Morphine Sulphate injection BP 30 mg/ml – patient leaflet, side effects, dosage

1. What Morphine Sulfate Injection is and what it is used for

This medicine has been prescribed for you for the treatment of severe pain, to help with breathing which becomes difficult because fluid has collected in the lungs (pulmonary oedema) due to heart failure. It can also be given prior to having an operation. It contains morphine sulfate which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. 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.

2. What you need to know before you take Morphine Sulfate Injection

You must not be given Morphine Sulfate Injection if you:

• 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 diarrhoea.

Morphine Sulfate is never given to patients in a coma.

If any of the above applies to you, do not use this medicine and talk to your doctor or nurse.

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.

Warnings and precautions

Talk to your doctor or pharmacist before you are given Morphine Sulfate Injection 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 of morphine sulfate 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.

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.

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 prescriber 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. Overuse and misuse can lead to overdose and/or death.

Take Special care with morphine sulfate injection:

Acute generalized exanthematous pustulosis (AGEP) has been reported in association with Morphine sulfate 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.

Talk to your doctor or pharmacist before if you experience any of the following symptoms while using Morphine sulphate 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 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.

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.

Children

This medicine is not recommended for use in children.

Other medicines and Morphine Sulfate Injection

Tell your doctor if you are taking, have recently taken or might take any other medicines. This is especially important if you are taking any of the medicines mentioned below or medicines for:

• 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.
• Anticholinergic drugs to relax smooth muscle and regulate the heart rate e.g. atropine
• Any other medicine, including medicines obtained without a prescription;
• Tricyclic antidepressants, which are used in the treatment of depression;
• 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
• Concomitant use of Morphine Sulfate 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 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.
• Some medicines used to treat blood clots (e.g. clopidogrel, prasugrel, ticagrelor) may have delayed and decreased effect when taken together with morphine.
• Gabapentin or pregabalin to treat epilepsy and pain due to nerve problems (neuropathic pain).

If any of the above applies to you talk to your doctor or nurse.

Morphine Injection with food, drink and alcohol

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

Pregnancy and breast-feeding

Pregnancy

Do not take Morphine Sulfate 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 morphine 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.

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 take Morphine Sulfate Injection while you are breastfeeding as morphine sulfate passes into breast milk and will affect your baby.

Driving and using machines

Morphine Sulfate Injection may cause drowsiness. If this happens to you, do not drive or use machinery.

Do not drive whilst using 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.

Information on sodium content: This medicine contains less than 1 mmol sodium (23 mg) per unit volume, that is to say essentially ‘sodium-free’.

Sodium metabisulfite: May rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Morphine Sulfate Injection

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using morphine sulfate injection, when and how long you need to take it, when to contact your doctor, and when you need to stop it (see also, If you stop taking morphine sulfate injection, in this section).

Morphine Sulfate injection will be given to you by a doctor or nurse in hospital. Your doctor will choose the dose that is right for you. Your prescriber should have discussed with you, how long the course of injection will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.

The following information is intended for healthcare professionals only:

Physicochemical incompatibility (formation of precipitates) has been demonstrated between solutions of morphine sulphate and 5- fluorouracil.

Recommended dose:

Adults

• The recommended adult dose for relief of pain by subcutaneous injection (an injection underneath the skin) or intramuscular injection (an injection into a muscle) is 10mg every four hours, if necessary;
• However, the amount may range from 5 mg to 20 mg depending on how severe your pain is and how you respond to the drug;
• For severe pain your doctor may give you a slow intravenous injection (an injection given slowly into a vein), the recommended dose for an adult is 2.5 mg to 15 mg with at least 4 hours between doses;
• Your doctor or nurse may adjust the dose of your medicine and the number of injections you are given each day until your pain is relieved.

Elderly

If you are elderly, severely run down including feeling weak and feeble, or have liver and kidney problems the dose will be lower. You may also be given a reduced dose if you suffer from any of the conditions listed in section 2 entitled “Talk to your doctor or pharmacist before Morphine Injection is given to you if you:”

Children

Morphine Sulfate Injection is not for use in children.

If you think you have been given more Morphine Sulfate Injection than you should

As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too little or too much, however, tell your doctor or nurse if you have any concerns. Symptoms of serious overdose include breathing difficulties, low blood pressure with your heart finding it difficult to pump blood around your body, a deepening coma, feeling cold, fits especially in infants and children and rapid break down of muscle tissue progressing to kidney failure.

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 have these symptoms, you will be given another medicine called Naloxone to reverse the effects of Morphine Sulfate Injection.

If you miss a dose of Morphine Injection

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.

