations, physical
and psychological dependence
Common: Decreased libido,
mood swings, restlessness

Eye disorders
thoracic and

Morphine Sulphate Injection contains sodium
metabisulphite (E223). This may rarely cause
severe hypersensitivity reactions and bronchospasm.
Morphine Sulphate Injection contains 0.24 mg
of sodium per ml. This should be taken into
consideration for patients on a controlled sodium diet.

Very Common: Drowsiness

Common: Blurred vision, miosis,
Very Common: Respiratory
Common: Bronchospasm,
pulmonary oedema, which can
lead to death
Not Known: Respiratory failure,
which also can lead to death


Common: Bradycardia,
circulatory failure, tachycardia
Uncommon: Palpitations


Common: Hypotension,
orthostatic hypotension


Very Common: Constipation,
nausea, vomiting
Common: Dry mouth, paralytic
Not Known: Intestinal functional
disorder, narcotic bowel


Common: Biliary spasm
Uncommon: Hepatic enzyme
Not Known: Spasm of the
sphincter of Oddi,

system and
breast disorders

Common: Erectile dysfunction

Renal and

Common: Urinary retention
Uncommon: Urethral spasm
Not Known: Renal failure

Immune system

Uncommon: Anaphylactic
reaction, hypersensitivity

and connective
tissue disorders

Not Known: Muscle rigidity,

Skin and
tissue disorders

Very Common: Pruritis

disorders and
site conditions

Very Common: Drug tolerance,

Common: Angioedema, contact
dermatitis, rash, urticaria

Common: Fatigue, facial
flushing, hypothermia, injection
site pain, injection site irritation,
withdrawal syndrome (babies
born to opioid-dependent
mothers are also at risk to
present withdrawal syndrome).

4.9 Overdose
Symptoms: respiratory depression, pin-point pupils
and coma. In addition, shock, reduced body
temperature and hypotension may occur. In mild
overdose, symptoms include nausea and vomiting,
tremor, miosis, dysphoria, hypothermia, hypoten
sion, confusion and sedation. In cases of severe
poisoning, hypotension with circulatory failure,
rhabdomyolosis progressing to renal failure,
respiratory collapse and death may occur.
Treatment: the patient must be given respiratory
support and the specific antagonist, naloxone,
should be administered at a dose of 0.4-2.0 mg
intravenously. This dose should be repeated at 2-3
minute intervals if improvement is not achieved, up
to a total of 10 mg. Fluid and electrolyte levels
should be maintained.
5.1 Pharmacodynamic properties
Morphine is a narcotic analgesic obtained from
opium, which acts mainly on the central nervous
system and smooth muscle.
5.2 Pharmacokinetic properties
Absorption: Variably absorbed after oral administra
tion; rapidly absorbed after subcutaneous or
intramuscular administration.
Blood concentration: After an oral dose of 10mg as
the sulphate, peak serum concentrations of free

morphine of about 10ng/ml are attained in 15 to 60
minutes; after an intramuscular dose of 10mg, peak
serum concentrations of 70 to 80ng/ml are attained
in 10 to 20 minutes; after an intravenous dose of
10mg, serum concentrations of about 60ng/ml are
obtained in 15 minutes falling to 30ng/ml after 30
minutes and to 10ng/ml after 3 hours; subcutaneous
doses give similar concentrations to intramuscular
doses at 15 minutes but remain slightly higher
during the following 3 hours; serum concentrations
measured soon after administration correlate closely
with the ages of the subjects studied and are
increased in the aged.
Half life: Serum half life in the period 10 minutes to
6 hours following intravenous administration, 2 to 3
hours; serum half life in the period 6 hours onwards,
10 to 44 hours.
Distribution: Widely distributed throughout the body,
mainly in the kidneys, liver, lungs and spleen; lower
concentrations appear in the brain and muscles;
morphine crosses the placenta and traces are
secreted in sweat and milk; protein binding, about
35% bound to albumin and to immunoglobulins at
concentrations within the therapeutic range.
Metabolic reactions: Mainly glucuronic acid
conjugation to form morphine-3 and
6-glucuronides, with sulphate conjugation.
N-demethylation, 0-methylation and N-oxide
glucuronide formation occurs in the intestinal
mucosa and liver; N-demethylation occurs to a
greater extent after oral than parenteral administra tion; the 0-methylation pathway to form codeine has
been challenged and codeine and norcodeine
metabolites in urine may be formed from codeine
impurities in the morphine sample studied.
Excretion: After an oral dose, about 60% is excreted
in the urine in 24 hours, with about 3% excreted as
free morphine in 48 hours; after parenteral dose,
about 90% is excreted in 24 hours, with about 10%
as free morphine, 65 to 70% as conjugated
morphine, 1% as normorphine and 3% as normor
phine glucuronide; after administration of large
doses to addicts about 0.1% of a dose is excreted as
norcodeine; urinary excretion of morphine appears to
be pH dependent to some extent: as the urine
becomes more acid more free morphine is excreted
and as the urine becomes more alkaline more of the
glucuronide conjugate is excreted; up to 10% of a
dose may be excreted in the bile.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the
prescriber, which are additional to those included in
other sections.
6.1 List of excipients
Sodium metabisulphite (E223)
Water for injections
Sodium hydroxide (for pH adjustment)
Sulphuric acid (for pH adjustment)
6.2 Incompatibilities
Morphine salts may be precipitated in alkaline
In the absence of compatibility studies, this
medicinal product must not be mixed with other
medicinal products.
6.3 Shelf life
20 months
6.4 Special precautions for storage
Keep the ampoule in its outer carton to protect from
light. Do not refrigerate or freeze.
6.5 Nature and contents of container
10/15/20 mg/ml: Type I Ph Eur clear glass ampoules
containing 1 ml.
30 mg/ml: Type I Ph Eur clear glass ampoules
containing 1 ml and 2ml.
5 or 10 ampoules per carton.
6.6 Special precautions for disposal and other
Any unused product or waste material should be
disposed of in accordance with local requirements.
Auden Mckenzie (Pharma Division) Ltd.,
Mckenzie House, Bury Street,
Ruislip, Middlesex, HA4 7TL, UK
10 mg/ml: PL 17507/0010
15 mg/ml: PL 17507/0011
20 mg/ml: PL 17507/0012
30 mg/ml: PL 17507/0013
Legal category POM
Auden Mckenzie (Pharma Division) Ltd


Auden Mckenzie

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