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MORPHINE SULFATE 1MG IN 1ML SOLUTION FOR INJECTION.

Active substance(s): MORPHINE SULFATE

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Patient Information Leaflet
Morphine Sulfate 1mg in 1mL Solution for Injection





Please read this leaflet carefully before you start using this medicine.
Keep this leaflet in a safe place, you may wish to read it again.
If you have any questions or are not sure about anything, ask your
doctor or pharmacist.
If any side effect gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What Morphine Sulfate Solution for Injection is and what it is used for
2. Before you are given Morphine Sulfate Solution for Injection
3. How Morphine Sulfate Solution for Injection is used
4. Possible Side Effects
5. How to store Morphine Sulfate Solution for Injection
6. Further information

1. What Morphine Sulfate Solution for Injection is and what it is used for
Morphine Sulfate, the active ingredient, belongs to a group of strong painkilling medicines called
opioids which must be used only under a doctor’s instruction.
This medicine 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. It is used in the
long term relief of moderate to severe pain, such as the pain caused by surgery, heart attacks and
cancer. This medicine also helps to reduce the anxiety and sleeplessness which may be caused
by the pain.

2. Before you are given Morphine Sulfate Solution for Injection
This medicine should NOT BE USED if you:
• Are allergic to Morphine Sulfate or any other strong painkilling drugs
• Have a history of alcohol abuse
• Suffer from malfunctioning of the adrenal gland (phaeochromocytoma)
• Have suffered a head injury
• Are at risk of a paralytic ileus (reduced gut motility)
• Have acute respiratory depression (breathlessness)
• Have raised pressure inside your skull
Check with your doctor if you are concerned about any of the above.

Before using this medicine please tell your doctor if you:
• Are pregnant or breast feeding
• Are taking medicines to treat depression
• Are taking medicines for sickness (phenothiazines), for drying secretions (anticholinergics e.g.
hyoscine) or other pain killers
• Are taking medicines to make you sleep, such as hypnotics or sedatives
• Have taken one of a group of drugs called monoamine oxidase inhibitors (used to treat
depression) within the last two weeks
• Are taking anti-psychotics, cimetidine, domperidone or metoclopramide
• Are taking esmolol, mexiletine or ritonavir
• Have taken this medicine in the last two weeks
Check with your doctor if you are concerned about any of the above.

This medicine may not be suitable for you to take, therefore please tell your doctor if
you:

• Suffer from asthma, chronic bronchitis or have any other illness which causes breathing
difficulties
• Suffer from kidney or liver problems
• Suffer from stomach or bowel problems
• Have difficulty in passing urine due to an enlarged prostate
• Suffer from bad headaches or feel sick
• Suffer from epilepsy or other fits
• Suffer from poor blood supply to the heart or other heart problems
• Have low blood pressure (hypotension)
• Have a tumour of the adrenal gland
• Suffer from myasthenia gravis
• Suffer from pain from gallstones (biliary colic)
• Suffer from thyroid problems
• Are elderly and/or debilitated
Check with your doctor if you are concerned about any of the above.
This medicine is only suitable for long lasting pain and is not intended for pain which only lasts for
short periods.
NEVER give your medication to other people even if their symptoms are the same as yours.
Important information about some of the ingredients in this medicine
This medicine contains up to 2mmol sodium per dose. Take into consideration if you are on a
low-sodium diet.

3. How Morphine Sulfate Solution for Injection is used
The doctor will decide what dose of this medicine you should be given. It will need to be given by
a nurse or doctor using a syringe and needle to draw up the injection for administration.
The syringe may be put into a small machine which allows a slow continuous injection of this
medicine to be given.
There is a procedure called Patient Controlled Analgesia (PCA) where you will be provided with a
button to press when you are in pain and the machine will then give you a small amount of this
medicine. 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 this medicine. Your
doctor may want to increase your dose of the medicine and/or give you some extra medicines for
the pain.
You must not use machinery whilst using this medicine.
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:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instruction given by the prescriber or in the information
provided with the medicine and
o 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 medicine.
If a dose of this medicine is not given at the correct time – the dose should be given as soon
as it is remembered. The next dose should be given at the usual time. A double dose should not
be given.
If more of this medicine is given than should be – tell your doctor as soon as possible. If you
are a medical practitioner administering this medicine please refer to the Summary of Product
Characteristics.


Additional information for Healthcare Professionals
(as stated on the Summary of Product Characteristics)
Therapeutic Indications
Morphine Sulfate Solution for Injection is indicated for the relief of moderate to severe pain.
Morphine 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.
Posology and Method of Administration
Adults and children over 12 years:
Morphine Sulfate Solution for Injection is formulated for use by the intravenous route in Patient
Controlled Analgesia (PCA) systems. PCA, which permits adjustment of dosage according to the
patient’s individual needs, must only be carried out in departments and by staff who are trained
and have experience of the system. Patient selection for the use of PCA must ensure that the
patient is capable of understanding and following the instructions of the medical/nursing staff. The
specific department or unit protocols must be covered to ensure aseptic transfer of the contents of
the ampoule or vial to the PCA system.
There is a considerable variation in analgesic requirements among patients and therefore
individualised treatment strategies are required. Dosage should be based on the severity of the
pain and the response and opiate tolerance of the patient.

