Venos Cough Syrup
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Veno’s Cough Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glucose liquid 3.18 g, Treacle 1.35 g
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Syrup
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Recommended for the symptomatic relief of sore throat and unproductive cough in minor upper respiratory tract infections.
4.2 Posology and method of administration
Adults and children over the age of 12: Take one 5 ml or 10 ml dose (one or two 5 ml spoonfuls). Repeat the dose every 2 or 3 hours.
Children aged 3 to under 12 years: Take one 5 ml dose (one 5 ml spoonful) and give every 2 to 3 hours. Do not give to children under 3 years except on medical advice.
Route of Administration
Oral
4.3 Contraindications
Hypersensitivity to glucose, treacle or any other of the ingredients.
4.4 Special warnings and precautions for use
Special Label Warnings
Keep all medicines out of the sight and reach of children. If symptoms persist, consult your doctor.
Total sugars content 3.6g per 5ml.
4.5 Interaction with other medicinal products and other forms of interaction
None.
4.6 Fertility, Pregnancy and lactation
Use in pregnancy and lactation is not contraindicated. However, as with all medicines, caution should be exercised during pregnancy and lactation.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
Immune system disorders
Hypersensitivity reactions e.g. skin rash.
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
The product does not contain any ingredient in a high enough concentration to cause toxic effects; therefore no specific symptoms of overdosage would be anticipated and no antidotes would be required.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Treacle and glucose liquid are demulcents, which will help relieve an unproductive cough and will soothe a sore throat.
5.2 Pharmacokinetic properties
None Stated.
5.3 Preclinical safety data
There are no preclinical data of any relevance additional to that already included in other sections of the SmPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Capsicum tincture, aniseed oil, xanthan gum, camphor racemic, glacial acetic acid, sodium benzoate, sodium metabisulphite (E223), levomenthol, water and colour caramel (E150).
6.2 Incompatibilities
None.
6.3 Shelf life
Unopened: Three years. Opened: Six months
6.4 Special precautions for storage
None.
6.5 Nature and contents of container
Clear glass bottle with a roll-on, pilfer proof, aluminium cap containing a melinex-coated aluminium-faced pulp-board wad. The bottle is contained in a boxboard carton.
Pack sizes: 100 ml, 160 ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Forest Laboratories UK Limited,
Whiddon Valley,
Barnstaple,
North Devon,
EX32 8NS,
United Kingdom.
8 MARKETING AUTHORISATION NUMBER(S)
PL 00108/0339
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28 September 1988 / 9 November 1993
10 DATE OF REVISION OF THE TEXT
18/09/2015