Symptoms include respiratory depression, extreme miosis, hypotension, hypothermia, coma. Treatment is by intravenous injection of naloxone 0.4mg, repeated every 2 to 3 minutes if necessary, or by an infusion of 2mg in 500ml of normal saline or 5% dextrose (0.004mg/ml).
In subjects dependent on morphine-like drugs, withdrawal symptoms may occur following injection of a high dose of naloxone. It should therefore be injected in gradually increasing doses to such subjects.
36 months.
Respiratory impairment, acute abdominal syndrome of unknown origin, severely impaired liver function, cranial trauma and raised intracranial pressure, convulsive state, acute alcoholic intoxication and delirium tremens, children, risk of paralytic ileus, known hypersensitivity to any of the ingredients contained in Zomorph, concurrent treatment with MAO (MAO = monoamine oxidase) inhibitors or within two weeks of their use.
Not applicable.
Sucrose, maize starch, polyethylene glycol 4000, ethyl-cellulose, cetyl alcohol, sodium lauryl sulphate, dibutyl sebacate, talc, gelatin, iron oxide ink (E172), titanium dioxide (E171) (for the 10mg, 30mg, 60mg and 100mg strengths), quinoline yellow (E104) (only for the 10mg strength), erythrosine (E127) (only for the 30mg strength), sunset yellow (E 110) (only for the 60mg strength).
Sustained-release capsules.
The most common side effects at usual doses are nausea, constipation, confusion and occasionally vomiting.
Other possible effects include: urticaria, pruritus, rashes, decreased libido or potency, mood changes, drowsiness, dry mouth, sweating, headache, facial flushing, vertigo, bradycardia, tachycardia, palpitations, postural hypotension, dysphoria, hypotension, hypothermia, miosis, dysuria, sedation or excitation (particularly in elderly subjects in whom delirium and hallucinations may occur), increased intracranial pressure which may aggravate existing cerebral disorders, increased pressure in the main bile duct and urinary retention in cases of prostatic adenoma or urethral stenosis. Mild respiratory depression occurs even at therapeutic doses. In the event of overdosage it may be severe, serious or even fatal. Physical and psychic dependence may appear after administration of therapeutic doses for periods of 1 to 2 weeks. Some cases of dependence have been observed after only 2 to 3 days.
Withdrawal syndrome: this may occur a few hours after withdrawal of a prolonged treatment, and is maximal between the 36th and 72nd hours.
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 at: www.mhra.gov.uk/yellowcard.
None stated.
Severe chronic pain and/or pain resistant to other analgesics, in particular pain associated with cancer.
Morphine is an opioid analgesic. It acts mainly on the central nervous system and smooth muscle.
Morphine exerts an analgesic action, and affects psychomotor behaviour: depending on the dose administered, it induces sedation (> 1cg) or, in some cases, excitation (< 1cg). At high doses, greater than those required to produce analgesia, it induces somnolence and sleep.
Absorption
This is a sustained-release form, which makes twice-daily oral administration possible. Morphine is immediately absorbed from the digestive tract following oral administration. The maximum serum concentrations of morphine are obtained in 2 to 4 hours.
Distribution
The percentage of binding to plasma proteins after absorption is low (about 34%). There is no clearly defined correlation between the plasma concentration of morphine and the analgesic effect.
Metabolism
A considerable quantity of morphine is metabolised by the liver to glucuronides, which undergo enterohepatic recirculation.
Excretion
The product is eliminated essentially in the urine, by glomerular filtration, mainly as glucuronides. A small amount (less than 10%) is eliminated in the faeces.
August 2016
ZOMORPH capsules 10mg, 30mg, 60mg, 100mg, 200mg
Ethypharm
194, Bureaux de la Colline - Bâtiment D
92213 Saint-Cloud cedex
France
Store below 25°C in a dry place protected from heat.
Blister packs (aluminium/PVC).
Boxes of 14, 30 and 60 capsules.
Not all pack sizes may be marketed.
10mg: PL 06934/0182
30mg: PL 06934/0183
60mg: PL 06934/0184
100mg: PL 06934/0185
200mg: PL 06934/0186
- Morphine sulphate BP 10mg
- Morphine sulphate BP 30mg
- Morphine sulphate BP 60mg
- Morphine sulphate BP 100mg
- Morphine sulphate BP 200mg
Caution should be exercised:
- in elderly subjects, in patients with impaired hepatic and/or renal functions, in patients with hypothyroidism or hypoadrenalism, in patients in a state of shock or with asthma. The dose of Zomorph should be reduced, or its use should be avoided in cases of hepatic or renal failure.
- in patients suffering from the following conditions: hypotension, convulsive disorders, dependence (severe withdrawal symptoms if withdrawn abruptly) and prostatic hypertrophy.
Urinary retention may occur in patients with urethral disease or prostatic hypertrophy.
Concomitant use of alcohol and Zomorph may increase the undesirable effects of Zomorph; concomitant use should be avoided.
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:
- The 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 prescribed 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
Route of administration : orally.
As directed by a medical practitioner.
Recommended dosage
Adults: Recommended dosage is one capsule twice daily, at 12-hourly intervals.
Elderly: As with all narcotics, a reduction in dosage may be advisable in the elderly, as appropriate.
Children: Not recommended.
The capsules should not be chewed and should normally be swallowed whole.
The dosage varies according to the severity of pain and the previous analgesic treatments received by the patient.
If the pain persists, or if the patient develops tolerance to morphine, the dosage may be increased by prescribing the 10mg, 30mg, 60mg, 100mg and 200mg capsules in various combinations or alone to obtain the desired relief.
Patients previously treated with immediate-release oral morphine should receive the same daily dose of sustained-release capsules, but in two divided doses at 12-hourly intervals.
Patients previously treated with parenteral morphine should be given a sufficiently increased dosage to compensate for any reduction of the analgesic effect associated with oral administration. The dosage should be adjusted to meet the individual requirements of each patient.
For patients who cannot swallow the capsules, their contents can be administered directly in semi-solid food (puree, jam, yoghurt) or via gastric or gastrostomy tubes of a diameter of more than 16 F.G. with an open distal end or lateral pores. It is sufficient to rinse the tube with 30ml to 50ml of water.
Not applicable.
16 July 2010 (10mg, 30mg)
17 July 2010 (60mg, 100mg & 200mg)
