Morphine Sulfate 15mg/ml Solution for Injection

• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor, pharmacist or nurse.
• 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.

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 should be given
4. Possible side effects
5. How to store Morphine Injection
6. Contents of the pack and other information

• are allergic to morphine sulfate or any of the other ingredients of this medicine (listed in section 6)
• have been told you have a tumour of the adrenal gland near your kidney called phaeochromocytoma
• have severe problems with breathing
• have increased pressure on the brain, have just had a head injury or if you are unconscious
• are suffering from acute alcoholism
• are at risk from a blocked intestine (paralytic ileus)
• have severe stomach cramps caused by a condition known as biliary colic
• are suffering from severe diarrhea.

Talk to your prescriber before taking this medicine if you:

• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs
• have previously suffered withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs
• feel you need to take more Morphine 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 prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.

Taking this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

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 use of how often you need to use it.

The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent 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 using Morphine Injection, it could be a sign that you have become dependent or addicted:

• you need to use the medicine for longer than advised by your doctor
• you need to use 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 using the medicine you feel unwell, and you feel better once using 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 treatment with Morphine Injection is stopped).

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 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.

Acute generalised 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 being given 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.

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 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.

Talk to your doctor if you experience any of the following symptoms when Morphine Injection is given to you:

• 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.

Talk to your doctor before Morphine Injection is given to you if you:

• are using drugs or have used drugs in the past
• suffer from asthma (your doctor may decide to administer Morphine Injection if your asthma is controlled. However, you should not be given this medicine if you are having an acute asthma attack)
• suffer from bronchitis (an inflammation of the lining of the tubes in the lungs, resulting in coughing spells accompanied by thick phlegm and breathlessness) or emphysema (a lung condition which leaves you struggling for breath)
• suffer from cor-pulmonale (a type of heart failure)
• are severely obese
• have a severely deformed spine
• are suffering from mental illness brought on by an infection
• have liver problems
• have kidney problems
• have problems with your bile duct
• suffer from an enlarged prostate gland (in men) or have difficulty passing urine
• have an under-active thyroid or adrenal gland
• have low blood pressure
• are in a state of severe shock
• are very run down
• have bowel disease, such as Crohn’s disease or ulcerative colitis
• suffer from blockages of the bowel
• suffer from convulsions (fits)
• are elderly
• are feeling weak and feeble.

If any of the above applies to you, speak to your doctor or nurse before Morphine Injection is given to you.

This medicine is not recommended for use in children.

Tell your doctor if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are taking any of the following:

• monoamine oxidase inhibitors (MAOIs) such as moclobemide or phenelzine used in the treatment of depression
• tricyclic antidepressants, which are used in the treatment of depression
• tranquillising drugs or sleeping tablets such as diazepam, nitrazepam and temazepam
• medicines used to treat mental illnesses, including schizophrenia (e.g. chlorpromazine, haloperidol)
• medicines used for diarrhoea (e.g. loperamide, kaolin)
• medicines which are used as premedication before operations and after heart attacks such as atropine
• medicines used to treat nausea and vomiting, such as metoclopramide or domperidone
• mexiletine, used to control heart rhythm
• some antihistamines, used to treat allergies, hayfever and asthma
• certain antibiotics, used to treat infections (e.g. ciprofloxacin and linezolid)
• selegiline, used in the treatment of Parkinson’s disease
• pethidine, used to treat pain
• rifampicin to treat e.g. tuberculosis
• gabapentin or pregabalin to treat epilepsy and pain due to nerve problems (neuropathic pain)
• 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.

You should not drink alcohol whilst being given Morphine Injection, as it will increase its effects.

Do not take 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 use Morphine Injection during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

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

If the injection makes you feel drowsy, do not drive or operate machinery.

This medicine can affect your ability to drive.

Do not drive whilst taking this medicine until you know how this medicine affects you.

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 http://www.gov.uk/drug-driving-law

Sodium metabisulfite may rarely cause severe hypersensitivity reactions and bronchospasm.

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 that an injection has been missed, speak to your doctor or nurse.

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 notice any of the following signs whilst taking 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 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 prescriber.

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. The injection is available in three strengths, 10mg/ml (10mg of active ingredient in 1ml of solution), 15mg/ml (15mg of active ingredient in 1ml of solution) and 30mg/ml (30mg of active ingredient in 1ml of solution).

The other ingredients are water for injections, sodium metabisulfite (E223), hydrochloric acid and sodium hydroxide.

Morphine Injection is a colourless or almost colourless solution, practically free from particles.

Morphine Sulfate 10mg/ml Solution for Injection is available in cartons containing 5 × 1ml glass ampoules and 10 × 1ml glass ampoules.

Morphine Sulfate 15mg/ml Solution for Injection is available in cartons containing 5 × 1ml glass ampoules and 10 × 1ml glass ampoules.

Morphine Sulfate 30mg/ml Solution for Injection is available in cartons containing 5 × 1ml glass ampoules and 10 × 1ml glass ampoules. It is also available in cartons containing 5 x 2ml ampoules.

Not all strengths and pack sizes may be marketed.

Other sources of information:

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Product Name Reference Number

Morphine Sulfate 10mg/ml Solution for Injection 29831/0146

Morphine Sulfate 15mg/ml Solution for Injection 29831/0145

Morphine Sulfate 30mg/ml Solution for Injection 29831/0147

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