Friday, August 31, 2012

Beechams Veno’s Expectorant





1. Name Of The Medicinal Product



Beechams Veno's Expectorant



Veno's Expectorant


2. Qualitative And Quantitative Composition



Guaifenesin 100 mg, Glucose, liquid 3.0 g, Treacle 1.35 g



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 cataarh, 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 6.68 g total sugars per 10 ml dose. This should be taken into account in patients with diabetes mellitus.



Patients with rare glucose-galactose malabsorption should not take this medicine.



Contains 9.6 mg sodium per 10 ml 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



Gatrsointestinal disorders:



Unknown: nausea, vomiting, abdominal discomfort



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 SmPC.



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 and 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 160 ml.



6.6 Special Precautions For Disposal And Other Handling



None.



7. Marketing Authorisation Holder



Beecham Group Plc



980 Great West Road



Brentford



Middlesex



TW8 9GS



United Kingdom



trading as: GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.



8. Marketing Authorisation Number(S)



PL 00079/0208



9. Date Of First Authorisation/Renewal Of The Authorisation



31 January 1983 / 10 December 1998



10. Date Of Revision Of The Text



September 2010




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