Skip to Content

UK Edition. Click here for US version.

MORPHINE SULFATE 20MG/ML ORAL SOLUTION

Active substance(s): MORPHINE SULFATE

View full screen / Print PDF » Download PDF ⇩
Transcript
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)
In particular tell your doctor or pharmacist if you are taking any of the
Read all of this leaflet carefully before you start taking this medicine.
following medicines:
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
· Medicines to help you sleep, make you feel less anxious or calm you
• This medicine has been prescribed for you. Do not pass it on to others.
down such as tranquilisers, hypnotics, sedatives, antipsychotics or
It may harm them, even if their symptoms are the same as yours.
tricyclic antidepressants
• If any of the side effects gets serious, or if you notice any side effects
· Anaesthetics - used during operations
not listed in this leaflet, please tell your doctor or pharmacist.
· Domperidone and metoclopramide - for feeling sick (nausea) and
being sick (vomiting)
In this leaflet:
· Mexiletine and esmolol - for controlling heart rhythm
1. What Morphine Sulfate Oral Solution is and what it is used for
· Ritonavir - for HIV infections
2. Before Morphine Sulfate Oral Solution is given
· Cimetidine - for stomach ulcers, indigestion or heartburn
3. How Morphine Sulfate Oral Solution is given
· Monoamine oxidase inhibitors (MAOIs) - for depression
4. Possible side effects
· Voriconazole - for some fungal infections
5. How Morphine Sulfate Oral Solution is stored
· Gabapentin - for epilepsy and long lasting pain caused by damage to
6. Further information
the nerves
1. What Morphine Sulfate Oral Solution is and what it is used for
Taking Morphine Sulfate Oral Solution with food and drink
The name of your medicine is Morphine Sulfate 20mg/ml Oral Solution
You should avoid alcohol whilst taking this medicine.
(called Morphine Sulfate Oral Solution in this leaflet).
Pregnancy and breast-feeding
• It contains a medicine called morphine sulfate. This belongs to a group
If you are pregnant or breast-feeding, think you may be pregnant or are
of medicines called ‘opioid analgesics’
planning to have a baby, ask your doctor or pharmacist for advice before
• It is used to relieve severe pain
taking this medicine.
2. Before you take Morphine Sulfate Oral Solution
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
Do not take Morphine Sulfate Oral Solution if:
risks. If you take this medicine during pregnancy or while breast-feeding,
• You are allergic (hypersensitive) to morphine sulfate or any of the other
ingredients of this medicine (listed in Section 6 below)
it may slow down the baby’s breathing. If you take this medicine for
• You have problems with your lungs or breathing such as
a long time whilst pregnant, it may mean that the baby will be born
‘hypoventilation’ or ‘Chronic Obstructive Pulmonary Disorder’ (COPD)
showing signs of withdrawal.
• You are having an asthma attack
Men, and women who could become pregnant, must use reliable
• You have sudden or recent liver problems
contraception while using Morphine Sulfate Oral Solution.
• You have recently had a head injury
• You have something called ‘phaeochromocytoma’. This is a rare tumour
You should not breast-feed during your treatment with this medicine as
which is not malignant
morphine is known to pass into breast milk.
• You have fits (convulsions) or raised pressure inside your skull
• The person taking the medicine is in a deep and prolonged
Operations and anaesthetics
unconscious state (coma)
Tell your doctor or pharmacist if you are due to have an operation or
• You are addicted to alcohol or have recently consumed large amounts
anaesthetic or if you have had an operation or an anaesthetic within the
of alcohol
last 24 hours.
• You are taking or have in the last two weeks taken medication to treat
Driving and using machines
depression such as monoamine-oxidase inhibitors (MAOI)
This medicine can affect your ability to drive. Do not drive whilst taking
• You have paralytic ileus (loss of intestinal movement)
this medicine until you know how this medicine affects you. It may be an
Do not take this medicine if any of the above apply to you. If you are not
offence to drive if your ability to drive safely is affected.
sure, talk to your doctor or pharmacist.
There is further information for patients who are intending to drive in
Great Britain – go to https://www.gov.uk/drug-driving-law
Take special care with Morphine Sulfate Oral Solution
Check with your doctor or pharmacist before taking your medicine if:
Important information about some of the ingredients of
• You are pregnant, trying to become pregnant or if you are
Morphine Sulfate Oral Solution
breast-feeding
This medicine contains Amaranth. This may cause allergic reactions including
• You have had an operation within the last 24 hours
asthma. Allergy is more common in people who are allergic to aspirin.
• You have a particular lung problem that causes shortness of breath
called emphysema
3. How Morphine Sulfate Oral Solution is given
• You have shock (circulatory failure)
• You have asthma
Always take this medicine exactly as your doctor has told you. You should
• You have gall bladder problems
check with your doctor or pharmacist if you are not sure.
• You have long term (chronic) liver or kidney problems
Taking this medicine
• You are a man who has prostate problems
• Take this medicine by mouth
• You have an under-active thyroid gland or swelling of your skin
• Use the oral syringe provided to measure your dose
(myxoedema)
• Place the bottle adaptor into the bottle neck then place the syringe in
• Your spine is unusually curved (kyphoscoliosis)
• You have bowel problems
the solution and pull the white plunger up so that liquid is drawn up
• You have an under-active adrenal gland (adrenocortical insufficiency)
into the syringe
• You are very overweight
• 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
If you are not sure if any of the above apply to you, talk to your doctor or

