Morphine Sulphate Injection 10mg/Ml
PACKAGE LEAFLET: INFORMATION FOR THE USER D00354
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. What Morphine Sulphate Injection is and what is it used for
2. Before you are given Morphine Sulphate Injection
3. How Morphine Sulphate Injection will be given
4. Possible side effects
5. How to store Morphine Sulphate Injection
6. 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.
3. How Morphine Sulphate Injection will be given
This medicine is an injection and will be given to you by your doctor. Your doctor will determine the dose you need.
Continued overleaf
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.
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: Manufacturer:
Aurum Pharmaceuticals Ltd., Federa SC
Bampton Road, Avenue Jean Jaureslaan, 71
Harold Hill, B-1030 Brussels
Romford, RM3 8UG, Belgium
United Kingdom.
This leaflet was last approved in: 09/2009 Product Licence Number: PL 12064/0084
Bampton Road, Harold Hill, Romford RM3 8UG, United Kingdom J
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