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MORPHINE SULFATE 1 MG PER ML SOLUTION FOR INJECTION

Active substance(s): MORPHINE SULFATE

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hameln
Package leaflet: Information for the patient
Morphine Sulfate 1 mg per ml solution for injection
Morphine sulfate

Important information about your medicine
Your doctor or nurse will give you the injection.
► If this injection causes you any problems talk to your doctor, nurse or pharmacist.
► Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to
any of the ingredients of this medicine.
► Please tell your doctor or pharmacist, if you are taking any other medicines.


Read all of this leaflet carefully before you start using 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 your 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 nurse. This includes any possible side effects not
listed in this leaflet. See section 4.



The name of your medicine is Morphine Sulfate 1 mg per ml solution for injection, which will
be referred to as Morphine Injection throughout this leaflet.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Morphine Injection is and what it is used for
What you need to know before you use Morphine Injection
How to use Morphine Injection
Possible side effects
How to store Morphine Injection
Contents of the pack and other information

1. What Morphine Injection is and what it
is used for
Morphine Injection belongs to a group of medicines
known as painkillers (opiate analgesics) which
must be used only under a doctor’s instruction.
Morphine Injection is used to relieve moderate to
severe pain often caused by surgery, heart attack
or cancer. Morphine also helps to reduce the
anxiety and sleeplessness which may be caused
by the pain.

2. What you need to know before you
use Morphine Injection
Do not use Morphine Injection if you:

• are allergic to morphine sulfate or any of the
other ingredients in this medicine (listed in
section 6)
• have a breathing disorder
• have a head injury or raised pressure around
your brain
• have a convulsive disorder (epilepsy) or suffer
from fits (seizures)
• have acute alcohol poisoning (intoxication)
• suffer from liver failure or kidney impairment
• suffer from biliary and renal tract spasm
• have an inflammation of your bowel or a bowel
obstruction
• have Phaeochromocytoma (a tumour of the
adrenal gland)
• are taking any of the anti-depressant medicines
known as monoamine oxidase inhibitors
(MAOIs) or have taken them during the last two
weeks
• are unconscious (coma)
• are at risk of a paralytic ileus (reduced gut
motility)

Warnings and precautions

Talk to your doctor or nurse before using Morphine
Injection, if you:
• have low blood pressure
• have an under-active thyroid gland
• have asthma or other breathing difficulties
• have kidney or liver disorders
• suffer from an enlarged prostate gland
• suffer from decreased secretion of hormones
• have diabetes
• suffer from severe heart disease
• have irregular heart beat
• suffer from shock
• had a total joint arthroplasty
• have a adrenocortical insufficiency
• have diseases of the biliary tract
• have myasthenia gravis
• are pregnant or breast-feeding
• have stomach or bowel problems
• suffer from bad headaches or feel sick
• are elderly and/or debilitated

Children

This medicine is not recommended for use in
children under 12 years of age.

Other medicines and Morphine Injection

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
This is especially important with the following
medicines as they may interact with your
Morphine Injection:
• monoamine oxidase inhibitors – MAOIs
(medicines used for depression) or if you have
taken them during the last two weeks
• medicines that depress the nervous system
(your doctor or pharmacist will know what these
are)
• other painkillers – especially pentazocine,
nalbuphine, or buprenorphine
• muscle relaxants
• diuretics (water tablets) - medicines that
increase urine excretion
• cimetidine – an anti-ulcer treatment
• disulfiram – a medication to treat chronic
alcoholism
• antiarrhythmics - medicines to control heart
rhythm or rate (e.g. mexiletine)
• ritonavir – a medicine to treat AIDS
• ciprofloxacin – an antibiotic
• medicines used to treat depression
• medicines used to treat anxiety
• medicines to help you sleep

• medicines for treatment of digestive tract
disorders (e.g. cisapride)
• medicines used for Parkinson’s Disease
(selegiline)
• medicines used to treat vomiting or indigestion
(e.g. domperidone or metoclopramide)
• anticholinergics (e.g. hyoscine)

Morphine Injection and alcohol
Alcohol should be avoided during treatment with
this medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before using this
medicine. This injection should not be used in
pregnant or breast-feeding women

Driving and using machines

You must not drive or use machinery while
receiving Morphine Injection.
The medicine can affect your ability to drive as it
may make you sleepy or dizzy.
• Do not drive while using 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 used 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

Morphine
chloride

Injection

contains

sodium

This medicine contains 35 mg sodium per
ampoule (3.5 mg/ml).
This should be taken into consideration by
patients on a controlled sodium diet.

3. How to use Morphine Injection
Your nurse or doctor will give you the injection.
Your doctor will decide the correct dosage for you
and how and when the injection will be given.
Morphine Injection is a solution for injection that
has been prepared in water so that it can be used
with specially designed pumps which provide a
continuous injection into the body.
There is a procedure called Patient Controlled
Analgesia (PCA) where you would be provided
with a button to press when you are in pain and
the machine would then give you a small amount
of Morphine Injection. There will be a safety
device on the machine so that you cannot exceed
the maximum number of doses.
Let your doctor or nurse know if your pain gets
worse while you are using Morphine Injection.
Your doctor may want to increase your dose of the
medicine and/or give you some extra medicines
for the pain.

