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Pfizer Consumer Healthcare

Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, UK
Telephone: +44(0)1304 616161
Fax: +44(0)1737 332 528
Medical Information Direct Line: 0845 111 0151
Medical Information e-mail: carelineuk@pfizer.com
Customer Care direct line: 0845 111 0151
Medical Information Fax: +44(0)1737 332 528

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Summary of Product Characteristics last updated on the eMC: 07/02/2014
SPC Robitussin Chesty Cough Medicine


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1. Name of the medicinal product

Robitussin Chesty Cough Medicine


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2. Qualitative and quantitative composition

Active Ingredient:

Guaifenesin Ph Eur 100mg per 5ml

For full list of excipients see section 6.1


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3. Pharmaceutical form

A deep wine-russet coloured oral solution with a raspberry odour and taste.


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4. Clinical particulars

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4.1 Therapeutic indications

Expectorant for the treatment of coughs.


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4.2 Posology and method of administration

Oral administration.

Adults, the elderly and children over 12 years: One 10ml measure up to four times daily.

Children under12 years: Do not use.


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4.3 Contraindications

Hypersensitivity to any of the constituents.

Use in children under 12 years.

.


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4.4 Special warnings and precautions for use

Causes of chronic cough should be excluded if symptoms are persistent. Any accompanying symptoms should be actively sought and appropriately investigated/treated. Stop use and ask a healthcare professional if your cough lasts more than 7 days, comes back or is accompanied by a fever, rash, or persistent headache.

Keep out of the sight and reach of children.

Do not exceed recommended dose.

Excipient warnings:

- Patients with rare hereditary problems of fructose intolerance should not take this medicine because this product contains Sorbitol and Maltitol.

- This medicinal product contains 2.7% v/v ethanol (alcohol), up to 214 mg per dose, (equivalent to approx 2 ml wine per dose). Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease, or epilepsy.


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4.5 Interaction with other medicinal products and other forms of interaction

None known.


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4.6 Pregnancy and lactation

Although adequate and well-controlled studies in pregnant women have not been performed, the Collaborative Perinatal Project monitored 197 mother-child pairs exposed to guaifenesin during the first trimester. An increased occurrence of inguinal hernias was found in the neonates. However, congenital defects were not strongly associated with guaifenesin use during pregnancy in 2 large groups of mother-child pairs.

Breastfeeding

Guaifenesin is excreted in breast milk in small quantities.

Caution should therefore be exercised by balancing the potential benefit of treatment against any possible risks.


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4.7 Effects on ability to drive and use machines

No or negligible influence.


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4.8 Undesirable effects

The following side effects may be associated with the use of Guaifenesin:

Gastrointestinal Disorders

Nausea, vomiting

Immune System Disorders

Hypersensitivity reactions

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.


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4.9 Overdose

Signs and Symptoms associated with an overdose of Guaifenesin:

Nausea and vomiting

Treatment:

Appropriate supportive therapy dependent upon individual response to the preparation.


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5. Pharmacological properties

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5.1 Pharmacodynamic properties

Guaifenesin has an expectorant action which increases the output of respiratory tract fluid by reducing adhesiveness and surface tension. The increased flow of less viscid secretions promotes ciliary action and facilitates the removal of mucus. This changes an unproductive cough to a cough that is more productive and less frequent.

Pharmacotherapeutic group: Expectorant

ATC code: RO5CAO3


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5.2 Pharmacokinetic properties

Guaifenesin is well absorbed from the gastro intestinal tract following oral administration. Guaifenesin has a plasma half-life of approximately 1 hour. It is rapidly hydrolyzed (60% within seven hours) and then excreted in the urine, with beta-(2-methoxyphenoxy)-lactic acid as its major urinary metabolite


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5.3 Preclinical safety data

No relevant information additional to that already contained elsewhere in the SPC.


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6. Pharmaceutical particulars

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6.1 List of excipients

Glycerol

Carmellose Sodium

Sodium Benzoate (E211)

Sodium Cyclamate

Ethanol (96%)

Levomenthol

Maltitol (E965)

Sorbitol Solution 70%

Natural Cherry Flavouring

Citric Acid Anhydrous

Caramel (E150)

Acesulfame Potassium

Purified Water


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6.2 Incompatibilities

Not applicable


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6.3 Shelf life

100ml bottles: 27 months

250ml bottles: 36 months.


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6.4 Special precautions for storage

Do not store above 25°C.

Keep out of the sight and reach of children.


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6.5 Nature and contents of container

PET bottles containing 100ml or 250ml with PET lined PP/HDPE screw caps.

A clear polypropylene measuring cap is also included.


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6.6 Special precautions for disposal and other handling

No special requirements


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7. Marketing authorisation holder

Pfizer Consumer Healthcare Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom


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8. Marketing authorisation number(s)

PL 00165/0097


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9. Date of first authorisation/renewal of the authorisation

1 September 1993


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10. Date of revision of the text

November 2013



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/15688/SPC/


Active Ingredients/Generics