This information is intended for use by health professionals

1. Name of the medicinal product

Covonia Chesty Cough Mixture Mentholated

Covonia Mucus Cough Oral Solution

2. Qualitative and quantitative composition

Levomenthol

4.0mg/5ml

Squill Tincture

0.6ml/5ml

Liquorice Liquid Extract

0.125ml/5ml

Excipient(s) with known effect

This medicine contains, per 5ml dose:

1.3g Sucrose

1.3g Glucose

7.5mg Sodium Parahydroxybenzoates

282mg Ethanol

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Oral solution.

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

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.

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

None.

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.

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. 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

None.

6. Pharmaceutical particulars
6.1 List of excipients

peppermint oil

anise oil

capsicum tincture (contains capsicum oleoresin, ethanol)

Syrup (contains sucrose)

liquid glucose

magnesium aluminium silicate

sodium methyl hydroxybenzoate (E219)

sodium ethyl hydroxybenzoate (E215)

sodium propyl hydroxybenzoate (217)

glycerol (E422)

caramel (E150c)

purified water.

6.2 Incompatibilities

None known.

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

None

7. Marketing authorisation holder

Thornton & Ross Ltd

Linthwaite Laboratories

Huddersfield

HD7 5QH

United Kingdom

8. Marketing authorisation number(s)

PL 00240/0047

9. Date of first authorisation/renewal of the authorisation

12/09/2007

10. Date of revision of the text

04/09/2020