1. Name of the medicinal product
Covonia Chesty Cough Mixture Mentholated
Covonia Mucus Cough Oral Solution
2. Qualitative and quantitative composition
Liquorice Liquid Extract
Excipient(s) with known effect
This medicine contains, per 5ml dose:
7.5mg Sodium Parahydroxybenzoates
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
A brown, viscous, opaque liquid
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
Adults, the elderly and children over 12 years: One or two 5ml spoonfuls.
Children 5-12 years: One 5ml spoonful.
The dose to be taken every four hours if required.
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.
Ingredients with specified warnings
This medicine contains 1.3g glucose and 1.3g of sucrose per 5ml dose. This should be taken into account in patients with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicine contains 282mg of alcohol (ethanol) in each 5ml dose. The amount in 5ml of this medicine is equivalent to less than 7ml of beer or 3ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects.
This medicine contains sodium methyl, ethyl and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
This medicine contains less than 1mmol sodium (23mg) per 5ml dose, that is to say essentially ‘sodium-free’.
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 Fertility, 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
4.8 Undesirable effects
Hypersensitivity reactions and gastrointestinal reactions have been reported with this product. Hypersensitivity reactions may include generalised urticaria, flushing and contact dermatitis.
Liquorice may cause sodium and water retention, and hypokalaemia.
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.
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. Colestyramine or colestipol may be of use in increasing the elimination of cardiac glycosides.
5. Pharmacological properties
5.1 Pharmacodynamic properties
R05C – Cough and cold preparations, expectorants, excl. combinations with cough suppressants
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
6. Pharmaceutical particulars
6.1 List of excipients
capsicum tincture (contains capsicum oleoresin, ethanol)
Syrup (contains sucrose)
magnesium aluminium silicate
sodium methyl hydroxybenzoate (E219)
sodium ethyl hydroxybenzoate (E215)
sodium propyl hydroxybenzoate (217)
6.3 Shelf life
50ml : 36 months unopened.
150ml: 36 months unopened.
180ml: 36 months unopened.
200ml: 36 months unopened.
300ml: 36 months unopened.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
50ml: Amber glass bottle with white 28mm cap with tamper evident band and
EPE/ Saranex liner.
150ml: Amber glass bottle with white 28mm cap with tamper evident band and EPE/ Saranex liner.
180ml: Amber glass bottle with white 28mm cap with tamper evident band and EPE/ Saranex liner.
200ml: Amber glass bottle with white 28mm cap with tamper evident band and EPE/ Saranex liner.
300ml: Amber glass bottle with white 28mm cap with tamper evident band and EPE/ Saranex liner.
6.6 Special precautions for disposal and other handling