Beechams Chesty Cough Oral Solution
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Beechams Chesty Cough Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Guaifenesin 100 mg, Glucose, liquid 3.0 g, Treacle 1.35 g For full list of excipients, see section 6-1
3 PHARMACEUTICAL FORM
Oral solution
A dark, brown, viscous liquid with the odours of liquorice and aniseed.
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 or 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 Fertility, Pregnancy and lactation
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.
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.
5.1 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
Deionised water, Macrogol 300, Glacial acetic acid, Sodium benzoate (E211), Capsicum tincture (contains ethanol), Sodium metabisulphite (E223), Aniseed oil, Xanthan gum, Levomenthol, Camphor, racemic, 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
None.
7 MARKETING AUTHORISATION HOLDER
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 44673/0025
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17/05/2011
09/08/2016