Patient leaflet - MORPHINE SULPHATE INJECTION 20 MG PER ML
Package Leaflet: Information for the patient
Morphine Sulphate Injection 20 mg per ml
- Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again
- If you have any 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.
The name of your medicine is Morphine Sulphate Injection 20 mg per ml, which will be referred to as Morphine Injection throughout this leaflet.
What is in this leaflet
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1. What Morphine Injection is and what it is used for
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2. What you need to know before you are given Morphine Injection
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3. How Morphine Injection is given
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4. Possible side effects
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5. How to store Morphine Injection
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6. Contents of the pack and other information
1. what morphine injection is and what it is used for
Morphine Injection belongs to a group of medicines known as painkillers (opiate analgesics). Morphine Injection is used to relieve severe or very severe pain.
2. what you need to know before you are given morphine injection are allergic to morphine injection or any of the other ingredients in this injection (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
- 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
- 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)
Warnings and precautions
Tell your doctor or nurse before being given the injection if you have:
- low blood pressure
- an under-active thyroid gland
- asthma or other breathing difficulties
- kidney or liver disorders
Other medicines and Morphine Injection
Please tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This is especially important with the following medicines as they may interact with your Morphine Injection:
- 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
- muscle relaxants
- diuretics (water tablets) – drugs that increase urine excretion
- Some medicines used to treat blood clots (e.g. clopidogrel, prasugrel, ticagrelor) may have delayed and decreased effect when taken together with morphine
- 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)
Children:
This medicine is not recommended for use in children under 12 years of age. If you have any concerns ask your doctor or pharmacist.
Alcohol:
Alcohol should be avoided during treatment.
Pregnancy and breast feeding:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine..
Please tell your doctor or nurse before being given this injection if you are breast feeding – this injection should not be used by nursing (breast feeding) mothers.
Morphine Injection contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per each 1 ml ampoule, that is to say essentially ‘sodium-free’
Driving and using machines:
You should not drive or use machinery while receiving Morphine Injection.
3. How Morphine Injection is given
Your nurse or doctor will give you the injection. Your doctor will decide the correct dosage for you and how and when the injection will be given. Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. 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
This medicine may cause dependence with long-term use. If your treatment is stopped too quickly then withdrawal symptoms may occur. Please tell your doctor or nurse if you think this is happening to you. However, when the dose of Morphine Injection is carefully adjusted to control pain, dependence and other side effects are rare.
4. possible side effects
Like all medicines, Morphine Injection can cause side effects, although not everybody gets them. All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor or nurse immediately if you get any sudden difficulties in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).
The following side effects have been reported:
Very common: may affect more than 1 in 10 people
- feeling sick (nausea)
- vomiting
- shallow breathing
- constipation
- sleepiness
- not knowing where you are (disorientation)
- itching
- sweating
- a perception of seeing or hearing things (hallucinations)
- uncomfortable mood
- feeling of very intense happiness and
well-being (euphoria)
- tolerance and dependence (with long-term treatment)
Common: may affect up to 1 in 10 people
- skin rash
- irregular skin patches and itching
- pain at injection site
- headache
- dizziness
- agitation
- fits
- impairment of taste
- mood changes
- changes in psychological functions and senses
- sleeplessness (insomnia)
- high pressure in your brain (you may have a headache and feel sick or vomit)
- involuntary trembling and quivering
- muscle cramps
- contraction of the pupils
- visual problems
- dry mouth
- stomach pain
- hiccups
- diarrhoea
- gallbladder spasms with stomach pain
- flushing
- chills
- slow or fast heartbeat
- high blood pressure
- heart failure
- fluid in the lungs
- spasms in the throat
- asthma-like symptoms
- decreased ability to cough
- problems with urination
- impotence
- swelling of the skin
- feeling hot or cold
- withdrawal symptoms
Uncommon: may affect up to 1 in 100 people
- severe allergic reactions after injection into a vein
5. how to store morphine injection
Your injection will be stored at less than 25°C and protected from light. The nurse or doctor will check that the injection is not past its expiry date before giving you the injection.
6. contents of the pack and other informationthe active substance is morphine sulphate. each 1 ml of solution contains 20 mg of morphine sulphate. the other excipients are sodium chloride, hydrochloric acid, water for injections and nitrogen.
What Morphine Injection looks like and contents of the pack:
Morphine Injection is a clear, colourless, sterile solution in a clear glass ampoule containing 1ml.
The marketing authorisation number of this medicine is: PL 01502 0065
Marketing Authorisation Holder:
hameln pharma ltd
Nexus, Gloucester Business Park
Gloucester, GL3 4AG, United Kingdom
Manufacturer:
hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln
Germany
For any information about this medicine, please contact the Marketing Authorisation Holder
This leaflet was last approved April 2021
EN-PL-UK.1
1.3.1. Pg. 4