Kaolin And Morphine Mixture
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kaolin and Morphine Mixture
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Kaolin Light (Grade A1) 1g
Sodium Hydrogen Carbonate Powder 250mg
Morphine Hydrochloride 0.458mg per 5ml dose.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Oral suspension.
A buff coloured suspension which separates on standing to give a buff coloured sediment and a brown supernatant liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
For relief of the symptoms of diarrhoea and upset stomachs.
4.2 Posology and method of administration
Oral.
Recommended doses:
Adults and children over 12 years: Two 5ml spoonfuls.
Children under 12 years: Not recommended for children under 12 years. Directions for use: Shake the bottle.
Dosage schedule:
The dose may be repeated 3 times daily or as directed.
4.3 Contra-indications
Kaolin is contraindicated in intestinal obstruction. Whilst this product only contains a small amount of morphine, theoretically it should be contraindicated in the same conditions as other morphine-containing preparations. These conditions include respiratory depression, obstructive airways disease, known morphine sensitivity, acute hepatic disease, acute alcoholism, head injuries, coma, convulsive disorders, where intracranial pressure is raised, and in concurrent administration with monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use.
Hypersensitivity to any of the other ingredients.
4.4 Special warnings and precautions for use
As this product contains sodium hydrogen carbonate, it should not be administered to patients with metabolic or respiratory alkalosis, hypocalcaemia or hypochlorhydria, and should be administered with caution in patients with congestive heart failure, renal impairment, cirrhosis of the liver, hypertension and to patients receiving corticosteroids.
Whilst this product only contains a small amount of morphine, it should (as with other morphine-containing preparations) be used with care in the elderly or debilitated (when the dose should be reduced), in prostatic hypertrophy, in hypotension, in hypothyroidism and where there is reduced respiratory reserve (avoid use during an asthma attack), and should not be given if paralytic ileus is likely to occur.
This product contains 6.4mmol (or 148mg) of sodium per 10ml dose. To be taken into account by patients on a controlled sodium diet.
This product contains sodium methyl and sodium propyl parahydroxybenzoates (E219 and E217 respectively) which may cause allergic reactions (possibly delayed).
The following warnings and precautions appear on the labels:
Do not exceed the stated dose.
Keep out of the sight and reach of children Do not take with alcoholic or hot drinks.
4.5 Interaction with other medicinal products and other forms of interaction
As kaolin is adsorbent, the absorption of other drugs from the gastro-intestinal tract administered concomitantly may be reduced. Kaolin possibly reduces absorption of aspirin, tetracycline, chloroquine and hydroxychloroquine, and phenothiazines.
Sodium hydrogen carbonate may also reduce or delay absorption of other drugs as a result of its antacid effect.
Morphine, whilst only present in a very low concentration, theoretically may potentiate the effects of tranquillisers such as barbiturates, anaesthetics, anxiolytics and hypnotics, sedatives and alcohol. The reduction in intestinal motility caused by morphine may delay the absorption or antagonise the gastrointestinal effects of other drugs. The effects of domperidone and metoclopramide on gastrointestinal activity are antagonised by opioid analgesics. Metabolism of opioid analgesics is inhibited by cimetidine leading to increased plasma concentration.
Opioid analgesics should be avoided when ciprofloxacin is to be used for antibacterial surgical prophylaxis as concomitant use can lead to decreased plasma concentration of ciprofloxacin. The opioid analgesics enhance effects of sodium oxybate, used to treat symptoms of narcolepsy and concomitant use should be avoided.
Possible CNS excitation or depression (hypertension or hypotension) can occur when opioid analgesics are given with antidepressants such as moclobemide and MAOIs (avoid concomitant use and for 2 weeks after stopping MAOIs). The sedative effects of morphine can possibly be increased when given with tricyclic antidepressants, with anxiolytics or hypnotics, or with sedating antihistamines. Antipsychotic medicines can enhance hypotensive and sedative effects when opioid analgesics are given with antipsychotics.
