COVONIA DRY & TICKLY COUGH LINCTUS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Covonia Dry & Tickly Cough Linctus

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Glycerol 1.36g/5ml

Excipient(s) with known effect

Each 5ml contains Syrup (1.7g sucrose), Liquid Glucose 280.0mg, Ethanol (less than 30mg), Propylene Glycol 20.6mg

For the full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Oral Solution

A dark brown syrupy liquid with the odours of liquorice, anise and honey.

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.

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

Ingredient information with specified warnings

This medicine contains 1.7g sucrose and 0.3g liquid glucose. To be taken into account in patients with diabetes millitis.

Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

This medicine contains 27mg alcohol (ethanol) per 5ml dose, equivalent to less than 1ml beer or 1ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.

This medicine contains 20.6mg propylene glycol per 5ml dose.

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 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.

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

Honey

Citric Acid (E330)

Syrup (Sucrose)

Caramel (E150)

Menthol

Peppermint Oil

Anise Oil

Capsicum Tincture (contains capsicum oleoresin, ethanol)

Blackcurrant Flavour (contains propylene glycol E1520, ethanol)

Liquorice Liquid Extract

Liquid Glucose

6.2 Incompatibilities

None

6.3 Shelf life

36 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

None stated.

7 MARKETING AUTHORISATION HOLDER

Thornton & Ross Ltd

Linthwaite Laboratories

Huddersfield

HD7 5QH ENGLAND

8 MARKETING AUTHORISATION NUMBER(S)

PL 00240/5092R

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

02/12/1988 / 26/05/2005