Morphine Oral Concentrate 100mg/5ml
PACKAGE LEAFLET: INFORMATION FOR THE USER D00258
Morphine Oral Concentrate 100mg/5ml
Morphine Sulphate BP
Read all this leaflet carefully before you use Morphine Oral Solution
• Keep this leaflet. You may need to read it again
• If you have any further questions, please ask your doctor or pharmacist
• This medicine has been prescribed for you personally. 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 become 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 Oral Concentrate is and what it is used for
2. Before you take Morphine Oral Concentrate
3. How to take Morphine Oral Concentrate
4. Possible side effects
5. Storing Morphine Oral Concentrate
6. Further information
1. What Morphine Oral Concentrate is and what it is used for
Morphine is an alkaloid with powerful pain relieving properties.
This medicine is used for the relief of severe pain.
2. Before you take Morphine Oral Concentrate
You should not use Morphine Oral Concentrate if you:
• are allergic (hypersensitive) to Morphine or any of the ingredients of this medicine (listed in section 6)
• suffer from asthma, shallow breathing and other breathing difficulties
• are suffering from severe headaches or have suffered a head injury
• suffer from alcoholism
• suffer from a convulsive disorder (fits) such as epilepsy
• have had any liver or kidney problems for a long period of time
• are suffering from a problem that could cause paralysis of the small intestine (paralytic ileus)
• are taking or have recently taken any drugs used to treat depression known as Monoamine Oxidase Inhibitors (MAOI's) (see 'Taking other medicines)
• have been told you are suffering from a condition known
as delayed gastric emptying, the symptoms of which include heartburn, feeling sick or being sick and feeling full quickly whilst eating
• are suffering from severe stomach pains
• suffer from severe heart and lung problems
• suffer from a tumour of the adrenal gland known as phaeochromocytoma
Take special care with Morphine Oral Concentrate
Tell your doctor if you:
• suffer from problems related to your adrenal gland (the organ responsible for stress levels), including Addisons disease (an illness caused by a lack of the hormone cortisol which controls stress levels)
• have any lung problems, in particular emphysema (enlarged and damaged lungs)
• have any prostate problems
• have an under active or over active thyroid gland
• are elderly and suffer from an under active or over active thyroid, liver or kidney problems, the dose may need to be reduced
• have had an operation in the last 24 hours
• are extremely overweight
• suffer from spine problems
• think you may be in shock as there is a risk of coma
• suffer from problems with your pancreas
• suffer from a muscle disorder known as myasthenia gravis
• suffer from an irregular heartbeat
• have been told you suffer from a severe heart problem known as cor pulmonale
• suffer from bowel problems
• suffer from a skin condition known as myxoedema, caused by problems with your thyroid
Taking other medicines:
Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without prescription.
Morphine Oral Concentrate must not be used with drugs used to treat severe depression, such as phenelzine or moclobemide, or if you are within 2 weeks of discontinuing them.
These drugs are known as Monoamine Oxidase Inhibitors (MAOI's),
Other medicines which may interact with Morphine Oral Concentrate include:
• medicines for sleeping problems and anxiety, such as chloral, diazepam, nitrazepam, promethazine and barbiturates.
• CNS depressants (drugs that act on the brain and make you feel drowsy or faint). These include sleeping pills, antihistamines (medicines used to treat allergies) that make you drowsy, medicines used to treat certain mental disorders, other pain killers or a general anaesthetic.
• anaesthetics
• alcohol
• medicines to treat depression (trycyclic antidepressants) such as clomipramine
• medicines used for anxiety and sickness, or for treating mental disorders such as chlorpromazine, triflupromazine, perphenazine and thioridazine
• muscle relaxants such as dicyclomine and hyoscyamine
Pregnancy and breast-feeding:
Morphine Oral Concentrate should not be used during pregnancy (especially during the first three months) as Morphine is known to cross the placenta.
This medicine should also not be used whilst breast-feeding as Morphine is known to cross the placenta and be present in breast milk and it may cause respiratory problems in newborn babies.
