This information is intended for use by health professionals

1. Name of the medicinal product

Covonia Chesty Cough Sugar Free Syrup

2. Qualitative and quantitative composition

INGREDIENT

QTY

UNIT

DOSE

Guaifenesin

200

mg

15 ml

For full list of excipients, see section 6.1

3. Pharmaceutical form

Syrup.

Deep red coloured, thick, syrupy liquid.

4. Clinical particulars
4.1 Therapeutic indications

To loosen stubborn mucus and clear chesty coughs.

4.2 Posology and method of administration

For oral use.

Adults, the Elderly and Children 12 years and over: 15ml in dosing cup provided.

The dose should not be repeated more frequently than every 6 hours.

Not more than 3 doses should be taken in any 24 hours. Do not exceed the stated dose.

This product is contraindicated in children under the age of 12 years (see section 4.3).

Do not take with any other cough and cold medicine.

4.3 Contraindications

Known hypersensitivity to any of the ingredients - Porphyria.

Not to be used in children under the age of 12 years.

4.4 Special warnings and precautions for use

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Contains Ponceau 4R E124 which may cause allergic reactions.

Keep out of the reach of children.

If symptoms persist consult your doctor.

4.5 Interaction with other medicinal products and other forms of interaction

None reported.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of Guaifenesin in pregnant women. As a result, this product is not recommended during pregnancy or in women of childbearing potential not using contraception.

Lactation

It is unknown whether Guaifenesin/metabolites are excreted in human milk therefore a risk to newborns/infants cannot be excluded. As a result, this product is not recommended during breast-feeding.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as:

Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to<1/1000) and very rare (<1/10,000), not known (cannot be estimated from the available data)

Immune system disorders

Unknown: hypersensitivity reactions

Gastrointestinal disorders

Unknown: Abdominal discomfort, nausea and vomiting

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

Very large doses of Guaifenesin can cause nausea and vomiting. Vomiting should be treated by fluid replacement and monitoring of electrolytes.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Expectorants

ATC code: R05CA03

Mechanism of action/effect

Guaifenesin is a well-known expectorant. Such expectorants are known to increase the volume of secretions in the respiratory tract and therefore to facilitate their removal by ciliary action and coughing.

5.2 Pharmacokinetic properties

Absorption and Fate:

Guaifenesin is absorbed from the gastro-intestinal tract. It is metabolised and excreted in the urine.

5.3 Preclinical safety data

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.

6. Pharmaceutical particulars
6.1 List of excipients

Glycerin

Sorbitol 70% Solution Non-Crystallising

Sodium Cyclamate

Sodium Saccharin

Carrageenan

Flavours

Potassium Sorbate

Ponceau 4R E124

Caramel E150

Purified Water

6.2 Incompatibilities

None.

6.3 Shelf life

Three years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Amber glass bottles with polypropylene/polythene caps containing 150ml of product.

6.6 Special precautions for disposal and other handling

Shake well before use.

7. Marketing authorisation holder

Thornton & Ross Limited

Linthwaite

Huddersfield

HD7 5QH

UK

8. Marketing authorisation number(s)

PL 00240/0380

9. Date of first authorisation/renewal of the authorisation

29/05/2014

10. Date of revision of the text

15/08/2018