J COLLIS BROWNES MIXTURE

Oral Adults and Children over 12 years of age.

For coughs:

One to two 5 ml medicinal teaspoonsful. May be repeated every four hours.

For diarrhoea:

Two to three 5 ml medicinal teaspoonsful. May be repeated once or twice at four hourly intervals if required. Elderly and debilitated patients; use with caution; a reduced dose can be recommended by a doctor.

Children under 12 years old:

Not recommended

The following undesirable effects have been reported for use of morphine or opioid analgesics and may arise from use of J. Collis Browne’s Mixture. Allergic reactions and dyspepsia may also be attributable to peppermint oil. The frequency of adverse effects cannot be estimated from available data.

Psychiatric disorders: hallucinations, dysphoria, euphoria, mood changes, confusion, dependence, restlessness, agitation, delirium, disorientation, excitation Nervous system disorders: dizziness, drowsiness, sleep disturbances, headache, vertigo, raised intracranial pressure, malaise, seizures, paraesthesia, opioid-induced hyperalgesia (OIH) Eye disorders: miosis, visual disturbances, nystagmus Cardiac disorders: palpitations, bradychardia, tachycardia Vascular disorders: postural hypotension, hypotension, hypothermia, facial flushing, oedema, hypertension, syncope Respiratory, thoracic and mediastinal disorders: respiratory depression (with larger doses), bronchospasm, inhibition of cough reflex, central sleep apnoea syndrome.

Gastrointestinal disorders: nausea, vomiting, constipation, abdominal pain, anorexia, pancreatitis, exacerbation of pancreatitis, dry mouth, paralytic ileus, dyspepsia, taste disturbances Hepatobiliary disorders: biliary spasm, spasm of sphincter of Oddi.

Skin and subcutaneous tissue disorders: rashes, urticaria, pruritis, sweating, acute generalised exanthematous pustulosis (AGEP). Musculoskeletal and connective tissue disorders: muscular rigidity (with higher doses), muscle fasciculation, myoclonus, weakness.

Renal and urinary disorders: difficulty with micturition, urinary retention, ureteric spasm Reproductive system and breast disorders: decreased libido or potency, amenorrhoea. Drug dependence Repeated use of J Collis Browne's Mixture can lead to drug dependence, even at therapeutic doses.

4). 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. uk/yellowcard or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.

Use with care in hypotension, shock, myasthenia gravis, prostatic hypertrophy, diseases of the biliary tract, and cardiac arrhythmias. Caution is advised in patients with asthma or other respiratory disorders, hepatic and renal disease, and a history of drug abuse.

Cough suppressants may cause sputum retention and this may be harmful in patients with chronic bronchitis, bronchiectasis and chronic obstructive pulmonary disease. A reduced dose is recommended in elderly or debilitated patients, in hepatic and renal impairment (but avoid if severe), in hypothyroidism, and in adrenocortical insufficiency.

J Collis Browne’s Mixture is not intended as a substitute for rehydration therapy in the treatment of diarrhoea; patients should take plenty of fluids. Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia.

Opioid use increases the risk of CSA in a dose- dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage. Severe cutaneous adverse reactions (SCARs) Acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, has been reported in association with morphine treatment.

Most of these reactions occurred within the first 10 days of treatment. Patients should be informed about the signs and symptoms of AGEP and advised to seek medical care if they experience such symptoms. If signs and symptoms suggestive of these skin reactions appear, morphine should be withdrawn and an alternative treatment considered.

Hepatobiliary disorders Morphine may cause dysfunction and spasm of the sphincter of Oddi, thus raising intrabiliary pressure and increasing the risk of biliary tract symptoms and pancreatitis. Opioid Use Disorder (abuse and dependence) Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as J Collis Browne's Mixture.

Hypersensitivity to the active substances, to any of the excipients or to menthol. Children under the age of 12 years. Acute respiratory depression, chronic obstructive pulmonary disease, acute alcoholism, risk of paralytic ileus, acute ulcerative colitis, acute abdomen, delayed gastric emptying, raised intra-cranial pressure and head injury, and phaeochromocytoma.

It should not be given during an attack of asthma or to patients with heart failure secondary to chronic lung disease. Concurrent administration with monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuation of their use.

Acute hepatic disease Obstructive bowel disorders Pancreatitis Coma Convulsive disorders Administration of some opioid analgesics to patients taking a monoamine oxidase inhibitor (MAOI) has been associated with very severe and sometimes fatal reactions.

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