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Junior Expectorant Cough Syrup

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Junior Expectorant Cough Syrup

COMPOSITION

UNIT mg/15 ml


2.    QUALITATIVE AND QUANTITATIVE

INGREDIENT    QTY

Guaifenesin    100

3.    PHARMACEUTICAL FORM

Liquid

4.1.    Therapeutic indications

Expectorant for the symptomatic relief of acute productive (chesty) cough.

4.2    Posology and method of administration

Children 6 - 12 years of age: 15 ml in dosing cup or as three spoonfuls in the 5 ml spoon provided. Not to be used for more than 5 days without the advice of a doctor. Parents or carers should seek medical attention if the child’s condition deteriorates during treatment.

This product is contraindicated in children under the age of 6 years (see section 4.3).

The dose should not be repeated more frequently than every 6 hours.

Not more than 3 doses should be taken in any 24 hours. Do not exceed the stated dose.

Do not take with any other cough and cold medicine.

Keep all medicines out of the reach and sight of children.

4.3.


Contraindications

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

Porphyria.

Not to be used in children under the age of 6 years.

4.4.    Special warnings and precautions for use

Ask a doctor before use if you suffer from a chronic cough, if you have asthma or are suffering from an acute asthma attack.

Stop use and ask a healthcare professional if your cough lasts for more than 5 days, comes back, or is accompanied by a fever, rash or persistent headache. Do not take with a cough suppressant.

4.5.    Interaction with other medicinal products and other forms of interaction

If urine is collected within 24 hours of a dose of this product, a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

4.6.    Pregnancy and Lactation

Not applicable.

4.7. Effects on Ability to Drive and Use Machines

None stated.

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.

4.9.    Overdose

Very large doses of Guaifenesin can cause nausea and vomiting.

Vomiting should be treated by fluid replacement and monitoring of electrolytes.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Mechanism of action/effect

Guaifenesin is a well known expectorant. It is reported to reduce the viscosity of tenacious sputum, resulting in more productive cough.

5.2. Pharmacokinetic Properties

Absorption and Fate

Guaifenesin is absorbed from the gastro-intestinal tract. It is metabolised and excreted in the urine.

5.3. Pre-clinical Safety Data

Not applicable.

6. PHARMACEUTICAL PROPERTIES

6.1.    List of Excipients

Glycerin

Sorbitol 70% Solution Non-Crystallising

Sodium Cyclamate

Sodium Saccharin

Carrageenan

Flavour Mix

Anthocyanin red (E163)

Potassium Sorbate Purified Water

6.2.    Incompatibilities

None.

6.4.


6.5.


6.6.


7.


8.


Three years.


Special Precautions for Storage

Do not store above 25°C.


Nature and Content of Container

Amber glass bottles with polypropylene/polythene caps containing 100ml or 150ml of product. A 15ml polypropylene measuring cup or 5ml polystyrene spoon are also included.


Instructions for Use, Handling and Disposal

Shake well before use.


MARKETING AUTHORISATION HOLDER

Wrafton Laboratories Limited

Wrafton

Braunton

North Devon

EX33 2DL


MARKETING AUTHORISATION NUMBER(S) PL 12063/0023


DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION


DATE OF REVISION OF THE TEXT

10


08/07/2015