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Active substance(s): MORPHINE SULFATE

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Package leaflet: Information for the user
Morphine Sulfate 20mg/ml Oral Solution
Morphine Sulfate
(Referred to as Morphine Sulfate Oral Solution in the remainder of the leaflet)
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• If any of the side effects 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 Oral Solution is and what it is used for
2. Before Morphine Sulfate Oral Solution is given
3. How Morphine Sulfate Oral Solution is given
4. Possible side effects
5. How Morphine Sulfate Oral Solution is stored
6. Further information
1. What Morphine Sulfate Oral Solution is and what it is used for
The name of your medicine is Morphine Sulfate 20mg/ml Oral Solution (called Morphine Sulfate Oral
Solution in this leaflet).
• It contains a medicine called morphine sulfate. This belongs to a group of medicines called ‘opioid
• It is used to relieve severe pain
2. Before you take Morphine Sulfate Oral Solution
Do not take Morphine Sulfate Oral Solution if:
• You are allergic (hypersensitive) to morphine sulfate or any of the other ingredients of this
medicine (listed in Section 6 below)
• You have problems with your lungs or breathing such as ‘hypoventilation’ or ‘Chronic Obstructive
Pulmonary Disorder’ (COPD)
• You are having an asthma attack
• You have sudden or recent liver problems
• You have recently had a head injury
• You have something called ‘phaeochromocytoma’. This is a rare tumour which is not malignant
• You have fits (convulsions) or raised pressure inside your skull
• The person taking the medicine is in a deep and prolonged unconscious state (coma)
• You are addicted to alcohol or have recently consumed large amounts of alcohol
• You are taking or have in the last two weeks taken medication to treat depression such as
monoamine-oxidase inhibitors (MAOI)
• You have paralytic ileus (loss of intestinal movement)
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or
Take special care with Morphine Sulfate Oral Solution

Check with your doctor or pharmacist before taking your medicine if:
• You are pregnant, trying to become pregnant or if you are breast-feeding
• You have had an operation within the last 24 hours
• You have a particular lung problem that causes shortness of breath called emphysema
• You have shock (circulatory failure)
• You have asthma
• You have gall bladder problems
• You have long term (chronic) liver or kidney problems
• You are a man who has prostate problems
• You have an under-active thyroid gland or swelling of your skin (myxoedema)
• Your spine is unusually curved (kyphoscoliosis)
• You have bowel problems
• You have an under-active adrenal gland (adrenocortical insufficiency)
• You are very overweight
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking
Morphine Sulfate Oral Solution.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
This includes medicines that you buy without a prescription and herbal medicines. This is because
Morphine Sulfate Oral Solution can affect the way some other medicines work. Also some other
medicines can affect the way Morphine Sulfate Oral Solution works.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
· Medicines to help you sleep, make you feel less anxious or calm you down such as tranquilisers,
hypnotics, sedatives, antipsychotics or tricyclic antidepressants
· Anaesthetics - used during operations
· Domperidone and metoclopramide - for feeling sick (nausea) and being sick (vomiting)
· Mexiletine and esmolol - for controlling heart rhythm
· Ritonavir - for HIV infections
· Cimetidine - for stomach ulcers, indigestion or heartburn
· Monoamine oxidase inhibitors (MAOIs) - for depression
· Voriconazole - for some fungal infections
· Gabapentin - for epilepsy and long lasting pain caused by damage to the nerves
Taking Morphine Sulfate Oral Solution with food and drink
You should avoid alcohol whilst taking 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 or pharmacist for advice before taking this medicine.
If you are pregnant or trying for a baby you should not be given this medicine unless your doctor
believes the benefits outweigh the potential risks. If you take this medicine during pregnancy or
while breast-feeding, it may slow down the baby’s breathing. If you take this medicine for a long
time whilst pregnant, it may mean that the baby will be born showing signs of withdrawal.
Men, and women who could become pregnant, must use reliable contraception while using
Morphine Sulfate Oral Solution.

You should not breast-feed during your treatment with this medicine as morphine is known to pass
into breast milk.
Operations and anaesthetics
Tell your doctor or pharmacist if you are due to have an operation or anaesthetic or if you have had
an operation or an anaesthetic within the last 24 hours.
Driving and using machines
This medicine can affect your ability to drive. Do not drive whilst taking this medicine until you know
how this medicine affects you. It may be an offence to drive if your ability to drive safely is affected.
There is further information for patients who are intending to drive in Great Britain – go to
Important information about some of the ingredients of Morphine Sulfate Oral Solution
This medicine contains Amaranth. This may cause allergic reactions including asthma. Allergy is more
common in people who are allergic to aspirin.
3. How Morphine Sulfate Oral Solution is given
Always take this medicine exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Use the oral syringe provided to measure your dose
• Place the bottle adaptor into the bottle neck then place the syringe in the solution and pull the
white plunger up so that liquid is drawn up into the syringe
• Draw the liquid into the syringe until it is level with the mark which shows your required dose. The
marks are in mls of liquid
• You may prefer to add your dose to a soft drink. If you do this, it should be swallowed immediately
after mixing.
How much to take
Your doctor will decide the amount of medicine to give you.
• The usual dose is 0.5 to 1 ml (10-20 mg) every four hours
Paediatric population
Children 13 to 18 years
• The most that should be taken is 0.25 to 1 ml (5-20 mg) every four hours
Children 6 to 12 years
• The most that should be taken is 0.25 to 0.5 ml (5-10 mg) every four hours
Children 1 to 5 years
• The most that should be taken is 0.25 ml (5 mg) every four hours
Children under 1 year
• Do not give this medicine to children under 1 year

