Product Summary

1.    Trade Name of the Medicinal Product

Morphine Suppositories 30mg BP Morphine Sulphate Suppositories BP 30mg

2.    Qualitative and Quantitative Composition

Morphine Sulphate BP 30mg

3.    Pharmaceutical Form

Suppository

Clinical Particulars

4.1. Therapeutic Indications For symptomatic relief of severe pain.

4.2.    Posology and Method of Administration

For Rectal Administration.

15 - 30mg every 4 hours as necessary.

A reduction of dose is advisable in the elderly.

Not recommended for paediatric use.

4.3.    Contra-indications

Respiratory depression, acute alcoholism, head injuries, increased intracranial pressure, bronchial asthma, heart failure secondary to lung disease. Patients who are taking (or have taken within the previous 2 weeks) monoamine oxidase inhibitors.

4.4. Special Warnings and Precautions for Use

Repeated use can cause tolerance and dependence. A reduction in dose is advisable in the elderly, in hypothyroidism, renal disease and chronic hepatic disease. Not recommended for paediatric use.

4.5. Interactions with other Medicaments and other forms of Interaction

Monoamine oxidase inhihitors (see section 4.3).

4.6.    Pregnancy and Lactation

Morphine should not be used during pregnancy or lactation as it crosses the placenta, is secreted in the milk and can cause respiratory depression and dependence in the neonate.

4.7.    Effects on Ability to Drive and Use Machines

Morphine may cause drowsiness, and if affected patients should not drive or operate machinery.

4.8.    Undesirable Effects

Nausea and vomiting, drowsiness, confusion, dry mouth, sweating, facial flushing and respiratory depression.

4.9.    Overdose

The likely symptoms would be:

Pin point pupils, respiratory depression, hypotension. Circulatory failure and coma may occur in more severe cases.

Treat with intravenous naloxone, maintain fluid and electrolyte levels and assist respiration if necessary.

Pharmacological Properties

5.1. Pharmacodynamic Properties

Morphine is a powerful analgesic and narcotic and also has central stimulant action. It depresses the thalamus, sensory cortex, respiratory and cough centres but stimulates the vomiting centre. Morphine increases the tone of involuntary muscle, especially the sphincters of the gastrointestinal tract.

5.2. Pharmacokinetic Properties

Morphine is rapidly absorbed after rectal administration. It is distributed throughout the body, but mainly in the kidneys. liver, lungs and spleen. Morphine crosses the placenta and traces are found in sweat and milk. It is about 35% plasma protein bound.

The plasma half-life is 2-3 hours and about 60% of the dose is excreted in the urine after 24 hours. A small amount of this is free morphine (a higher proportion is excreted in alkaline urine) and about 60 - 70% is conjugated. A small amount may be excreted in the bile.

Preclinical Safety Data

No additional data of relevance to the prescriber.

Pharmaceutical Particulars

6.1.    List of Excipients Suppocire Osil Base.

6.2.    Incompatibilities

Not applicable.

6.3.    Shelf Life

36 months.

6.4.    Special Precautions for Storage

Do not store above 25°C.

6.5.    Nature and Contents of Container

10 or 12 suppositories in rotoplast plastic moulds in a cardboard carton or 10 or 12 suppositories wrapped in cellophane and packed in a carton

6.6.    Instruction for Use/Handling

None stated.

Administrative Data

7. Marketing Authorisation Holder

Macarthy’s Laboratories Ltd t/a Martindale Pharmaceuticals Bampton Road Harold Hill Romford RM3 8UG.

8. Marketing Authorisation Number

PL 01883/5891R

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

02/03/2009

DATE OF REVISION OF THE TEXT

02/03/2009