Oramorph Oral Solution 10 mg/5 ml
(morphine sulphate)
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 troublesome or serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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
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 sulphate. This belongs to a group of medicines called ‘opioid analgesics’
- It is used to relieve severe pain
Before You Take Oramorph Oral Solution
Do not take ORAMORPH if:
- You are allergic (hypersensitive) to morphine sulphate 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 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 ORAMORPH
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 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 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 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 withdrawal.
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.
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
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 normal
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
- 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.
Adults
- The usual dose is 5 to 10 ml (one 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 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 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 breath 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.
Possible Side Effects
Like all medicines, ORAMORPH 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
- Your 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 ORAMORPH. This can happen with any morphine product
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.
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.
Further Information
What ORAMORPH contains
- Each 5 ml contains 10 mg of morphine sulphate as the active ingredient
- 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.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for ORAMORPH is held by:
and the solution is manufactured by:
This leaflet was revised in April 2009.
© Boehringer Ingelheim Limited 2009
437736/GB/10
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