This information is intended for use by health professionals

1. Name of the medicinal product

Covonia Catarrh Relief Formula.

Natures Aid Herbal Catarrh Relief Formula

2. Qualitative and quantitative composition

Each 5ml contains:-

0.25ml of extract (as liquid extract) from Burdock root (Arctium lappa L) (1:1) (equivalent to 0.25gm Burdock root).

Extraction solvent: Water.

0.35ml of extract (as liquid extract) from Hyssop herb (Hyssopus officinalis L) (1:1) (equivalent to 0.35gm Hyssop herb).

Extraction solvent: Water.

Excipients:

Each 5ml contains 11.5vol% ethanol (alcohol)

Each 5ml contains 3.75mg dextrose (glucose).

For full list of excipients, see section 6.1.

3. Pharmaceutical form

Oral Liquid.

A brown opaque liquid.

4. Clinical particulars
4.1 Therapeutic indications

A traditional herbal medicinal product used to relieve the symptoms of nasal catarrh and catarrh of the throat based on traditional use only.

4.2 Posology and method of administration

For oral use only.

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

The use in children and adolescents under 18 years of age is not recommended (see section 4.4 “Special warnings and precautions for use”).

Duration of use:

Do not use for more than one week.

4.3 Contraindications

Hypersensitivity to the active substances, other plants of the Asteraceae (Compositae) family or to any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

This medicinal product contains 11.5vol% 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.

This medicinal product contains 3.75 mg dextrose (glucose). Patients with rare glucose-galactose malabsorption should not take this medicine.

This medicinal product contains methyl and propyl hydroxybenzoates and may cause allergic reactions (possibly delayed).

The use in children and adolescents under 18 years of age is not recommended due to lack of adequate data and the alcohol content.

If symptoms worsen or persist for more than one week, a doctor or a qualified healthcare practitioner should be consulted.

If dyspnoea, fever or purulent sputum occurs, a doctor or a qualified healthcare practitioner should be consulted.

4.5 Interaction with other medicinal products and other forms of interaction

Contains alcohol and should therefore be avoided in patients taking other medication known to interact with alcohol e.g. Metronidazole.

4.6 Fertility, pregnancy and lactation

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Studies on fertility have not been performed.

4.7 Effects on ability to drive and use machines

No studies on the effect on the ability to drive or operate machines have been performed.

This product contains alcohol (see section 2).

4.8 Undesirable effects

Anaphylactic shock has been reported with Burdock root. The frequency is not known.

If other adverse reactions not mentioned occur, a doctor or a qualified healthcare practitioner should be consulted.

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.

4.9 Overdose

No cases known.

Overdose of this product may result in alcohol intoxication. The amount of alcohol in a full bottle (9.06gm in 100ml; 13.59gm in 150ml equivalent to 0.4 and 0.6 large glasses of wine, respectively) may result in alcohol intoxication and should be treated accordingly.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Not required as per article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.2 Pharmacokinetic properties

Not required as per article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6. Pharmaceutical particulars
6.1 List of excipients

Ethanol

Caramel (E150)

Glycerol (E422)

Propyl parahydroxybenzoate

Methyl parahydroxybenzoate (E218)

Capsicum Tincture (containing capsicum oleoresin, ethanol and water)

Viscarin SD 389 (contains dextrose/carageenan (E407)

Menthol

Sodium saccharin (E954)

Purified water.

6.2 Incompatibilities

None known.

6.3 Shelf life

Three years unopened.

Once opened use within 28 days.

6.4 Special precautions for storage

Do not store above 25 °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 with a 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.

Not all packs may be marketed.

6.6 Special precautions for disposal and other handling

There are no special precautions for disposal.

7. Marketing authorisation holder

Thornton & Ross Ltd

Linthwaite, Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing authorisation number(s)

THR 00240/0370

9. Date of first authorisation/renewal of the authorisation

21/03/2013

10. Date of revision of the text

25/07/2017