Robitussin Chesty Cough - Summary of Product Characteristics (SPC)

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Pfizer Consumer Healthcare
9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland Telephone: +353 (0)1 467 6500 Fax: +353 (0)1 467 6501 Medical Information Direct Line: +353 (0)1 467 6627

Summary of Product Characteristics last updated on medicines.ie: 14/11/2011

SPC	Robitussin Chesty Cough

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipient(s)
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Robitussin Chesty Cough 100mg/5ml Oral Solution

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5 ml contains 100 mg guaifenesin

This solution also contains ethanol (103mg per 5ml), maltitol (E965) and sorbitol (E420).

For a full list of excipients, see section 6.1

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3. PHARMACEUTICAL FORM

Oral solution

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 used as an adjunct in the treatment of productive cough.

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4.2 Posology and method of administration

Adults and children over 12 years:

The usual daily dose is 10ml four times daily

Children under 12 years:

Do not use

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4.3 Contraindications

Use in children under 12 years of age.

Hypersensitivity to the active substance or to any of the excipients.

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4.4 Special warnings and precautions for use

Caution should be exercised in patients with chronic cough as occurs with smoking or chronic lung disease such as asthma or emphysema.

A doctor or healthcare professional should be sought if cough lasts more than 5 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Not more than 4 doses should be given in any 24 hours. Do not exceed the stated dose.

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4.5 Interaction with other medicinal products and other forms of interaction

None stated

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4.6 Pregnancy and lactation

Consult a doctor before use

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4.7 Effects on ability to drive and use machines

None Stated

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4.8 Undesirable effects

Immune system disorders	Hypersensitivity
Gastrointestinal disorders	Nausea, vomiting

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4.9 Overdose

In case of accidentally overdose, discontinue use and seek professional assistance immediately.

The following signs and symptoms may be associated with an overdose of Guaifenesin:

Gastrointestinal disorders

Nausea, vomiting

Treatment is by gastric lavage together with appropriate supportive therapy dependent upon individual response to the various constituents of the preparation.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Guaifenesin is a proven expectorant which loosens mucous in the chest and make it easier to bring out.

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5.2 Pharmacokinetic properties

Guaifenesin is absorbed from the GI tract. It undergoes metabolism and is excreted in the urine.

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5.3 Preclinical safety data

None Stated

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Glycerol

Carmellose sodium

Sodium Benzoate (E211)

Ethanol

Levomenthol

Citric Acid Anhydrous

Liquid Maltitol (Lycasin 80/55) (E965)

Caramel E150

Natural Cherry Flavour*

Liquid Sorbitol Non-Crystallising (E420)

Sodium Cyclamate

Acesulfame Potassium Salt

Purified Water

* contains: ethanol, propylene glycol and natural flavourings

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6.2 Incompatibilities

Not applicable

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6.3 Shelf life

3 years

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6.4 Special precautions for storage

Do not store above 25°C

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6.5 Nature and contents of container

PET bottles containing 100ml 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)

PA 172/34/1

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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 1^st April 1983

Date of last renewal: 1^st April 2008

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10. DATE OF REVISION OF THE TEXT

September 2011

Link to this document from your website:
http://www.medicines.ie/medicine/2806/SPC/Robitussin+Chesty+Cough/

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Active Ingredients

Guaifenesin

Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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