What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

Morphine 10mg/5ml Oral Solution

PACKAGE LEAFLET: INFORMATION FOR THE USER

Morphine 10mg/5ml Oral Solution

Morphine Sulfate

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

  • Keep this leaflet, you may need to read it again
  • If you have any further questions, please ask your doctor, pharmacist or nurse.
  • If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is In this leaflet:

1. What Morphine Oral Solution is and what it is used for
2. What you need to know before you take Morphine Oral Solution
3. How to take Morphine Oral Solution
4. Possible side effects
5. How to store Morphine Oral Solution
6. Contents of the pack and other information

1. What Morphine Oral Solution is and what it is used for

Morphine is an alkaloid with powerful pain relieving properties. It belongs to a group of medicines called ‘opioid analgesics’.

This medicine is used for the relief of severe pain.

2. What you need to know before you are given Morphine Oral Solution

Do not take Morphine Oral Solution if:

  • you are allergic (hypersensitive) to Morphine sulfate or any of the ingredients of this medicine (listed in section 6).
  • 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 recently had a head injury
  • you are addicted to alcohol or have recently consumed large amount of alcohol
  • you have fits (convulsions) or increased pressure inside your skull
  • you have sudden or recent liver problems
  • you have paralytic ileus (loss of intestinal movement)
  • you are taking or have in the last two weeks taken medication to treat depression such as Monoamine-Oxidase Inhibitors (MAOI’s) (see ‘Taking other medicines’)
  • you have something called ‘phaeochromocytoma’. This is a rare tumour which is not malignant
  • the person taking this medicine is in a deep and prolonged unconscious state (coma)

Do not take this medicine if any of the above applied to you If you are not sure, talk to your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking Morphine Oral Solution if:

  • you are pregnant, trying to become pregnant or if you are breast-feeding
  • You have a particular lung problem that causes shortness of breath called emphysema
  • you are a man who has prostate problems
  • you have an under-active adrenal gland (adrenocortical insufficiency)
  • you have asthma
  • you have gall-bladder problems
  • you have long term (chronic) liver or kidney problems
  • you have an under-active thyroid gland or swelling of your skin (myxoedema)
  • you have had an operation in the last 24 hours
  • you are extremely overweight
  • your spine is unusually curved (kyphoscoliosis)
  • you have shock (circulatory failure)
  • you suffer from bowel problems

Talk to your doctor, pharmacist or nurse if you experience any of the following symptoms while taking Morphine Oral Solution:

  • Increased sensitivity to pain despite the fact that you are taking increasing doses (hyperalgesia). Your doctor will decide whether you will need a change in dose or a change in strong analgesic (“painkiller”), (see section 2).
  • Weakness, fatigue, lack of appetite, nausea, vomiting or low blood pressure. This may be a symptom of the adrenals producing too little of the hormone cortisol, and you may need to take hormone supplement.
  • Loss of libido, impotence, cessation of menstruation. This may be because of decreased sex hormone production.
  • If you have once been dependent on drugs or alcohol. Also tell if you feel that you are becoming dependent on Morphine Sulfate while you are using it. You may have started to think a lot about when you can take the next dose, even if you do not need it for the pain.
  • Abstinence symptoms or dependence. The most common abstinence symptoms are mentioned in section 3. If this occurs, your doctor may change the type of medicine or the times between doses.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Morphine Oral solution.

Other medicines and Morphine Oral Solution

Tell your doctor if you are taking or have recently taken any other medicines, including those obtained without prescription. This includes medicine that you buy without a prescription and herbal medicines. This is because Morphine Oral Solution can affect the way some other medicines work. Also some other medicines can affect the way Morphine Oral Solution works. Morphine Oral Solution 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).

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, anaesthetics, hypnotics, sedatives, antipsychotics, tricyclic antidepressants (clomipramine) and alcohol
  • CNS depressants (drugs that act on the brain to cause drowsiness)
  • medicines for controlling heart rhythm such as esmolol and mexiletine
  • medicines to treat stomach ulcers, indigestion or heartburn such as cimetidine
  • medicines for feeling sick (nausea) and being sick (vomiting) such as domperidone, metoclopramide or phenothiazide
  • medicines to treat HIV infections such as ritonavir
  • medicines used to treat fungal infections such as voriconazole
  • medicines to treat epilepsy and long lasting pain caused by damage to the nerves such as gabapentin
  • medicines to treat tuberculosis and other infections such as Rifampicin
  • Concomitant use of Morphine Oral solution and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However if your doctor does prescribe Morphine Oral solution together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

Taking Morphine Oral Solution with alcohol

You should avoid alcohol whilst taking this medicine.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. If you take this medicine during pregnancy or while breast-feeding, it may slow down the baby’s breathing. If Morphine Oral Solution is used for a long time during pregnancy, there is a risk of the new-born child having drug withdrawal (abstinence) symptoms which should be treated by a doctor.

