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Package leaflet: Information for the user


Morphine Sulfate Injection 10 mg per ml
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 nurse.
• 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 Injection 10 mg per ml, which will be referred to
as Morphine Injection throughout this leaflet.

What is in this leaflet

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). Morphine Injection is used to relieve
severe or very severe pain.

• drugs for treatment of digestive tract disorders
(e.g. cisapride).
• drugs used for Parkinson’s Disease
• drugs used to treat vomiting or indigestion (e.g.
domperidone or metoclopramide).
Morphine Injection and alcohol:

2. What you need to know before you
use Morphine Injection

Alcohol should be avoided during treatment.

Do NOT use Morphine Injection:

If you are pregnant, think you may be pregnant or
are planning to have a baby, ask your doctor for
advice before using this medicine. The doctor will
then decide if the injection is suitable for you.

• if you are sensitive or allergic to morphine
or any of the other ingredients of this medicine
(listed in section 6)
• if you have a breathing disorder
• if you have a head injury or raised pressure
around your brain.
• if you have a convulsive disorder (epilepsy) or
suffer from fits (seizures).
• if you have acute alcohol poisoning (intoxication).
• if you suffer from liver or kidney failure.
• if you have a narrowing of the tubes leading to
your bladder.
• if you have inflammation of your pancreas
• if you have impaired function of your gallbladder.
• if you have an inflammation of your bowel or a
bowel obstruction.
• if you have low blood pressure with a lack of
adequate circulatory filling.
• if you suffer from an enlarged prostate gland.
• if you have a thyroid problem.
• if you have Phaeochromocytoma - a tumour
of the adrenal gland.
• if you are taking any of the antidepressant
medicines known as monoamine oxidase
inhibitors (MAOIs) or have taken them during
the last two weeks.
• if you are unconscious (coma).
Warnings and precautions:
Tell your doctor or nurse before using Morphine

if you have low blood pressure
if you have an under-active thyroid gland
if you have asthma or other breathing difficulties
if you have kidney or liver disorders

Pregnancy and breast feeding:

If you are breast-feeding, ask your doctor for
advice before using this medicine - this injection
should not be used by nursing (breast-feeding)
Driving and using machines:
You should not drive or use machinery while
receiving Morphine Injection.
Details regarding a new driving offence
concerning driving after drugs have been taken in
the UK may be found here:

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
Talk to your doctor or pharmacist if you are not
sure whether it is safe for you to drive while taking
this medicine.


3. How to use Morphine Injection

This medicine is not recommended for use in
children under 12 years of age. If you have any
concerns ask your doctor or pharmacist.

Your nurse or doctor will give you the injection.

Other medicines and Morphine Injection:
Tell your doctor or nurse if you are using or
have recently used or might use any other
medicines, including medicines obtained without a
prescription. 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.
• drugs 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) - drugs that increase
urine excretion .
• cimetidine - an anti-ulcer treatment
• antiarrhythmics - drugs to control heart rhythm or
rate (e.g. mexiletine).
• drugs used to treat depression.
• drugs used to treat anxiety.
• medicines to help you sleep.

Your doctor will decide the correct dosage for
you and how and when the injection will be
If you use more Morphine Injection than you
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, you must tell the person giving you
the injection. Tell your doctor or nurse immediately
if any of the following symptoms of overdose
• 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

5. How to store 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.

Keep this medicine out of the sight and reach of
Do not use this medicine after the expiry date
which is stated on the label/ carton after “EXP:”
The expiry date refers to the last day of that
Your injection will be stored at less than 25°C and
protected from light.

If you have any further questions on the use of
this medicine, ask your doctor or nurse.

6. Contents of the pack and other

4. Possible side effects

What Morphine Injection contains:

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

The active substance is morphine sulfate. In
Morphine Injection, each 1 ml of solution contains
10 mg of morphine sulfate.
The other ingredients are: sodium chloride,
hydrochloric acid, water for injections and nitrogen.

All medicines can cause allergic reactions,
although serious allergic reactions are very rare.
Tell your doctor or nurse immediately if you get
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:

Very common (more than 1 in 10 patients)

feeling sick (nausea)
shallow breathing
not knowing where you are (disorientation)
a perception of seeing or hearing things
• uncomfortable mood
• feeling of very intensive happiness and wellbeing (euphoria)
• tolerance and dependence (with long-term

Common (in less than 1 in 10, but more
than 1 in 100 patients)

skin rash
irregular skin patches and itching
pain at injection site
impairment of taste
mood changes
changes in psychological functions and senses
sleeplessness (insomnia)
high pressure in your brain (you may have a
headache and feel sick or vomit)
involuntary trembling and quivering
muscle cramps
contraction of the pupils
visual problems
dry mouth
stomach pain
gallbladder spasms with stomach pain
slow or fast heartbeat
high blood pressure
heart failure
fluid in the lungs
spasms in the throat
asthma-like symptoms
decreased ability to cough
problems with urination
swelling of the skin
feeling hot or cold
withdrawal symptoms

Uncommon (in less than 1 in 100, but
more than 1 in 1000 patients)
• severe allergic reactions after injection into a
If you think this injection is causing you any
problems, or you are at all worried, talk to
your doctor, nurse or pharmacist.

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

What Morphine Injection looks like and
contents of the pack:
Morphine Injection is a clear, colourless, sterile
solution in a clear glass ampoule containing 1ml.
The marketing authorisation number of this
medicine is: PL 01502/0063
Marketing Authorisation Holder:
hameln pharmaceuticals ltd
Nexus, Gloucester Business Park
Gloucester, GL3 4AG, United Kingdom
hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln, Germany
hameln rds a.s.
Horná 36
900 01 Modra, Slovak Republic
HBM Pharma s.r.o.
03680 Martin
Slovak Republic
For any information about this medicine,
please contact the Marketing Authorisation
This leaflet was last approved July 2015.

Expand Transcript

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.