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Morphine Sulfate Injection Bp 10mg/1ml (Aqueous Solution

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Package leaflet: information forthe user

Morphine Sulfate Injection BP 10mg/ml, 15mg/ml, 20mg/ml & 30mg/ml

Morphine Sulfate

Read 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.

If any of the side effects gets 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 it is used for

2.    Before you are given Morphine Sulfate Injection

3.    How Morphine Sulfate Injection will be given

4.    Possible side effects , 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 properties.

This medicine is used forthe relief of severe pain.

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

•    you suffer from breathing difficulties (asthma or chronic obstructive airways disease)

•    you have suffered a head injury

•    you suffer from alcoholism

•    you suffer from heart problems

•    you are suffering from stomach pains

•    you are suffering from a tumour of the adrenal gland known as phaeochromocytoma

•    you are pregnant or breast-feeding

•    your child has a liver or kidney problem.

Take special care with Morphine Sulfate Injection if:

•    you suffer from low blood pressure

•    you suffer from underactive thyroid

•    you suffer from problems with your prostate gland

•    you suffer from any liver or kidney diseases

•    you suffer from fits 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 (MAOIs) e.g. moclobemide.Tell your doctor even if you have stopped taking them within the last two weeks

•    medicines used to help you to sleep (hypnotics) e.g. chloral and barbiturates

•    medicines used to treat anxiety (anxiolytics) e.g. diazepam

•    ciprofloxacin, a medicine used to treat bacterial infections

Pregnancy and breast-feeding:

This medicine should not be used if you are pregnant, trying for a baby or breast-feeding.

Morphine is known to cross the placenta.

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

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

This medicine is an injection and will be given to you by your doctor. Your doctor will determine the dose you need.

Morphine Sulfate Injection is administered either into a muscle, under the surface of the skin or into a vein. Under some circumstances your doctor may prescribe a dose higher than those stated here.

Adults

Initially you will be given 10 - 20mg This may be repeated every 4 - 6 hours The elderly

It is recommended that a reduced dose be used

Children and teenagers aged 1 to 17 years old

The dosage in children depends on their age, the type and amount of pain and the way that the medicine is njected. Your doctor will perform a risk assessment on your child before deciding on the appropriate dose.

If you are given too much of Morphine Sulfate Injection:

This medicine will be given to you by your doctor so it is unlikely you will receive too much. Your doctor has nformation on how to recognise and treat an overdose.

If you experience any of the following, tell your doctor mmediately:

•    difficulty in breathing

•    pinpoint pupils

•    low blood pressure

Continued overieat

100mm Measurement Verification Bar

4. Possible Side Effects

.ike all medicines Morphine Sulfate Injection can cause side effects, although not everybody gets them. Possible side effects include: hallucinations (seeing or hearing things that aren't real)

confusion mood changes headaches dizziness drowsiness sw eating

feeling faint when getting up from a seated position pinpoint pupils

a fast, slow or irregular heartbeat

feeling your heart beat (palpitations)

facial flushing

constipation

feeling or being sick

dry mouth

spasms in the lower abdomen rashes and itching

difficulty achieving or maintaining an erection difficulty in passing urine

If any of these side effects gets 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 sightand reach of children.

Vou should not be given Morphine Sulfate Injection after the expiry date on the ampoule 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 oassed this date.

Do not store above 25°C and protect from light.

Medicines should not be disposed of via wastewater or Household waste. Askyour pharmacist how to dispose of medicines no longer required. These measures will Help to protect the environment.


6. Further Information

What Morphine Sulfate Injection contains:

The active ingredient:    morphine sulfate BP.

Each ampoule contains 1,1.5,2 or 3%w/v of morphine sulfate.

The other ingredients: sodium chloride, sodium metabisulphite and water for injections. This medicine may also contain sodium hydroxide solution or sulphuric acid solution.

What Morphine Sulfate Injection looks like and contents of the pack:

Morphine Sulfate Injection is a sterile solution, supplied in clear, colourless 1 ml glass ampoules.This medicine is supplied to your doctor in packs of 10 ampoules.

Marketing Authorisation Holder and Manufacturer:

Martindale Pharmaceuticals Ltd., Bampton Road,

Harold Hill, Romford, RM3 8UG, United Kingdom. Product Licence Numbers:

PL 01883/6138. PL 01883/6176. PL 01883/6177. PL 01883/6178

Date of last revision: January 2014


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Martindale Pharmaceuticals

Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom


D0268800000


2688-D