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Covonia Dry & Tickly Cough Linctus

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Covonia Dry & Tickly Cough Linctus

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

1.36g Glycerol BP

Excipients: Each 5ml contains Syrup(sucrose) 2.436gm, Liquid Glucose 280.0mg For full list of excipients see section 6.1

3    PHARMACEUTICAL FORM

Oral Solution

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: two 5ml spoonfuls.

Children over 1 year: one 5ml spoonful.

Dosage schedule When Required.

Shake the bottle.

4.3    Contraindications

Hypersensitivity to any of the ingredients

4.4    Special warnings and precautions for use

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

Not suitable for children under 1 year.

Not suitable for use in diabetics.

If symptoms persist, consult your doctor.

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.

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 Syrup Caramel Menthol Peppermint Oil Anise Oil

Capsicum Tincture (contains capsicum oleoresin, ethanol)

Blackcurrant Flavour (contains propylene glycol, ethanol)

Liquorice Liquid Extract Liquid Glucose

6.2    Incompatibilities

None

6.3    Shelf life

24 months unopened

Use within 28 days of opening

6.4    Special precautions for storage

None

6.5    Nature and contents of container

150ml: glass bottle with 28mm cap with tamper evident band and EPE/Saranex 180ml: glass bottle with 28mm cap with tamper evident band and EPE/Saranex 300ml: glass bottle with 28mm cap with tamper evident band and EPE/Saranex


liner. liner. 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 THE

AUTHORISATION

02/12/1988 / 26/05/2005

10 DATE OF REVISION OF THE TEXT

31/12/2014