Morphine Sulphate Injection 15 Mg Per Ml
Morphine Sulphate Injection 15 mg per ml
Patient Information Leaflet
Important information about your medicine
Important information about your medicine f Your doctor or nurse will give you the injection.
f If this injection causes you any problems talk to your doctor, nurse or pharmacist. f Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to any of the ingredients of this medicine.
f Please tell your doctor or pharmacist, if you are taking any other medicines.
• Read all of this leaflet carefully before you start using this medicine. In some circumstances this may not be possible and this leaflet will be kept in a safe place should you wish to read it.
• Keep this leaflet. You may need to read it again
• If you have any further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
The name of your medicine is Morphine Sulphate Injection 15 mg per ml, which will be referred to as Morphine Injection throughout this leaflet.
Where to find information in this leaflet
1. What Morphine Injection is and what it isused for
2. Before you are given Morphine Injection
3. How to use Morphine Injection
4. Possible side effects
5. Storing Morphine Injection
6. Further 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. Before you are given Morphine Injection
You should NOT be given Morphine Injection if you:
• are sensitive or allergic to Morphine Injection or any of the other ingredients in this injection (see the list of ingredients 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)
Please 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
Using other medicines:
Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 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
• 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 or breast feeding:
Please tell your doctor or nurse before being given this injection if you are pregnant. The doctor will then decide if the injection is suitable for you.
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.
Driving and using machines:
You should not drive or use machinery while receiving Morphine Injection.
3. How to use Morphine Injection
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 (more than 1 in 10 patients)
• 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 (in less than 1 in 10, but more than
1 in 100 patients)
• 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 (in less than 1 in 100, but more than 1 in 1000 patients)
• severe allergic reactions after injection into a vein
If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.
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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. Storing 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. Further information
What Morphine Injection contains:
This injection contains the active ingredient morphine sulphate. Each 1 ml of solution contains 15 mg of morphine sulphate.
This injection contains the following inactive ingredients: 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 0064
Marketing Authorisation Holder: hameln pharmaceuticals 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 February 2015