Covonia Herbal Mucus Cough Syrup

1. Name Of The Medicinal Product

Allens Pine and Honey Balsam

Covonia Herbal Mucus Cough Syrup

2. Qualitative And Quantitative Composition

Ipecacuanha liquid extract 0.0076ml/5ml

Liquorice liquid extract 0.l25m1/5ml

Squill oxymel 0.78ml/5ml

For full list of excipients, see section 6.1

3. Pharmaceutical Form

Syrup

4. Clinical Particulars

4.1 Therapeutic Indications

A traditional herbal remedy used for relief of the symptoms of coughs, colds and bronchitis.

4.2 Posology And Method Of Administration

Oral

Recommended doses and dosage schedule

Adults and children over 12 years: l0ml

Elderly: dose as for adults, unless otherwise directed.

The dose may be repeated after 4 hours if required.

4.3 Contraindications

Squill should not be administered to patients with impaired renal function, and is inadvisable in patients with cardiac disorders. Sensitivity to colophony containing products e.g. some lipsticks and eyeshadows etc.

Children under 12 years of age

4.4 Special Warnings And Precautions For Use

Shake the bottle.

Keep all medicines away from children.

Do not give to children under 12 years.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Administration with carbenoxolone or diuretics may cause increased toxicity of squill if hypokalaemia occurs.

4.6 Pregnancy And Lactation

All drugs should be avoided if possible during the first trimester. Insufficient evidence is available to indicate safety of this product during pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

No effects known.

4.8 Undesirable Effects

Adverse effects of squill include nausea and vomiting, which may also be caused by ipecacuanha which has an irritant effect on the gastrointestinal tract. Emetine is known to accumulate in muscle and may interfere with muscle fibre contactility of heart muscle.

Liquorice may cause reversible sodium retention and potassium loss leading to hypertension, water retention and electrolyte imbalance.

4.9 Overdose

The symptoms of overdose of squill and ipecacuanha include nausea and vomiting. Treatment of overdose would depend upon the symptoms, cardiac irregularities, which may be caused by squill, may be treated by emesis or aspiration and lavage. In cases of severe cardiac arrhythmias, potassium and/or anti-arrhythmic agents may be given. Prolonged vomiting may be a symptom of overdose of ipecacuanha alkaloids, which may be controlled by intramuscular injection of 25 -50mg of chlorpromazine or of a comparable dose of a related phenothiazine; fluid and electrolyte imbalance should also be corrected.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Squill is used for its reflex expectorant action. Liquorice acts as a demulcent and expectorant. Ipecacuanha, in small doses, has a reflex expectorant action useful for the treatment of the symptoms of acute and chronic bronchitis, and in coughs

5.2 Pharmacokinetic Properties

Several procedures have been reported for the determination of ipecacuanha alkaloids but the classical acid-based titrimetric method would still appear to be the recommended one.

5.3 Preclinical Safety Data

None

6. Pharmaceutical Particulars

6.1 List Of Excipients

Pumilio Pine Oil

Anise oil

Capsicum tincture

Chloroform

Ethanol (96%)

Diethyl ether (peroxide free)

Arrowroot

Menthol

Peppermint oil

Syrup

Treacle black

Purified water

6.2 Incompatibilities

None known

6.3 Shelf Life

150m1: 36 months unopened.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

150ml bottle-amber glass with a child resistant tamper evident 28mm cap with a Melinex/Aluminium/EPE liner.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Thornton & Ross Ltd.,

Linthwaite Laboratories,

Huddersfield,

HD7 5QH

8. Marketing Authorisation Number(S)

PL 00240/5209R

9. Date Of First Authorisation/Renewal Of The Authorisation

02/03/2009

10. Date Of Revision Of The Text

03/02/2011