Being given more or less of this medicine
• For some people, it may be necessary for the doctor to give a higher dose
• For other people (for example the elderly, people with kidney or liver problems and people that
should not be sedated) the doctor may decide to use a lower dose
Your body may get used to the medicine (tolerance)
• Do not take more than your doctor has prescribed
• If you have been taking your medicine for some time you may find that it does not seem to be
working as well as it did. If this happens, talk to your doctor
If you take more Morphine Sulfate Oral Solution than you should
If you take more of this medicine than you should, talk to a doctor or go to a hospital straight away.
Take the medicine pack with you. This is so the doctor knows what you have taken.
If you take more than you should, the following effects may happen:
• The black circle in the centre of your eyes (pupil) gets smaller
• You breathe more slowly
• You have low blood pressure
In more severe cases, very high doses could cause your blood circulation to slow down and cause
unconsciousness for a long time, or even death.
In children a high dose may cause fits (convulsions).
If you forget to take Morphine Sulfate Oral Solution
• If you forget a dose, take it as soon as you remember it and take your next dose at the usual time
• If it is nearly time for the next dose, skip the missed dose. This is because the time between doses
should be at least 4 hours
• Do not take a double dose to make up for a forgotten dose
If you stop taking Morphine Sulfate Oral Solution
It is important to talk to your doctor if you want to stop taking your medicine. Do not stop taking
your medicine suddenly. This is because your body may have got used to it. Also, you may need to
have your dose lowered slowly.
4. Possible side effects
Like all medicines, Morphine Sulfate Oral Solution can cause side effects, although not everybody
gets them. The following side effects may happen with this medicine:
Allergic reactions
If you have a severe allergic reaction, stop taking this medicine and see a doctor straight away. Signs
may include swelling of the mouth and face, difficulty breathing, dizziness and skin reactions such as
rash and itching.
Tell your doctor straight away if you notice the following side effects.
You may need urgent medical treatment:
• Having a headache. This could be a sign of raised pressure inside your skull
• Feeling dizzy or unsteady when you stand up. This could be a sign of a temporary fall in blood
pressure (orthostatic hypotension)
• Shallow breathing, with a slow heartbeat (bradycardia) and cold clammy skin
• Feeling restless, irritable or having changes in your mood

• Stomach pain caused by spasm (cramps) of the tubes that carry urine to the bladder or bile to the
Other side effects
• Feeling sick (nausea) or being sick (vomiting)
• Constipation, which can be treated with appropriate laxatives
• Difficulty in passing water (urine)
• Feeling drowsy
• Dry mouth, sweating and flushing of your face
• Your heart rate getting faster (tachycardia) or slower (bradycardia) or fast and uneven
• Lower body temperature (hypothermia)
• Lowered sex drive
• Seeing or hearing things that are not there (hallucinations) or feeling confused
• Muscles feeling tense
• The black circle in the centre of your eyes (pupil) getting smaller (miosis)
• Dependence on Morphine Sulfate Oral Solution. This can happen with any morphine product
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 national reporting
systems listed below:
United Kingdom:
Yellow Card Scheme
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517;
Website:; e-mail:
By reporting side effects you can help provide more information on the safety of this medicine.
5. How Morphine Sulfate Oral Solution is stored
Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original container in order to protect from light.
Do not use this medicine after the expiry date which is stated on the bottle label and the outer
carton. The expiry date refers to the last day of the month.
Once opened the product should be used within four months. Medicines should not be disposed of
via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Further information
What Morphine Sulfate Oral Solution contains
• Each ml contains 20 mg of morphine sulfate as the active ingredient
• The other ingredients are disodium edetate, sodium benzoate (E211), citric acid anhydrous,
amaranth (E123) and purified water.

What Morphine Sulfate Oral Solution looks like and content of the pack
Morphine Sulfate Oral Solution is a clear pink solution. The finished product is packed in 120ml, 50ml
and 30ml amber soda glass bottles fitted with a white polypropylene push and turn, tamper evident
In addition the product is supplied with a 1ml dispensing oral syringe and bottle adaptor.
Not all pack sizes may be marketed.
Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
This Medicinal Product is authorised in the Member States under the following names:
UK & Ireland: Morphine Sulfate 20mg/ml Oral Solution
Germany: Morphin Aristo Lösung 20mg/ml
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name
Morphine Sulfate 20mg/ml Oral Solution

Reference number

This is a service provided by the Royal National Institute of Blind People.
For the Republic of Ireland please call + 44 1978 669272
This leaflet was last revised in 11/2017.

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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.