4. Possible side effects
As with all medicines, there may be some side effects with this medicine. The most common side
effects are respiratory depression (slow or shallow breathing), nausea, vomiting, constipation,
feeling more sleepy than normal and feeling confused.
Other common side effects are:
• Muscle rigidity
• Tachycardia (fast heartbeat)
• Inability to concentrate
• Postural hypotension (low blood pressure on
• Itchiness
sitting or standing)
• Decreased effectiveness
• Spasm of the tubes of the kidney, bladder or
• Hypothermia
gallbladder
• Disorientation
• Vertigo
• Agitation
• Rash due to an allergic reaction in the skin
• Feeling of sadness
• Excitation
• Affected eye sight
• Feeling of well being
• Upset stomach or indigestion
• Dizziness
• Severe allergic reaction to medicine
• Transient loss of consciousness
• Pain and irritation at the injection site
• Abdominal pain
• Increased pressure inside the skull
• Feeling unwell
• Rashes
• Itchy rash of skin with raised bumps
• Affects normal sleep
Tell your doctor, nurse or pharmacist immediately if you think you have any of these, or
other problems.

LONG-TERM TREATMENT WITH THIS MEDICINE
Further side effects can occur during long-term treatment with this medicine. These side effects
include:
• Difficulty in urinating or unable to pass
• Recurrence of pancreatitis
urine
• Uncontrolled movement of the eyes
• Hallucinations
• Fluid retention
• Colic
• Increased blood pressure
• Contractions of the pupils
• Loss of weight due to poor eating
• Dry mouth
• Total or partial bowel blockage
• Restlessness
• Muscle jerk
• Sweating/ facial flushing
• Muscle twitch
• Mood changes
• Infertility
• Headache
• Severe muscle pain
• Decreased libido
• Difficulty in coughing
• Palpitations
• Depression
• Disruption of the menstrual cycle
• Lack of strength in muscles
• Slowed heartbeat
• Inability to obtain or sustain an erection
• Reduced blood pressure
of the penis
• Spasm of the airways
• Decreased effectiveness
• Changes in taste
• Increased sensitivity to the pain
• Fitting
• Reduced adrenal gland function
Tolerance and dependence are likely to occur after long-term treatment, and you may experience
withdrawal symptoms if you stop taking this medicine suddenly. If you are concerned that you are
becoming dependent on this medicine, speak to your doctor.
Reporting of Side Effects
If you get any side effects, talk to your doctor, nurse or pharmacist. 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 Sulfate Solution for Injection
This medicine has an expiry date printed on the ampoule or bottle (vial) and carton label. Before
use the doctor or nurse will check the medicine has not passed this date and that the medicine
does not show any sign of deterioration. The expiry date refers to the last day of the month.
After the expiry date return any unused medicine to a pharmacy.
Store this medicine away from sunlight and below 25ºC.
Store this medicine in a safe place where children cannot see or reach it.

6. Further information
What this medicine contains:
• The active ingredient is Morphine Sulfate at a strength of 1mg in 1mL.
• It also contains the inactive ingredients Sodium Chloride and Water for Injections.
What this medicine looks like and contents of the pack:
This medicine is a clear and colourless or almost colourless solution. This medicine is available in
1mL, 5mL and 10mL ampoules, and 50mL single use vials. The medicine is packed into cartons
containing 10 ampoules, 1 vial or 10 vials. Both pack sizes of vials may not be available at the
same time.
Marketing Authorisation Holder: Torbay and South Devon NHS Foundation Trust,
Torbay Pharmaceuticals, Wilkins Drive, Paignton, Devon, TQ4 7FG
Sites of Manufacture
Torbay and South Devon NHS Foundation
Trust
Torbay Pharmaceuticals
Long Road
Paignton
Devon
TQ4 7TW

Torbay and South Devon NHS Foundation
Trust
Torbay Pharmaceuticals
Wilkins Drive
Paignton
Devon
TQ4 7FG

This leaflet was last revised in: 12/2015
PL 13079/0001
PIL /1/11


Loading Dose
Loading doses of typically between 1mg and 10mg (maximum 15mg) of morphine sulfate may be
given by intravenous infusion over four or five minutes. The loading dose used will depend upon
the patient’s diagnosis and conditions.
PCA demand dose
An initial demand dose of 1mg Morphine Sulfate Injection with a lockout period of 5 to 10 minutes
is recommended. Dosages may vary depending on the loading dose, the tolerance and condition
of the patient, and whether a background infusion of morphine sulfate is being given.
The patient should be specifically monitored for pain, sedation and respiratory rate during the first
few hours of treatment to ensure that the dosage regimen is suitable.
The duration of treatment should be kept to a minimum, although dependence and tolerance are
not generally a problem when morphine is used legitimately in patients with opioid-sensitive pain.
Use in children:
Not recommended for children under 12 years.
Use in the elderly:
Morphine doses need to be reduced in elderly patients.
Incompatibilities
Morphine Sulfate Solution for Injection should not be mixed with other preparations.
Morphine salts are incompatible with aminophylline, sodium salts of barbiturates and phenytoin,
aciclovir sodium, furosemide, heparin sodium, pethidine HCl, prochlorperazine edisylate and
promethazine HCl.

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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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