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Morphine Sulphate Injection 1mg/Ml

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PACKAGE LEAFLET: INFORMATION FOR THE USER    D02463|

Morphine Sulphate Injection 1mg/ml

Morphine Sulphate Ph. Eur

Read all of this leaflet carefully before you start using 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 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 Sulphate Injection is and what is it used for

2.    Before you are given Morphine Sulphate Injection

3.    How Morphine Sulphate Injection will be given

4.    Possible side effects

5.    How to store Morphine Sulphate Injection

6.    Further information

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

Morphine is a powerful substance with pain relieving properties. This medicine is used for the relief of severe pain.

2.    Before you are given Morphine Sulphate Injection

You should not be given Morphine Sulphate Injection if:

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

•    you suffer from breathing difficulties.

•    you suffer from liver 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 have suffered a head injury.

•    you suffer from fits.

•    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 Sulphate Injection Tell your doctor if:

•    you suffer from low blood pressure.

•    you suffer from underactive thyroid.

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

•    you are pregnant or breast-feeding.

•    you are elderly or ill.

•    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.

If any of the above apply to you or your child, please tell your doctor.

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 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.

If you are in any doubt please tell your doctor of any medication you are taking.

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 Sulphate Injection should be given to you with great care. Driving and using machines:

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

Having Morphine Sulphate Injection with food and drink

You are advised not to drink alcohol during your treatment with this medicine.

3.    How Morphine Sulphate Injection will be given

Morphine Sulphate Injection is given to you as an injection into the vein, under the skin or into a muscle. 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.

Your doctor will still determine the dose you need however 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.

Contin ued overleaf

Adults and children over 12 years

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 Sulphate Injection once every 5-10 minutes.

The elderly and ill

It is recommended that a reduced dose be used.

Children under 12 years

Not recommended.

If you are given too much of Morphine Sulphate Injection:

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

If you feel unwell after being given this medicine, or are at all concerned you have been given too much, tell your doctor or nurse. If you have any further questions on the use of this product, ask your doctor or nurse.

4.    Possible side effects

Like all medicines Morphine Sulphate Injection can cause side effects, although not everybody gets them.

Repeated use of morphine can result in tolerance and addiction.

If any of the following symptoms occur tell your doctor immediately.

These are symptoms of a serious allergic reaction.

•    swelling of eyelids, face or lips

•    skin lumps or hives

•    skin rash (red spots), itchiness, fever

•    collapse

Other possible side effects include:

•    feeling or being sick

•    constipation

•    drowsiness

•    confusion

•    difficulty in passing urine

•    spasms in the lower abdomen

•    dry mouth

•    sweating

•    facial flushing

•    a feeling of spinning and dizziness (vertigo)

•    feeling your heartbeat (palpitations)

•    a slow heartbeat

•    feeling faint after getting up from a seated position

•    feeling restless

•    mood changes

•    hallucinations (seeing or hearing things that are not real)

•    pinpoint pupils

•    enlarged pupils

•    headaches

•    muscle stiffness

•    slowed breathing

•    low blood pressure

•    fits

•    water on the lungs

•    an itchy rash

•    sore, red and swollen skin

•    loss of appetite

•    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

If 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 Sulphate Injection

Keep out of the reach and sight of children.

You should not be given Morphine Sulphate Injection after the expiry date on the carton and syringe labels. 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.

Store below 25°C. Keep in the outer carton.

6.    Further information

What Morphine Sulphate Injection contains

The active ingredient is morphine sulphate Ph. Eur 1mg/ml.

The other ingredients are sodium chloride, sulphuric acid, nitrogen and water for injections.

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

Morphine Sulphate Injection is a clear, colourless solution, supplied in a pre-filled syringe. Each pre-filled syringe contains either 10ml or 50ml of the solution.

Marketing Authorisation Holder:

Aurum Pharmaceuticals Ltd,

Bampton Road,

Harold Hill,

Romford, RM3 8UG,

United Kingdom

Manufacturer:

Agila Specialties Polska Sp. z o.o.

