Medine.co.uk

Morphine Oral Solution 10mg/5ml

PACKAGE LEAFLET: INFORMATION FORTHE USER


Morphine Oral Solution lOmg / 5ml


Morphine Sulfate BP


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Read all this leaflet carefully before you use Morphine

Oral Solution

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

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

•    This medicine has been prescribed for you personally. Do not pass it on to others, it may harm them even if their symptoms are the same as yours.

•    If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


In this leaflet:

1.    What Morphine Oral Solution is and what it is used for

2.    Before you take Morphine Oral Solution

3.    How to take Morphine Oral Solution t. Possible side effects

5. Storing Morphine Oral Solution 5. Further information

1.    What Morphine Oral Solution 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.

2.    Before you take Morphine Oral Solution

You should not take Morphine Oral Solution if:

•    you are allergic (hypersensitive) to Morphine or any of the ingredients of this medicine (listed in section 6 &'lmportant information about some of the ingredients, column 2).

•    you are having an asthma attack, shallow breathing and other breathing difficulties

•    you are suffering from severe headaches. This could be a sign of raised pressure inside your skull

•    you have suffered a head injury

•    you suffer from alcoholism

•    you have fits (convulsions)

•    you have any liver problems

•    you have paralytic ileus (loss of intestinal movement)

•    you are taking or have in the last two weeks taken medication to treat depression such as Monoamine-Oxidase Inhibitors (MAOI's) (see'Taking other medicines')

•    you have something called 'phaeochromocytoma'.This is a rare tumour which is not malignant

•    the person taking this medicine is in a deep and prolonged unconscious state (coma)

Take special care with Morphine Oral Solution Fell your doctor if:

•    You have a particular lung problem that causes shortness of breath called emphysema

•    you have any prostate problems

•    you have an under-active adrenal gland (adrenocortical insufficiency)

•    you have asthma

•    you have long term (chronic) liver or kidney problems

•    you have an under-active thyroid gland or swelling of your skin (myxoedema)

•    you have had an operation in the last 24 hours

•    you are extremely overweight

•    your spine is unusually curved (kyphoscoliosis)

•    you have shock (circulatory failure)

•    you suffer from bowel problems

Taking other medicines:

3lease tell your doctor if you are taking or have recently taken any other medicines, including those obtained without orescription.

Morphine Oral Solution must not be used with drugs used to treat severe depression, such as phenelzine or moclobemide, or if you are within 2 weeks of discontinuing them.

These drugs are known as Monoamine Oxidase Inhibitors (MAOI's),

Other medicines which may interact with Morphine Oral Solution include:

•    medicines to help you sleep, make you feel less anxious or calm you down such as tranquilisers, anaesthetics, hypnotics, sedatives, antipsychotics, tricyclic antidepressants (clomipramine) and alcohol

•    CNS depressants (drugs that act on the brain to cause drowsiness)

•    medicines for controlling heart rhythm such as esmolol and mexiletine

•    medicines to treat stomach ulcers, indigestion or heartburn such as cimetidine

•    medicines for feeling sick (nausea) and being sick (vomiting such as domperidone and metoclopramide

•    medicines to treat HIV infections such as ritonavir

•    medicines used to treat fungal infections such as voriconazole

•    medicines to treat epilepsy and long lasting pain caused by damage to the nerves such as gabapentin

Pregnancy and breast-feeding:

Morphine Oral Solution should not be used during pregnancy (especially during the first three months) as Morphine is known to cross the placenta.

This medicine should also not be used whilst breast-feeding as Morphine is known to be present in breast milk and it may cause respiratory problems in newborn babies.

If you take this medicine for a long time whilst pregnant, it may mean that the baby will be born showing signs of withdrawal.

Stomach upset and risk of inflammation of the lungs in mother when giving birth.

Effects on the ability to drive and use machinery:

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.

This effect is even more enhanced, when used in combination with alcohol or CNS depressants (medicines for sleeping disorders and anxiety). Do not drive or operate machinery if you feel drowsy or cannot think clearly.

Important information about some of the ingredients:

•    If you have been told by your doctor that you have an intolerance to some sugars (sucrose), contact your doctor before taking this medicinal product

•    sodium propyl hydroxybenzoate (E217) and sodium methyl hydroxybenzoate (E219) may cause an allergic reaction which could be delayed. Although rare, you may have difficulty breathing.