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

This medicine can affect your ability to drive and operate machinery as it may make you sleepy or dizzy.

  • Do not drive while taking this medicine until you know how it affects you.
  • 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 problem and
    • 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.

This effect is even more enhanced, when used in combination with alcohol or CNS depressants (medicines for sleeping disorders and anxiety). Do not drive or operate machinery if you feel drowsy or cannot think clearly.

Important information about some of the ingredients:

  • If you have been told by your doctor that you have an intolerance to some sugars (sucrose), contact your doctor before taking this medicinal product
  • sodium propyl hydroxybenzoate (E217) and sodium methyl hydroxybenzoate (E219) may cause an allergic reaction which could be delayed. Although rare, you may have difficulty breathing.
  • Morphine Oral Solution contains alcohol which may be harmful to those suffering from alcoholism. The amount of alcohol should also be considered if you are pregnant or breast-feeding, have long term (chronic) liver problems or epilepsy, or if you are a child.
  • This medicine contains less than 1mmol sodium (23mg) per 1ml. that is to say essentially ‘sodium-free’.

3. How to take Morphine Oral Solution

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 of morphine medication your doctor may have to change your dose.

This medicine is for oral use

Adults: Recommended dose is one or two 5ml spoonfuls (10-20mg) every 4 hours

Elderly and infirm patients: A reduced dose is recommended

Children: 13 to 18 years: Recommended dose is half or two 5ml spoonfuls (5-20mg) every 4 hours

6 to 12 years: Recommended dose of is half or one 5ml spoonfuls (5-10mg) every 4 hours

1 to 5 years: recommended dose is half a 5ml spoonful (5mg) every 4 hours

Under 1 year: not recommended

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 under active thyroid 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 Morphine 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. Symptoms of an overdose include sudden or unexpected difficulty in breathing, pin-point pupils (the black circle in the centre of your eyes (pupil) getting smaller) or a drop in blood pressure. In the case of infants and children they may suffer fits (convulsions).

People who have taken an overdose may get pneumonia from inhaling vomit or foreign matter, symptoms may include breathlessness, cough and fever.

People who have taken an overdose may also have breathing difficulties leading to unconsciousness or even death.

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.

If you forget to take Morphine Oral Solution

  • 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.
  • 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 Oral Solution

Do not stop treatment with Morphine Oral Solution unless agreed with your doctor. If you want to stop the treatment with Morphine Oral Solution, ask your doctor how to slowly decrease the doses so you avoid abstinence symptoms. Abstinence symptoms may include body aches, tremors, diarrhoea, stomach pain, nausea, flu-like symptoms, fast heartbeat and large pupils. Psychological symptoms include an intense feeling of unsatisfaction, anxiety and irritability.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible Side Effects

Like all medicines, Morphine Oral Solution can cause side effects but not everyone gets them.

Repeated use of morphine can result in tolerance and addiction

Allergic reaction

If you have a severe allergic reaction, stop taking this medicine and see and doctor straight away. Signs may include swelling of the mouth and face, difficult 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 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
  • Difficulty breathing (not linked to an allergic reaction)

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 feeling confused
  • Muscles feeling tense
  • The black circle in the centre of your eyes (pupil) getting smaller (miosis)
  • An increased sensitivity to pain
  • Abstinence symptoms or dependence (for symptoms see section 3: If you stop taking Morphine Oral Solution).

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Morphine Oral Solution

Keep this medicine out of the sight and reach 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 90 days of first opening.

Do not store above 25°C. Store in the original container in order to protect from light.

Please return any remaining medicine to your pharmacist 90 days 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. Contents of the pack and other Information

What Morphine Oral Solution contains:

Active ingredient: Morphine Sulfate Ph Eur 10mg in each 5ml of solution.

Other ingredients: sugar (sucrose), alcohol, disodium edetate, sodium propyl hydroxybenzoate (E217), sodium methyl hydroxybenzoate (E219), raspberry flavour, purified water and may include hydrochloric acid.

Each 5ml dose of this solution contains 0.4ml of alcohol and 2.25g of sugar.

What Morphine Oral Solution looks like and contents of the pack:

The clear, colourless solution is supplied in amber glass bottles containing 100ml, 250ml, 300ml or 500ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Martindale Pharmaceuticals Ltd
Bampton Road
Romford
Essex
RM3 8UG
UK

Product Licence No.: PL 00156/0036

This leaflet was last revised in: October 2018

MARTINDALE PHARMA
Bampton Road
Harold Hill
Romford
RM3 8UG
UK

The following information is intended for healthcare professionals only:

Physicochemical incompatibility (formation of precipitates) has been demonstrated between solutions of morphine sulphate and 5- fluorouracil

D04501