Expectorant Cough Syrup
1. NAME OF THE MEDICINAL PRODUCT
Expectorant Cough Syrup
Care Mucus Cough Sugar Free 200mg/15ml Syrup
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
|
INGREDIENT |
QTY |
UNIT |
DOSE |
|
Guaifenesin |
200 |
mg |
15ml |
3. PHARMACEUTICAL FORM
Liquid
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
To loosen stubborn mucus and clear chesty coughs.
4.2. Posology and Method of Administration
Adults, the Elderly and Children 12 years and over: 15 ml 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 Special Precautions for Use
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.
Pregnancy and Lactation
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
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 cilary 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. Pre-clinical Safety Data
Not applicable.
6.
PHARMACEUTICAL PROPERTIES
List of Excipients
6.1.
Glycerin BP
Sorbitol 70% Solution Non-Crystallising EP
Sodium Cyclamate EP
Sodium Saccharin EP
Carrageenan
Flavour Mix
Potassium Sorbate BP
Ponceau 4R E124
Caramel E150
Purified Water BP
6.2. Incompatibilities
None.
6.3. Shelf-Life
Three years.
6.4. Special Precautions for Storage
Do not store above 25°C.
6.5. Nature and Content of Container
Amber glass bottles with polypropylene/polythene caps containing 150 ml of product.
Instructions for Use, Handling and Disposal
6.6.
Shake well before use.
7. MARKETING AUTHORISATION HOLDER
Wrafton Laboratories Limited
Wrafton
Braunton
North Devon
EX33 2DL
8. MARKETING AUTHORISATION NUMBER(S)
PL 12063/0021
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/08/2007
10 DATE OF REVISION OF THE TEXT 09/10/2015