•    Morphine Oral Solution contains alcohol which may be harmful to those suffering from alcoholism.

3. How to take Morphine Oral Solution

Your doctor will decide on the dose and duration of your therapy. Always follow the instructions of your doctor and pharmacist. If you are changing from other types of morphine medication your doctor may have to change your dose.

This medicine is for oral use

Adults:    Usual dose is one or two 5ml

spoonfuls (10 - 20mg) every 4 hours

Elderly and infirm patients: A reduced dose is recommended

Children:    Under 1 year: not recommended

1 to 5 years: maximum of half a 5ml spoonful (5mg) every 4 hours

6 to 12 years: maximum of one 5ml spoonful (5-1 Omg) every 4 hours

If you forget to take Morphine Oral Solution

If you have missed a dose take it as soon as you remember unless it is nearly time for your next dose.Then continue your normal dose times. Do not take a double dose.

If you take more Morphine Oral Solution than you should:

If you take too much of your medicine seek immediate medical advice from your doctor or your nearest hospital.

Symptoms of an overdose include sudden or unexpected difficulty in breathing, pin-point pupils (the black circle in the centre of your eyes (pupil) getting smaller) or a drop in blood pressure. In the case of infants and children they may suffer fits (convulsions).

In more severe cases, very high doses could cause your blood circulation to slow down and cause unconsciousness for a long time, or even death.

Continued overieai

100mm Measurement Verification Bar

tyou stop taking Morphine Oral Solution

You should not stop taking Morphine Oral Solution until advised to do so by your doctor. If you stop treatment too iuddenly you may experience symptoms of withdrawal such as stomach pains, feeling sick and feeling anxious. Your doctor will advise you how to stop your treatment with Morphine Dral Solution.

4. Possible side effects

_ike all medicines, Morphine Oral Solution can cause side affects but not everyone gets them.

Repeated use of morphine can result in tolerance and addiction

Serious side effects:

f any of the following symptoms occur contact your doctor or nearest accident and emergency department immediately.

symptoms of respiratory depression: breathing difficulties (weak, shallow breathing)

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

Dther side effects that may occur include:

•    confusion

•    restlessness

•    changes in mood

•    drowsiness

•    constipation

•    dry mouth

•    feeling sick (nausea)

•    being sick (vomiting)

•    facial flushing

•    sweating

•    a fast heartbeat (tachycardia)

•    a slow heartbeat (bradycardia)

•    a fast and uneven heartbeat (palpitations)

•    reduced blood pressure

•    difficulty passing urine

•    lower abdomen spasms

•    the black circle in the centre of your eyes (pupil) getting smaller (pin-point pupils)

•    a feeling of dizziness or spinning (vertigo)

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

•    tense muscles

•    lowered sex drive

•    lower body temperature (hypothermia)

•    severe headache. This could be a sign of raised pressure inside your skull

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

5.    Storing Morphine Oral Solution

<eep all medicines out of the reach and sight of children.

Do not use this product after the expiry date which is stated an the carton. The expiry date refers to the last day of that month. Keep container in the outer carton. Use within 90 days af first opening.

Do not store above 25°C

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

6.    Further Information

What Morphine Oral Solution contains:

Active ingredient: Morphine Sulfate Ph Eur lOmg in each 5ml af solution.

Other ingredients: sugar (sucrose), alcohol, disodium edetate, sodium propyl hydroxybenzoate (E217), sodium methyl aydroxybenzoate (E219), raspberry flavour, purified water and may include hydrochloric acid.

Each 5ml dose of this solution contains 0.4ml of alcohol and 2.25g of sugar.

What Morphine Oral Solution looks like and contents of the pack:

The clear, colourless solution is supplied in amber glass bottles containing 100ml, 250ml, 300ml or 500ml.

Marketing Authorisation Elolder and Manufacturer:

Martindale Pharmaceuticals Ltd. Bampton Road, Romford, Essex, RM3 8UG, UK

Product Licence No.: PL 00156/0036 Date of last revision January 2014 D Martindale Pharmaceuticals

Martindale hJL Pharmaceuticals fVi

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

D02692 ___________l|

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MARTJNDALE PHARMA

DEVELOPMENT ARTWORK

Component Code: D02692

Paper size: 170 x 296mm


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17/01/14

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10/02/14

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