Morphine Sulfate 1mg in 1mL Solution for Injection

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

1. What Morphine Sulfate Injection is and what it is used for
2. What you need to know before you use Morphine Sulfate Injection
3. How to use Morphine Sulfate Injection
4. Possible Side Effects
5. How to store Morphine Sulfate Injection
6. Contents of the pack and other information.

This medicine contains morphine sulfate which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop using it suddenly.

• Are allergic to morphine sulfate or any other strong painkilling drugs
• Have a history of alcohol abuse
• Suffer from malfunctioning of the adrenal gland (phaeochromocytoma)
• Have suffered a head injury
• Are at risk of a paralytic ileus (reduced gut motility)
• Have acute respiratory depression (breathlessness)
• Have raised pressure inside your skull

Check with your doctor if you are concerned about any of the above.

Talk to your doctor, pharmacist or nurse before using this medicine if you:

• Are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
• Have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
• Feel you need to take more Morphine Sulfate Injection to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your doctor, pharmacist or nurse who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.
• Are pregnant or breast feeding
• Have taken this medicine in the last two weeks
• Suffer from asthma, chronic bronchitis or have any other illness which causes breathing difficulties
• Suffer from kidney or liver problems
• Suffer from stomach or bowel problems
• Have difficulty in passing urine due to an enlarged prostate
• Suffer from bad headaches or feel sick
• Suffer from epilepsy or other fits
• Suffer from poor blood supply to the heart or other heart problems
• Have low blood pressure (hypotension)
• Have a tumour of the adrenal gland
• Suffer from myasthenia gravis
• Suffer from pain from gallstones (biliary colic)
• Suffer from thyroid problems
• Are elderly and/or debilitated
• Have increased sensitivity to pain despite the fact that you are using 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).
• Have 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.
• Suffer loss of libido, impotence, cessation of menstruation. This may be because of decreased sex hormone production.

Check with your doctor if you are concerned about any of the above. This medicine is only suitable for long lasting pain and is not intended for pain which only lasts for short periods.

Using this medicine regularly, particularly for a long time, can lead to addiction. Your doctor, pharmacist or nurse should have explained how long you will be using it for and when it is appropriate to stop, how to do this safely.

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your doctor, pharmacist or nurse about your treatment.

Addiction can cause withdrawal symptoms when you stop using 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, pharmacist or nurse will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop using 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. Using higher doses, or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

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 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 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 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 Injection).

Take special care with Morphine Sulfate Injection:

Acute generalized exanthematous pustulosis (AGEP) has been reported in association with Morphine Sulfate 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 Injection or other opioids. Stop using Morphine Sulfate 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.

Sleep-related breathing disorders

Morphine Sulfate 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 using, have recently used or might use any other medicines.

This is especially important if you are taking any of the medicines mentioned below or medicines for:

• Rifampicin to treat e.g. tuberculosis
• Concomitant use of Morphine Sulfate 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 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.
• Are taking gabapentin or pregabalin to treat epilepsy and pain due to nerve problems (neuropathic pain)
• Are taking medicines to treat depression
• Are taking medicines for sickness (phenothiazines), for drying secretions (anticholinergics e.g. hyoscine) or other pain killers
• Have taken one of a group of drugs called monoamine oxidase inhibitors (used to treat depression) within the last two weeks
• Are taking anti-psychotics, cimetidine, domperidone or metoclopramide
• Are taking esmolol, mexiletine or ritonavir
• Some medicines used to treat blood clots (e.g clopidogrel, prasugrel, ticagrelor) may have delayed and decreased effect when taken together with morphine.

Do not use Morphine Sulfate Injection if you are pregnant or think you might be pregnant unless you have discussed this with your doctor, pharmacist or nurse and the benefits of treatment are considered to outweigh the potential harm to the baby.

If you use Morphine Sulfate Injection during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Do not use Morphine Sulfate Injection while you are breastfeeding as morphine sulfate passes into breast milk and will affect your baby.

You must not use machinery whilst using this medicine.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

• Do not drive while using 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 instruction given by the doctor, pharmacist or nurse 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 using this medicine.

This medicine contains 3.6mg sodium (main component of cooking/table salt) in each mL. This is equivalent to 0.2% of the WHO recommended daily intake of 2g sodium for an adult.

Tell your doctor as soon as possible. If you are a medical practitioner administering this medicine please refer to the Summary of Product Characteristics.

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.

The dose should be given as soon as it is remembered. The next dose should be given at the usual time. Do not take a double dose to make up for a forgotten dose.

Do not suddenly stop using this medicine. If you want to stop using this medicine, discuss this with your doctor, pharmacist or nurse 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 using this medicine.

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

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

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

Tell your doctor, nurse or pharmacist immediately if you think you have any of these, or other problems.

Further side effects can occur during long-term treatment with this medicine. These side effects include:

• Difficulty in urinating or unable to pass urine
• Hallucinations
• Colic
• Contractions of the pupils
• Dry mouth
• Restlessness
• Sweating/ facial flushing
• Mood changes
• Headache
• Decreased libido
• Palpitations
• Disruption of the menstrual cycle
• Slowed heartbeat
• Reduced blood pressure
• Spasm of the airways
• Changes in taste
• Fitting
• Recurrence of pancreatitis
• Uncontrolled movement of the eyes
• Fluid retention
• Increased blood pressure
• Loss of weight due to poor eating
• Total or partial bowel blockage
• Muscle jerk
• Muscle twitch
• Infertility
• Severe muscle pain
• Difficulty in coughing
• Depression
• Lack of strength in muscles
• Inability to obtain or sustain an erection of the penis
• Decreased effectiveness
• Increased sensitivity to the pain
• Reduced adrenal gland function

If you get any side effects, talk to your doctor, nurse or pharmacist. 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.

• The active substance is morphine sulfate at a strength of 1mg in 1mL.
• The other ingredients are Sodium Chloride and Water for Injections.

This medicine is a clear and colourless or almost colourless solution. This medicine is available in 1mL, 5mL and 10mL ampoules, and 50mL single use vials. The medicine is packed into cartons containing 10 ampoules, 1 vial or 10 vials. Both pack sizes of vials may not be available at the same time.