Covonia Catarrh Relief Formula

1. Name Of The Medicinal Product

Covonia Catarrh Relief Formula

2. Qualitative And Quantitative Composition

Each 5ml contains:-

Liquid Extract Boneset (1:1 21% alcohol) 0.6ml

Liquid Extract Blue Flag (1:1 37% alcohol) 0.05ml

Liquid Extract Burdock Root (1:1 21% alcohol) 0.25ml

Liquid Extract Hyssop (1:1 21% alcohol) 0.35ml

3. Pharmaceutical Form

Oral Liquid

4. Clinical Particulars

4.1 Therapeutic Indications

A herbal remedy traditionally used for the symptomatic relief of nasal catarrh and catarrh of the throat.

4.2 Posology And Method Of Administration

Adults and the Elderly (only): One 5ml spoonful three times a day.

Children over 12: One 5ml spoonful morning and evening

Children under 12: Not recommended

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

This medicinal product contains 11.5 vol% ethanol (alcohol), i.e. up to 453 mg per dose, equivalent to 12 ml beer, 5 ml wine per dose.

Harmful for those suffering from alcoholism.

To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

Patients with rare glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Refer to 4.4

4.6 Pregnancy And Lactation

There are no adequate data from the use of Covonia Catarrh Relief Formula in pregnant women. Covonia Catarrh Relief Formula should not be used in pregnancy.

4.7 Effects On Ability To Drive And Use Machines

None

4.8 Undesirable Effects

None

4.9 Overdose

No cases known.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Boneset and Hyssop are specific herbal anticatarrhals. Boneset is also immune-stimulant.

5.2 Pharmacokinetic Properties

No information available.

5.3 Preclinical Safety Data

No information available.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Chloroform spirit (containing chloroform, ethanol and purified water), methyl parahydroxybenzoate (E218), tincture capsicum (containing capsicum oleoresin, ethanol and water), colour solution (containing nipagen m, caramel (E150), glycerol (E422), chloroform, water), viscarin SD 389 (contains dextrose/carageenan (E407)), menthol, sodium saccharin (E954), and purified water.

6.2 Incompatibilities

None.

6.3 Shelf Life

Three years unopened.

Once opened use within 28 days.

6.4 Special Precautions For Storage

Do not store above 25 degrees C.

6.5 Nature And Contents Of Container

100ml amber glass sirop bottle with 28mm polypropylene white tamper-evident cap with EPE/Aluminium/Melinex liner.

150ml amber glass bottle embossed “Covonia” with a 28mm polypropylene white tamper evident cap with EPE/Aluminium/Melinex liner.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Thornton & Ross Ltd

Linthwaite, Huddersfield

West Yorkshire HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0142

9. Date Of First Authorisation/Renewal Of The Authorisation

22/02/2006

10. Date Of Revision Of The Text

04/10/2010