Covonia Chesty Cough Sugar Free Syrup
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Covonia Chesty Cough Sugar Free Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
INGREDIENT QTY UNIT DOSE
Guaifenesin 200 mg 15 ml
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Syrup.
Deep red coloured, thick, syrupy liquid.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
To loosen stubborn mucus and clear chesty coughs.
4.2 Posology and method of administration
For oral use.
Adults, the Elderly and Children 12 years and over: 15ml in dosing cup provided.
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.
This product is contraindicated in children under the age of 12 years (see section 4.3).
Do not take with any other cough and cold medicine.
4.3 Contraindications
Known hypersensitivity to any of the ingredients - Porphyria.
Not to be used in children under the age of 12 years.
4.4 Special warnings and precautions for use
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Contains Ponceau 4R E124 which may cause allergic reactions.
This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 15ml dose.
Keep out of the reach of children.
If symptoms persist consult your doctor.
4.5 Interaction with other medicinal products and other forms of interaction
None reported.
4.6 Fertility, pregnancy and lactation
Use in pregnancy and lactation not contra-indicated.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as:
Very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to<1/1000) and very rare (<1/10,000), not known (cannot be estimated from the available data)
Immune system disorders
Unknown: hypersensitivity reactions
Gastrointestinal disorders
Unknown: Abdominal discomfort, nausea and vomiting
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.
5.1 Pharmacodynamic properties
Pharmacotherapeutic Group: Expectorants ATC code: R05CA03
Mechanism of action/effect
Guaifenesin is a well-known expectorant. Such expectorants are known to increase the volume of secretions in the respiratory tract and therefore to facilitate their removal by ciliary action and coughing.
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 Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glycerin
Sorbitol 70% Solution Non-Crystallising
Sodium Cyclamate
Sodium Saccharin
Carrageenan
Flavours
Potassium Sorbate Ponceau 4R E124 Caramel E150 Purified Water
6.2 Incompatibilities
None.
6.3 Shelf life
Three years.
6.4 Special precautions for storage
Do not store above 25°C.
Nature and contents of container
6.5
6.6
7
8
9
Amber glass bottles with polypropylene/polythene caps containing 150ml of product.
Special precautions for disposal
Shake well before use.
MARKETING AUTHORISATION HOLDER
Thornton & Ross Limited
Linthwaite
Huddersfield
HD75QH
UK
MARKETING AUTHORISATION NUMBER(S)
PL 00240/0380
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/05/2014
DATE OF REVISION OF THE TEXT
23/04/2015
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