This information is intended for use by health professionals

1. Name of the medicinal product

Covonia Dry & Tickly Cough Sugar Free 1.36g/5ml Oral solution

2. Qualitative and quantitative composition

Glycerol 1.36g/5ml

Excipient(s) with known effect

Each 5ml contains Propylene Glycol 31mg, Sodium Benzoate 2.5mg, Sorbitol 920mg and Maltitol Liquid 1150mg

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Oral Solution

A dark brown viscous liquid with the odours of anise, blackcurrant and menthol.

4. Clinical particulars
4.1 Therapeutic indications

A soothing preparation for relief of the symptoms of coughs and sore throats.

4.2 Posology and method of administration

Oral

Recommended doses

Adults and Children over 12 years: two 5ml spoonfuls.

Children over 1 year: one 5ml spoonful.

Dosage schedule

Repeat dose as required, up to a maximum of 4 times a day.

This product may be taken for up to 5 days following which, if symptoms persist, medical advice should be sought.

Shake the bottle before use.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Keep all medicines out of the sight and reach of children.

Not suitable for children under 1 year.

This medicine contains 31mg propylene glycol and 2.5mg sodium benzoate in each 5ml dose

This medicine also contains 920mg sorbitol in each 5ml dose. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.

This medicine contains 1150mg maltitol liquid in each 5ml dose. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

If symptoms persist for more than 5 days, consult your doctor or pharmacist.

4.5 Interaction with other medicinal products and other forms of interaction

None known

4.6 Fertility, pregnancy and lactation

No adverse effects are considered likely if this product is used in the above conditions, however, as with all medicines, its use should be avoided unless recommended by a doctor.

4.7 Effects on ability to drive and use machines

None known

4.8 Undesirable effects

None anticipated at the recommended dosage.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Overdose with this preparation is unlikely to occur, however, large doses of glycerin may cause thirst, headache, nausea, vomiting, diarrhoea, hyperglycaemia, dehydration, dizziness and mental confusion. Cardiac arrhythmias have been reported. If ingestion is recent gastric lavage should be administered, other treatment should be symptomatic.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Glycerol acts as a demulcent to soothe the passage of the upper respiratory tract.

ATC Code: R05X

5.2 Pharmacokinetic properties

Glycerol is readily absorbed from the intestine and is metabolised to carbon dioxide and glycogen.

5.3 Preclinical safety data

None known

6. Pharmaceutical particulars
6.1 List of excipients

Purified Water

Citric Acid (E330)

Caramel (E150)

Maltitol Liquid (contains sorbitol E420)

Blackcurrant & Menthol Flavour FLA94255 (contains E1520 propylene glycol)

Capsicum Oleoresin 500,000 WS

Anise Flavour L7802 (contains E1520 propylene glycol)

Hydroxyethyl Cellulose

Sodium Benzoate (E211)

Saccharin Sodium

6.2 Incompatibilities

None

6.3 Shelf life

24 months unopened

Use within 28 days of opening

6.4 Special precautions for storage

Do not store above 25 °C

6.5 Nature and contents of container

150ml: glass bottle with 28mm cap with tamper evident band and EPE/Saranex liner.

180ml: glass bottle with 28mm cap with tamper evident band and EPE/Saranex liner.

300ml: glass bottle with 28mm cap with tamper evident band and EPE/Saranex liner

6.6 Special precautions for disposal and other handling

None stated.

7. Marketing authorisation holder

Thornton & Ross Ltd

Linthwaite Laboratories

Huddersfield

HD7 5QH

ENGLAND

8. Marketing authorisation number(s)

PL 00240/0411

9. Date of first authorisation/renewal of the authorisation

23/03/2018

10. Date of revision of the text

TBC