Morphine Sulfate 10 mg/ml solution for injection

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

This medicine contains morphine which is an opioid, which can cause addiction.

You can get withdrawal symptoms if you stop receiving it suddenly.

The name of your medicine is Morphine Sulfate 10 mg/ml solution for injection, which will be referred to as Morphine Injection throughout this leaflet.

What is in this leaflet

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

• are allergic to morphine or any of the other ingredients of this medicine (listed in section 6);
• have a breathing disorder
• have a head injury or raised pressure around your brain
• have a convulsive disorder (epilepsy) or suffer from fits (seizures)
• have acute alcohol poisoning (intoxication)
• suffer from liver or kidney failure
• have a narrowing of the tubes leading to your bladder
• have inflammation of your pancreas
• have impaired function of your gallbladder
• have an inflammation of your bowel or a bowel obstruction
• have low blood pressure with a lack of adequate circulatory filling
• suffer from an enlarged prostate gland
• have a thyroid problem
• have Phaeochromocytoma - a tumour of the adrenal gland
• are taking any of the antidepressant medicines known as monoamine oxidase inhibitors (MAOIs) or have taken them during the last two weeks
• are unconscious (coma).

Tell your doctor or nurse before being given Morphine Injection if you:

• have low blood pressure
• have an under-active thyroid gland
• have asthma or other breathing difficulties
• have kidney or liver disorders
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.

Talk to your doctor or nurse if you experience any of the following symptoms while using Morphine Injection:

• 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).
• 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 a hormone supplement.
• Loss of libido, impotence, cessation of menstruation. This may be because of decreased sex hormone production.

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 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 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 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 Injection).

Addiction can cause withdrawal symptoms when you stop receiving 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 prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop receiving 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. Overuse and misuse can lead to overdose and/or death.

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.

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

This medicine is not recommended for use in children under 12 years of age. If you have any concerns ask your doctor or pharmacist.

Tell your doctor or nurse if you are using or have recently used or might use any other medicines, including medicines obtained without a prescription. This is especially important if you are taking any of the medicines mentioned below:

• Rifampicin to treat e.g. tuberculosis
• Concomitant use of Morphine 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 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.

• Monoamine oxidase inhibitors - MAOIs (medicines used for depression) or if you have taken them during the last two weeks
• drugs that depress the nervous system (your doctor or pharmacist will know what these are).
• other painkillers - especially pentazocine, nalbuphine, or buprenorphine
• Gabapentin or pregabalin to treat epilepsy and pain due to nerve problems (neuropathic pain)
• muscle relaxants
• diuretics (water tablets) - drugs that increase urine excretion
• cimetidine - an anti-ulcer treatment
• antiarrhythmics - drugs to control heart rhythm or rate (e.g. mexiletine)
• drugs used to treat depression
• drugs used to treat anxiety
• medicines to help you sleep
• drugs for treatment of digestive tract disorders (e.g. cisapride)
• drugs used for Parkinson’s Disease
• drugs used to treat vomiting or indigestion (e.g. domperidone or metoclopramide)
• Some medicines used to treat blood clots (e.g. clopidogrel, prasugrel, ticagrelor) may have delayed and decreased effect when taken together with morphine.

Alcohol should be avoided during treatment.

You should not be given Morphine Injection 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 receive Morphine Injection during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

You should not be given Morphine Injection while you are breastfeeding as morphine passes into breast milk and will affect your baby.

You should not drive or use machinery while receiving Morphine Injection.

Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law

The medicine can affect your ability to drive 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 medicine contains less than 1 mmol sodium (23 mg) per each 1 ml ampoule, that is to say essentially ‘sodium-free’

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. 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 think you have been given too much, you must tell the person giving you the injection. Tell your doctor or nurse immediately if any of the following symptoms of overdose occur:

• shallow breathing
• blue skin
• contraction of the pupils
• feeling extremely sleepy
• muscle weakness
• cold and clammy skin
• very slow heart rhythm
• fall in blood pressure

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

• You need to take the medicine for longer than advised by your prescriber
• You feel you need to use more than the recommended dose
• You are using the medicine for reasons other than prescribed
• When you stop receiving 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 prescriber.

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse 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. 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. In Morphine Injection, each 1 ml of solution contains 10 mg of morphine sulfate.

The other ingredients are: sodium chloride, hydrochloric acid, water for injections and nitrogen.

Morphine Injection is a clear, colourless, sterile solution in a clear glass ampoule containing 1ml.