Junior Expectorant Cough Syrup
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.
7.
Three years.
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.
DATE OF REVISION OF THE TEXT
10
08/07/2015