Venos Honey And Lemon Syrup
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Veno’s Honey & Lemon Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glucose, liquid 4.00 g, Purified Honey 0.29 g, Lemon Juice Concentrate 0.25 g (equivalent to Lemon Juice 0.9 ml).
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Syrup
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the symptomatic relief of tickly coughs and sore throats.
4.2 Posology and method of administration
Route of Administration
Oral
Dosage Instructions
Adults (including the elderly) and children aged 12 years and over:
Take a 15 ml dose (three 5 ml spoonfuls) and repeat every two to three hours. Do not exceed 8 doses in any 24 hours.
Children aged 6 to under 12 years:
Take a 10 ml dose (two 5 ml spoonfuls) and repeat every two to three hours. Do not exceed 6 doses in any 24 hours.
Children aged 2 to under 6 years:
Take a 5 ml dose (one 5 ml spoonful) and repeat every two to three hours.
Do not exceed 4 doses in any 24 hours. Do not exceed the stated dose.
Consult a pharmacist or other healthcare professional before use in children under 6 years.
Do not take with any other cough and cold medicine.
Not to be given to children under two years of age.
4.3 Contraindications
Known hypersensitivity to any of the constituents.
4.4 Special warnings and precautions for use
Labelling
Keep all medicines out of the sight and reach of children.
If symptoms persist, consult your doctor.
Carbohydrate content: 3.5 g per 5 ml.
Children aged 2 to under 6 years:
Consult a pharmacist or other healthcare professional before use in children under 6 years.
Do not take with any other cough and cold medicine.
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Fertility, Pregnancy and lactation
The product is not contraindicated during pregnancy and lactation. However, the advice of a doctor should be sought before use.
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
There are no side effects associated with normal use of the product. 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 special symptoms of overdosage would be anticipated and no antidotes would be required.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Glucose liquid, honey and lemon juice are demulcents.
5.2 Pharmacokinetic properties
Pharmacokinetic considerations do not arise since the pharmacological action is local to the oropharyngeal cavity and the constituents are systematically innocuous in the concentration used.
5.3 Preclinical safety data
There are no preclinical data of any relevance additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ammonium chloride, citric acid monohydrate, xanthan gum, sodium metabisulfite, sodium benzoate, sodium citrate, levomenthol, propylene glycol, water, lemon flavour 730024E, honey flavour 510553E and caramel colour.
6.2 Incompatibilities
None known
6.3 Shelf life
Unopened: Three years Opened: Six months
6.4 Special precautions for storage
None
6.5 Nature and contents of container
Cylindrical glass bottle with a roll-on, pilfer proof, aluminium cap, containing a melinex-coated, aluminium-faced pulp-board wad. Each bottle is packed in a boxboard carton together with a graduated, polypropylene measuring cup. Pack sizes: 100 or 160 ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
Forest Laboratories UK Limited,
Whiddon Valley,
Barnstaple,
North Devon,
EX32 8NS,
United Kingdom.
8 MARKETING AUTHORISATION NUMBER(S)
PL 00108/0337
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/10/2005
10 DATE OF REVISION OF THE TEXT
13/06/2016