If you stop taking Morphine sulphate injection

Do not stop treatment with Morphine Sulphate injection unless agreed with your doctor. If you want to stop the treatment with Morphine Sulphate injection, ask your doctor how to slowly decrease the doses so you avoid abstinence symptoms. Abstinence symptoms may include such as body aches, , difficulty sleeping, agitation, feeling your heartbeat (palpitations), large pupils, increased blood pressure, feeling or being sick (nausea), diarrhoea, stomach pain, shaking (tremors), shivering or sweating, flu-like symptoms. Psychological symptoms include an intense feeling of unsatisfaction, anxiety and irritability.

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

4. Possible side effects

Like all medicines this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse immediately if you experience the following serious side effect:

• Serious allergic reaction which causes difficulty in breathing, dizziness, shock or low blood pressure. If you suffer such a reaction, you should not be given any more morphine. Your doctor will decide on the appropriate treatment for allergic reactions.

• Severe skin reaction with blistering, widespread scaly skin, pus-filled spots together with fever. This could be a condition called Acute Generalized Exanthematous Pustulosis (AGEP).

  Difficulty in breathing and physical and psychological dependence are possible serious side effects. It is possible that you could become dependent on morphine (for symptoms see section 3: If treatment with Morphine Injection is stopped).

Other possible side effects:

Side effects that are common include (may affect up to 1 in 10 people):

• Drowsiness;
• Feeling sick or being sick;
• Constipation;
• Dizziness.

Apart from constipation, these side effects tend to disappear with time.

Side effects that are uncommon include (may affect up to 1 in 100 people):

• Sweating;
• Feeling faint on standing up;
• Small pupils (in the eye);
• Blurred vision;
• Double vision or other changes in vision;
• Mental clouding or confusion;
• Mood changes, feeling extremely happy for no particular reason, or a feeling of emotional and mental unease (dysphoria);
• Imagining things (hallucinations);
• Headache;
• Vertigo;
• Facial flushing;
• Dry mouth;
• Difficulty or pain in passing urine;
• Passing less urine than usual;
• Biliary spasm (causing pain in the right side of your abdomen, particularly after eating a meal, which may spread towards your right shoulder);
• Palpitations (being aware of your heart beat);
• Slower or faster pulse;
• Skin rash;
• Wheals (lumpy, red rash) or itching;
• Red, itchy, scaly skin at the injection site;
• Pain and irritation at the injection site;
• Reduced sexual drive or impotence after long term use;
• Muscle twitching.
• An increased sensitivity to pain

Side effects with an not known frequency (frequency cannot be estimated from the available data)

• Abstinence symptoms or dependence (for symptoms see section 3: If you stop taking

  Morphine Sulphate).and addiction (see section “How do I know if I am addicted?”).

• 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.

  Drug Withdrawal

  When you stop taking Morphine Sulfate Injection, 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.

How do I know if I am addicted?

If you notice any of the following signs whilst taking morphine sulfate, 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.

Reporting of side effects

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.

5. How to store Morphine Sulfate Injection

• Keep this medicine out of the sight and reach of children.

• Do not use Morphine Sulfate Injection after the expiry date which is stated on the carton.

  The expiry date refers to the last day of that month.

• Do not store above 25°C. Keep the ampoule in the outer carton to protect from light.
• Your doctor or nurse will make sure your medicine is correctly stored and disposed of.

6. Contents of the pack and other information

What Morphine Sulfate Injection contains

• The active substance is morphine sulfate 10 mg, 15 mg or 30 mg in each 1 ml of solution.
• The other ingredients are sodium metabisulphite (E223), sodium hydroxide, sulphuric acid and water for injections.

What Morphine Sulfate Injection looks like and content of the pack

Morphine Sulfate Injection is a sterile solution for injection in a clear glass container called an ampoule.

Morphine Sulfate Injection comes in cartons of 5 or 10 ampoules containing either 10 mg/ml, 15 mg/ml, 30 mg/ml and 60 mg/2 ml. Morphine Sulfate

Injection also comes in ampoules attached to an adhesive vinyl label packed in cartons of 5 or 10 ampoules containing 10 mg/ml, 15 mg/ml or 300 mg/10ml packed in a carton of 1 ampoule. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bristol Laboratories Ltd.,

Unit 3, Canalside, Northbridge Road,

Berkhamsted, Hertfordshire,

HP4 1EG, United Kingdom

Manufacturer

Recipharm Limited, Vale of Bardsley Ashton-under-Lyne, Lancashire, OL7 9RR, UK

Morphine Sulfate Injection 10 mg in 1 ml; PL 17907/0597

Morphine Sulfate Injection 15 mg in 1 ml; PL 17907/0598

Morphine Sulfate Injection 30 mg in 1 ml; PL 17907/0599

This leaflet was last updated May 2024.

To request a copy of this leaflet in braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.