Covonia Chesty Cough Mixture Mentholated

C

1. Name Of The Medicinal Product

Covonia Chesty Cough Mixture Mentholated

2. Qualitative And Quantitative Composition

Levomenthol

4.0mg/5ml

Squill Tincture

0.6ml/5ml

Liquorice Liquid Extract

0.125ml/5ml

For excipients, see 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.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine as it contains sucrose and glucose.

This medicine contains up to 600mg ethanol per 10ml dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breastfeeding women, children and high-risk groups such as people with liver disease or epilepsy.

May cause allergic reactions, possibly delayed as this medicine contains sodium methyl, ethyl and propyl hydroxybenzoates (E219, E215 and E217)

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. 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 capsicum oleoresin, ethanol), sucrose, liquid glucose, magnesium aluminium silicate, sodium nipasept (E215, E217, E219), glycerol (E422), caramel (E150) and 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

15/02/2011

Covonia Chesty Cough Mixture Mentholated

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