Morphine Sulfate 10mg in 1ml Solution for Injection

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

This medicine will be referred to as Morphine Sulfate Solution for Injection in the rest of this leaflet.

1. What Morphine Sulfate Solution for Injection is and what it is used for
2. Before you are given Morphine Sulfate Solution for Injection
3. How Morphine Sulfate Solution for Injection will be given
4. Possible side effects
5. How to store Morphine Sulfate Solution for Injection
6. Contents of the pack and other information

• you are allergic to Morphine or any of the other ingredients of this medicine (listed in section 6)
• you are currently taking drugs used to treat depression known as monoamine oxidase inhibitors (MAOIs) or have taken them in the last 2 weeks
• you suffer from breathing difficulties (asthma attack or chronic obstructive airways disease)
• you have suffered a head injury
• you suffer from alcoholism
• you suffer from heart problems
• you are suffering from stomach pains
• you are suffering from a tumour of the adrenal gland known as phaeochromocytoma
• you suffer from severe diarrhoea.

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 Solution for Injection 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 Solution for Injection 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 Solution for Injection, 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 Solution for Injection)

Talk to your doctor or pharmacist before being given Morphine Sulfate Solution for Injection if you:

• suffer from low blood pressure
• suffer from underactive thyroid or adrenal gland
• suffer from problems with your prostate gland and have difficulty passing urine
• suffer from any liver or kidney diseases
• suffer from fits
• suffer from asthma
• have bowel disease, such as Crohn’s disease or ulcerative colitis
• suffer from blockages of the bowel
• have problems with your bile duct

Talk to your doctor or pharmacist if you experience any of the following symptoms while being given Morphine Sulfate Solution for Injection:

• 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 Solution for Injection 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.
• Acute generalized exanthematous pustulosis (AGEP) has been reported in association with Morphine Sulfate Solution for Injection 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 Solution for Injection or other opioids. Stop using Morphine Sulfate Solution for Injection and seek medical attention immediately, if you notice any of the following symptoms: blistering, widespread scaly skin or pus-filled spots together with fever.

Morphine Sulfate Solution for Injection 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.

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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without prescription.

Please tell your doctor if you are taking any of the following medicines:

• medicines used to treat severe depression known as monoamine oxidase inhibitors (MAOIs) e.g. moclobemide. Tell your doctor even if you have stopped taking them within the last two weeks
• medicines used to help you to sleep (hypnotics) e.g. chloral and barbiturates
• medicines used to treat anxiety (anxiolytics) e.g. diazepam
• medicines used to treat bacterial infections e.g. ciprofloxacin and linezolid
• medicines used to control heart rhythm e.g mexiletine
• medicines used to treat pain e.g. pethidine
• medicines used in the treatment of Parkinson’s disease e.g. selegiline
• medicines used to treat depression e.g. tricyclic antidepressants
• medicines used to treat mental illness including schizophrenia e.g. chlorpromazine, haloperidol
• medicines used to treat allergies, hay fever and asthma e.g. antihistamines
• medicines used to treat diarrhoea e.g. Loperamide, kaolin
• medicines used as premedication before operations and after heart attacks e.g. atropine
• medicines used to treat nausea and vomiting e.g. metoclopramide, domperidone
• rifampicin to treat e.g. tuberculosis
• Some medicines used to treat blood clots (e.g. clopidogrel, prasugrel, ticagrelor) may have delayed and decreased effect when taken together with opium
• Gabapentin or pregabalin to treat epilepsy and pain due to nerve problems (neuropathic pain).
• concomitant use of Morphine Sulfate Solution for Injection 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 Sulfate Solution for Injection 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.

This medicine should not be used if you are pregnant, trying for a baby or breast-feeding.

Morphine is known to cross the placenta.

If Morphine Sulfate injection 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.

This medicine may cause drowsiness. If you are affected do not drive or use 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.

You are advised not to drink alcohol during your treatment with this medicine.

10 mg

This medicinal product contains 3.26 mg sodium per dose, equivalent to 0.16 % of the WHO recommended maximum daily intake of 2g sodium for an adult.

15 mg

This medicinal product contains 3.02 mg sodium per dose, equivalent to 0.15% of the WHO recommended maximum daily intake of 2g sodium for an adult.

20 mg

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’

30 mg

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’

The sodium metabisulfite may rarely cause severe hypersensitivity reactions and bronchospasm

This medicine will be given to you by your doctor so it is unlikely you will receive too much. Your doctor has information on how to recognise and treat an overdose.

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.

If you experience any of the following, tell your doctor immediately:

• difficulty in breathing
• pinpoint pupils
• low blood pressure
• feeling cold
• fits
• confusion
• severe drowsiness
• slow heartbeat
• severe nervousness or restlessness

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

Do not stop treatment with Morphine Sulfate Solution for Injection unless agreed with your doctor. If you want to stop the treatment with Morphine Sulfate Solution for Injection, 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 get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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.

The active ingredient: morphine sulfate.

Each ampoule contains 10, 15, 20 or 30 mg morphine sulfate.

The other ingredients: sodium chloride, sodium metabisulfite (E223) and water for injections. This medicine may also contain sodium hydroxide solution or sulfuric acid solution.

Morphine Sulfate Solution for Injection is a clear, colourless or almost colourless, particle free solution, supplied in clear, colourless 1ml glass ampoules. This medicine is supplied to your doctor in packs of 10 ampoules.

Product Licence Numbers:

PL 01883/6138. PL 01883/6176. PL 01883/6177.

PL 01883/6178