Morphine Sulfate 10mg/5ml Oral Solution

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.

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

• If you are allergic (hypersensitive) to morphine sulfate or any of the other ingredients of this medicine (listed in Section 6 below)
• If you have problems with your lungs or breathing such as ‘hypoventilation’ or ‘Chronic Obstructive Pulmonary Disease’ (COPD)
• If you are having an asthma attack
• If you have sudden or recent liver problems
• If you have recently had a head injury
• If you have something called ‘phaeochromocytoma’. This is a rare tumour which is not malignant
• If you have fits (convulsions) or increased pressure inside your skull
• If the person taking the medicine is in a deep and prolonged unconscious state (coma)
• If you are addicted to alcohol or have recently consumed large amounts of alcohol
• If you are taking or have in the last two weeks taken medication to treat depression such as monoamine-oxidase inhibitors (MAOIs)
• If 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.

Tolerance, dependence, and addiction

This medicine contains morphine which is an opioid medicine.

Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Morphine Sulfate Oral Solution can also lead to dependence, abuse, and addiction, which may result in life-threatening overdose.

The risk of these side effects can increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Morphine Sulfate Oral Solution if:

• You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”)
• You are a smoker
• You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs whilst taking Morphine Sulfate Oral Solution, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor
• You need to take more than the recommended dose
• You are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’).

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (see section 3, If you stop taking Morphine Sulfate 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”),
• Weakness, fatigue, lack of appetite, nausea, vomiting or low blood pressure. This may be a symptom of your adrenal glands producing too little of a hormone called cortisol, and you may need to take a hormone supplement
• Loss of libido (sex drive), difficulty getting an erection, menstrual periods stopping. This may be because of your body producing less sex hormones.

Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your doctor will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.

Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else.

Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment. Overuse and misuse can lead to overdose and/or death.

Acute generalised exanthematous pustulosis (AGEP) has been reported in association with Morphine Sulfate Oral Solution treatment. Symptoms usually occur within the first 10 days of treatment. Tell your doctor if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Morphine Sulfate Oral Solution or other opioids. Stop using Morphine Sulfate Oral Solution and seek medical attention immediately, if you notice any of the following symptoms: blistering, widespread scaly skin or pus-filled spots together with fever.

Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system.

Morphine Sulfate Oral Solution can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

• If you are pregnant, trying to become pregnant or if you are breast-feeding
• If you have had an operation within the last 24 hours
• If you have a particular lung problem that causes shortness of breath called emphysema or you have heart failure
• If you have shock (circulatory failure)
• If you have asthma
• If you have gall bladder problems
• If you have long term (chronic) liver or kidney problems
• If you are a man who has prostate problems
• If you have an under-active thyroid gland or swelling of your skin (myxoedema)
• If your spine is unusually curved (kyphoscoliosis)
• If you have bowel problems
• If you have an under-active adrenal gland (adrenocortical insufficiency)
• If you are very overweight
• If you are or have ever been addicted to opioids, alcohol, prescription medicines or illegal drugs
• If you have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.

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

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 Morphine Sulfate Oral Solution can affect the way some other medicines work. Also some other medicines can affect the way Morphine Sulfate Oral Solution 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
  • Taking Morphine Sulfate Oral Solution with 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, taking Morphine Sulfate Oral Solution should only be considered when other treatment options are not possible. However if your doctor does prescribe Morphine Sulfate 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
• 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
• Some medicines used to treat blood clots (e.g. clopidogrel, prasugrel, ticagrelor) may have delayed and decreased effect when taken together with opium
• Cimetidine - for stomach ulcers, indigestion or heartburn
• Monoamine oxidase inhibitors (MAOIs) - for depression
• Rifampicin – used to treat tuberculosis and other infections
• Gabapentin or pregabalin – to treat epilepsy and pain due to nerve problems (neuropathic pain).

You should avoid alcohol whilst taking this medicine.

Do not take Morphine Sulfate Oral Solution if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby. If you use Morphine Sulfate Oral Solution during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Do not take Morphine Sulfate Oral Solution while you are breast-feeding as morphine sulfate passes into breast milk and will affect your baby.

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.

You may feel drowsy while taking this medicine. If this happens, do not drive or use any tools or machines.

It may be an offence to drive if your ability to drive safely is affected. There is further information for patients who are intending to drive in Great Britain – go to https://www.gov.uk/drug-driving-law

Additional information for patients in the UK:

• 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.

• Sucrose and Glucose: This product contains 3g sucrose and 1g of glucose in each 10 ml dose. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. May be harmful to the teeth.
• Methyl parahydroxybenzoate (E218) and propylparahydroxybenzoate (E216): These may cause allergic reactions in some people that could occur sometime 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.

• Take this medicine by mouth only
• Use the oral syringe provided to measure your dose
• Place the bottle adaptor into the bottle neck then place the syringe in the solution and pull the white plunger up so that liquid is drawn up into the syringe
• 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.

Do not drink directly from the bottle as this may result in you taking the incorrect dose (too little or too much) Taking too much may result in an overdose with potential for serious consequences including unconsciousness and even death.

Your doctor will decide the amount of medicine to give you. The recommended doses are:

Adults

• The most that should be taken is 5 to 10ml every four hours

Paediatric population

Children 13 to 18 years

• The most that should be taken is 2.5 to 10 ml every four hours

Children 6 to 12 years

• The most that should be taken is 2.5 to 5 ml every four hours

Children 1 to 5 years

• The most that should be taken is 2.5 ml 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, 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 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.

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

In more severe cases, very high doses could cause your blood circulation and breathing 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 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.

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum.

Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

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 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)
• Dry mouth or sweating
• Seeing or hearing things that are not there (hallucinations) or feeling confused
• Increased sensitivity to pain
• Dependence and addiction (see section “How do I know if I am addicted”).

When you stop taking Morphine Sulfate Oral Solution, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

If you notice any of the following signs whilst taking Morphine Sulfate Oral Solution, it could be a sign that you have become addicted.

• You need to take the medicine for longer than advised by your doctor
• You feel you need to use more than the recommended dose
• You are using the medicine for reasons other than prescribed
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again.

If you notice any of these signs, it is important you talk to your doctor.

• Feeling sick (nausea) or being sick (vomiting)
• Constipation, which can be treated with appropriate laxatives
• Difficulty in passing water (urine)
• Feeling drowsy
• 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
• Muscles feeling tense
• The black circle in the centre of your eyes (pupil) getting smaller (miosis)
• Sleep apnoea (breathing pauses during sleep)
• Symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system, e.g. severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever.

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, Website: 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.

• Each 5ml contains 10 mg of morphine Sulfate as the active ingredient
• The other ingredients are Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216), Sucrose, liquid glucose, Sodium hydroxide solution (for pH adjustment), Hydrochloric acid solution (for pH adjustment) and Purified water.

Morphine Sulfate 10mg/5ml Oral Solution is a clear colourless to pale yellow solution. The solution may become more yellow over time. The finished product is packed in either 100ml, 250ml, 300ml or 500ml amber soda glass bottles fitted with a 28mm white, polypropylene, push and turn, tamper evident cap.

In addition the product is supplied with a 5ml dispensing oral syringe and bottle adaptor.

Not all pack sizes may be marketed.

Other sources of information:

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).

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Product name Reference number

Morphine Sulfate 10mg/5ml Oral Solution 29831/0563

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