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ZOMORPH Capsules 10mg
ZOMORPH Capsules 10mg
ZOMORPH Capsules 10mg
sulphate BP 10mg
Morphine sulphate BP 30mg
Morphine sulphate BP 60mg
Morphine sulphate BP 100mg
Morphine sulphate BP 200mg
Sustained-release capsules.
As serious and sometimes fatal reactions have occurred following administration of pethidine to patients
receiving monoamine oxidase inhibitors, pethidine and related drugs are contra-indicated in patients
taking monoamine oxidase inhibitors or within 14 days of stopping such treatment; morphine and other
opioid analgesics should be given with extreme caution.
The depressant effects of opioid analgesics are enhanced by depressants of the central nervous system
such as alcohol, anaesthetics, antipsychotics, anxyolitics, hypnotics and sedatives, tricyclic
antidepressants and phenothiazines.
Cyclizine may counteract the haemodynamic benefits of opioids.
Opioid analgesics with some antagonist activity, such as buprenorphine, butorphanol, nalbuphine or
pentazocine may precipitate withdrawal symptoms in patients who have recently used pure agonists such
as morphine. The actions of opioids may in turn affect the activities of other compounds. For instance,
their gastro-intestinal effects may delay absorption as with mexiletine or may be counteractive as with
metoclopramide, domperidone and possibly cisapride.
Plasma concentrations of morphine are possibly increased by ritonavir.
Alcohol may enhance the pharmacodynamic effects of Zomorph; concomitant use should be avoided.
4.6 Use during pregnancy and lactation
Since this product rapidly crosses the placental barrier, it should not be used during the second stage of
labour or in premature delivery because of the risk of secondary respiratory depression in the newborn
infant. If the mother is addicted, a withdrawal syndrome is observed in the newborn infant characterised
by: convulsions, irritability, vomiting, increased mortality. As with all drugs, it is not advisable to administer
morphine during pregnancy.
4.7 Effects on ability to drive and use machines
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
4.8 Undesirable effects
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.
4.9 Overdose
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.
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.
5.2 Pharmacokinetic properties
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.
5.3 Preclinical safety data
None stated.
Ethypharm
194, Bureaux de la Colline Btiment D
92213 Saint-Cloud cedex
France
10mg: PL
06934/0182
30mg: PL 06934/0183
60mg: PL 06934/0184
100mg: PL 06934/0185
200mg: PL 06934/0186
August 2016
Submitted By:
Florexan M. Pason BEED
3A
Submitted To:
Ms. Ma. Luisa R. Tejada
Reference: https://www.medicines.org.uk/emc/latestmedicines-updates