Effects on the ability to drive and use machines:
This medicine can affect your ability to drive and operate machinery. Do not drive or operate machinery if you feel drowsy or cannot think clearly.
3. How to take Morphine Oral Concentrate
Your doctor will decide on the dose and duration of your therapy. Always follow the instructions of your doctor and pharmacist. If you are changing from other types or morphine medication your doctor may have to change your dose.
Taking this medicine
• Take this medicine by mouth
• Use the oral dosing pipette provided to measure your dose
• Place the pipette in the solution and squeeze the bulb so that liquid is drawn up into the pipette
• Draw the liquid into the pipette 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.
Continued overleaf
How much to take
Adults: Usual dose is 0.5ml to 1ml (10 - 20mg) every 4 hours Elderly and infirm patients: A reduced dose is recommended
Children: Under 1 year: not recommended.
1 to 5 years: maximum of 0.25ml
(5mg) every 4 hours
6 to 12 years: maximum of 0.25ml to 0.5ml
(5-10mg) every 4 hours
If you forget to take Morphine Oral Concentrate
If you have missed a dose take it as soon as you remember unless it is nearly time for your next dose. Then continue your normal dose times. Do not take a double dose.
If you take more Morphine Oral Concentrate than you should:
If you take too much of your medicine seek immediate medical advice from your doctor or your nearest hospital. Symptoms of an overdose include sudden or unexpected difficulty in breathing, pin-point pupils or a drop in blood pressure. In the case of infants and children they may suffer fits.
If you stop taking Morphine Oral Concentrate
You should not stop taking Morphine Oral Concentrate until advised to do so by your doctor. If you stop treatment too suddenly you may experience symptoms of withdrawal such as stomach pains, feeling sick and feeling anxious. Your doctor will advise you how to stop your treatment with Morphine Oral Concentrate.
4. Possible side effects
Like all medicines, Morphine Oral Concentrate can cause side effects but not everyone gets them.
Repeated use of morphine can result in tolerance and addiction
If any of the following symptoms occur contact your doctor or nearest accident and emergency department immediately. These are symptoms of a serious allergic reaction.
• sudden wheeziness and tightness of chest
• swelling of eyelids, face or lips
• skin lumps or hives
• skin rash (red spots), itchiness, fever
• collapse
Other side effects that may occur include:
• breathing difficulties
• confusion
• restlessness
• changes in mood
• drowsiness
• constipation
• dry mouth
• feeling sick (nausea)
• being sick (vomiting)
• facial flushing
• sweating
• a slow heartbeat
• palpitations (an irregular heart rhythm or missed beats)
• reduced blood pressure, the symptoms of which include feeling dizzy or light-headed, feeling weak and fainting
• feeling faint on standing up from a seated position
• difficulty passing urine
• lower abdomen spasms
• pin-point pupils
• a feeling of dizziness or spinning
• lower body temperature
• severe headache
• an itchy rash or redness
• loss of appetite
• indigestion
• worsening of a condition that affects the pancreas known as pancreatitis. The symptoms of this include stomach pain and feeling or being sick.
• changes in the way things taste
• seizures (fits).
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. Storing Morphine Oral Concentrate
Keep all medicines out of the reach and sight of children.
Do not use this product after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Keep container in the outer carton. Use within 6 months of first opening.
Do not store above 25°C
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 Oral Concentrate contains:
The active ingredient: Morphine Sulphate 2% w/v The other ingredients: sodium benzoate, carmoisine (E122), disodium edetate, hydrochloric acid and purified water
What Morphine Oral Concentrate looks like and contents of the pack:
Morphine Oral Concentrate is a clear, red solution supplied in amber glass bottles containing 30ml or 120ml. Each carton also contains a dropper to measure your dose with.
Marketing Authorisation Holder and Manufacturer:
Martindale Pharmaceuticals Ltd. Bampton Road, Romford, Essex, RM3 8UG, UK
Product Licence No.: PL 00156/0037 Date of Approval: 08/2009
MARTIN DALE
Pharmaceuticals
Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom
CO
LO
r^j
o
o
o