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MORPHINE SULPHATE INJECTION 10MG/ML

Active substance(s): MORPHINE SULPHATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

D00354

Morphine Sulphate Injection 10mg/ml
Morphine Sulphate Ph. Eur
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, please ask your doctor or
nurse.
• If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or nurse.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Morphine Sulphate Injection is and what is it used for
Before you are given Morphine Sulphate Injection
How Morphine Sulphate Injection will be given
Possible side effects
How to store Morphine Sulphate Injection
Further information

1. What Morphine Sulphate Injection is and
what it is used for
Morphine is an alkaloid with powerful pain relieving properties.
This medicine is used for the relief of severe pain.

2. Before you are given Morphine Sulphate
Injection
You should not be given Morphine Sulphate Injection if you:
• are allergic (hypersensitive) to Morphine Sulphate or any of
the ingredients listed in section 6 of this leaflet
• are currently taking drugs used to treat depression known as
monoamine oxidase inhibitors (MAOIs) or have taken them in
the last 2 weeks
• suffer from any breathing problems such as asthma, slowed
breathing or difficulty breathing
• have suffered a head injury or are experiencing severe
undiagnosed headaches
• suffer from alcoholism
• suffer from heart problems
• have been told you are suffering from a condition known as
delayed gastric emptying, the symptoms of which include
heartburn, feeling sick or being sick and feeling full quickly
whilst eating
• are suffering from severe stomach pains
• suffer from severe heart and lung problems
• suffer from a tumour of the adrenal gland known as
phaeochromocytoma
• suffer from severe liver problems
• suffer from seizures (fits)
Take special care with Morphine Sulphate Injection
Tell your doctor if you:
• suffer from underactive thyroid
• suffer from any liver or kidney diseases
• are elderly or ill
• are dependent on morphine
• suffer from problems with your pancreas
• suffer from a muscle disorder known as myasthenia gravis
• suffer from an irregular heartbeat
• have been told you suffer from a severe heart problem
known as cor pulmonale
• suffer from bowel problems
• suffer from low blood pressure
• are pregnant or breast-feeding
If any of the above apply to you or your child, please tell your
doctor.
Taking other medicines
Please tell your doctor or nurse if you are taking, or have recently
taken, any other medicine including medicines obtained without
prescription.
Please tell your doctor if you are taking any of the following
medicines:
• medicines used to help you to sleep (hypnotics) e.g. chloral
and barbiturates
• medicines used to treat anxiety (anxiolytics) e.g. diazepam
• medicines used to treat severe depression known as
monoamine oxidase inhibitors (MAOIs). Tell your doctor, even
if you have stopped taking them in the last 2 weeks.
Pregnancy and breast-feeding:
Morphine Sulphate Injection should not be used during
pregnancy (especially during the first three months) as Morphine
is known to cross the placenta.
This medicine should also not be used whilst breast-feeding as
Morphine is known to be present in breast milk and it may cause
respiratory problems in newborn babies.
Effects on ability to drive and use machinery:
This medicine may cause drowsiness. If you are affected do not
drive or use machines.
Having Morphine Sulphate Injection with food and drink
You are advised not to drink alcohol during your treatment with
this medicine.
Important information about some of the ingredients:
This medicine contains sodium metabisulphite which may cause
allergic (hypersensitive) type reactions in some people and can
lead to breathing difficulties or collapse. People with a history of
asthma or allergies are most likely to experience these problems.

Morphine Sulphate Injection is administered either into a muscle, under
the surface of the skin or into a vein.
Under some circumstances your doctor may prescribe a dose higher than
those stated here.
Adults
Initially you will be given 10 - 20mg
This may be repeated every 4 - 6 hours
The elderly and ill
It is recommended that a reduced dose be used
Children 6-12 years (after risk/benefit assessment)
Your child will be given 5 - 10mg into a muscle or under the skin.
Children under 6 years
Not recommended
If you are given too much of Morphine Sulphate Injection:
This medicine will be given to you in hospital so it is unlikely you will
receive too much. Your doctor has information on how to recognise and
treat an overdose.

DEVELOPMENT ARTWORK

If you feel unwell after being given this medicine, or are at all concerned
your have been given too much, tell your doctor or nurse.

4. Possible Side Effects
Like all medicines Morphine Sulphate Injection can cause side effects,
although not everybody gets them.
Repeated use of morphine can result in tolerance and addiction
If any of the following symptoms occur tell your doctor immediately.
These are symptoms of a serious allergic reaction.
• sudden wheeziness and tightness of chest
• swelling of eyelids, face or lips
• skin lumps or hives
• skin rash (red spots), itchiness, fever
• collapse
Other possible side effects include:
• feeling sick
• being sick
• drowsiness
• confusion
• dry mouth
• sweating
• facial flushing
• feeling your heart beat (palpitations)
• a slower heartbeat than usual
• slowed breathing
• low blood pressure, the symptoms of which include feeling dizzy or
light-headed, feeling weak and fainting
• loss of appetite
• indigestion
• worsening of a condition that affects the pancreas known as
pancreatitis. The symptoms of this include stomach pain and
feeling or being sick.
• changes in the way things taste
• seizures (fits)
• constipation
• difficulty in passing urine
• spasms in the lower abdomen
• a feeling of spinning and dizziness (vertigo)
• feeling faint after getting up from a seated position
• feeling restless
• mood changes
• hallucinations (seeing or hearing things that are not real)
• pinpoint pupils
• enlarged pupils
• headaches
• muscle stiffness
• water on the lungs
• an itchy rash
• sore, red and swollen skin
If any of these side effects get serious, or you notice any other 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.
You should not be given Morphine Sulphate Injection after the expiry date
on the carton and syringe labels. The expiry date refers to the last day of
that month. The doctor or nurse will check that the product has not
passed this date.
Do not store above 25°C. Store in the original container.

6. Further Information
What Morphine Sulphate Injection contains
The active ingredient: Morphine Sulphate Ph Eur 10mg/ml.
The other ingredients: sodium chloride, sodium metabisulphite and
water for injections, sulphuric acid and nitrogen.
What Morphine Sulphate Injection looks like and contents of the pack:
Morphine Sulphate Injection is a clear, colourless solution, supplied in a
pre-filled syringe. Each pre-filled syringe contains 1ml of the solution.
Marketing Authorisation Holder:
Aurum Pharmaceuticals Ltd.,
Bampton Road,
Harold Hill,
Romford, RM3 8UG,
United Kingdom.

Manufacturer:
Federa SC
Avenue Jean Jaureslaan, 71
B-1030 Brussels
Belgium

This leaflet was last approved in: 09/2009
Product Licence Number: PL 12064/0084

This medicine is an injection and will be given to you by your doctor. Your
doctor will determine the dose you need.
Continued overleaf

D00354

3. How Morphine Sulphate Injection will be given

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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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