Forest Laboratories UK Limited

Veno's Expectorant, Oral Solution

Guaifenesin 100mg/5ml

Liquid glucose 3g/5ml

Treacle 1.35g/5ml

Excipients: contains 2.5 mg/5ml sodium metabisulphite.

For full list of excipients, see section 6.1.

Oral Solution

Dark brown viscous oral solution.

For use as an expectorant and demulcent in the treatment of productive cough.

Directions for use

Shake the bottle before use.

Oral administration only.

Do not exceed the stated dose.

Should not be used with other cough and cold medicines.

Recommended Dose and Dosage Schedule

Adults (including elderly) and children aged 12 years and over:

Fill the measure cup to the 10ml mark (two 5ml teaspoonfuls) and repeat every 2 - 3 hours.

Do not use in children under 12 years.

Not more than 4 doses should be given in any 24 hours.

Contraindicated in patients with a history of hypersensitivity to guaifenesin, treacle, glucose or to any of the excipients.

Contraindicated in children under 12 years of age.

Do not take with any other cough and cold medicine.

Keep out of the reach and sight of children.

If symptoms persist consult your doctor.

Do not exceed the stated dose.

This product should only be used when clearly necessary.

Do not give to children under 12 years of age.

Contains sodium benzoate and sodium metabisulphite which may rarely cause severe hypersensitivity reactions and bronchospasm.

Contains 4.8mg sodium per 5ml. This should be taken into consideration in patients on a controlled sodium diet.

Contains 3.34g of sugars per 5ml. This should be taken into account in patients with diabetes mellitus.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

None known

Pregnancy

The safety of guaifenesin during pregnancy has not been established. Medical advice should be sought before use in pregnancy and this medicine should not be used unless the potential benefit to the mother outweighs the possible risk to the developing foetus.

Lactation

No relevant data available. Should not be used whilst breastfeeding without medical advice.

None

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Adverse events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by System Organ Class. As these reactions are reported voluntarily from a population of uncertain size, the frequency of these events is unknown but likely to be rare.

Immune system disorders:

Unknown: allergic reactions, angioedema, anaphylactic reactions

Respiratory, thoracic and mediastinal disorders:

Unknown: dyspnoea*

*dyspnoea has been reported in association with other symptoms of hypersensitivity

Gastrointestinal disorders:

Unknown: nausea, vomiting, abdominal discomfort

Skin and subcutaneous disorders:

Unknown: rash, urticaria

Very large doses of guaifenesin can cause nausea and vomiting. Vomiting may be treated by fluid replacement and monitoring of electrolytes if indicated. In the unlikely event of emesis not occurring, gastric lavage should be carried out. Thereafter, treatment is symptomatic.

Guaifenesin is a well known expectorant which reduces the viscosity of tenacious sputum.

Treacle and Liquid Glucose exhibit demulcent properties.

Guaifenesin is absorbed from the gastrointestinal tract. It is rapidly metabolised by oxidation to β-(2 methoxy-phenoxy) lactic acid which is excreted via the urine.

There is no preclinical data of relevance to the prescriber which is additional to that already included in other sections of the SmPC.

Macrogol 300

Caramel SCS 20 (E 150)

Glacial acetic acid

Sodium benzoate

Capsicum tincture

Sodium metabisulphite (E223)

Anise oil

Xanthan gum

Levomenthol

Racemic Camphor

Sodium cyclamate

Acesulfame K

Liquorice aniseed flavour 510877E

Water

Not applicable

Unopened: 3 years

Opened: 6 months

Do not store above 25°C.

The product is packaged in 100ml and 160ml cylindrical glass bottles fitted with a roll-on, aluminium cap containing a Melinex-coated, aluminium-faced, pulpboard wad, packaged in a box with a PP measuring cup.

Not all pack sizes may be marketed.

No special requirements.

Forest Laboratories UK Limited

Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford

Kent

DA2 6SL

U.K.

PA 0100/050/001

Date of the first authorisation: 10 November 1987

Date of the last renewal: 10 November 2007

April 2012