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pACKAGb LFAFLF I: INFORMAI ION FOR I HF USER

Morphine Sulfate Injection BP 1 mg/ml & 2mg/ml

Morphine Sulfate BP

Read all of this leaflet carefully before you are given this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, please ask your doctor or nurse.

•    Ifany of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

In this leaflet:

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

2.    Before you are given Morphine Sulfate Injection

3.    How Morphine Sulfate Injection will be given t. Possible side effects

5. How to store Morphine Sulfate Injection 5. Further information

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

Morphine is an alkaloid with powerful pain relieving oroperties.

This medicine is used for the relief of severe pain after major surgery.

2.    Before you are given Morphine Sulfate Injection

You should not be given Morphine Sulfate Injection if:

•    you are allergic (hypersensitive) to Morphine or any of the ingredients listed in section 6 of this leaflet

•    you suffer from asthma, shallow breathing and other breathing difficulties

•    you suffer from liver or kidney problems

•    you are suffering from severe stomach pains

•    you are currently taking drugs used to treat depression known as monoamine oxidase inhibitors (MAOIs) or have taken them in the last 2 weeks

•    you are suffering from severe headaches or have suffered a head injury

•    you suffer from a convulsive disorder (fits) such as epilepsy

•    you are suffering from a problem that could cause paralysis of the small intestine (paralytic ileus)

•    you suffer from alcoholism

•    you have been told you are suffering from a condition known as delayed gastric emptying, the symptoms of which include heartburn, feeling sick or being sick and feeling full quickly whilst eating

•    you suffer from severe heart and lung problems Take special care with Morphine Sulfate Injection Fell your doctor if:

•    you suffer from low blood pressure

•    you suffer from problems related to your adrenal gland (the organ responsible for stress levels), including Addisons disease (an illness caused by a lack of the hormone cortisol which controls stress levels)

•    you have any lung problems, in particular emphysema (enlarged and damaged lungs)

•    you have any prostate problems

•    you have had an operation in the last 24 hours

•    you are extremely overweight

•    you suffer from spine problems

•    you think you may be in shock as there is a risk of coma

•    you suffer from thyroid problems

•    you are currently having an asthma attack or you usually suffer from asthma

•    you are pregnant or breast-feeding

•    you are elderly or ill.The dose may have to be reduced

•    you are dependent on morphine

•    you suffer from problems with your pancreas

•    you suffer from a muscle disorder known as myasthenia gravis

•    you suffer from an irregular heartbeat

•    you have been told you suffer from a severe heart problem known as cor pulmonale

•    you suffer from bowel problems Taking other medicines

Please tell your doctor or nurse if you are taking, or have recently taken, any other medicine including medicines obtained without prescription.

Please tell your doctor if you are taking any of the following medicines:

•    medicines used to treat severe depression known as monoamine oxidase inhibitors (MAO|s) e.g. moclobemide.Tell your doctor even if you have stoppec taking them within the last two weeks

•    medicines used to help you to relax (sedatives)

•    medicines used to help you to sleep (hypnotics)

•    medicines used to treat depression (tricyclics)

•    medicines used to treat serious mental disorders (phenothiazines)

•    painkillers e.g. buprenorphine, butorphanol, nalbuphine, or pentazocine

•    mexilitine, a medicine used to treat an irregular heartbeat

•    medicines used to treat anxiety (anxiolytics)

•    cisapride, a medicine used to treat acid reflux and heartburn

•    medicines used to prevent sickness e.g. domperidone and metoclopramide

•    selegiline, a medicine used to treat Parkinson's disease

•    cimetidine, a medicine used to treat stomach ulcers

•    anaesthetics

Pregnancy and breast-feeding:

If you are pregnant, trying for a baby or breast-feeding you should ask your doctor for advice before you are given this medicine. Morphine Sulfate Injection should be given to you with great care.

Effects on the ability to drive and use machinery:

This medicine may cause drowsiness. If you are affected do not drive or use machines.

This medicine can affect your ability to drive and operate machinery 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 Falk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Con tin ued over leal

	Having Morphine Sulfate Injection with food and drink you are advised not to drink alcohol during your treatment with this medicine. 3.    How Morphine Sulfate Injection will be given Morphine Sulfate Injection is given to you as a slow nfusion (drip) into the vein. It is given as Patient Controlled Analgesia (PCA), meaning that you will be able to administer pain relief to yourself rather than your doctor or nurse doing it for you. four doctor will still determine the dose you need aowever you will be able to give yourself pain relief as and when you need it. You will not be able to give yourself more than the maximum dose. Under some circumstances your doctor may prescribe a dose higher than those stated here. Adults the usual initial dose is 5-15mg given by slow infusion, followed by 2.5-mg every hour after that. You will only be able to give yourself Morphine Sulfate Injection once every 5-10 minutes. The elderly and ill t is recommended that a reduced dose be used f you are given too much of Morphine Sulfate njection: This medicine will be given to you in hospital so it is unlikely you will receive too much. Your doctor has nformation on how to recognise and treat an overdose. f you feel unwell after being given this medicine, or are at all concerned you have been given too much, tell your doctor or nurse. 4.    Possible Side Effects _ike all medicines Morphine Sulfate Injection can cause side effects, although not everybody gets them. Repeated use of morphine can result in tolerance and Addiction f any of the following symptoms occur tell your doctor or aurse immediately. These are symptoms of a serious allergic reaction. •    sudden wheeziness and tightness of chest •    swelling of eyelids, face or lips •    skin lumps or hives •    skin rash (red spots), itchiness, fever •    collapse Other side effects include: •    constipation •    drowsiness •    difficulty thinking clearly •    dry mouth •    slowed breathing •    hallucinations (seeing or hearing things that are not real) •    dizziness •    feeling or being sick •    itching •    difficulty focusing your eyes or blurred vision •    fever •    difficulty in passing urine •    muscle spasms •    feeling your heart beat (palpitations) •    feeling cold •    feeling restless •    mood changes •    pinpoint pupils •    enlarged pupils		•    flushing •    sore, red and swollen skin •    loss ofappetite •    indigestion •    worsening of a condition that affects the pancreas known as pancreatitis.The symptoms of this include stomach pain and feeling or being sick. •    changes in the way things taste •    seizures (fits). f any of these side effects get serious, or you notice any other side effects not listed in this leaflet, please tell your doctor or nurse. 5.    How to Store Morphine Sulfate Injection <eep out of the sight and reach of children. You should not be given Morphine Sulfate Injection after the expiry date on the vial and carton label.The expiry date refers to the last day of that month.The doctor or nurse will check that the product has not passed this date. To not store above 25°C. Keep in the outer carton. 6.    Further Information What Morphine Sulfate Injection contains The active ingredient: morphine sulfate BP 0.1 %w/v or 3.2%w/v. The other ingredients: sodium chloride 0.9% and water for injections. What Morphine Sulfate Injection looks like and contents of the pack: Morphine Sulfate Injection is a sterile solution, supplied in dear glass vials. Each vial contains 50ml or 100ml of the solution. Marketing Authorisation Holder: Aurum Pharmaceuticals Ltd., Bampton Road, Harold Hill, Romford, RM3 8UG, UK Manufacturer: Rotexmedica GMBH Arzneimittel Werk 3unsenstrasse 4, D-22946Trittau Germany Product Licence Number(s): % 12064/0007 % 12064/0008 Date of last revision: January 2014
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100mm Measurement Verification Bar