10 Daniszewska St.

03-230 Warsaw Poland

This leaflet was last revised in 07/2013 Product Licence Number: PL 12064/0102


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

Aurum


D02463


D02463-C


PACKAGE LEAFLET: INFORMATION FOR THE USER    D02516|

Morphine Sulphate Injection 1mg/ml

Morphine Sulphate Ph. Eur

Read all of this leaflet carefully before you start using 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 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 Sulphate Injection is and what is it used for

2.    Before you are given Morphine Sulphate Injection

3.    How Morphine Sulphate Injection will be given

4.    Possible side effects

5.    How to store Morphine Sulphate Injection

6.    Further information

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

Morphine is a powerful substance with pain relieving properties. This medicine is used for the relief of severe pain.

2.    Before you are given Morphine Sulphate Injection

You should not be given Morphine Sulphate Injection if:

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

•    you suffer from breathing difficulties.

•    you suffer from liver 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 have suffered a head injury.

•    you suffer from fits.

•    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 Sulphate Injection Tell your doctor if:

•    you suffer from low blood pressure.

•    you suffer from underactive thyroid.

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

•    you are pregnant or breast-feeding.

•    you are elderly or ill.

•    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.

If any of the above apply to you or your child, please tell your doctor.

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 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.

If you are in any doubt please tell your doctor of any medication you are taking.

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 Sulphate Injection should be given to you with great care. Driving and using machines:

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

Having Morphine Sulphate Injection with food and drink

You are advised not to drink alcohol during your treatment with this medicine.

3.    How Morphine Sulphate Injection will be given

Morphine Sulphate Injection is given to you as an injection into the vein, under the skin or into a muscle. 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.

Your doctor will still determine the dose you need however 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.

Contin ued overleaf

Adults and children over 12 years

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 Sulphate Injection once every 5-10 minutes.

The elderly and ill

It is recommended that a reduced dose be used.

Children under 12 years

Not recommended.

If you are given too much of Morphine Sulphate Injection:

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

If you feel unwell after being given this medicine, or are at all concerned you have been given too much, tell your doctor or nurse. If you have any further questions on the use of this product, ask your doctor or nurse.

4.    Possible side effects

Like all medicines Morphine Sulphate Injection can cause side effects, although not everybody gets them.

Repeated use of morphine can result in tolerance and addiction.

If any of the following symptoms occur tell your doctor immediately.

These are symptoms of a serious allergic reaction.

•    swelling of eyelids, face or lips

•    skin lumps or hives

•    skin rash (red spots), itchiness, fever

•    collapse

Other possible side effects include:

•    feeling or being sick

•    constipation

•    drowsiness

•    confusion

•    difficulty in passing urine

•    spasms in the lower abdomen

•    dry mouth

•    sweating

•    facial flushing

•    a feeling of spinning and dizziness (vertigo)

•    feeling your heartbeat (palpitations)

•    a slow heartbeat

•    feeling faint after getting up from a seated position

•    feeling restless

•    mood changes

•    hallucinations (seeing or hearing things that are not real)

•    pinpoint pupils

•    enlarged pupils

•    headaches

•    muscle stiffness

•    slowed breathing

•    low blood pressure

•    fits

•    water on the lungs

•    an itchy rash

•    sore, red and swollen skin

•    loss of appetite

•    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

If 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 Sulphate Injection

Keep out of the reach and sight of children.

You should not be given Morphine Sulphate Injection after the expiry date on the carton and syringe labels. 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.

Store below 25°C. Keep in the outer carton.

6.    Further information

What Morphine Sulphate Injection contains

The active ingredient is morphine sulphate Ph. Eur 1mg/ml.

The other ingredients are sodium chloride, sulphuric acid, nitrogen and water for injections.

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

Morphine Sulphate Injection is a clear, colourless solution, supplied in a pre-filled syringe. Each pre-filled syringe contains either 10ml or 50ml of the solution.

Marketing Authorisation Holder:

Aurum Pharmaceuticals Ltd,

Bampton Road,

Harold Hill,

Romford, RM3 8UG,

United Kingdom

Manufacturer:

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

This leaflet was last revised in 07/2013 Product Licence Number: PL 12064/0102


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

Aurum


D02516


D02516-A


100mm Measurement Verification Bar