If you use more Morphine Injection than
you should

Since the injection will be given to you by a doctor
or nurse, it is unlikely that you will be given too
much. If you think you have been given too much,
tell your doctor or nurse.
Tell your doctor or nurse immediately if any of the
following symptoms of overdose occur:
• shallow breathing
• blue skin
• contraction of the pupils
• feeling extremely sleepy
• muscle weakness
• cold and clammy skin
• very slow heart rhythm
• fall in blood pressure

If you stop using Morphine Injection

This medicine may cause dependence with
long-term use. If your treatment is stopped
too quickly then withdrawal symptoms may
occur. Please tell your doctor or nurse if you think
this is happening to you. However, when the dose
of Morphine injection is carefully adjusted to
control pain, dependence and other side effects
are rare.
If you have any further questions on the use of

--------------------------------------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:
PREPARATION GUIDE:

hameln

Morphine Sulfate 1 mg per ml solution for injection
Please refer to the Summary of Product
Characteristics for full prescribing and other
information.
Therapeutic indications
Morphine sulfate injection is indicated for the relief
of moderate to severe pain. Morphine sulfate
injection is used especially in pain associated
with cancer, myocardial infarction and surgery.
Morphine also helps to relieve the anxiety and
insomnia which may be associated with severe
pain.

Administration
For intravenous injection.
Dilution
The product should not be diluted before use.
(Continued overleaf)

this medicine, ask your doctor or nurse.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
All medicines can cause allergic reactions,
although serious allergic reactions are very rare.

Tell your doctor or nurse immediately

if you experience any sudden difficulties in
breathing, swelling of the eyelids, face or lips,
rash or itching (especially affecting your whole
body).

The following side effects have been
reported:
• feeling sick
(nausea)
• vomiting
• shallow breathing
• constipation
• sleepiness
• not knowing
where you are
(disorientation)
• itching
• sweating
• a perception
of seeing or
hearing things
(hallucinations)
• feeling of very
intense happiness
and well-being
(euphoria)
• skin rash

• low or high blood
pressure
• spasms in the lung
• decreased ability to
cough
• problems with
urination
• impotence
• swelling of the skin

Marketing Authorisation Holder
hameln pharmaceuticals ltd
Gloucester
United Kingdom

Manufacturer

hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln
Germany
hameln rds a.s
Horná 36, 900 01 Modra
Slovak Republic

This leaflet was
September 2015

last

revised

in

46801/41/15

• feeling cold
• withdrawal symptoms
• drowsiness

• confusion

• feeling of dizziness
or “spinning” (vertigo)
• restlessness

• irregular skin
patches and itching
• pain at injection site • excitation
• headache
• tingling or numbness
in the hands or feet
(paraesthesia)
• dizziness
• feeling your
heartbeat
(palpitation)
• agitation
• fainting (syncope)
• fits
• upset stomach or
indigestion
• impairment of taste • total or partial bowel
blockage
• mood changes
• loss of appetite
(anorexia)
• high pressure in
• abnormal muscle
your brain (you may
breakdown which
have a headache
can lead to
and feel sick or
kidney problems
vomit)
(rhabdomyolysis)
• involuntary
• contraction of the
trembling and
tubes connecting the
quivering
kidney and bladder
(ureteric spasm)
• muscle rigidity
• disruption of the
menstrual cycle
• contraction of the
• infertility
pupils
• visual problems
• decreased libido
• dry mouth
• feeling of discomfort
(malaise)
• stomach pain
• weakness
• gallbladder spasms • reduction of adrenal
with stomach pain
gland function
• facial flushing
• worsening of
inflammation of your
pancreas
• chills
• increased sensitivity
to pain
• slow or fast
• tolerance and
heartbeat
dependence (with
long-term treatment)
• coma

This medicine may cause dependence with longterm use. If your treatment is stopped too quickly
then withdrawal symptoms may occur. Please tell
your doctor or nurse if you think this is happening
to you. However, when the dose of Morphine
Injection is carefully adjusted to control pain,
dependence and other side effects are rare.

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. By reporting side effects you can
help provide more information on the safety of this
medicine.

5. How to store Morphine Injection
Do not store above 25°C. Keep the ampoules in
the outer carton in order to protect them from light.
The nurse or doctor will check that the injection is
not past its expiry date and that the injection does
not show any sign of deterioration before giving
you the medicine.
Keep this medicine out of the sight and reach of
children.

6.
Contents of the pack and other
information
What Morphine Injection contains

The active substance is morphine sulfate.
Each 1 ml of solution contains 1 mg of morphine
sulfate.
The other ingredients are: sodium chloride,
hydrochloric acid, water for injections.

What Morphine Injection looks like and
contents of the pack
Morphine Injection is a sterile solution in a clear
glass ampoule containing 10 ml.

--------------------------------------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:
(Continued from overleaf)

hameln

Morphine Sulfate 1 mg per ml solution for injection
Incompatibilities
Morphine sulfate injection is physically
incompatible with aciclovir sodium, aminophylline,
amobarbital sodium, cefepime hydrochloride,
chlorothiazide
sodium,
floxacillin
sodium,
furosemide, gallium nitrate, heparin sodium,
meperidine hydrochloride, meperidine sodium,
methicillin sodium, minocycline hydrochloride,
pentobarbital sodium, phenobarbital sodium,
phenytoin sodium, sargramostim, sodium
bicarbonate, thiopental sodium.

Shelf life
24 months.
Special precautions for storage
Do not store above 25°C. Keep the ampoules in
the outer carton in order to protect from light.

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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.

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