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1. Morphine Sulphate Suppositories 10mg
2. Morphine Sulphate Suppositories 10mg

1 NAME OF THE MEDICINAL PRODUCT

Morphine sulfate suppositories 10mg

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Morphine sulfate 10mg (equivalent to morphine base 15mg)

3. PHARMACEUTICAL FORM

Suppository

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

For the relief of acute & chronic severe pain

4.2 Posology and method of administration

Adults and children over 12 years

Morphine sulfate suppositories should be used at 4 hourly intervals the dosage is dependent upon the severity of the pain and the patients previous history of analgesic requirements. An oploid naive patient presenting with severe pain should normally be started on a dosage of morphine sulfate suppositories 10mg 4-hourly. Increasing severity of pain will require increased dosage of morphine sulfate suppositories using the 20mg or 30mg strengths to achieve the desired relief.

Children under 12 years of age Not recommended.

Elderly

A reduction in adult dosage may be advisable.

4.3. Contraindications

Respiratory depression, acute abdomen, obstructive airways disease, known morphine sensitivity, acute hepatic disease, acute alcoholism, concurrent administration of mono amine oxidase inhibitors or within two weeks of discontinuation of their use. Avoid in patients with a risk of paralytic ileus.

Use should be avoided where intracranial pressure is raised, where there is a known or suspected head injury or where a neurological assessment may be required.

4.4 Special warnings and precautions for use

Patients who are about to undergo cordotomy or other pain relieving procedures should not receive morphine sulfate suppositories for 4 hours prior to surgery. A reduction in dosage may be advisable in adrenocortical insufficiency, hypothyroidism, hypotension, inflammatory or obstructive bowel disorders, renal and chronic hepatic disease, prostatic hypertrophy, myasthenia gravis, shock or reduced respiratory reserve. Avoid in patients with convulsive disorder or phaeochromocytoma.

Interactions with other medicinal products and other forms of interaction

• Alcohol, anaesthetics, antipsychotics, anxiolytics, hypnotics, other CNS depressants and tricyclic antidepressants. - Sedative effect of morphine is enhanced.

• Alcohol and antipsychotic drugs - Increase hypotensive effects.

Myelosuppressive antipsychotic drugs there is a risk of increased toxicity.

Cimetidine - Inhibits the metabolism of morphine.

• Ciprofloxacin - Manufacturer advises that pre-medication with opioid analgesics is avoided as the concentration of ciprofloxin may be reduced.

• Domperidone - The effect on gastro-intestinal activity is antagonised by morphine.

• Esmolol - Plasma concentration may be increase by morphine.

• Metoclopramide - The effect on gastro-intestinal activity is antagonised by morphine.

• Mexiletine - Absorption of mexilitine may be delayed by morphine.

• Moclobemide - Hypotension or hypertension may be caused.

• Ritonavir - Plasma concentration of morphine may be increased.

4.6. Pregnancy and lactation

Not recommended.

4.7 Effects on ability to drive and use machines

Treatment with morphine sulfate suppositories may cause sedation and it is not recommended that patients drive or use machines if they experience drowsiness.

This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

•    This medicine is likely to affect your ability to drive

•    Do not drive until you know how the medicine affects you

•    It is an offence to drive while under the influence of this medicine

•    However, you would not be committing an offence (called ‘statutory defence’) if:

o The medicine has been prescribe to treat a medical or dental problem and o You have taken it according to the instructions given by the prescriber and in

the information provided with the medicine and o It was not affecting your ability to drive safely

4.8 Undesirable effects

Constipation, drowsiness, nausea, hypotension, including postural hypotension, respiratory depression, urinary retention and vomiting. Other side effects include bradycardia, hypothermia, confusion, dry mouth, facial flushing, palpitations, pruritus, reduced libido or potency, rashes, sweating, tachycardia, urticaria, vertigo, ureteric or biliary spasms. Restlessness, mood changes and hallucinations may occur. Continued use of morphine may give rise to dependence.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: http://www.mhra.gov.uk/yellowcard.

4.9. Overdose

In the case of accidental or deliberate overdose, signs of morphine toxicity and overdosage include pinpoint pupils, respiratory depression and hypotension.

Circulatory failure and deepening coma may occur in more severe cases.

Treatment of morphine overdosage includes administration of naloxone 0.4 mg intravenously repeated at 2-3 minute intervals as necessary or an infusion of 2 mg in 500 ml of normal saline or 5% dextrose (0. 004 mg/ml). The infusion should be run at a rate related to the previous bolus doses administered and should be in accordance with the patient’s response.

Respiration may require assistance. Fluid and electrolyte levels should be maintained.

5.1. Pharmacodynamic properties

Morphine acts as an agonist at opiate receptors in the CNS particularly mu and to a lesser extent kappa receptors. Mu receptors are thought to mediate supra spinal analgesia, respiratory depression and euphoria.

Kappa receptors are thought to mediate spinal analgesia, miosis and sedation. Morphine also has a direct action on the bowel wall nerve plexus reducing gut

motility.

5.2. Pharmacokinetic properties

The half life for morphine in the plasma is approximately 2.5 - 3.0 hours the major urinary metabolite is morphine - 3 - gluconuride but much smaller amounts of morphine - 6 -gluconuride are also formed, following conjugation in the liver, morphine - 3 - gluconuride appears in the bile and is secreted in the gut where it undergoes hydrolysis. The resulting free morphine is absorbed.

5.3. Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6.5. Nature and contents of container

PVC coated with polythene cavities - either 6, 12, 24 & 48 suppositories in a printed carton.

6.6. Instruction for use/handling

Not applicable.

Administrative Data

7. MARKETING AUTHORISATION HOLDER

Aurum Pharmaceuticals ltd,

Bampton road,

Harold hill,

Romford,

Essex RM3 8UG

MARKETING AUTHORISATION NUMBER