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ORAMORPH ORAL SOLUTION 10MG/5ML
Active substance(s): MORPHINE SULFATE
10 mg/5 ml
Package Leaflet: Information for the User
In this leaflet:
1. What ORAMORPH Oral Solution is and what it is used for
2. Before you take ORAMORPH Oral Solution
3. How to take ORAMORPH Oral Solution
4. Possible side effects
5. How to store ORAMORPH Oral Solution
6. Further information
1. WHAT ORAMORPH ORAL SOLUTION IS AND WHAT IT IS USED FOR
The name of your medicine is ORAMORPH Oral Solution 10 mg/5 ml
(called ORAMORPH 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 ORAMORPH ORAL SOLUTION
Do not take ORAMORPH if:
• You are allergic (hypersensitive) to morphine sulfate or any of the
other ingredients of ORAMORPH (listed in Section 6 below)
• You have problems with your lungs or breathing such as
‘hypoventilation’ or ‘Chronic Obstructive Pulmonary Disease’ (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 increased 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 (MAOIs)
• 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 ORAMORPH
Check with your doctor or pharmacist before taking your medicine if:
• You are pregnant, trying to become pregnant or if you are
• You have had an operation within the last 24 hours
• You have a particular lung problem that causes shortness of breath
called emphysema or you have heart failure
• 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
• Your spine is unusually curved (kyphoscoliosis)
• You have bowel problems
• You have an under-active adrenal gland (adrenocortical
• 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 ORAMORPH.
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
ORAMORPH can affect the way some other medicines work. Also
some other medicines can affect the way ORAMORPH works.
In particular tell your doctor or pharmacist if you are taking any of the
• Medicines to help you sleep, make you feel less anxious or calm you
down such as tranquilisers, hypnotics, sedatives, antipsychotics or
• Anaesthetics - used during operations
• Domperidone, metoclopramide or phenothiazine - medicines 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
• Rifampicin - used to treat tuberculosis and other infections
• Gabapentin - for epilepsy and long lasting pain caused by damage to
Taking ORAMORPH 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
Operations and anaesthetics
Tell your doctor or pharmacist if you are due to have an operation
or an anaesthetic or if you have had an operation or an anaesthetic
within the last 24 hours.
Driving and using machines
You may feel drowsy while taking this medicine. If this happens,
do not drive or use any tools or machines.
Additional information for patients in the UK:
• Do not drive while taking this medicine until you know how it
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental
- You have taken it according to the instructions given by the
prescriber or in the information provided with the medicine and
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe
for you to drive while taking this medicine.
Important information about some of the ingredients of ORAMORPH
This medicine contains:
• Ethanol (Alcohol): This product contains 10 volume % ethanol
(alcohol). Each dose contains up to 0.81 g of alcohol which is
equivalent to 20 ml beer or 8.3 ml wine. This medicine is harmful if
you are addicted to alcohol. The amount of alcohol should also be
considered if you are pregnant or breast-feeding, have long term
(chronic) liver problems or epilepsy, or you are a child
• Sucrose: This product contains 30 g of sucrose in the 100 ml bottle,
90 g of sucrose in the 300 ml bottle, and 150 g of sucrose in the
500 ml bottle. When taken according to the dosage recommendations
each dose supplies up to 3 g of sucrose. You should not take this
product if you have a bowel condition that makes you intolerant to
some sugars such as fructose, glucose, galactose or sucrose
• Methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (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
Issue date of TD:
PPM SKU version:
Issue date of artwork:
D = 2 mm
Mat. No. Pack. Site:
Legend case version:
V4.0 01/OCT/2012 (please do not change or remove it)
Additional Requirements of Packaging Site
a = Batch No.
b = Expiry date
c = Manufacturing date
d = Price/Sample/Clinic
Dimensions: mm 200 x 305 folded at 36
D = 1 mm
E = 0,65 mm
F = 0,35 mm
E = 5 mm
F = 1mm
G = 9 mm
Min. font size:
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
• If any of the side effects gets troublesome or serious, or if you
notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
G = 10 mm
H = 46,5 mm
I =2 mm
3. HOW TO TAKE ORAMORPH ORAL SOLUTION
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 only
• Use a 5 ml plastic spoon to measure your dose
• They are available from your pharmacist
How much to take
Your doctor will decide the amount of medicine to give you.
• The most that should be taken is 5 to 10 ml (one to two teaspoons)
every four hours
Children 13 to 18 years
• The most that should be taken is 2.5 to 10 ml (half to two
teaspoons) every four hours
Children 6 to 12 years
• The most that should be taken is 2.5 to 5 ml (half to one
teaspoon) every four hours
Children 1 to 5 years
• The most that should be taken is 2.5 ml (half a teaspoon) every
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, an underactive adrenal or thyroid gland or prostate
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 ORAMORPH 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 ORAMORPH
• 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 ORAMORPH
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.
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 or erection problems
• Seeing or hearing things that are not there (hallucinations) or
• Muscles feeling tense
• The black circle in the centre of your eyes (pupil) getting smaller
• Dependence on ORAMORPH. This can happen with any morphine
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 (see details below). By reporting
side effects you can help provide more information on the safety of
Yellow Card Scheme
IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
5. HOW TO STORE ORAMORPH ORAL SOLUTION
Keep out of the reach and sight 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.
Do not store ORAMORPH above 25°C. Store in the original container
in order to protect from light.
Please return any remaining medicine to your pharmacist 3 months
after first opening.
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 ORAMORPH contains
• Each 5 ml contains 10 mg of morphine sulfate as the active
• The other ingredients are alcohol (ethanol), corn syrup, sucrose,
methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216) and purified water
What ORAMORPH looks like and content of the pack
ORAMORPH is a solution and is available in bottles of 100, 250,
300 and 500 ml. The bottles come in cartons.
4. POSSIBLE SIDE EFFECTS
Not all pack sizes may be marketed.
Like all medicines, ORAMORPH can cause side effects, although not
everybody gets them. The following side effects may happen with this
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for ORAMORPH is held by:
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 increased pressure inside
• 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
• 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
• Difficulty breathing (not linked to an allergic reaction)
Boehringer Ingelheim Limited, Ellesfield Avenue,
Bracknell, Berkshire, RG12 8YS, United Kingdom
and the solution is manufactured by:
Istituto de Angeli S.r.l. at:
Località Prulli Si Sotto n. 103/C, 50066 Reggello (FI), Italy
This leaflet was revised in June 2015.
© Boehringer Ingelheim Limited 2015
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.