This information is intended for use by health professionals

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.

Each 5ml dose contains 0.46%vol ethanol (alcohol)

Each 5ml dose contains 3.2mmol (74mg) sodium

Each 5ml dose contains 0.08g sucrose

Each 5ml dose contains 0.000025mg benzyl alcohol

Each 5ml dose contains 32.5mg sodium methyl hydroxybenzoate

Each 5ml dose contains 3.4mg sodium propyl hydroxybenzoate

For the 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 supematant liquid.

4. Clinical particulars
4.1 Therapeutic indications

For relief of the symptoms of diarrhoea and upset stomachs in adults and children over 12 years.

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 Contraindications

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 excipients listed in section 6.1.

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.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption should not take this medicine.

This product contains 6.4mmol (or 148mg) of sodium per 10ml dose, equivalent to 7.4% of the WHO recommended maximum daily intake of 2g sodium for an adult.

This product contains sodium methyl and sodium propyl parahydroxybenzoates (E219 and E217 respectively) which may cause allergic reactions (possibly delayed).

This product contains benzyl alcohol which may cause allergic reactions.

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 Fertility, pregnancy and lactation

This product should not be used in pregnancy or whilst breastfeeding 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 or search for “MHRA Yellow Card” in the Google Play or Apple App Store.

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.

5.3 Preclinical safety data

No data of relevance to the prescriber, which is additional to that included in other sections of the SPC.

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 Flavour (contains E1518 glyceryl triacetate, E1520 propylene glycol, E1505 triethyl citrate & benzyl alcohol)

Syrup

Purified water

6.2 Incompatibilities

None.

6.3 Shelf life

200ml: 18 months unopened.

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 Special precautions for disposal and other handling

None.

7. Marketing authorisation holder

L.C.M. Ltd.

Linthwaite Laboratories

Huddersfield

HD7 5QH

8. Marketing authorisation number(s)

PL 12965/0021

9. Date of first authorisation/renewal of the authorisation

25th October 1993

10. Date of revision of the text

21/05/2019