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BEECHAMS CHESTY COUGH ORAL SOLUTION

Active substance(s): GLUCOSE LIQUID / GUAIFENESIN / TREACLE

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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
4.1

CLINICAL PARTICULARS
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

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
5.1

PHARMACOLOGICAL PROPERTIES
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
6.1

PHARMACEUTICAL PARTICULARS
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
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 00079/0663

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17/05/2011

10

DATE OF REVISION OF THE TEXT
07/07/2011

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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