Morphine also has the following specific interaction information. Morphine possibly increases plasma concentration of the beta-blocker esmolol which may be used as an anti-arrythmic.
The plasma concentration of morphine is possibly reduced by the antiviral ritonavir. Morphine increases the bioavailability of the anticonvulsant medication gabapentin.
4.6 Pregnancy and lactation
This product should not be used in the above conditions unless recommended by a doctor.
4.7 Effects on Ability to Drive and Use Machines
Although it is not considered that the product will have any effect, morphine may cause drowsiness, patients should not drive or operate machinery if affected.
4.8 Undesirable effects
The sodium hydrogen carbonate in this product may cause stomach cramps and flatulence. Morphine, whilst only present in a low concentration, may theoretically cause nausea, vomiting, constipation, drowsiness and confusion. Prolonged use may lead to tolerance and dependence.
Although there are qualitative and quantitative differences in side effects for the opioid analgesics, other recognised possible side effects include:
difficulty with micturition; ureteric or biliary spasm; dry mouth; sweating; headache; facial flushing; vertigo; bradycardia, tachycardia or palpitation; postural hypotension; hypothermia; hallucinations, dysphoria or mood changes; miosis; decreased libido or potency; rashes, urticaria, pruritis and opioid-induced hyperalgesia (OIH).
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
In the unlikely event of overdosage with this product, signs of morphine toxicity and overdosage include pin-point pupils, respiratory depression and hypotension. Circulatory failure and deepening coma may occur in more severe cases.
Treatment should consist of naloxone administration, aspiration and gastric lavage with assisted respiration (if necessary), and maintenance of fluid and electrolytes.
Excessive administration of sodium hydrogen carbonate may lead to metabolic alkalosis.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties
A07 DA52 - Antipropulsives
Kaolin is an adsorbent, it adsorbs toxic and other substances from the alimentary tract and increases the bulk of the faeces.
Sodium hydrogen carbonate is an alkalising agent and antacid.
Morphine reduces the peristaltic activity of the intestines.
5.2 Pharmacokinetic Properties
Kaolin is not absorbed following oral administration. It remains unchanged throughout transit of the gastrointestinal tract.
Sodium hydrogen carbonate is neutralised in the stomach with the formation of carbon dioxide. Any remaining is absorbed and excreted as bicarbonate and sodium ions in the urine in the absence of a plasma deficit.
Morphine is well absorbed from the gastrointestinal tract but has poor bioavailability due to extensive first pass metabolism in the liver. It is distributed throughout the body but mainly in the kidneys, liver, lungs and spleen, with lower concentrations in the brain and muscles. Morphine diffuses across the placenta and traces appear in milk and sweat. About 35% is protein bound. Conjugation to 3- and 6- glucuronides occurs in the liver and gut. Up to 10% of morphine is excreted as conjugates in the bile and faeces and the remainder is excreted in the urine. About 90% of total morphine is excreted in 24 hours with traces in the urine up to 48 hours or more.
Preclinical Safety Data
5.3
No data of relevance to the prescribes which is additional to that included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ethanol (96%)
Peppermint Oil
Anise oil
Saccharin sodium
Sodium methyl hydroxybenzoate
Sodium propyl hydroxybenzoate
Treacle black commercial
Liquorice liquid extract
Syrup
Purified water
6.2 Incompatibilities
None.
6.3
Shelf Life
18 months unopened.
200ml:
6.4 Special Precautions for Storage
Store below 25°C. Keep tightly closed.
6.5 Nature and Contents of Container
200ml: Glass bottle with polypropylene cap.
6.6 Instructions for Use, Handling and Disposal
None.
7. MARKETING AUTHORISATION HOLDER
L.C.M. Ltd.
Linthwaite Laboratories
Huddersfield HD7 5QH
PL 12965/0021
9.
10
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25th October 1993
DATE OF REVISION OF THE TEXT
29/04/2016