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SOUTH DEV

H EALTHCARE    Patient Information Leaflet

PLEASE READ THIS LEAFLET CAREFULLY. IF YOU HAVE ANY QUESTIONS OR ARE NOT SURE ABOUT ANYTHING, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET IN A SAFE PLACE, YOU MAY WISH TO READ IT AGAIN.

1.    WHAT IS MORPHINE SULFATE INJECTION AND WHAT IS IT USED FOR?

Morphine Sulfate, the active ingredient, belongs to a group of strong painkilling medicines called opioids which must be used only under a doctor's instruction.

Morphine Sulfate Injection 2mg in 1ml is a solution for injection that has been prepared in water so that it can be used with specially designed pumps which provide a continuous injection into the body. It is used in the long term relief of moderate to severe pain, such as the pain caused by surgery, heart attacks and cancer. Morphine also helps to reduce the anxiety and sleeplessness which may be caused by the pain.

2.    BEFORE USING MORPHINE SULFATE INJECTION Morphine Sulfate Injection should NOT BE USED if you:

•    Are allergic to Morphine Sulfate or any other strong painkilling drugs.

•    Have a history of alcohol abuse

•    Suffer from malfunctioning of the adrenal gland (phaeochromocytoma)

•    Have suffered a head injury

•    Are at risk of a paralytic ileus (reduced gut motility)

•    Have acute respiratory depression (breathlessness)

•    Have raised pressure inside your skull

Check with your doctor if you are concerned about any of the above.

Before using Morphine Sulfate Injection please tell your doctor if you:

•    Are pregnant or breast feeding

•    Are taking medicines to treat depression

•    Are taking medicines for sickness (phenothiazines), for drying secretions (anticholinergics e.g. hyoscine) or other pain killers

•    Are taking medicines to make you sleep, such as hypnotics or sedatives

•    Have taken one of a group of drugs called monoamine oxidase inhibitors (used to treat depression) within the last two weeks

•    Are taking anti-psychotics, cimetidine, domperidone or metoclopramide

•    Are taking esmolol, mexiletine or ritonavir

•    Have taken this medicine in the last two weeks

Check with your doctor if you are concerned about any of the above.

This medicine may not be suitable for you to take, therefore please tell your doctor if you:

•    Suffer from asthma, chronic bronchitis or have any other illness which causes breathing difficulties

•    Suffer from kidney or liver problems

•    Suffer from stomach or bowel problems

•    Have difficulty in passing urine due to an enlarged prostate

•    Suffer from bad headaches or feel sick

•    Suffer from epilepsy or other fits

•    Suffer from poor blood supply to the heart or other heart problems

•    Have low blood pressure (hypotension)

•    Have a tumour of the adrenal gland

•    Suffer from myasthenia gravis

•    Suffer from pain from gallstones (biliary colic)

•    Suffer from thyroid problems

•    Are elderly and/or debilitated

Check with your doctor if you are concerned about any of the above.

Morphine Sulfate Injection is only suitable for long lasting pain and is not intended for pain which only lasts for short periods. NEVER give your medication to other people even if their symptoms are the same as yours.

3.    HOW TO USE MORPHINE SULFATE INJECTION

The doctor will decide what dose of Morphine Sulfate Injection you should take. It will need to be given by a nurse or doctor using a syringe and needle to draw up the injection for administration.

The syringe may be put into a small machine which allows a slow continuous injection of Morphine Sulfate to be given.

There is a procedure called Patient Controlled Analgesia (PCA) where you would be provided with a button to press when you are in pain and the machine would then give you a small amount of Morphine Sulfate Injection. There will be a safety device on the machine so that you cannot exceed the maximum number of doses.

Let your doctor or nurse know if your pain gets worse while you are using Morphine Sulfate Injection. Your doctor may want to increase your dose of the drug and/or give you some extra medicines for the pain.

You must not use machinery whilst using Morphine.

The medicine can affect your ability to drive 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.

continued from overleaf

• However, you would not be committing an offence if: o The medicine has been prescribed to treat a medicial or dental problem and

o You have taken it according to the instruction given by the prescriber or in the information provided with the medicine and o It was not affecting your ability to drive safety

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

If you forget to take a dose of Morphine Sulfate - take that dose as soon as you remember. Then take the next dose at the usual time. Do not take a double dose.

If you take more Morphine Sulfate than you should - tell your doctor immediately. If you are a medical practitioner administering this medicine please refer to the Summary of Product Characteristics.

4. POSSIBLE SIDE EFFECTS

As with all medicines, there may be some side effects with Morphine Sulfate Injection. The most common side effects are respiratory depression (slow or shallow breathing), nausea, vomiting, constipation, feeling more sleepy than normal and feeling confused.

Other common side effects are: muscle rigidity inability to concentrate itchiness

decreased potency hypothermia disorientation agitation feeling of sadness may affect eye sight upset stomach or indigestion severe allergic reaction to medicine pain and irritation at the injection site increased pressure inside the skull rashes

TeM your doctor, nurse or pharmacist immediately if you have any of these, or other, problems. LONG-TERM TREATMENT WITH MORPHINE

Further side effects can occur during long-term treatment with Morphine. These side-effects include:

hallucinations contractions of the pupils restlessness mood changes decreased libido

disruption of the menstrual cycle reduced blood pressure changes in taste

may reduce adrenal gland function

may cause uncontrolled movement of eyes

increased blood pressure

total or partial bowel blockage

muscle twitch

severe muscle pain

depression

inability to obtain or sustain an erection of the penis increased sensitivity to the pain

Tolerance and dependence are likely to occur after long-term treatment, and you may experience withdrawal symptoms if you stop taking Morphine suddenly. If you are concerned that you are becoming dependent on this medicine, speak to your doctor.

5.    HOW TO STORE MORPHINE SULFATE INJECTION

Morphine Sulfate Injection has an expiry date printed on the bottle (vial) and carton label. Before use the doctor or nurse will check the product has not passed this date and that the injection does not show any sign of deterioration.

After the expiry date return any unused product to a pharmacy.

Store Morphine Sulfate Injection away from sunlight and do not store above 25°C.

Store this medicine in a safe place where children cannot see or reach it.

6.    FURTHER INFORMATION

The injection contains Morphine Sulfate at a strength of 2mg in 1ml as the active ingredient. It is available in 50ml and 60ml single use vials. The product is packed into boxes which contain 10 vials. Morphine Sulfate Injection also contains the following inactive substances:

• Sodium Chloride •Water for Injection

The manufacturer and marketing authorisation holder is:

South Devon Healthcare, Torbay PMU, Long Road, Paignton, Devon, TQ4 7TW The leaflet was revised in: 01/2014

PL 13079/0006