Gees Linctus Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gee’s Linctus BP
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Opium Tincture 0.083ml per 5ml.
Squill Oxymel 1.667ml per 5ml.
For excipients, see 6.1.
3. PHARMACEUTICAL FORM
Oral solution.
A straw coloured to light brown opalescent or turbid liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For relief of the symptoms of coughs.
4.2. Posology and method of administration
Oral.
Recommended doses
Adults and children over 12 years: 5ml.
Children under 12 years: Not recommended.
The elderly: Use with care, not exceeding the recommended adult dose. Dosage schedule
The dose may be repeated after 4 hours if required but not more than 4 doses in any 24 hours.
If symptoms persist for more than 7 days consult a doctor.
4.3. Contra-indications
Contraindicated in patients with known hypersensitivity to any of the ingredients. Also contraindicated in patients with cardiac disorders and in impaired hepatic or renal function.
Contraindicated in cases of moderate to severe respiratory depression, alcoholism, head injuries and conditions in which intracranial pressure is raised, also in acute asthma, and heart failure secondary to chronic lung disease.
Contraindicated in patients receiving treatment with monoamine oxidase inhibitors or within 14 days of stopping such treatment.
4.4. Special warnings and precautions for use
The linctus should be given with caution to patients with: hypothyroidism, adrenocortical insufficiency, inflammatory or obstructive bowel disorders, prostatic hypertrophy, shock, myasthenia gravis, hypotension, the elderly and patients with general debilitation. Reduced doses may be required in these conditions.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Warnings to appear on labels:
Do not exceed the stated dose.
Recommended diluent: syrup BP
Keep out of the reach and sight of children.
If symptoms persist for more than 7 days consult a doctor.
Do not take if allergic to any of the ingredients, have heart, liver or kidney disease, or breathing difficulty or suffer from alcoholism or raised pressure in the head.
4.5. Interactions with other medicinal products and other forms of interaction
The linctus should not be taken by patients receiving monoamine-oxidase inhibitors or within 14 days of stopping such treatment.
Narcotic analgesics cause delayed absorption of mexiletine, they also cause potentiation of the effects of hypnotics and anxiolytics and other CNS depressants. They have opposing effects on gastro-intestinal activity to domperidone and metoclopramide. Toxicity of squill glycosides may be increased when given in combination with thiazides or loop diuretics, as these cause hypokalaemia and hypomagnesaemia which may lead to cardiac arrhythmias.
Hypokalaemia may result from simultaneous treatment with corticosteroids, amphotericin, sodium polystyrene sulphonate and carbenoxolone.
Absorption may be affected by intestinal absorptive agents and antacids including metoclopramide and propantheline. Simultaneous administration of spironolactone, phenobarbital or rifampicin may reduce renal excretion.
4.6. Pregnancy and lactation
Should be used with caution if at all during pregnancy and lactation.
4.7. Effects on ability to drive and use machines
At the recommended dose the linctus is unlikely to cause drowsiness, however, if affected do not drive or operate machinery.
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
Narcotic analgesics may cause nausea, vomiting, constipation, drowsiness, confusion. Larger doses may cause respiratory depression, difficulty with micturition, urticaria, pruritis, flushing and hypotension. Tolerance gradually develops with long term use although not constipation, and dependence is liable to be caused. Squill contains cardiac glycosides and may cause nausea, vomiting and anorexia, diarrhoea and abdominal pain may also occur.
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
Signs of morphine overdosage include pin-point pupils, depressed respiration, circulatory failure, pulmonary oedema, convulsions, renal failure and coma. Gastric lavage should be performed as soon as possible after ingestion, and intensive supportive therapy carried out. Naloxone may be given as an antidote (initially 0.8 - 2.0 mg, to a maximum of 10mg, by intravenous injection).
Common symptoms of digoxin overdosage are headache, facial pain, fatigue, weakness, dizziness, drowsiness, disorientation, mental confusion, bad dreams and more rarely delirium, acute psychoses, and hallucinations. Visual disturbances including blurred and misted vision may occur. Colour vision may be affected with objects appearing yellow or occasionally green, red, brown, blue or white. Convulsions have been reported.
Large doses of squill produce nausea, vomiting and diarrhoea, it has a digitalis-like effect on the heart. Supraventricular or ventricular arrhythmias and defects of conduction may be an early indication of excessive dosage.
Treatment of acute digoxin poisoning consists of emptying the stomach by emesis or aspiration and lavage. Activated charcoal may be given. Cardiac toxicity should be treated under ECG control and serum electrolytes should be monitored. Anti-arrhythmic treatment may be necessary and should be determined by the specific arrhythmia present. Atropine may be given intravenously to control bradycardia, and in patients with heart block; cardiac pacing may be necessary if atropine is not effective. Colestyramine or colestipol may be of use in increasing the elimination of cardiac glycosides.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
R05F A02 - Cough suppressants and expectorants, combinations - opium derivatives and expectorants.
Morphine and other related opioids are effective for the suppression of cough. They depress the cough reflex, at least in part by a direct effect on a cough centre in the medulla.
Squill has an irritant effect on the gastric mucosa, it has a reflex expectorant action.
5.2. Pharmacokinetic properties
Opioids are readily absorbed from the gastrointestinal tract. The major pathway for detoxification of morphine is conjugation with glucuronic acid. Small amounts of free morphine and larger amounts of conjugated morphine are excreted in the urine, accounting for most of the administered drug. 90% of total excretion occurs during the first day, however, traces may be detectable in the urine for over 48 hours. The major route of elimination of the metabolites is by glomenilar filtration. 7-10% of administered morphine eventually appears in the faeces, this comes mostly from the bile as conjugated morphine. Enterohepatic circulation of morphine and morphine glucuronide occurs, this accounts for the presence of morphine in the urine several days after the last dose.
Squill glycosides are poorly absorbed from the gastrointestinal tract, they are of short acting duration and are not cumulative. The drug promotes mild gastric irritation, causing a reflex secretion from the bronchioles.
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
Anise oil Benzoic Acid Camphor Ethanol (96%)
Purified Water Tolu flavour solution Syrup
Incompatibilities
6.2.
No major incompatibilities known.
6.3 Shelf life
36 months unopened.
6.4. Special precautions for storage
Store below 25°C.
6.5 Nature and contents of container
200ml: amber glass bottle with white 28mm cap with tamper evident band and EPE Saranex liner
6.6 Special precautions for disposal
None.
7. MARKETING AUTHORISATION HOLDER
L.C.M. Ltd
Linthwaite Laboratories
Huddersfield
HD75QH
8. MARKETING AUTHORISATION NUMBER
PL 12965/0034
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24 March 1994
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DATE OF REVISION OF THE TEXT
30/03/2015