1. Name Of The Medicinal Product
Mentholated Bronchial Balsam or Covonia Mentholated Cough Mixture or Superdrug Mentholated Bronchial Mixture or Gordons Chesty Cough Linctus.
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Mixture
4. Clinical Particulars
4.1 Therapeutic Indications
For the symptomatic relief of productive (chesty) coughs and sore throats.
4.2 Posology And Method Of Administration
Oral
Recommended doses
Adults, the elderly and children over 12 years: one or two 5ml spoonfuls.
Children 5 – 12 years: one 5ml spoonful.
Dosage schedule
The dose to be taken every four hours if required.
4.3 Contraindications
Contraindicated in patients with known hypersensitivity to any of the ingredients. Also contraindicated in patients with cardiac disorders.
4.4 Special Warnings And Precautions For Use
If symptoms persist or worsen consult your doctor.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Toxicity of squill glycosides may be increased when given in combination with thiazides or loop diuretics, as these may cause hypokalaemia and hypomagnesaemia which may lead to cardiac arrhythmias.
When used with carbenoxolone it may produce sodium and water retention and hypokalaemia, and may give rise to greater toxicity of squill.
4.6 Pregnancy And Lactation
There are no adverse reports when used in recommended doses. However, as with all medicines care should be taken when using this product in pregnancy and medical advice sought if necessary.
4.7 Effects On Ability To Drive And Use Machines
None
4.8 Undesirable Effects
No adverse effects have been reported with this product, however, a few cases of hypersensitivity reactions to menthol have been reported. These include generalised urticaria and flushing, menthol may give rise to contact dermatitis.
Liquorice may cause sodium and water retention, and hypokalaemia.
4.9 Overdose
Ingestion of large doses of the active ingredients has been reported to cause the following effects: gastrointestinal disturbances such as abdominal pain, nausea, vomiting and diarrhoea would be expected to occur with the menthol and squill. Common symptoms of digoxin overdosage include headache, facial pain, fatigue, weakness, dizziness, drowsiness, disorientation, mental confusion, bad dreams and more rarely delirium, acute psychoses, and hallucinations. Convulsions have been reported. Visual disturbances including blurred vision may occur. Colour vision may be affected with objects appearing yellow or less frequently green, red, brown, blue or white.
Adverse effects on the heart may result from the cardiac glycosides in squill. Toxic doses may cause or aggravate heart failure. Supraventricular or ventricular arrhythmias and defects of conduction are common and may be an early indication of excessive dosage.
In addition CNS effects such as vertigo, ataxia and drowsiness have been reported after ingestion of large quantities of menthol; reported adverse effects following excessive ingestion of liquorice include hypertension, congestive heart failure, cardiac arrest, headache, muscle weakness, myopathy, myoglobinuria, paralysis, hyperprolactinaemia and amenorrhoea. In the unlikely event of overdosage with this preparation, gastric lavage and / or symptomatic treatment together with supportive measures should be employed.
Treatment of acute digoxin poisoning consists of emptying the stomach by emesis or 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. Cholestyramine or colestipol may be of use in increasing the elimination of cardiac glycosides.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Menthol dilates the blood vessels causing a sensation of coldness followed by analgesic effect. It is used to relieve the symptoms of bronchitis, sinusitis and similar conditions.
Squill has an irritant effect on the gastric mucosa, it has a reflex expectorant action.
Liquorice is a demulcent and mild expectorant.
5.2 Pharmacokinetic Properties
After absorption menthol is excreted in the bile and urine as a glucuronide.
Squill glycosides are poorly absorbed from the gastro-intestinal tract, they are of short acting duration and are not cumulative; they are excreted in the urine and faeces.
No information is available on the pharmacokinetics of liquorice.
5.3 Preclinical Safety Data
None
6. Pharmaceutical Particulars
6.1 List Of Excipients
Peppermint oil BP, anise oil BP, capsicum tincture BPC, syrup BP, liquid glucose BPC 1963, veegum k, sodium nipasept, glycerol BP, caramel BPC and purified water BP.
6.2 Incompatibilities
None known
6.3 Shelf Life
150ml: 36 months unopened
200ml: 36 months unopened
6.4 Special Precautions For Storage
Store below 25°C
6.5 Nature And Contents Of Container
150ml: amber glass bottle with plastic cap with EPE/Saranex liner or white plastic child resistant cap with EPE/Saranex liner or white 28mm cap with tamper evident band and EPE Saranex liner or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner
200ml: amber glass bottle with plastic cap with EPE/Saranex liner or white plastic child resistant cap with EPE/Saranex liner or white 28mm cap with tamper evident band and EPE Saranex liner or white 28mm Child-resistant cap with Tamper Evident band and EPE/Saranex Liner
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 12965/0026
9. Date Of First Authorisation/Renewal Of The Authorisation
24.03.94 / 13.04.99
10. Date Of Revision Of The Text
August 2004
11 DOSIMETRY
Not Applicable
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Not Applicable
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