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MORPHINE SULFATE 10MG/5ML ORAL SOLUTION

Active substance(s): MORPHINE SULFATE

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Package leaflet: Information for the user

Morphine Sulfate 10mg/5ml 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 you take Morphine Sulfate Oral Solution
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 10mg/5ml 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 analgesics’
• 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 pharmacist.
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
Talk to your doctor before taking this medicine if you are pregnant,
trying to become pregnant or if you are breast-feeding. 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.
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 https://www.gov.uk/drug-driving-law
Important information about some of the ingredients of
Morphine Sulfate Oral Solution
This medicine contains:
• Sucrose and Glucose: This product contains 30g of sucrose and
10g of glucose in the 100ml bottle, 75g of sucrose and 25g of glucose
in the 250ml bottle, and 150g of sucrose and 50g of glucose in the
500ml bottle. When taken according to the dosage recommendations
each dose supplies up to 3g of sucrose and 1g of glucose in 10ml. This
should be taken into account in patients with diabetes mellitus. May
be harmful to teeth. If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor before taking this
medicinal product.
• Methyl parahydroxybenzoate (E218) and
propylparahydroxybenzoate (E216): These may cause allergic
reactions in some people that could occur some time after taking this
medicine. The signs may include swelling of the mouth and face, sudden
breathing difficulties and your blood pressure being lower than normal.
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.
How much to take
Your doctor will decide the amount of medicine to give you.
Adults
• The usual dose is 5 to 10ml every four hours

Measure bar should be 150mm at 100% scale

artwork.leicester@multipkg.com

Clearly mark any amendments on one proof and return to MPS

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.
IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Customer

Wockhardt UK Limited

Colours Used

Description

Morphine sulfate 10mg oral leaflet

Process Black

Item Code

107198/2

Profile

n-a

Size

297 x 210mm

Min. Point Size

9pt (main body) / 9pt (variables)

Market

UK

Language

English

Proof By

matt.pirie-scott

Proof No.

1

Date

26/01/2016

Artwork No.

629658

Keyline (non-printing)
Text free area (non-printing)

Pharma
Code

FPO

• 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

Paediatric population
Children 13 to 18 years
• The most that should be taken is 2.5 to 10 ml every four hours
Children 6 to 12 years
• The most that should be taken is 2.5 to 5 ml every four hours
Children 1 to 5 years
• The most that should be taken is 2.5 ml every four hours

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:

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

United Kingdom:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland:
HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517; Website: www.hpra.ie;
e-mail: medsafety@hpra.ie
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 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.
Store below 25°C. Store in the original container in order to protect from light.
Once opened the product should be used within three months.

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.

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 5ml contains 10 mg of morphine Sulfate as the active ingredient
• The other ingredients are Methyl parahydroxybenzoate (E218),
Propyl parahydroxybenzoate (E216), Sucrose, liquid glucose,
Sodium hydroxide solution (for pH adjustment), Hydrochloric acid
solution for pH adjustment) and Purified water
What Morphine Sulfate Oral Solution looks like and content of the pack
Morphine Sulfate 10mg/5ml Oral Solution is a clear colourless to pale
yellow solution. The solution may become more yellow over time.
The finished product is packed in either 100ml, 250ml, 300ml or 500ml
amber soda glass bottles fitted with a 28mm white, polypropylene,
push and turn, tamper evident cap.
In addition the product is supplied with a 5ml 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.

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 intestines

Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham,
LL13 9UF, UK.

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 (palpitations)
• Lower body temperature (hypothermia)
• Lowered sex drive

Please be ready to give the following information:

This Medicinal Product is authorised in the Member States under the
following names:
UK & Ireland: Morphine Sulfate 10mg/5ml Oral Solution
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)
Product name
Morphine Sulfate 10mg/5ml Oral Solution

Reference number
29831/0563

This is a service provided by the Royal National Institute of Blind people.
For the Republic of Ireland please call + 1978 661 261
This leaflet was last revised in 01/2016
107198/2

Measure bar should be 150mm at 100% scale

artwork.leicester@multipkg.com

Clearly mark any amendments on one proof and return to MPS

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.
IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Customer

Wockhardt UK Limited

Colours Used

Description

Morphine sulfate 10mg oral leaflet

Process Black

Item Code

107198/2

Profile

n-a

Size

297 x 210mm

Min. Point Size

9pt (main body) / 9pt (variables)

Market

UK

Language

English

Proof By

matt.pirie-scott

Proof No.

1

Date

26/01/2016

Artwork No.

629658

Keyline (non-printing)
Text free area (non-printing)

Pharma
Code

FPO

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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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