Venos Expectorant
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Veno’s Expectorant
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Guaifenesin BP 100mg, Liquid Glucose BPC (1963) 3.0g, Treacle 1.35g
3 PHARMACEUTICAL FORM
Oral Solution
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
An expectorant for the symptomatic relief of coughs (including bronchial cough) and chesty catarrh, particularly associated with colds and flu.
The product also has a soothing, protective, demulcent action on a sore, irritated, tickling and inflamed throat.
4.2 Posology and method of administration
Adults and children over the age of 12: Take one 10ml dose (two 5ml spoonfuls) and repeat every 2 to 3 hours.
Route of Administration
Oral
4.3 Contraindications
Known hypersensitivity to guaifenesin, treacle, glucose or to any of the excipients.
4.4 Special warnings and precautions for use
Patients suffering from chronic cough or asthma should consult a physician before taking this product.
Patients should stop using the product and consult a health care professional if cough lasts for more than 5 days or comes back, or is accompanied by a fever, rash or persistent headache.
Do not take with a cough suppressant.
Special Label Warnings
Keep out of the reach and sight of children.
If symptoms persist, consult your doctor.
Do not exceed the stated dose.
Do not use with other cough and cold medicines.
Contains 6.68g total sugars per 10ml dose. This should be taken into account in patients with diabetes mellitus.
Patients with rare glucose-galactose malabsorption should not take this medicine.
Contains 9.6mg sodium per 10ml dose. This should be taken into consideration in patients on a controlled sodium diet.
Contains sodium benzoate and sodium metabisulphite, which may rarely cause severe allergic reactions and bronchospasm.
4.5 Interaction with other medicinal products and other forms of interaction
None
4.6 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:
Unknown: allergic reactions, angioedema, anaphylactic reactions Respiratory, thoracic and mediastinal disorders:
Unknown: Dyspnoea (in association with other symptoms of hypersensitivity)
Skin and subcutaneous disorders:
Unknown: Rash, urticaria
Gastrointestinal disorders:
Unknown: nausea, vomiting, abdominal discomfort
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professional are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov .uk/yellowcard
4.9 Overdose
Very large doses of guaifenesin cause nausea and vomiting. Vomiting would be treated by fluid replacement and monitoring of electrolytes if indicated.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Guaifenesin is an expectorant.
Treacle and Liquid Glucose are demulcents.
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 SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Macrogol Glacial acetic acid Sodium benzoate (E211)
Capsicum tincture
Sodium metabisulphite (E223)
Aniseed oil Xanthan gum
Levomenthol Camphor Sodium cyclamate Acesulfame potassium Liquorice aniseed flavour Caramel colour (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
Amber cylindrical glass bottle fitted with a child resistant and tamper evident plastic screw cap.
Pack size: 100 or 160ml.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Forest Laboratories UK Limited, Whiddon Valley,
Barnstaple,
North Devon,
EX32 8NS,
United Kingdom.
MARKETING AUTHORISATION NUMBER(S)
PL 00108/0338
9
10
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
31/01/1983 / 06/09/2004
DATE OF REVISION OF THE TEXT
07/09/2015