You may prefer to add your dose to a soft drink. If you do this, it should
pharmacist before taking Morphine Sulfate Oral Solution.
be swallowed immediately after mixing.
Taking other medicines
How much to take
Please tell your doctor or pharmacist if you are taking or have recently
Your doctor will decide the amount of medicine to give you.
taken any other medicines. This includes medicines that you buy without
a prescription and herbal medicines. This is because Morphine Sulfate Oral
Adults
Solution can affect the way some other medicines work. Also some other
• The usual dose is 0.5 to 1 ml (10-20 mg) every four hours
medicines can affect the way Morphine Sulfate Oral Solution works.

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

Actilla 20mg_Oral Solution

Process Black

Item Code

Actilla 20mg_ml Oral Solution

Profile

n/a

Size

297mm x 210mm

Min. Point Size

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

Market

UK

Language

English

Proof By

matt.pirie-scott

Proof No.

11

Date

20/10/2015

Artwork No.

605394

Pharma
Code

Keyline (non-printing)
Text Free Area (non-printing)

FPO

Paediatric population

• Y
 our heart rate getting faster (tachycardia) or slower (bradycardia) or
fast and uneven (palpitations)
• 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

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

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

United Kingdom:
Yellow Card Scheme
Website: http://www.mhra.gov.uk/yellowcard

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

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 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.

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.

What Morphine Sulfate Oral Solution looks like and content of the pack
Morphine Sulfate 20mg/ml Oral Solution is a clear red 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 cap.
In addition the product is supplied with a 1ml dispensing oral syringe and
bottle adaptor.
Not all pack sizes may be marketed.

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 intestines
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

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
Lösung
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

Reference number

Morphine Sulfate 20mg/ml Oral Solution

29831/0524

This is a service provided by the Royal National Institute of Blind People.
For the Republic of Ireland please call +
This leaflet was last revised in 1/2015.
107205/1

23LF01263PW

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

Actilla 20mg_Oral Solution

Process Black

Item Code

Actilla 20mg_ml Oral Solution

Profile

n/a

Size

297mm x 210mm

Min. Point Size

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

Market

UK

Language

English

Proof By

matt.pirie-scott

Proof No.

11

Date

20/10/2015

Artwork No.

605394

Pharma
Code

Keyline (non-printing)
Text Free Area (non-printing)

FPO

Expand view ⇕

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.

Hide